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Marković, Ana, Miroslava Spasić, Vesna Savić, Slavica Sunarić, and Marija Tasić-Kostov. "Spectrophotometric method in comparative in vitro dissolution test of branded and generic ibuprofen tablets." Acta Facultatis Medicae Naissensis 38, no. 2 (2021): 147–55. http://dx.doi.org/10.5937/afmnai38-28337.
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The dissolution test is a simple and important in vitro method for assessing the bioequivalence, which aims to compare the bioavailability of generic and branded drugs. It implies the use of a proper apparatus (usually pharmacopoeially defined) in which the dosage form is dissolved, and the dissolution process itself is monitored/quantified using an appropriate analytical method among which high-performance liquid chromatography (HPLC) is widely used. Spectrophotometry could be a significant substitute, through its advantages in terms of simplicity and costs of analysis. In the present study, possible differences in bioavailability between branded and generic ibuprofen coated tablets were predicted using a dissolution test for solid dosage forms. The ibuprofen content and the amount of ibuprofen released in the dissolution test were determined using a simple spectrophotometric method. Based on the obtained results, no significant differences in the dissolution rate of ibuprofen from generic and branded coated tablets were observed. It can be concluded that the spectrophotometric method applied for the dissolution test, among other suitable methods, could be used for bioequivalence screening in conditions where rapid and simple assessment is required or where HPLC method is not available.
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Sirait, Septilina Melati, Hanafi Hanafi, and Lintannisa Rahmatia. "A Comparative In-vitro Dissolution Profiles of Generic and Branded Amoxicillin." PHARMACY: Jurnal Farmasi Indonesia (Pharmaceutical Journal of Indonesia) 17, no. 2 (2020): 501. http://dx.doi.org/10.30595/pharmacy.v17i2.6618.
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There are two types of Amoxicillin in the form of tablets, generic and branded medicines. Generally, drug products undergo systemic absorption through a series of processes, including disintegration of drug products followed by drug release, dissolution of drugs in aqueous media, and absorption through cell membranes into the systemic circulation. Dissolution profiles of generic and branded Amoxicillin were used to reference the public to choose generic Amoxicillin or branded Amoxicillin. It was because branded Amoxicillin is more expensive than generic Amoxicillin. This study aims to determine the dissolution profile and physical properties of both generic and branded amoxicillin tablets produced by the same pharmaceutical manufacturer. The Measurement of physical properties was carried out with several parameters: uniformity in weight and size, fragility test (friability), and disintegration test. All the results can meet the acceptance requirements that refer Indonesian Pharmacopoeia 5th edition in 2013. The physical properties result obtained by each. The dissolution test was done using an ultraviolet spectrophotometric method; dissolution tools were typed two apparatuses at 75 rpm with aquadest for 30 minutes, 37 ± 0,5 oC. The dissolution profile of generic Amoxicillin was declared identical or similar to branded Amoxicillin. It can be seen from F1 value = 3.40 and F2 value = 67.77, each of which meets the identical category's standard. Dissolution profiles of generic and branded Amoxicillin were declared identical, which means the Amoxicillin's quality control was equally excellent.
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Sirait, Septilina Melati, Hanafi Hanafi, and Lintannisa Rahmatia. "A Comparative In-vitro Dissolution Profiles of Generic and Branded Amoxicillin." PHARMACY: Jurnal Farmasi Indonesia (Pharmaceutical Journal of Indonesia) 17, no. 2 (2020): 501. http://dx.doi.org/10.30595/pharmacy.v17i2.6618.
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There are two types of Amoxicillin in the form of tablets, generic and branded medicines. Generally, drug products undergo systemic absorption through a series of processes, including disintegration of drug products followed by drug release, dissolution of drugs in aqueous media, and absorption through cell membranes into the systemic circulation. Dissolution profiles of generic and branded Amoxicillin were used to reference the public to choose generic Amoxicillin or branded Amoxicillin. It was because branded Amoxicillin is more expensive than generic Amoxicillin. This study aims to determine the dissolution profile and physical properties of both generic and branded amoxicillin tablets produced by the same pharmaceutical manufacturer. The Measurement of physical properties was carried out with several parameters: uniformity in weight and size, fragility test (friability), and disintegration test. All the results can meet the acceptance requirements that refer Indonesian Pharmacopoeia 5th edition in 2013. The physical properties result obtained by each. The dissolution test was done using an ultraviolet spectrophotometric method; dissolution tools were typed two apparatuses at 75 rpm with aquadest for 30 minutes, 37 ± 0,5 oC. The dissolution profile of generic Amoxicillin was declared identical or similar to branded Amoxicillin. It can be seen from F1 value = 3.40 and F2 value = 67.77, each of which meets the identical category's standard. Dissolution profiles of generic and branded Amoxicillin were declared identical, which means the Amoxicillin's quality control was equally excellent.
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Darusman, Fitrianti, Taofik Rusdiana, Iyan Sopyan, Ratih Aryani, and Eka Darma Gita Cahya. "The in vitro equivalence study of polymorph-modified glimepiride tablets compared to Amaryl®." Pharmacia 70, no. (4) (2023): 1027–37. https://doi.org/10.3897/pharmacia.70.e110374.
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Glimepiride (GMP) is an oral antidiabetic drug classified as BCS class II, demonstrating extremely limited solubility, with a solubility level below 0.00384 mg/mL. Some generic drug manufacturers producing GMP (copy product) tablets encountered bioavailability issues due to poor dissolution, which did not meet the requirements. Therefore, measures were taken to enhance solubility through the modification of polymorphs. It is known that GMP exists in two polymorphic forms, namely Form I and an alternative Form II, which exhibits higher solubility in water. This study aims to produce and characterize the polymorph-modified GMP compared to non-modified GMP, develop an optimal formulation for polymorph-modified GMP tablets that adhere to pharmaceutical requirements as a representative copy drug model, and determine its similarity factor to Amaryl® as the innovator. The research methodology involved initiating the study by examining the polymorph transformation of GMP through the utilization of techniques such as neat grinding, solvent drop grinding, and solvent evaporation. The resulting samples were characterized using DSC, PXRD, and SEM analysis. The performance assessment encompassed the evaluation of flow properties, compressibility index, solubility, and dissolution rate compared to the non-modified GMP. Based on the characterization results, the best polymorph-modified GMP sample was used to produce a tablet formulation containing 4 mg of GMP using the direct compression method as a copy tablet model. In vitro equivalence testing was performed using a comparative dissolution test on the polymorph-modified GMP tablet compared to its innovator, Amaryl® 4 mg, in three different dissolution media, followed by determining the equivalence status using the similarity factor (f2) calculation. Based on the screening results of polymorph transformation, it was determined that the polymorph-modified GMP, using all three techniques, did not undergo a transition from Form I to Form II. Instead, it underwent amorphization, primarily observed in the solvent evaporation technique. Tablets containing polymorph-modified GMP using the solvent evaporation technique were able to enhance the in vitro dissolution rate profile compared to non-modified GMP tablets. The f2 values for the comparative in vitro dissolution test in acetate buffer pH 4.5 and phosphate buffer pH 6.8 were 60.15 ± 0.27 and 88 ± 0.35, respectively within acceptance criteria of 50–100. However, in KCl/HCl buffer pH 1.2, the f2 value was 45.15 ± 0.23. It was concluded that the polymorph-modified GMP tablet was not similar to its innovator, Amaryl®.
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Achkoska, Tina, Marijana Bozhinovska, Angela Arnaudova, Packa Antovska, Liljana Anastasova, and Rumenka Petkovska. "Bootstrap analysis for dissolution similarity factor f2 - bringing confidence for borderline results – a case study." 68 68, no. 02 (2022): 97–102. http://dx.doi.org/10.33320/maced.pharm.bull.2022.68.02.010.
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In vitro dissolution testing is one of the most important tools for characterizing the performance of oral solid dosage forms. In order to demonstrate similarity between test and reference product, comparative dissolution profiles are performed. Selection of a suitable method for comparison of the dissolution profile of the reference product and the test product is of great importance especially in the case of biowaivers when similarity assessment is based on the in vitro data only. Various approaches have been developed for the comparison of dissolution profiles, however the usage of the f2 similarity factor is widely accepted due to its simplicity. When the conditions for using f2 similarity factor are not fulfilled due to high variable dissolution profiles, f2 bootstrap method is then recommended. The focus of this study is to see whether it is benefitial f2 bootstrap analysis to replace the usage of simple f2 for comparison of dissolution profiles that fulfill the prerequisites for using the f2 method in cases when borderline f2 results are obtained. Keywords: Bootstrap analysis, comparative dissolution profiles, similarity factor f2
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Kumar, Manish, Shahnwaj Tyagi, Shailendra Bhatt, et al. "Comparative Evaluation of Two Different Marketed Brands of Enalapril maleate." Journal of Drug Delivery and Therapeutics 8, no. 6-s (2018): 265–68. http://dx.doi.org/10.22270/jddt.v8i6-s.2127.
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Efficacy of pharmaceuticals dosage form generally depends on their formulation properties and manufacturing methods, hence it is likely that the quality of dosage form may vary. Renin acts on angiotensinogen to form angiotensin I, which is converted to angiotensin II by angiotensin-converting enzyme (ACE). Angiotensin II, a potent vasoconstrictor increases blood pressure by increasing vasopressin production and aldosterone secretion. Enalaprilat, the active metabolite of enalapril, inhibits ACE, hence decreases levels of angiotensin II resulting in less vasoconstriction and decreased blood pressure. The study was exclusively experimental that used IP and other standard books to check in vitro quality of enalapril maleate tablet using different analytical techniques and procedure. Test for weight variation, hardness, friability, disintegration time, and dissolution were conducted. The dissolution test was performed at pH 6.8 for both the brands of the tablet. Further all the tablets passed weight variation, hardness, friability and disintegration test as per the pharmacopoeial standard. Hence we can conclude that both the brands of tablets are equal and both the brands contain equal quantity of active pharmaceutical ingredient (API). Both the brands having higher and lower costs exert similar action.
 Keywords: Enalapril maleate, In Vitro, Dissolution test, Enalapril
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Baula, O. P., O. O. Saliy, V. I. Bessаrabov, and A. М. Gerasimchuk. "Comparative studies of the kinetics of dissolution of medicines on the basis of clopidogrel." Farmatsevtychnyi zhurnal, no. 1 (February 17, 2021): 26–34. http://dx.doi.org/10.32352/0367-3057.1.21.03.
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Generic medicines occupy dominant positions both in the pharmaceutical market of Ukraine and in industrial production by domestic pharmaceutical enterprises. The use of generic drugs in medical practice is of significant medical and social importance for expanding the accessibility of the general population to essential drugs. In Ukraine, more than twenty generic medicines based on clopidogrel, both foreign and domestic, are registered. All generic drugs containing clopidogrel bisulfate must comply with pharmaceutical bisulfate must comply with pharmaceutical equivalence, the kinetics of release of the active pharmaceutical ingredient using the Dissolution test in vitro, and pharmacokinetic parameters in vivo.
 The aim of the work was to carry out comparative studies of the dissolution kinetics of four samples of generic drugs based on clopidogrel with the dissolution kinetics of the original drug Plavix®, to evaluate the similarity factor of dissolution profiles and to determine the effect of biopharmaceutical factors on the equivalence of generics. Comparative studies of the kinetics of dissolution were carried out by the in vitro method according to the «Dissolution» test using a device with a blade with a
 rotation speed of 50 rpm, a dissolution medium with a pH value of 2.0 in a volume of 900 ml at a temperature of 37 ± 1 °C. The determination of the quantitative content of clopidogrel, which passed into the dissolution medium, was carried out by the method of adsorption spectrophotometry in the ultraviolet region at a wavelength of
 about 240 ± 2 nm. Based on the data obtained, the dissolution profiles of the original drug Plavix® and the studied samples of generic drugs were constructed, the similarity of which was assessed by the value of the similarity factor. According to the research results, it was found that one sample of the generic drug proved its equivalence by the in vitro method to Plavix®, and three other samples of generics had differences in dissolution kinetics in comparison with the original drug. Biopharmaceutical factors were analyzed that could affect the dissolution kinetics of the studied generic drugs, from which the physicochemical characteristics of clopidogrel bisulfate, the qualitative and quantitative composition of excipients and the features of the technological process were determined.
 Thus, on the basis of the comparative studies of the dissolution kinetics of drugs based on clopidogrel, generics were found that did not correspond to the in vitro equivalence according to the Dissolution test to the original drug, which could be due to the influence of a combination of biopharmaceutical factors.
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Tanishka, A. Pawar1 Trupti Y. Pawar1* Rahul K. Godge2. "A Comparative Analysis Of In-Process Quality Control Parameters Of Montelukast Sodium Tablets." International Journal in Pharmaceutical Sciences 2, no. 4 (2024): 652–63. https://doi.org/10.5281/zenodo.10958153.
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<strong>Objective:</strong> The study's objective is to evaluate and compare the oral Montelukast sodium tablet 10 mg quality control standards of the different brands of pharma companies which are mostly prescribed in the surrounding area by medical practitioners. <strong>Method:</strong> All four brands are named as A, B, C and D respectively taken. In vitro quality control test like Physical appearance, Thickness test, Weight variation test, Hardness test, Friability test, In vitro Disintegration test, In vitro Dissolution test using USP Paddle II method and analyzed by UV Spectrophotometer of each brands are performed. <strong>Result & discussion: </strong> To determine the quality of the tablets, the quality control standards of four distinct brands of Montelukast tablets were analysed and tested. Quality control tests are carried out to ensure that brands A, B, C, and D meet specified characteristics. These tests include weight variation, hardness, thickness, friability, disintegration, and dissolution. The Brand A & Brand B are film coated tablet, comparing with their dissolution profile it was that Brand B(99.2%) has shown good drug release rather than Brand A(96.24%) but both are complying their standards of drug release according to Indian Pharmacopeia. Brand C & Brand D are Un-coated tablet, comparing with their dissolution profile it was that Brand D (99.52%) has shown good drug release rather than Brand C (96.46%) but both are complying their standards of drug release according to Indian Pharmacopeia. <strong>Conclusion:</strong> The pharmaceutical industries produce Montelukast tablets that meet Indian Pharmacopoeia standards and are generally of uniform quality, with minimal difference amongst them.
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Kar, Ayan Kumar, and Banhishikha Kar. "In-Vitro Comparative Dissolution Study of Commercially Available Paracetamol Tablet." Journal of Drug Delivery and Therapeutics 10, no. 1 (2020): 18–23. http://dx.doi.org/10.22270/jddt.v10i1.3817.
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Quality is the most important issue in the pharmaceutical field due to the presence of a drug which is considered as safe and therapeutically active agent. In-vitro evaluation ensures their quality, bioavailability as well as optimum therapeutic activity. Paracetamol (acetaminophen) which are the active metabolites of phenacetin is commonly used for the relief of headaches and pains, and is a major ingredient in numerous cold and flu remedies. Paracetamols are available in different brands in Indian market. The main objective of the present study was to conduct the comparative in-vitro dissolution studies of various brands collected from the local market to determine whether all the formulations used were equivalent or significantly different. The calibration curve was constructed covering the concentration range of 1 to 10 mcg/ml at 268 nm by UV spectrophotometer (UV 2203 Double beam spectrophotometer, Shimadzu). Five different brands of Paracetamol of 500 mg conventional tablets from different manufacturers were selected in the study and dissolution testing in Phosphate buffer at pH 7.4 was conducted from each brands for 90 mins by using dissolution testing apparatus USP type-II. The dissolution rate was subjected to various mathematical models like zero order, first order, Higuchi and Hixson-Crowell equations to elucidate the kinetic behavior of drug release from the test samples. Different release kinetics model of all the selected brands was assuring the quality standard of manufacturing.
 Keywords: Paracetamol, Marketed Tablet, In-Vitro dissolution study, Release profile.
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Loucas, Spiro P., Paul Maager, and Bernard Mehl. "Comparative Studies on the in Vitro Drug Dissolution Profiles for Hydroxyzine Hydrochloride Tablets." Annals of Pharmacotherapy 27, no. 1 (1993): 13–18. http://dx.doi.org/10.1177/106002809302700102.
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OBJECTIVE: A significant practical problem in the standardization of dissolution testing is addressed. In vitro releasing characteristics of hydroxyzine hydrochloride tablets are presented to further the documentation of bioequivalency criteria. DESIGN: The assessment model compares the official United States Pharmacopeia disintegration approach for dissolution analysis with that of the Food and Drug Administration's recommended rotating paddle technique for inducing aqueous disruption of the solid oral dosage form. RESULTS: The rationale and significance of the study focuses attention on the variation in release of the active ingredient observed relative to the four formulation strengths. With differences in the extent of dissolution noted and official standards in mind, emphasis is placed on the development of an alternate test protocol. CONCLUSIONS: Dissolution data derived via ultraviolet spectrophotometry revealed statistically significant differences in the amount of hydroxyzine hydrochloride being released from its coated structure, the extent of which was found to be dependent on the acid nature of the simulated gastric dissolution medium used and intensity of mixing action employed.
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Shivani, S. Pangarekar* Tanaya S. Pawar Sakshi S. Rashinkar G.V.Taware. "Comparative Study Of Vildagliptin Branded And Generic Marketed Antidiabetics Tablets." International Journal of Pharmaceutical Sciences 2, no. 9 (2024): 161–79. https://doi.org/10.5281/zenodo.13646699.
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Vildagliptin is an important antidiabetic drugs used for treatment of diabetes mellitus. The main goal of the current study is to assess the pharmaceutical equivalence of four marketed generics of vildagliptin 50 mg tablets compared to the branded product (Vylda & Agivilda 50 mg). This surveillance study aims to evaluate the product quality of different generics and brands of Vildagliptin tablets, sourced from various pharmaceutical manufacturer’s in India by assessing their pharmaceutical and chemical equivalence to determine the appropriateness of their interchangeability. We calibrated pure Vildagliptin & tested the tablets for the content uniformity, hardness, friability, disintegration, dissolution, and potency. The dissolution data were fitted with kinetic models to investigate the release pattern of the studied brands. The in vitro dissolution test was used as a quality control tool to obtain the dissolution profile of vildagliptin compared to the reference drugs. The results revealed that all tested samples exhibited dissolution behavior like standard drug. Comparison studies of innovator drug product & generic drug products were conducted to determine percentage drug release. In-vitro chemical equivalence is not always correspond to bioequivalence. Therefore, continuous evaluation of marketed products is essential to ensure the desired quality. In this study, all the six types of the tablets passed the IP/BP or USP standards for in vitro evaluation tests with a very slight deviation. All brands complied with the standards for weight variation, Hardness, thickness, disintegration and dissolution to determine percentage drug release.
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Malik, Anirudha, R. S. Raghuvanshi, Gaurav Pratap Singh, Anirudha Malik, and Rajiv K. Tonk. "Comparative Study of Itopride Hydrochloride in-Vitro Drug Release in Various Brands of Sustained Release Capsules By RP-HPLC." Journal of Biomedical and Pharmaceutical Research 13, no. 5 (2024): 47–60. http://dx.doi.org/10.32553/jbpr.v13i5.1126.
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Background: The World Health Organisation has advocated the use of generic medicines to make them accessible and affordable but studies have revealed that marketed products do not produce same therapeutic effects and hence are not interchangeable. Dissolution testing of generic solid dosage forms serves as a valuable tool for acquiring dissolution profiles and for assessing the similarity or dissimilarity between the formulations under examination. Objectives: To evaluate the in-vitro drug release profiles of different generic brands of Itopride Sustained release capsules that are commercially available in Indian market and compare them with the innovator product using model dependant and as well as model independent methods. To determine whether same medicine manufactured by different brands are interchangeable. Materials & Methods: In this study Eight generic brands of Itopride 150mg sustained release capsules available in the Indian market were evaluated using dissolution test with the aim to assess their bioequivalence with the innovator product (Ganaton OD). Dissolution studies were performed using USP type II apparatus at 100 rpm in 900 ml 0.1N HCl while maintaining a temperature of 37±0.5 ºC. The samples were estimated by a validated HPLC method. Dissolution test results were statistically evaluated by employing both model dependant and model independent methods. In model dependant experimental data obtained for each dissolution profile were transformed by applying the equations of different kinetic models and the best-fit model was selected whereas in model independent approach fit factors, dissolution efficiency and mean dissolution times were calculated. Results: The Weibull model best explained the release of drugs from all the brands. Upon statistical evaluation of dissolution test results its was found that while similarity factor f2 was within the limits for all generic brands, difference factor f1 of two brands was out of acceptable range thus questioning their bioequivalency with the innovator product. Also the dissolution efficiency of four out of the brands was out of acceptable limits. Keywords: bioequivalence, difference factor (f1), similarity factor (f2), dissolution profile, comparison and evaluation..
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P D, GOKULAN, SENTHILKUMAR K L, VASANTHAN V, et al. "COMPARATIVE IN VITRO EVALUATION OF SOME COMMERCIAL BRANDS OF RAMIPRIL TABLETS MARKETED IN INDIA." Current Research in Pharmaceutical Sciences 12, no. 1 (2022): 32–39. http://dx.doi.org/10.24092/crps.2022.120105.
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The availability of several brands of Ramipril tablets in Indian pharmacies now poses a generic replacement concern for doctors. The goal of this study was to evaluate and compare different brands of Ramipril manufactured by various Indian pharmaceutical businesses under various trade names in order to reduce health risks and ensure the safety of local residents. General quality assessments of these tablets, such as diameter, thickness, hardness, weight variation, friability, disintegration, and dissolution tests, were also carried out according to recognised protocols, with test results falling within the acceptable range. Active components were measured using an approved UV spectrophotometric technique. This type of research is useful for determining the idealness of commercial products. KEYWORDS: Ramipril, In vitro evaluation, Dissolution study, Disintegration test
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Jannatul, Farhana Md. Najem Uddin* Md. Robiul Islam. "COMPARATIVE IN VITRO QUALITY EVALUATION OF SOME PARACETAMOL TABLETS, COMMERCIALLY AVAILABLE IN BANGLADESH DRUG MARKET." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 01 (2018): 527–33. https://doi.org/10.5281/zenodo.1162266.
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Paracetamol is a widely used non-prescription analgesic and antipyretic medicine. It is one of the most commonly used drugs worldwide with non-prescription sales exceeding 25 thousand million doses per year in the United States of America. The study was conducted to assess the comparative in-vitro quality control parameters through the evaluation of weight variation, hardness, friability, disintegration time and dissolution profile among the commercially available tablet brands of paracetamol. To assess the quality, Seven different marketed Paracetamol 500 mg tablet were selected and in-vitro dissolution test, potency, disintegration time was carried out. Other general quality parameters of these tablets like weight variation, hardness, friability were also determined according to established protocols. All the brands comply the requirements of ‘‘United State Pharmacopoeia’’ as they showed acceptable weight variation range. Friability of all brands was less than 1%. No significant differences were founding disintegration time as they disintegrated within 5 minutes. In case of dissolution profile all brands showed better dissolution time as they released more than 60% of drug in 40 minute. The hardness of one brand was within the range 6 kg/cm2 to 10 kg/cm2 . The limitation of the potency must be within 95-105%. All three brands meet this specification. This study suggested that most commercially available Paracetamol tablet in Bangladesh maintain the quality and comply with the USP specifications. It can be concluded that standard quality control parameters always should be maintained not for paracetamol but also for all kinds of medicine for getting better drug products. Key words: Paracetamol, Comparative, Quality control parameters, Evaluation, Potency, Dissolution profile
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Hailu, Gebremedhin Solomon, Girma Belachew Gutema, Hailemichael Zeru Hishe, Yimer Said Ali, and Adissu Alemayehu Asfaw. "Comparative In vitro Bioequivalence Evaluation of Different Brands of Amoxicillin Capsules Marketed in Tigray, Ethiopia." International Journal of Pharmaceutical Sciences and Nanotechnology 6, no. 1 (2013): 1966–71. http://dx.doi.org/10.37285/ijpsn.2013.6.1.7.
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The availability of multisource generic brands of amoxicillin in the market today places health professionals and patients in a difficult situation about the choice of a suitable product among numerous generic brands. The purpose of this study was to estimate the bioequivalence of amoxicillin capsules marketed in Ethiopia using in vitro tests in order to determine their interchangeability. The in vitro dissolution study was carried out on the six brands of amoxicillin capsules according to USP guidelines. To compare the dissolution profiles, a difference factor (f1), similarity factor (f2), dissolution efficiency (DE) and statistical methods were employed. Results have shown significant differences in the dissolution profiles of the brands based on the statistical analysis (p<0.0001). Pair-wise comparisons using Dunnett’s test indicated that the innovator brand has a significantly faster dissolution than the generic brands, except brand D. According to f1, f2 and DE calculations, only brand D was found to have similar dissolution profile with the innovator. Based on the in vitro studies, only brand D may be considered bioequivalent and interchangeable, while the other brands may not be considered bioequivalent and interchangeable with the innovator brand. This research highlights among other things the need for constant monitoring and surveillance on the marketed drugs by regulatory bodies to ascertain bioequivalence and quality medicines, especially for drugs like amoxicillin for which there exists evidence of non-bioequivalence from different firms, resulting in efficacy issues.
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Ramenskaya, G. V., I. E. Shokhin, N. I. Gaponova, and V. R. Abdrakhmanov. "Assessment of in Vitro Comparative Dissolution Kinetics of Moxonidine Products as a Factor Potentially Determining Effectiveness of Antihypertensive Treatment." Rational Pharmacotherapy in Cardiology 14, no. 6 (2019): 951–57. http://dx.doi.org/10.20996/1819-6446-2018-14-6-951-957.
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Aim. Investigation of comparative dissolution kinetics of generic medicinal products containing moxonidine versus reference drug. Material and methods. Objects of the research were film-coated tablets containing moxonidine (INN) in a dose 0.4 mg: a reference drug Physiotens® and 4 generic drugs. In vitro dissolution test of moxonidine from the study drugs was performed using comparative dissolution kinetics test (CDKT). The CDKT was performed in the media with the following pH: 1.2 (1:9 mixture of 0.1 M hydrochloric acid and water), 4.5 (acetate buffer solution, prepared as per State Pharmacopoeia, XIII), and 6.8 (phosphate buffer solution, prepared as per State Pharmacopoeia, XIII). The sampling for dissolved moxonidine was performed 5, 10, 15, 20, and 30 min after the test was started. An high performance liquid chromatography method with ultraviolet detection at 220 nm was used to assay. Results. Within 15 min more that 85% of moxonidine dissolved from the reference drug and all study drugs at pH 1.2; dissolution profiles were similar without calculation of similarity factor f2. Similarly, at pH 4.5 dissolution profiles of study drugs #2 and #3 were similar to that of the reference drug, and the similarity factor f2 was not calculated. However, in case of study drugs #1 and #4 significant differences were observed at a single time point (15 min), which suggests that their dissolution profiles are non-similar to that of the reference drug. Similarity factors f2 were calculated 17.52 and 35.30, respectively (less than 50). At pH 6.8 similarity factors f2 for all study generic drugs were also less than 50 (23.8, 49.8, 38.6, and 35.9), so their dissolution curves were non-similar to that of reference drug. Conclusion. In our study we observed difference in release in vitro of medicinal products containing moxonidines: none of the study drugs was fully similar to the reference drug in all media. The differences observed at pH 6.8 were noteworthy, where the samples had or faster kinetics (study drugs #2 and #3), or slower dissolution kinetics (test drugs #1 and #4). Observed differences in moxonidine release rate may impact absorption of active pharmaceutical ingredient into the blood following drug administration.
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SANDHIYA, J., and K. BALAMURUGAN. "A comparative analysis on generic product vs branded product of prednisolone tablet." GSC Biological and Pharmaceutical Sciences 26, no. 3 (2024): 050–54. https://doi.org/10.5281/zenodo.11044572.
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The main aim and objective of present research work is to evaluate and compare the standard concerning quality of generic and branded anti-inflammatory drug. The drug are evaluated and research showed that branded and generic meet the Pharmacopoeial specification. All tablet passed for the test of weight variation, hardness, thickness, friability, disintegration, dissolution as per pharmacopeia. Hence, we can say that branded and nonbranded drugs of anti-inflammatory are equal. So, healthcare professionals are suggested to prescribe generic drugs so that everyone can reach the cost of drugs and maintain health.
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Al-kotaji, Myasar. "Comparative study of different meloxicam generic products with the brand product." Al Mustansiriyah Journal of Pharmaceutical Sciences 19, no. 4 (2019): 116–24. http://dx.doi.org/10.32947/ajps.v19i4.643.
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This study aims to evaluate different products of meloxicam Table; Five meloxicam immediate-release generic products (15 mg Tables) were compared with the innovator, reference product, (Mobic®, Boehringer) to find the interchangeable product with the innovator product.
 Different physical tests were conducted including weight uniformity, thickness, diameter, hardness, friability and disintegration test. In addition, prediction of in-vivo behavior was assessed by measuring the dissolution profile of meloxicam for all the products. Similarity factor (f2) was calculated to compare between the dissolution profile of the generic products with the dissolution profile of innovator product.
 The results revealed that all the studied products are complied with the British Pharmacopoeia requirements. However, not all of them showed similar in-vitro profile to the brand product. Four out of five generic products, included in this study, showed similarity in dissolution profile to the brand one, which indicates possible bio-equivalency, with the advantages of money saving of using such generic products. One generic product showed similarity factor less than 50, which might give an indication that this generic product is not capable to be bioequivalent with the brand (innovator) product.
 Overall, this study can be considered an important applicable study that gives an indication about the in-vivo performance of different products. In addition, the study demonstrates the applicability of a simple in-vitro dissolution study as a surrogate way of assessing product bioavailability instead of an expensive and complicated in-vivo bioequivalent study.
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Kanij Nahar, Deepa, Sultana Sharifa, and Zaman, KH Ahammad Uz. "In Vitro Comparative Analysis of Ciprofloxacin- Hcl Tablet Available in Bangladesh." DIU Journal of Health and Life Sciences 1, no. 01 & 02 (2014): 121–26. http://dx.doi.org/10.36481/diuhls.v01i1-2.6cy91z85.
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Five generic ciprofloxacin HCl 500 mg tablets from different manufacturer have been evaluated to assess their bioequivalence using in vitro tests. Other general quality assessments of these tablets like assay, weigh variation, hardness, friability, disintegration and dissolution time were also determined and all these generic tablets passed compendial specifications. All the tablets contained ciprofloxacin from 90.51 ± 0.29 to 104.74 ± 1.53 of the labeled claim. The hardness of all generic tablets were within the range between 5.42 ± 0.25 to 6.76 ± 0.44 kg/cm2. Friability test is used to evaluate the tablet resistance to abrasion. The friability (%) of all generic tablets was within the range of 0.11 to 0.22. We observed that Ciprofloxacin-HCl tablets have a disintegration time from 3.11 ± 0.54 to 11.77 ± 0.75 minutes and more than 96% of drug undergo dissolution within 30 minutes which meet compendial specifications. These results indicated that all generic ciprofloxacin HCl tablets included in this investigation were good in quality and meet compendial specifications
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Kanij Nahar, Deepa,, Sultana, Sharifa, and Zaman KH Ahammad Uz. "In Vitro Comparative Analysis of Ciprofloxacin- Hcl Tablet Available in Bangladesh." DIU Journal of Health and Life Sciences 1, no. 01 & 02 (2014): 121–26. http://dx.doi.org/10.36481/diuhls.v01i1-2.94pht674.
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Five generic ciprofloxacin HCl 500 mg tablets from different manufacturer have been evaluated to assess their bioequivalence using in vitro tests. Other general quality assessments of these tablets like assay, weigh variation, hardness, friability, disintegration and dissolution time were also determined and all these generic tablets passed compendial specifications. All the tablets contained ciprofloxacin from 90.51 ± 0.29 to 104.74 ± 1.53 of the labeled claim. The hardness of all generic tablets were within the range between 5.42 ± 0.25 to 6.76 ± 0.44 kg/cm2. Friability test is used to evaluate the tablet resistance to abrasion. The friability (%) of all generic tablets was within the range of 0.11 to 0.22. We observed that Ciprofloxacin-HCl tablets have a disintegration time from 3.11 ± 0.54 to 11.77 ± 0.75 minutes and more than 96% of drug undergo dissolution within 30 minutes which meet compendial specifications. These results indicated that all generic ciprofloxacin HCl tablets included in this investigation were good in quality and meet compendial specifications
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Deepa, Kanij Nahar, Sharifa Sultana, and KH Ahammad Uz Zaman,. "In Vitro Comparative Analysis of Ciprofloxacin- Hcl Tablet Available in Bangladesh." DIU Journal of Allied Health Sciences 1, no. 01 & 02 (2014): 121–26. https://doi.org/10.36481/diujahs.v01i1-2.6cy91z85.
Full textAbstract:
Five generic ciprofloxacin HCl 500 mg tablets from different manufacturer have been evaluated to assess their bioequivalence using in vitro tests. Other general quality assessments of these tablets like assay, weigh variation, hardness, friability, disintegration and dissolution time were also determined and all these generic tablets passed compendial specifications. All the tablets contained ciprofloxacin from 90.51 ± 0.29 to 104.74 ± 1.53 of the labeled claim. The hardness of all generic tablets were within the range between 5.42 ± 0.25 to 6.76 ± 0.44 kg/cm2. Friability test is used to evaluate the tablet resistance to abrasion. The friability (%) of all generic tablets was within the range of 0.11 to 0.22. We observed that Ciprofloxacin-HCl tablets have a disintegration time from 3.11 ± 0.54 to 11.77 ± 0.75 minutes and more than 96% of drug undergo dissolution within 30 minutes which meet compendial specifications. These results indicated that all generic ciprofloxacin HCl tablets included in this investigation were good in quality and meet compendial specifications
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Martínez-Reséndiz, Jorge Ignacio, Urias Bautista-Sánchez, Alejandro Chehue-Romero, Alejandra Bautista-Ruíz, Ana María Téllez-López, and Ana Luisa Robles-Piedras. "Validation of a simple analytical method by UV-Spectroscopy, for the quantification of metformin in tablets, applied to dissolution profiles." GSC Biological and Pharmaceutical Sciences 10, no. 3 (2020): 104–9. https://doi.org/10.5281/zenodo.4279728.
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In Mexico, Metformin (MTF) is an oral hypoglycemic drug that is part of the group of biguanides used as a first-line treatment for the management of Type 2 Diabetes Mellitus. In the Mexican pharmaceutical market, there is a wide variety of medicines containing this drug, hence the importance of evaluating the quality of the medicines sold in the country. One of the important chemical tests performed both in the drug development phase, and in the quality evaluation criteria during its production, is the dissolution test. This is the test where it simulates in vitro, the time it takes for a given drug to pass into its soluble form, thus establishing its release time. The dissolution test to assess bioavailability in vitro has already been included in several official regulations, as a quality control method that allows predicting the behavior of the drug in the pharmaceutical form after its administration. The aim of this work was to validate a simple and reliable analytical method to quantify MTF in immediate-release tablets by UV spectroscopy, for a comparative study of in vitro dissolution profiles. In dissolution medium of 0.68% potassium monobasic phosphate at pH 6.8, adjusted with sodium hydroxide, the method demonstrated linearity in the range of 2 to 16 µg/L. The parameters evaluated complied with the provisions of the national and international guidelines for the validation of analytical methods; therefore, the analytical method meets the requirements for the quantification of Metformin in dissolution studies.
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Ignаtieva, Е. V., Z. S. Shprakh, I. V. Yartseva, and E. V. Sanarova. "Test “Dissolution” as an integral part of quality complex evaluation of capsules with sekoisolariciresinol." Russian Journal of Biotherapy 18, no. 1 (2019): 95–100. http://dx.doi.org/10.17650/1726-9784-2019-18-1-95-100.
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Background . Test “Dissolution” is one of the main methods for quality evaluation of solid dosage drug forms, which enables characterization of the drug both in technological and biopharmacological aspects. The test may be also used for comparative studies of drugs bioavailability in vitro. Objective . Development of the “Dissolution” test for the drug Secoisolariciresinol, capsules 100 mg.Materials and methods . The study used: Secoisolariciresinol, capsules 100 mg; hydrochloric acid (c. p.); Twin-80 (Polysorbate LAUROPAN T/80, Italy); purified water (рН 6.5); 0.1 М and 0.2 М solutions of hydrochloric acid; phosphate buffer solution (рН 6.8). Equipment and devices: dissolution tester ERWEKA, series 700, type – paddle mixer (ERWEKA, Germany); recording spectrophotometer Cary-100 (Varian, USA); рН-meter HANNA рН 211 (Hanna Instruments, Germany); analytical balances Sartorius 2405 (Sartorius AG, Germany).Results . Methodology for performing the “Dissolution” test for the drug Secoisolariciresinol, capsules 100 mg was developed according to Russian State Pharmacopoeia (XIV) requirements for solid dosage drug forms.Conclusions . Optimal conditions were chosen for performing the study “Dissolution” for capsules containing 100 mg of secoisolariciresinol. Analytical methodology was designed for quantitative assessment of secoisolariciresinol release from capsules, which enables accurate control of pharmaceutical substance content in different dissolution media. Methodology for the “Dissolution” test of the drug Secoisolariciresinol, capsules 100 mg was developed on the base of the obtained experimental data.
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Patel, Kanharam Narayanlal, Seema Vikas Bhagat, Dhananjay Panigrahi, Snehal Sameer Muchhala, Rahul Tarachand Rathod, and Bhavesh Prabhudas Kotak. "A comparative study of the dissolution rate and Acid-Neutralizing capacity of Aceproxyvon with other marketed drugs." Indian Journal of Pharmacy and Pharmacology 10, no. 3 (2023): 183–89. http://dx.doi.org/10.18231/j.ijpp.2023.035.
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Quality is one of the most important issues in the pharmaceutical industry. Drugs must be marketed as safe and therapeutically effective formulations whose performance is consistent and foreseeable. evaluation verifies and ensures their quality, bioavailability, and optimum therapeutic activity. Aceclofenac and Paracetamol (acetaminophen) are commonly used for the relief of headaches and pain. The combination of these two drugs is available in different brands in the Indian market. The main objective of the present study was to conduct a comparative dissolution release test and acid neutralizing capacity test (ANC) of Test products versus Reference products. Brands that are similar in both composition and concentration were used in the study to compare the in vitro dissolution profile and ANC in different pH buffer solutions. Three marketed brands of Aceclofenac 100 mg and Paracetamol 325 mg, i.e., Aceproxyvon (test product Brand A), Brand B, and Brand C (Reference products), were used in the study. Brand D being an antacid was used as a reference product to compare the acid-neutralizing capacity of the drugs.The dissolution rates of paracetamol were similar across all formulations at various pH mediums. Aceclofenac showed a higher dissolution rate in Brand A as compared to Brand B and C at pH 4.5, while the dissolution rates of aceclofenac were comparable in all formulations using pH 6.8 and pH 7.5 phosphate media. The ANC of Brand A was found to be higher (7.42 mEq/g) compared to Brand B (6.74 mEq/g) and Brand C (7.18 mEq/g). Brand A showed faster dissolution and higher acid neutralizing capacity as compared to reference products. This enhancement in dissolution rate may further result in a rapid onset of action and better therapeutic efficacy.
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Milkesa, Abera, Gemmechu Hasen, Tesfaye Mohammed, et al. "In vitro comparative quality evaluation of different brands of Amlodipine Tablets Commercially available in Jimma Town, South-western Ethiopia." PLOS ONE 19, no. 11 (2024): e0310828. http://dx.doi.org/10.1371/journal.pone.0310828.
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Background The incidence of hypertension in persons 25 years of age and older is estimated to be 46% in Africa, where it is still very common. This concerning rate could be explained by the pharmaceutical markets’ accessibility to poor quality antihypertensive drugs. Thus, the purpose of this study was to evaluate and compare the quality different brands of Amlodipine Tablets Commercially available in Jimma Town, South-western Ethiopia. Methods The quality control test was conducted from August 30, 2019 to February 27, 2020 at Jimma University in the Laboratory of Drug Quality Control (JuLaDQ). The laboratory test was carried out in accordance with WHO inspection guidelines and United States Pharmacopeia. A statistically significant was considered when P<0.05. For further comparison of the in-vitro dissolution profiles of amlodipine tablets, model-independent model-dependent parameters and statistical Dunnetts tests for ensuring bioequivalence were used to further compare the in-vitro dissolution profiles. Results With the exception of brand AMD-5 (1/10), the remaining nine (n = 9) brands were within WHO visual inspection criteria. The quality control parameters such as friability, weight variation, identity, assay, and dissolution test were within the United States Pharmacopeia. The model independent parameters (f1, and f2) confirmed that, all generic products were bio-equivalence, and interchangeable with comparator product. The model dependent approaches revealed the Weibull model (AMD-10), the Zero order (AMD-3), and the Korsemeyer-Peppas models were the most effective predictions for the release of the pharmaceutical substance from the dosage form. The Korsemeyer-Peppas model (r2 ≥0.9695) was the best descriptive model for determining the amlodipine drug kinetics from the point of view of all brands examined. The evaluated amlodipine brand tablets were in line with quality standards. The model independent methods confirmed that the generic brand tablets were interchangeable in clinical practice. The tested products follow more than two drug release kinetics. Conclusion The study revealed a manifest discrepancy in the dissolution profiles’ releases. Therefore, it is strongly advised to use appropriately designed dissolution profile evaluation methods with various pH values in the dissolution media, as well as to do comprehensive visual inspections. This will make it easier to do a thorough investigation of any potential quality issues that might be related to various generic products available in the pharmaceutical market.
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Ejaz, Agha* Haroon Khan Nisar Ahmed Ghulam Murtaza Ashiq Hussain Muhammad Saood. "QUALITY CONTROL ANALYSIS AND ASSESSMENT OF DIFFERENT MARKET BRANDS OF CIPROFLOXACIN." Indo American Journal of Pharmaceutical Sciences 04, no. 12 (2017): 4253–64. https://doi.org/10.5281/zenodo.1095491.
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Dose structures are basically pharmaceutical items in the structure in which they are showcased for use, normally including a blend of dynamic medication parts and nondrug segments (excipients), alongside other non-reusable material that may not be considered either fixing or bundling, (for example, a container shell, for instance). The term unit measurements can now and then envelop non-reusable bundling too (particularly when every medication item is exclusively packaged. Different measurements structures might exist for a solitary specific medication, since various medicinal conditions can warrant distinctive courses of organization. For instance, steady queasiness and heaving might make it hard to utilize an oral dose structure, and in such a case, it might be important to use a backup course of action, for example, inhalational, buccal, sublingual, nasal, suppository or parenteral. The primary objective was in vitro comparative study of 5 different brands of Ciprofloxacin Tablets available in markets of Pakistan by The in vitro comparative study of 5 different brands of Ciprofloxacin Tablets available in markets of Pakistan Weight variation Test, Disintegration Test, Hardness Test, Chemical Assay and In vitro dissolution study was conducted. After conducting color, friability, weight variation, hardness test and disintegration tests of various brands of Ciprofloxacin, the results were found under the acceptance range. The hardness showed variation among the tablets of various brands but there was no significant variation of hardness among the tablets of same brand. The Axcin indicated maximum drug potency (102%) and (101%) respectively while minimum potency was 93.07%. The in-vitro evaluation of 5 different F.P.Ps of Ciprofloxacin HCl film coated tablets available in the pharmaceutical market of Pakistan showed that all of brands of Ciprofloxacin satisfied the USP potency specifications and showed evidences of satisfactory initial in-vitro dissolution behavior.
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Shin, Meong, Jin-Ki Kim, and Chong-Kook Kim. "Bioequivalence Evaluation of Two Brands of Lisinopril Tablets by in vitro Comparative Dissolution Test and in vivo Bioequivalence Test." Arzneimittelforschung 58, no. 01 (2011): 11–17. http://dx.doi.org/10.1055/s-0031-1296460.
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Darusman, Fitrianti, Taofik Rusdiana, Iyan Sopyan, Ratih Aryani, and Gita Cahya Eka Darma. "The in vitro equivalence study of polymorph-modified glimepiride tablets compared to Amaryl®." Pharmacia 70, no. 4 (2023): 1027–37. http://dx.doi.org/10.3897/pharmacia.70.e110374.
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Glimepiride (GMP) is an oral antidiabetic drug classified as BCS class II, demonstrating extremely limited solubility, with a solubility level below 0.00384 mg/mL. Some generic drug manufacturers producing GMP (copy product) tablets encountered bioavailability issues due to poor dissolution, which did not meet the requirements. Therefore, measures were taken to enhance solubility through the modification of polymorphs. It is known that GMP exists in two polymorphic forms, namely Form I and an alternative Form II, which exhibits higher solubility in water. This study aims to produce and characterize the polymorph-modified GMP compared to non-modified GMP, develop an optimal formulation for polymorph-modified GMP tablets that adhere to pharmaceutical requirements as a representative copy drug model, and determine its similarity factor to Amaryl® as the innovator. The research methodology involved initiating the study by examining the polymorph transformation of GMP through the utilization of techniques such as neat grinding, solvent drop grinding, and solvent evaporation. The resulting samples were characterized using DSC, PXRD, and SEM analysis. The performance assessment encompassed the evaluation of flow properties, compressibility index, solubility, and dissolution rate compared to the non-modified GMP. Based on the characterization results, the best polymorph-modified GMP sample was used to produce a tablet formulation containing 4 mg of GMP using the direct compression method as a copy tablet model. In vitro equivalence testing was performed using a comparative dissolution test on the polymorph-modified GMP tablet compared to its innovator, Amaryl® 4 mg, in three different dissolution media, followed by determining the equivalence status using the similarity factor (f2) calculation. Based on the screening results of polymorph transformation, it was determined that the polymorph-modified GMP, using all three techniques, did not undergo a transition from Form I to Form II. Instead, it underwent amorphization, primarily observed in the solvent evaporation technique. Tablets containing polymorph-modified GMP using the solvent evaporation technique were able to enhance the in vitro dissolution rate profile compared to non-modified GMP tablets. The f2 values for the comparative in vitro dissolution test in acetate buffer pH 4.5 and phosphate buffer pH 6.8 were 60.15 ± 0.27 and 88 ± 0.35, respectively within acceptance criteria of 50–100. However, in KCl/HCl buffer pH 1.2, the f2 value was 45.15 ± 0.23. It was concluded that the polymorph-modified GMP tablet was not similar to its innovator, Amaryl®.
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Anjali, Pawar* Shreya Sabale Deven Pardeshi Sneha Vikhe. "A Comparative Analysis of In-Process Quality Control Parameters of Pantoprazole Gastro-Resistant Tablets." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 1364–75. https://doi.org/10.5281/zenodo.15378649.
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Objectives: This study aimed to evaluate and compare the quality control standards of four different brands of pantoprazole gastro-resistant tablets IP 20 mg, which are commonly prescribed by medical practitioners in the surrounding area. Method: Four brands, labelled A, B, C, and D, were assessed using various in vitro quality control tests. These tests included physical appearance, thickness measurement, weight variation, hardness, friability, disintegration, and dissolution testing. The dissolution test was performed using the USP Paddle II method, and the drug release was analyzed using a UV Spectrophotometer. Results & Discussion: Quality control tests were conducted to assess whether the four pantoprazole tablet brands met the required standards. The tests examined parameters, such as weight variation, hardness, thickness, friability, disintegration, and dissolution. All four brands (A, B, C, and D) were enteric-coated tablets. When comparing dissolution profiles, Brand A demonstrated a superior drug release of 99.72%, followed by Brand B at 98.41%. Both brands met the Indian Pharmacopoeia standards for drug release. Similarly, Brand D exhibited better drug release (96.23%) than Brand C (92.74%), although both were within acceptable limits as per Indian Pharmacopoeia standards [1][2].
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A, Kolawole Jacob, and Bana DJ. "Comparative Evaluation of the Physicochemical and In Vitro Dissolution Properties of Some Expired and Unexpired Brands of Metformin Tablets." Der Pharma Chemica 15, no. 1 (2023): 9. https://doi.org/10.5281/zenodo.13318759.
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The comparative evaluation of the physicochemical properties and in vitro dissolution of some expired and unexpired brands of metformin tablets, six brands of expired (serial 1)and also unexpired (serial 2) of the same brand were used. The samples were determined using thin layer chromatography (TLC). Pharmacopoeia tests such as uniformity of weight, hardness, friability and assay were used to assess the physicochemical equivalence of the expired and unexpired metformin tablet brands. In vitro dissolution testing was conducted for both the expired and the unexpired tablets. All the brands (expired-serial 1) and (unexpired-serial 2) conformed to the British pharmacopoeia standard. All brands complied except C1 and F1 (within the range of not more than 1% (BP 2013) therefore brand C1 and F1 failed the friability test, the unexpired brand has higher crushing strength than the expired brands. Also for the assay content the unexpired brands has higher percentage content than the expired. The Dissolution test carried out, all the unexpired brands met the 70% drug released in 45 min (BP 2013) specification. The expired brands A1, D1, E1, F1 has lower percentage of drug released at 45 min, the unexpired brands has higher percentage of drug released at 45min compared to the unexpired. The thin layer chromatography (TLC) shows higher Rf value for the expired and there was an additional spot for the expired brands as compared to the unexpired brands.
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Jacob, A. Kolawole, and DJ Bana. "Comparative Evaluation of the Physicochemical and In Vitro Dissolution Properties of Some Expired and Unexpired Brands of Metformin Tablets." DER PHARMA CHEMICA 15, no. 1 (2023): 9. https://doi.org/10.4172/0975-413X.15.1.21-29.
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The comparative evaluation of the physicochemical properties and in vitro dissolution of some expired and unexpired brands of metformin tablets, six brands of expired (serial 1)and also unexpired (serial 2) of the same brand were used. The samples were determined using thin layer chromatography (TLC). Pharmacopoeia tests such as uniformity of weight, hardness, friability and assay were used to assess the physicochemical equivalence of the expired and unexpired metformin tablet brands. In vitro dissolution testing was conducted for both the expired and the unexpired tablets. All the brands (expired-serial 1) and (unexpired-serial 2) conformed to the British pharmacopoeia standard. All brands complied except C1 and F1 (within the range of not more than 1% (BP 2013) therefore brand C1 and F1 failed the friability test, the unexpired brand has higher crushing strength than the expired brands. Also for the assay content the unexpired brands has higher percentage content than the expired. The Dissolution test carried out, all the unexpired brands met the 70% drug released in 45 min (BP 2013) specification. The expired brands A1, D1, E1, F1 has lower percentage of drug released at 45 min, the unexpired brands has higher percentage of drug released at 45min compared to the unexpired. The thin layer chromatography (TLC) shows higher Rf value for the expired and there was an additional spot for the expired brands as compared to the unexpired brands.
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Kolawole, Jacob A., and DJ Bana. "Comparative Evaluation of the Physicochemical and In Vitro Dissolution Properties of Some Expired and Unexpired Brands of Metformin Tablets." Der Pharma Chemica 15, no. 1 (2023): 9. https://doi.org/10.5281/zenodo.10934596.
Full textAbstract:
The comparative evaluation of the physicochemical properties and in vitro dissolution of some expired and unexpired brands of metformin tablets, six brands of expired (serial 1)and also unexpired (serial 2) of the same brand were used. The samples were determined using thin layer chromatography (TLC). Pharmacopoeia tests such as uniformity of weight, hardness, friability and assay were used to assess the physicochemical equivalence of the expired and unexpired metformin tablet brands. In vitro dissolution testing was conducted for both the expired and the unexpired tablets. All the brands (expired-serial 1) and (unexpired-serial 2) conformed to the British pharmacopoeia standard. All brands complied except C1 and F1 (within the range of not more than 1% (BP 2013) therefore brand C1 and F1 failed the friability test, the unexpired brand has higher crushing strength than the expired brands. Also for the assay content the unexpired brands has higher percentage content than the expired. The Dissolution test carried out, all the unexpired brands met the 70% drug released in 45 min (BP 2013) specification. The expired brands A1, D1, E1, F1 has lower percentage of drug released at 45 min, the unexpired brands has higher percentage of drug released at 45min compared to the unexpired. The thin layer chromatography (TLC) shows higher Rf value for the expired and there was an additional spot for the expired brands as compared to the unexpired brands.
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Ahmad, Muhammad Masood, Tanveer Ahmed Khan, and Muhammad Anwar Bashir. "A PRELIMINARY COMPARATIVE QUALITY EVALUATION TESTING OF ACETAMINOPHEN TABLET MARKETED IN SAKAKA CITY, SAUDI ARABIA." Hamdard Journal of Pharmacy 2, no. 2 (2022): 15–26. http://dx.doi.org/10.61744/hjp.v2i2.30.
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Acetaminophen is a medication used as an antipyretic and analgesic. It is commonly available as an Over the Counter (OTC). Different dosage forms of acetaminophen are available in the market; we have selected solid dosage form as acetaminophen tablet. The main stressing point of the current study is to evaluate and compare quality control of three brands of acetaminophen tablets available in Sakaka, Saudi Arabia. Each of the sample of having 500mg as an active constituent that was purchased from the local retail pharmacy outlets and their quality evaluation, were assessed by using in-vitro tests according to official monograph of US and BP. The parameter for quality evaluation of the tablet which was studied including content uniformity, weight variations, thickness, hardness, friability, disintegration, and assay and dissolution study according to the given specification of the official monograph. The weight variation, friability, and hardness values of each of the branded tablet were complied with specifications. In-vitro disintegration and dissolution analysis showed that the disintegration time of all three brands was within 15min and dissolution test results represented that more than 80% drug released within 30min. The results represented that the overall finding of the quality control evaluation of all tested brands of acetaminophen tablets that are available in Sakaka city, Saudi Arabia was being observed with the official requirement of USP and BP specification for quality control purposes.
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Sharifa, Sultana. "In Vitro Comparative Quality Evaluation of Some Brands of Cephradine Capsules Available in Selected Community Pharmacies in Dhaka City." DIU Journal of Health and Life Sciences 6, no. 1 & 2 (2019): 01–07. http://dx.doi.org/10.36481/diuhls.v06i1-2.5f1c0490.
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Cephradine is a first-generation cephalosporin antibiotic used to treat infectious diseases caused by bacteria such as upper respiratory infections, ear infections, skin infections, and urinary tract infections. This project involved evaluating the quality of different brands of cephradine capsules available in the local market. Five different brands of marketed samples of cephradine capsules were collected from different retail pharmacy shops of Bangladesh. This study has been conducted by comparing various quality control parameters such as weight variation test, loss on drying, potency test, disintegration, dissolution test, and assay test from top, middle and lower grades pharmaceutical company of Bangladesh using standard techniques. The values were compared with the official specifications. The obtained result for weight variation is 0.58+0.71 to 2.13+3.01% and disintegration time were between 2.30+0.17 and 5.19+0.14 minutes. Loss on drying of all batches were in between 2.0933.17 and 2.52+2.84% and potency or assay result were 98.08+0.52 to 100.25+0.19%. Moreover, the release rate of different brands of cephradine was satisfactory within 45 minutes where the mean dissolution rate is 93.96+0.13 %. The obtained results of all parameters were complied with the pharmacopoeial limit. By evaluating these parameters, we can ensure the quality of the marketed cephradine capsules.
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Sultana, Sharifa. "In Vitro Comparative Quality Evaluation of Some Brands of Cephradine Capsules Available in Selected Community Pharmacies in Dhaka City." DIU Journal of Allied Health Sciences 6, no. 1 & 2 (2019): 01–07. https://doi.org/10.36481/diujahs.v06i1-2.5f1c0490.
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Cephradine is a first-generation cephalosporin antibiotic used to treat infectious diseases caused by bacteria such as upper respiratory infections, ear infections, skin infections, and urinary tract infections. This project involved evaluating the quality of different brands of cephradine capsules available in the local market. Five different brands of marketed samples of cephradine capsules were collected from different retail pharmacy shops of Bangladesh. This study has been conducted by comparing various quality control parameters such as weight variation test, loss on drying, potency test, disintegration, dissolution test, and assay test from top, middle and lower grades pharmaceutical company of Bangladesh using standard techniques. The values were compared with the official specifications. The obtained result for weight variation is 0.58+0.71 to 2.13+3.01% and disintegration time were between 2.30+0.17 and 5.19+0.14 minutes. Loss on drying of all batches were in between 2.0933.17 and 2.52+2.84% and potency or assay result were 98.08+0.52 to 100.25+0.19%. Moreover, the release rate of different brands of cephradine was satisfactory within 45 minutes where the mean dissolution rate is 93.96+0.13 %. The obtained results of all parameters were complied with the pharmacopoeial limit. By evaluating these parameters, we can ensure the quality of the marketed cephradine capsules.
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Sharifa, Sultana, Mominur Rahman Md., Islam Fahadul, and Parvin Sumaiya. "In Vitro Comparative Quality Evaluation of Some Brands of Cephradine Capsules Available in Selected Community Pharmacies in Dhaka City." DIU Journal of Allied Health Science 6, no. 1 (2019): 1–7. https://doi.org/10.5281/zenodo.10990514.
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Cephradine is a first-generation cephalosporin antibiotic used to treat infectious diseases caused by bacteria such as upper respiratory infections, ear infections, skin infections, and urinary tract infections. This project involved evaluating the quality of different brands of cephradine capsules available in the local market. Five different brands of marketed samples of cephradine capsules were collected from different retail pharmacy shops of Bangladesh. This study has been conducted by comparing various quality control parameters such as weight variation test, loss on drying, potency test, disintegration, dissolution test, and assay test from top, middle and lower grades pharmaceutical company of Bangladesh using standard techniques. The values were compared with the official specifications. The obtained result for weight variation is 0.58+0.71 to 2.13+3.01% and disintegration time were between 2.30+0.17 and 5.19+0.14 minutes. Loss on drying of all batches were in between 2.0933.17 and 2.52+2.84% and potency or assay result were 98.08+0.52 to 100.25+0.19%. Moreover, the release rate of different brands of cephradine was satisfactory within 45 minutes where the mean dissolution rate is 93.96+0.13 %. The obtained results of all parameters were complied with the pharmacopoeial limit. By evaluating these parameters, we can ensure the quality of the marketed cephradine capsules.
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Ali, Bassam Abduh, Mohammed Gameel Al-haddad, and Abdullah Ahmed Areqi. "Comparative Evaluation of Some Commercial Clopidogrel Tablets Available in Yemen." Majalah Farmaseutik 13, no. 2 (2018): 79. http://dx.doi.org/10.22146/farmaseutik.v13i2.40917.
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Clopidogrel is a medication to reduce the risk of heart disease and taken orally. Quality of drug characterizes the production process and every phamaceutical company strives for it but often it is very difficult to achieve. This study was to investigate quality control parameters of some marketed Clopidogrel tablets. To assess the quality, eight different marketed brands of Clopidogrel 75 mg tablets available in Yemeni market collected from different pharmacies in Hodeida city. Different quality parameters like weight variation, hardness, thickness and friability were determined according to established protocols. Then the in-vitro dissolution test, potency, disintegration time were also carried out. UV-spectrophotometer was used to determine the percentage released and assay at 218 nm. All the brands comply the requirements of Pharmacopoeia as they showed acceptable weight variation range. Friability of all brands was less than 1% and no significant differences in disintegration times as they disintegrated within 15 minutes. In case of dissolution profile, all brands except C6 showed acceptable dissolution time as they released more than 60% of drug in 45 minute. The hardness of only two brands was within the range. All brands also meet the potency specifications. This study suggested that most commercially Clopidogrel tablets in Yemen maintain the quality and comply with the pharmacopeia specifications.
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Abraham, Woldemichael, Habtamu Abuye, Selass Kebede, and Sultan Suleman. "In Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South-West Ethiopia." Advances in Pharmacological and Pharmaceutical Sciences 2021 (February 9, 2021): 1–10. http://dx.doi.org/10.1155/2021/6645876.
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Background. Persistent postmarket quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces a biopharmaceutical and therapeutically equivalent list of the products to the prescribers and users of it. This in turn facilitates access to essential medicines by breaking the high-cost barrier imposed by a few expensive brands of the product. This study was aimed at determining the quality and evaluating the equivalence of doxycycline hyclate capsules and tablets in Jimma, Ethiopia. Methods. Ten brands of doxycycline hyclate capsules and tablets were tested for product identity, dosage uniformity, assay, and in vitro dissolution; and tablets were tested for friability and hardness. Results. All investigated brands of doxycycline complied with the USP for dosage uniformity, an assay of the active ingredient, and single-point dissolution tests. One brand, D09, failed both hardness and friability tests. Comparisons of dissolution profiles applying fit factors confirmed that only brands D04, D06, and D07 had similarities with the innovator. Ratio test approaches also showed that significant variability exists between test products and comparators. Weibull model was found to provide the best adjustment curve for all brands, from model-dependent approaches employed for explaining the overall release of drug from the dosage forms. Conclusions. Doxycycline is a biowaiver product. Hence, in vitro dissolution evaluation suffices its market approval. In this quality assessment study, however, the samples passed quality control tests, except D09 brand which failed friability; it has been revealed that five out of eight brands had problems with interchangeability. Only three doxycycline hyclate brands were found to be equivalent to the comparators.
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Mitić, R., Z. Stanojević, and J. Popović. "THE ASSESSMENT OF BIOLOGICAL EQUIVALENCE (BIOEQUIVALENCE) OF DRUGS BASED ON THEIR PHARMACODYNAMIC VARIABLES." Praxis medica 38, no. 2 (2010): 99–102. http://dx.doi.org/10.70949/pramed201002372m.
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&lt;p&gt;Biological equality assessments are carried out by means of: a) comparative pharmacokinetic study; b) comparative pharmacodynamic study; c) controlled comparative clinical experimentation; d) comparative in vitro assay (dissolution test). The first method mentioned, i.e. determining the concentration of a drug in the blood of healthy volunteers, is the most accurate and most frequently employed. In this paper, a study conducted on healthy volunteers that displays the possibility of evaluating biological equality using pharmacodynamic variable data, giving the example of such assay of retard tablets of verapamil produced by two different companies, is presented. Taking into account the effects of this drug, biological equivalence was proved by comparing pharmacodynamic variables such as PR interval, systolic and diastolic blood pressure and heart rate.&lt;/p&gt;
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Roushan, Kumar Singh 1. Suman Kumar Sinha 2. Anil Parasnath Sao 3*. "In Vitro Comparative Evaluation of Paracetamol and Metformin Branded and Generic Tablets." International Journal in Pharmaceutical Sciences 2, no. 9 (2024): 576–83. https://doi.org/10.5281/zenodo.13749353.
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Despite a huge amount of government funding for health care, a significant Indian population lack access to basic medications due to economic limitations. With the sky-rocketing healthcare costs, the interest in generic drugs has increased all over the world, amongst rich or poor. There is lot of myths about quality of generic products because of different types of packaging and labeling of products. This project was carried out to compare and evaluate some of the physico-chemical parameters and establish the quality of branded-generic equivalents of selected commonly used medicines manufactured by the anonymous pharmaceutical company in India. For this research purpose we procured branded and generic tablet formulations of Paracetamol and Metformin drugs from local market of Kishanganj district of Bihar state and different test evaluation like hardness, weight variation, friability, content uniformity, disintegration and dissolution test were performed at in-vitro level to achieve on a conclusion. The result of the entire quality control test concluded that the branded and generic dosage forms of Paracetamol and Metformin were as par similar apart from hardness of the branded tablets showed more pressure to break than its generic forms. No significant differences were observed in the content of drug and disintegration parameters of the branded and generic products. The differences observed huge in value regarding the cost of these two versions of drug though the manufacturing cost of the generic is less as compared to branded, while retailers get attracted to lucrative profit margin which generic hidden offers.
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GO, Ikeh, Nwafor MN, Ndubuisi MN, and Okolo KO. "Oral Biopharmaceutics and In vitro Pharmacokinetics of Commercially Available Pharmaceutical Formulations of Paracetamol: Implications in Paediatric Medicine." Journal of Complementary and Alternative Medical Research 25, no. 12 (2024): 146–64. https://doi.org/10.9734/jocamr/2024/v25i12603.
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Aim: This study aimed to compare the oral pharmacokinetics of different paediatric paracetamol dosage forms that are commercially available in Nigeria. Study Design: Experimental. Place and Duration of Study: Faculty of Pharmaceutical Sciences, Enugu State University of Science and Technology, between March and December 2023 Methodology: The study used the regular in vitro dialysis membrane method to predict the in vivo drug release of commercially available paracetamol syrups (n=5) and dispersible tablets (n=5) in the Nigerian market. The sink condition followed the Conventional USP dissolution method, using a dialysis membrane sac. The drug samples were studied in simulated salivary fluid of pH 7.4, simulated gastric fluid of pH 1.2, and simulated intestinal fluid of pH 6.5 over 8 hours to simulate their passage in the gastrointestinal tract. At predetermined time intervals, 5 ml of the dissolution medium was drawn out from the system, diluted appropriately and its absorbance measured against a suitable blank at λ = 250 nm using a UV/Vis Spectrophotometer, while a fresh volume of 5 ml of dissolution medium was introduced into the dissolution vessel after each withdrawal. Results: Syrup dosage forms showed a faster drug release kinetics, based on their values. Kinetic parameters obtained from the linear regression analysis of the in vitro release resulted in a zero-order release kinetics, with for paracetamol paediatric syrups, and for tablets. Two-way ANOVA test of the AUC of dosage forms showed that the time required to elicit therapeutic response was extremely significant (F=44.37, DFn=3, DFd= 32 and P-value < 0.0001). Conclusion: The comparative in vitro pharmacokinetic study of paracetamol dosage forms revealed that the paediatric syrup formula has a better release kinetics than the scaled down adult formula.
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Katke. N. G., Kalshetti M. S., Vangari. A. N, Waghmare. O. A, Yawalkar. N. S, and Zade. M. R. "A Comparative Quality Control Study of Brand and Generic Amlodipine Tablets by In-Vitro Testing." International Journal of Scientific Research in Science and Technology 11, no. 3 (2024): 442–50. http://dx.doi.org/10.32628/ijsrst24113117.
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The objective of this study was to conduct in-vitro quality control testing of brand versus generics of Amlodipine tablets. One brand and two generic Amlodipine tablets were used in the study. In the terms of weight variation, Brand, Generic A and Generic B have an above the mean weight limit variation of 2.15%, 2.23%, & 1.43% respectively. The lower mean weight limit variations are 1.85%, 1.92% & 1.23% respectively which are within the 7.5% standard limit of IP. Friability test shows that Brand, Generic A & Generic B have an average friability of 0.5%, 0.480% ,0.3% mass loss, which are within 1%. mass lost limit of IP. Hardness test shows that Brand, Generic A & Generic B have an average hardness of 0.9 kg/cm2, 2.3 kg/cm2 and 1 kg/cm2 respectively. The disintegration test shows that Brand, Generic A & Generic B fall within 15-minutes time interval segment with disintegration time determined 20 sec, 3 min, 2.5 min respectively. In terms of drug assay brand, Generic A & Generic B fall under IP limit of 90% to 110%. The Brand, Generic A & Generic B have a drug dissolution percentage of 101%, 104%, 104% respectively within 30 minutes sampling time interval. The QC tests results for amlodipine tablets show that Brand, Generic A and Generic B confirm to the IP standards.
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Bakshi, Vasudha, Swapna S., Deepa Kumari Choudhary, Ch Revanth, B. Sai KumarCh. Praveen, and Ch Praveen. "Design and characterization of metoprolol floating matrix tablet." Pharmaceutical and Biological Evaluations 4, no. 2 (2017): 118. http://dx.doi.org/10.26510/2394-0859.pbe.2017.18.
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Objective: The objective of the present research was to develop a matrix embedded floating tablet of Metoprolol for the sustained activity and prolongation of gastric residence time to improve the bioavailability of the drug. Metoprolol was chosen as a model drug because it is better absorbed in the stomach than the lower gastro intestinal tract.Methods: The experimental work was divided into pre-formulation studies, formulation development, and evaluation. Standardization of drug and excipients confirmed the authentication of the samples. Floating test were conducted for all formulations, In vitro dissolution studies were carried out in a dissolution testing apparatus-II, FTIR study was performed to interpret the drug ,excipient interaction.Results: Floating tests were also performed for 15 formulations and among them five formulations have passed the floating tests (F1, F3, F5, F7, and F14). The In-vitro release kinetics study of this tablet indicated sustained release for Metoprolol and followed zero order release and 95% drug in 8 h in vitro. The drug release profile of formulated product was compared with marketed product Metolar. The floating tablets extended the drug release up to 8 hours. The drug-polymer interaction was evaluated by fourier transform infrared spectroscopy (FTIR).Conclusions: F3 formulation showed the best floating results. The comparative study between F3 and Metolar (Marketed Product) showed the similar in vitro drug release profile. Thus, the optimzed formulation F-3 can be successfully used for the management of hypertension.
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Bukhari, Syed Manzoor Ul Haq, Sheeeban Rashid, and Rahil Bhat. "Comparative evaluation of the effectiveness of various solvents on dissolving efficacy of gutta percha- An in vitro- study." International Dental Journal of Student's Research 11, no. 3 (2023): 121–25. http://dx.doi.org/10.18231/j.idjsr.2023.026.
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This study's objective was to compare how well xylene, chloroform, turpentine oil, halothane, and orange oil dissolved materials at three different immersion time intervals.For the investigation. An ISO no. 40 cone and gutta-percha cones with a 0.06 taper were gathered. In each of the tested solvents, five batches of samples were made and submerged for 6, 12, and 18 minutes. To ascertain the process of gutta-percha dissolution in the solvents, the weight before immersion and the weight after immersion in the solvents were measured on a digital analytical scale. Analysis of Variance (ANOVA) and multiple comparisons with Scheffe's test (p 0.05) were used to statistically analyse the data. With xylene, the best solvency capacity was attained. Halothane, orange oil, and chloroform all had comparable dissolving abilities.
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Tamader, Elghnimi1* Wadiaa Benamer2 Rehab Walli3 Mawadda Benshaban1 Marwa Benashour1. "Comparative in-vitro Evaluation of Some Desloratadine Tablets Marketed in Tripoli Libya." Alq J Med App Sci 5, no. 2 (2022): 556–64. https://doi.org/10.5281/zenodo.7391018.
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<strong>Background and aims.</strong> Desloratadine is a tricyclic, potent, rapidly effective, long acting, non-sedative antihistamine, which has a selective and peripheral H1 receptor antagonist action, used to treat the allergies. The availability of several brands of Desloratadine tablets in Libyan pharmacies today places health practitioners and a pharmacist in a problem of drug substitution in case of a particular brand is not available. The aim of the present study was the evaluation and comparison of pharmaceutical equivalence of five different Desloratadine tablets 5 mg, which are commercially available in the private pharmacies in Tripoli city with different price ranges, produced by various pharmaceutical companies. <strong>Methods</strong>. The pharmaceutical evaluation of five brands of Desloratadine tablets were done using official and unofficial quality control tests prescribed in different Pharmacopoeia including uniformity of weight, thickness, hardness, disintegration time, drug content as well as dissolution rate and identification test. Acceptable external features as well as uniformity in diameter and thickness were revealed for all the tablets. <strong>Results</strong>. The entire selected brands complied with the official specifications for uniformity of weight, hardness and disintegration, more than 80% of their drug dissolved in the medium within 60 minutes. <strong>Conclusion</strong>. It can be concluded that all the brands could be regarded as bioequivalent and therefore can be interchanged in the clinical practice; this sort of study is good indicator for the evaluation of the idealness of commercial products and showed the importance of post marketing investigation for the drugs imported and distributed in Libya.
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Silva Floriano, Thaís, Yara Santiago de Oliveira, and Cristiani Lopes Capistrano Gonçalves de Oliveira. "Equivalência Farmacêutica e Perfil de Dissolução de Comprimidos de Ibuprofeno Comercializados em Fortaleza." Ensaios e Ciência C Biológicas Agrárias e da Saúde 26, no. 3 (2022): 299–307. http://dx.doi.org/10.17921/1415-6938.2022v26n3p299-307.
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Os anti-inflamatórios não esteroidais (AINEs) constituem um grupo terapêutico de interesse, pois têm propriedades analgésicas, antipiréticas e anti-inflamatórias, sendo uma das classes mais consumidas no mundo. No Brasil, os AINEs são facilmente encontrados em farmácias e alguns são comercializados sem a apresentação do receituário, sendo que o Ibuprofeno é o fármaco de primeira escolha entre os AINES. A qualidade e a intercambialidade de diferentes medicamentos é garantida pela comprovação da equivalência farmacêutica, bioequivalência, boas práticas de fabricação e controle de qualidade na indústria farmacêutica. O presente trabalho teve por objetivo realizar a equivalência farmacêutica e perfil de dissolução de comprimidos de ibuprofeno 600 mg (referência, genérico e similar) comercializados em Fortaleza, com o intuito de avaliar a qualidade dos medicamentos similares e genéricos em relação ao medicamento de referência. Para as análises foram utilizados o medicamento referência, um medicamento genérico e quatro similares. As análises realizadas foram determinação de peso, dureza, friabilidade, teste de desintegração, uniformidade de dose unitária, teste de dissolução, doseamento e testes de segurança biológica de acordo com a Farmacopeia Brasileira 6ª Edição, bem como o perfil de dissolução comparativo. Os comprimidos analisados estavam dentro da especificação para todos os testes físico-químicos e microbiológicos realizados. Contudo, em relação ao perfil de dissolução, somente um medicamento similar foi semelhante ao medicamento referência analisado nas condições de ensaio in vitro empregadas, sendo equivalente farmacêutico ao de referência. Palavras-chave: Ibuprofeno. Equivalência Farmacêutica. Controle de Qualidade. Medicamentos Genéricos. Abstract Non-steroidal anti-inflammatory drugs (NSAIDs) are a therapeutic group of interest, as they have analgesic, antipyretic and anti-inflammatory properties, being one of the most consumed classes in the world. In Brazil, NSAIDs are easily found in pharmacies and some are sold without prescriptions and Ibuprofen is the drug of first choice among NSAIDs. The quality and interchangeability of different drugs are guaranteed by proof of pharmaceutical equivalence, bioequivalence, good manufacturing practices and quality control in the pharmaceutical industry. This study aimed to carry out the pharmaceutical equivalence and dissolution profile of ibuprofen tablets 600 mg (reference, generic and similar) commercialized in Fortaleza, in order to assess the quality of similar and generic drugs in relation to the reference drug. For the analyses, the reference drug, a generic drug and four similar drugs were used. The analyzes performed were determination of weight, hardness, friability, disintegration test, uniformity of unit dose, dissolution test, dosage and biological safety tests according to the Brazilian Pharmacopoeia 6th Edition, as well as the comparative dissolution profile. The tablets analyzed were within the specification for all the physical-chemical and microbiological tests performed. However, in relation to the dissolution profile, only one similar drug was similar to the analyzed reference drug under the in vitro test conditions used, being pharmaceutical equivalent to the reference drug. Keywords: Ibuprofen. Pharmaceutical equivalence. Quality control. Generic Drugs.
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Anurova, M. N., E. O. Bakhrushina, I. V. Lapik, et al. "Biopharmaceutical Properties of New Mucoadhesive Dosage Form for Eye Degenerative Diseases Treatment." Drug development & registration 12, no. 3 (2023): 41–48. http://dx.doi.org/10.33380/2305-2066-2023-12-3-41-48.
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Introduction. Degenerative retinal diseases, including glaucoma, are the main cause of vision loss in the adult population. The development and improvement of drug treatment of this group of diseases is an urgent problem.Aim. Study of a new dosage form of methylethylpyridinol in the form of an ophthalmic gel.Materials and methods. The objects of the study were samples of eye gels containing methylethylpyridinol, for which mucoadhesion was studied by a combination of in vitro / ex vivo methods. Biodegradation and release kinetics of the active substance from the dosage form were studied using a dissolution tester in an artificial tear fluid medium. The shelf life of the dosage form was established in accordance with the stability study program. Determination of the local irritative action was carried out by conjunctival test in 10 rabbits of chinchilla breed weighing 3,6–4,1 kg.Results and discussion. The article presents the results of the study of biopharmaceutical characteristics of the previously developed ophthalmic gel of methylpyridinol based on a nonionic polymer – hydroxyethylcellulose brand Natrosol™ 250 HHX. A comparative study of mucoadhesion by in vitro / ex vivo flow of ophthalmic gel samples in the range of hydroxyethylcellulose concentration in the gel of 1–1.5 % was performed. The sample with 1.5 % polymer content had the best adhesive characteristics because it had a minimum flow rate: in vitro 2.7 · 106 m/s and ex vivo 2.3 · 106 m/s. Dissolution kinetics and visual biodegradation of the sample after "Dissolution" test were studied, which indicates prolonged release of methyl ethyl pyridinol from the gel. The stability of the developed dosage form under long-term and stress conditions was shown. The local irritating effect was estimated by the conjunctival test.Conclusion. The main biopharmaceutical characteristics of the developed ophthalmic gel methylpyridinol were determined and it was shown that it can be used as a delivery system for the treatment of degenerative retinal diseases because it possesses marked bioadhesive properties and prolonged release. The shelf life of the dosage form was determined, which was 2 years. Stress studies of methylethylpyridinol gel were carried out. The developed ophthalmic gel has no local irritating effect.
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Nankar, Meenakshi, Hrishikesh Walimbe, Mohammed Nadeem Ahmed Bijle, Ujwal Kontham, Ananth Kamath, and Sneha Muchandi. "Comparative Evaluation of Cariogenic and Erosive Potential of Commonly Prescribed Pediatric Liquid Medicaments: An in vitro Study." Journal of Contemporary Dental Practice 15, no. 1 (2014): 20–25. http://dx.doi.org/10.5005/jp-journals-10024-1481.
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ABSTRACT Introduction Liquid oral medicines being the most accepted form of medication in children are frequently prescribed. The harmful effects of these liquid medicaments on a child's dental health are not known to many. The present study aimed to evaluate and compare the cariogenic and erosive potential of 5 most commonly prescribed pediatric liquid medicaments (PLM) in Pimpri Chinchwad and Pune city, Pune district. Materials and methods Most commonly prescribed PLM in Pune district were selected as opined by 50 pediatricians. The selected medicaments were Syr. Augmentin®Duo, Syr. Valparin®, Syr. Combiflam®, Syr. Visyneral and Syr. Orofer®. An estimation of pH, percentage of sucrose concentration and calcium dissolving capacity of these preparations was carried out. The results as obtained were subjected to statistical analysis using SPSS v 17.0 for windows. The statistical test as undertaken was Pearson's correlation coefficient(r). Results Sucrose was seen to be present in Syr. Combiflam® (35.75% ± 0.25%) and Syr. Visyneral (18.48% ± 0.43%). Acidic pH was observed for Syr. Visyneral (mean pH 3.63 ± 0.04), Syr. Combiflam® (mean pH 5.03 ± 0.02) and Syr. Augmentin® (mean pH 6.22 ± 0.02). Highest calcium dissolution was seen with Syr. Combiflam® (295.86 mg/ml) and the least with Syr. Orofer® (25.51 mg/ml). No statistical significant correlation was observed with calcium dissolution potential of PLM in comparison with their respective pH. Conclusion Syr. Combiflam® can be regarded as the highest cariogenic and erosive potential medicament among the compared and tested PLM. Clinical significance Considering syrups with high cariogenic and erosive potential should always follow with proper oral hygiene practices or search for an alternative drugs void of such detrimental effects. How to cite this article Nankar M, Walimbe H, Bijle MNA, Kontham U, Kamath A, Muchandi S. Comparative Evaluation of Cariogenic and Erosive Potential of Commonly Prescribed Pediatric Liquid Medicaments: An in vitro Study. J Contemp Dent Pract 2014;15(1):20-25.
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Салій, О. О., О. В. Лось, О. П. Баула, and В. Ю. Турчина. "Development of composition and evaluation of equivalence of diacerein hard gelatin capsules." Farmatsevtychnyi zhurnal, no. 6 (December 20, 2021): 62–72. http://dx.doi.org/10.32352/0367-3057.6.21.06.
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Diacerein is a new generation of symptomatic slow-acting agent for the treatment of osteoarthritis, when taken orally, it exhibits moderate anti-inflammatory and analgesic activity, slows down the decay of cartilage tissue and relieves pain and swelling, but its physicochemical properties it is practically insoluble in water, due to which only 35‒56% the drug reaches systemic circulation. Therefore, the search for approaches to increase the dissolution rate of a practically insoluble API using the formulation, type of excipients, degree of solubility and kinetics of the substance release from hard gelatin capsules should provide guaranteed drug efficacy.
 The aim of the work is to develop the composition of the drug in the form of hard gelatin capsules based on diacerein, to experimentally study the solubility of diacerein, and to evaluate the composition by studying the kinetics of dissolution of the drug.
 Determination of the pH-dependent solubility of diacerein was carried out in the conditions: the volume of the dissolution medium is 250 ml; dissolution temperature 37.0 ± 0.5 ºС. The highest recommended single dose of 50 mg was investigated. The development of the composition of the drug Diacerein, capsules, 50 mg was carried out with the use of various types of excipients and their modifications to achieve the proper technological properties in terms of fluidity (flowability) and a short disintegration time of the capsules for the release of the active substance. Comparative studies of the kinetics of dissolution were carried out by the in vitro method, the test «Dissolution» was studied a «Paddle apparatus» with a rotation speed of 75 rpm, a dissolution medium with a pH value of 1.2, 4.5 and 6.8, in a volume of 900 ml at a temperature of 37 ± 0.5 ºС. The reference drug was used «Artrodarin®», capsules of 50 mg, manufactured by TRB PHARMA S. A.,vArgentina.
 It was found that diacerein is practically insoluble in a buffer solution with a pH of 1.2, has a relatively low solubility in a buffer solution with a pH of 4.5, while the solubility of diacerein increases with an increase in the pH of the medium to 6.8. The optimal composition of capsules with diacerein using the wet granulation technology has been developed. The obtained data for bulk density and Carr&apos;s index indicate satisfactory flowability of the encapsulating mass. Comparative studies of the dissolution kinetics of the investigational medicinal product and the original drug «Artrodarin®», capsules of 50 mg were carried out. According to the calculations, all the obtained values of the similarity factor are in the range from 50 to 100 and indicate the similarity in buffer media with pH 1.2, 4.5 and 6.8. The developed composition of the preparation is equivalent in dissolution kinetics to the original medicine.
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Temesgen, Abrham, Yohannis Eshetu, and Muluken Nigatu. "Comparative Evaluation of Different Brands of Loratadine Tablets Marketed in Addis Ababa, Ethiopia." International Journal of Pharmaceutical Sciences and Nanotechnology 12, no. 4 (2019): 4580–84. http://dx.doi.org/10.37285/ijpsn.2019.12.4.3.
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The impact of counterfeit and substandard medicines has been increasing and becoming a public health problem as it significantly increases mortality and morbidity in low income countries. Loratadine is among the drug classes which are most falsified worldwide and is a frequently prescribed anti-allergy medication. As Ethiopia is one of the low-income countries and depends mostly on imported pharmaceutical products, it is necessary to evaluate the quality of drug products being marketed. This study was conducted with the objective of evaluating and comparing the quality of different brands of loratadine 10 mg tablets collected from pharmacy outlets in Addis Ababa city. Tablets were evaluated for weight variation, thickness, hardness, friability, disintegration time and in vitro drug release. All products complied with the pharmacopeial specifications for weight variation and friability. With regard to disintegration time, all sample products disintegrate in less than 15 min as per the pharmacopeial requirement except one product (product E) which is out of the pharmacopeial specification. Dissolution test showed that all the tested products released more than 80% of drug content within 60 min which is in agreement with the pharmacopeial specification.