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Journal articles on the topic 'Combination dosage form'
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Alamsyah, Natalia, Ratna Djamil, and Deni Rahmat. "ANTIOXIDANT ACTIVITY OF COMBINATION BANANA PEEL (MUSA PARADISIACA) AND WATERMELON RIND (CITRULLUS VULGARIS) EXTRACT IN LOTION DOSAGE FORM." Asian Journal of Pharmaceutical and Clinical Research 9, no. 9 (2016): 300. http://dx.doi.org/10.22159/ajpcr.2016.v9s3.14926.
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ABSTRACTObjective: Test the antioxidant activity of banana peel extract, watermelon rind extract, and combinations, also in lotion dosage form.Methods: The antioxidant activity of each extract and their combinations were tested with 2,2-diphenyl-1-picrylhydrazil method and formulated intoa lotion dosage forms. Evaluation of the lotion dosage forms, including organoleptic, homogeneity, pH, viscosity and rheology, microbiology, acutedermal irritation test, as well as the antioxidant activity test.Results: Antioxidant activity test on the extract showed inhibitory concentration 50% (IC50) values of banana peel is 64.03 part per million (ppm)and watermelon rind extract of 300.12 ppm. Combination of banana peel and watermelon rind extract with three different concentrations, IC50:IC50,inhibitory concentration at 75% (IC75):inhibitory concentration at 25% (IC25), IC25:IC75 resulted the best antioxidant activity is a combination of bananapeel, and watermelon rind extract IC75:IC25 with IC50 value of 177.56 ppm. The antioxidant activity test in lotion dosage form showed IC50 values oflotion base is 853.16 ppm, lotion banana peel extract is 472.50 ppm, lotion watermelon rind extract is 496.71 ppm, and the combination of bananapeel and watermelon rind extract are 300.04 ppm.Conclusion: Lotion dosage form formula that meets the requirements of quality, efficacy, and safety with the best antioxidant activity is lotion dosageform combination of banana peel and watermelon rind extract formula (IC75:IC25).Keywords: Antioxidant activity, Banana peel (Musa paradisiaca), Watermelon rind (Citrullus vulgaris), Combination of banana peel and watermelonrind extract, Lotion of antioxidant.
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Sanjaykumar, Gayakwad*1 Alisha Patel2 Neel Shah3. "A Review Of 3D Printing Techniques for Dosage Form Development." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 3032–48. https://doi.org/10.5281/zenodo.15280466.
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Traditional ‘single-drug-single-target’ approach, where a drug molecule interacts with a specific target, falls short in effectively treating complex and refractory diseases which typically require multiple medications. Prescriptions to take multiple medications results in increased dosage burden for patients leading to lower patient compliance. Fixed dose combination medications simplify treatment and reduce dosage burden for patients requiring multiple medications but limit prescription flexibility. With the emergence of personalized medicine, there is a growing need for technologies enabling customizable dosage forms and combinations to overcome these limitations. 3D printing is a cutting-edge technology that enables creation of customizable medications as per individual patient requirements. This gives 3D printing a significant advantage over conventional manufacturing methods. Thus, this review focuses on various 3D printing technologies and their advantages and limitations in the development of pharmaceutical dosage forms.
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Singh, Dr Prashant Kumar, Mithilesh Kumar Shah, and Binod Singh. "LITERARY REVIEW ON CHURNA - AYURVEDA DOSAGE FORM." Journal of Ayurveda Campus 2, no. 1 (2021): 103–9. http://dx.doi.org/10.51648/jac.31.
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Bhaishajya Kalpana describes various types of dosage forms mainly prepared from herbal ingredients. The term Churna may be applied to the powder prepared by a single drug or a combination of more drugs. It may be considered as modified form of Kalka Kapana. For attaining better therapeutic results, it is advisable to powder all the drugs of formulation separately and then only they are supposed to be mixed together uniformly. It can be used as main medicament in the treatment of many diseases. It has both advantages and disadvantages. It can be used as Prakshepaka Dravya along with quantity & Sevana Vidhi. Hence, the prepared drug is to be stored in Air tight containers for packaging with maintaining quality parameters.
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Navrátilová Radinová, Eva, Eliška Mašková, Kateřina Kubová, and Jakub Vysloužil. "Nanoparticles as a Dosage Form in Practice." Chemické listy 117, no. 10 (2023): 604–12. http://dx.doi.org/10.54779/chl20230604.
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Nanoparticles belong to a modern and developing group of drug delivery systems with great potential for further future use. To pharmacotherapy, it brings a number of advantages. The combination of their size, specific properties of used excipients and a suitable drug can result in a more targeted therapy for some serious diagnoses. However, potential adverse effects are also associated with the subcellular size of the pharmaceutical form, and although research is being conducted with countless excipients and types of nanoparticles, only a small proportion of them have made it into clinical practice. This brief overview discusses these classes, it presents the basic characteristics, classification, and possible clinical use. The article also includes an up-to-date overview of representatives of individual nanoparticle drug delivery classes currently registered in the Czech Republic.
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Kim, Dong-Wook, and Kwon Yeon Weon. "Pharmaceutical application and development of fixed-dose combination: dosage form review." Journal of Pharmaceutical Investigation 51, no. 5 (2021): 555–70. http://dx.doi.org/10.1007/s40005-021-00543-x.
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Zhu, Xiaolin. "Discovery of Traditional Chinese Medicine Prescription Patterns Containing Herbal Dosage Based on Multilevel Top-K Weighted Association Rules." Computational Intelligence and Neuroscience 2022 (May 25, 2022): 1–12. http://dx.doi.org/10.1155/2022/5466011.
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In traditional Chinese medicine (TCM), drug dosage is an important part of the prescription. Different doses of the same drug can have varying curative effects. Doctors must determine the drug combination and dosage in clinical practice based on the patient’s symptoms and treatment efficacy. Existing studies on the prescription pattern of TCM on the treatment of osteoporosis only analyze the frequency that a certain drug combination is used, without considering the treatment efficacy or drug dosage. As a result, we searched for and recorded existing literature on randomized controlled trials of TCM treatment of osteoporosis, calculated weights based on the treatment efficacy of the prescriptions used in the randomized controlled trials, and created the TCM weighted transaction database. Then, a new multilevel Top-K weighted association rule algorithm is proposed to obtain effective prescription patterns that include drug dosages, which can assist doctors in clinical practice in choosing a combination of drugs to form a prescription with good curative effects.
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Chikukwa, Mellisa T. R., Roderick B. Walker, and Sandile M. M. Khamanga. "Formulation and Characterisation of a Combination Captopril and Hydrochlorothiazide Microparticulate Dosage Form." Pharmaceutics 12, no. 8 (2020): 712. http://dx.doi.org/10.3390/pharmaceutics12080712.
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Cardiovascular diseases such as hypertension and cardiac failure in South African children and adolescents are effectively managed long term, using a combination treatment of captopril and hydrochlorothiazide. The majority of commercially available pharmaceutical products are designed for adult patients and require extemporaneous manipulation, prior to administration to paediatric patients. There is a need to develop an age appropriate microparticulate dosing technology that is easy to swallow, dose and alter doses whilst overcoming the pharmacokinetic challenges of short half-life and biphasic pharmacokinetic disposition exhibited by hydrochlorothiazide and captopril. An emulsion solvent evaporation approach using different combinations of polymers was used to manufacture captopril and hydrochlorothiazide microparticles. Design of experiments was used to develop and analyse experimental data, and identifyoptimum formulation and process conditions for the preparation of the microparticles. Characterisation studies to establish encapsulation efficiency, in vitro release, shape, size and morphology of the microparticles were undertaken. The microparticles produced were in the micrometre size range, with an encapsulation efficiency >75% for both hydrochlorothiazide and captopril. The microparticulate technology is able to offer potential resolution to the half-life mediated dosing frequency of captopril as sustained release of the molecule was observed over a 12-h period. The release of hydrochlorothiazide of >80% suggests an improvement in solubility limited dissolution.
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Mishra, Sushmita, Shalini Sharma, Sandeep Sahu, and Amrita Chourasia. "DEVELOPMENT OF GASTRORETENTIVE MUCOADHESIVE SOLID DOSAGES FORM CONTAINING AMOXICILLIN TRIHYDRATE AND RANITIDINE HCL FOR THE TREATMENT OF HELICOBACTER PYLORI INFECTIONS." Journal of Applied Pharmaceutical Sciences and Research 6, no. 1 (2023): 34–40. http://dx.doi.org/10.31069/japsr.v6i1.05.
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Mucoadhesion can be explored in the design of drug delivery system. Mucoadhesive drug delivery systems interact with the mucus layer covering the mucosal epithelial surface, and mucin molecules, thus increasing the residence time of the dosage form at the site of absorption. The drugs having local action or possessing maximum absorption in gastrointestinal tract (GIT) requires increased duration of stay in GIT. Gastroretentive Mucoadhesive solid dosages form containing Amoxicillin Trihydrate and Ranitidine HCL were formulated to prolong the residence time of the dosage form at the site of application or absorption, and it results in intimate contact of the dosage form with the underline absorption surface. This combination is approved by FDA for the treatment of Helicobacter Pylori Infections. The formulation results in efficient absorption, enhanced bioavailability of the drugs due to a high surface to volume ratio and an improved therapeutic performance of the drug. The prolonged release of drug resulted in reduced frequency of drug administration and improved patient compliance. The optimized formulation was evaluated for various parameters i.e. hardness, friability, thickness, weight variation, drug content, dissolution study and swelling index.
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Janczura, Magdalena, Szymon Sip, and Judyta Cielecka-Piontek. "The Development of Innovative Dosage Forms of the Fixed-Dose Combination of Active Pharmaceutical Ingredients." Pharmaceutics 14, no. 4 (2022): 834. http://dx.doi.org/10.3390/pharmaceutics14040834.
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The development of innovative forms of combination drugs is closely related to the invention of the multilayer tablet press, polymers for pharmaceutical applications, the hot-melt extrusion process, and 3D printing in the pharmaceutical industry. However, combining multiple drugs within the same dosage form can bring many physicochemical and pharmacodynamic interactions. More and more new forms of fixed-dose combinations (FDCs) have been developed due to work to overcome the incompatibility of active substances or to obtain different drug release profiles in the same dosage form. This review provides discussions of the application of various innovation formulation technologies of FDC drugs such as bilayer system, multilayer tablet, active film coating, hot-melt extrusion, and 3D printing, taking into account the characteristics of the key ingredients in the FDC formulation and presenting technological problems and challenges related to the development of combination drugs. Moreover, the article summarizes the range of dosage forms that have been made using these technologies over the past 30 years.
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Dr., Sushil Kumar Sharma, Ajay Mishra Dr., Ekta Sharma Dr., and Sharma Yatendra. "Incorporation of Physical Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anti-Counterfeiting." RESEARCH REVIEW International Journal of Multidisciplinary 03, no. 08 (2018): 800–803. https://doi.org/10.5281/zenodo.1405001.
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This document is intended to provide guidance to pharmaceutical manufacturers who want to use physical-chemical identifiers (PCIDs) in solid oral dosage forms (SODFs). A PCID is a substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form.
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Mian, Syed Shariq, Tajuddin Tajuddin, and Sukirti Upadhyay. "Anti-Arthritic Evaluation of Ginger, Colchicum and Detoxified Nux-Vomica combination for Poly Herbal Unani Formulation." Biomedical and Pharmacology Journal 14, no. 3 (2021): 1219–29. http://dx.doi.org/10.13005/bpj/2224.
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Introduction: Arthritis (Wajaul Mafasil) is a condition which is growing worldwide due to lifestyle, environmental and genetic factors. In Unani literature, there are many herbs which are praised for treatment of Arthritis. So polyherbal formulation contains Ginger, Colchicum and Nux- Vomica is taken in combination for arthritis study. This combination is not previously reported but used by unani practitioners. Method: Three crude herbs (Ginger, Colchicum and Nux vomica) were extracted out in both aqueous and hydro-alcoholic solvent. LD-50 of all extracts (aqueous and hydro-alcoholic extract) was determined. Now respective extracts were mixed in effective dose ratio to obtain aqueous and hydro-alcoholic dosage form. Finally both effective combinations (aqueous and hydro-alcoholic) convert into tablet dosage form to determine its anti-arthritic activity by Carrageenan Induced Oedema Test, Cotton Pellet Induced Granuloma Test and Freund’s adjuvant Induced Arthritis Test. The efficacy of the Unani formulation was compared with reference drug (Diclofenac sodium). Result and Discussion: in Carrageenan Oedema Test, animals in high dose hydro-alcoholic, shows decrease in paw volume significantly after 3 hours of Carrageenan injection. In Cotton Pellet Induced Granuloma Test, animals in high dose hydro-alcoholic, shows reduction in granuloma formation significantly. In Freund’s Adjuvant Induced Arthritis Test, The significant reduction in paw volume was found in high dose hydro-alcoholic. Conclusion: Conclusively this study establishes anti-arthritic potential of polyherbal extract in unani literature. Thus these drugs possess synergistic anti-arthritic potential in combination against acute, sub-acute as well as chronic arthritis. So in future compatible dosages form may be prepared for treating arthritis.
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K., Rekha Rani* Y. Navya Reddy R. Mohana Priya. "FORMULATION AND EVALUATION OF SUSTAINED RELEASE DOSAGE FORM OF KETOPROFEN." indo American Journal of Pharmaceutical Sciences 04, no. 05 (2017): 1384–90. https://doi.org/10.5281/zenodo.804916.
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Sustained release Ketoprofen matrix tablets were prepared by direct compression method. The nature of the polymer influences the physical and release characteristics of the matrix tablet. The hydrophobic polymer, Ethyl cellulose has retarded the drug release from the tablet and the hydrophilic polymer, HPMC (15 cps) has release the drug. While making the combination of both hydrophilic and hydrophobic polymers i.e HPMC and Ethylcellulose with optimized ratio (F7) leads to sustained release of drug from matrix tablet for 12 hours was observed Key words: Ketoprofen, HPMC (15 cps), Ethyl cellulose
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Zhang, Dan, Alfred C. F. Rumondor, Wei Zhu, et al. "The Development of Minitablets for a Pediatric Dosage Form for a Combination Therapy." Journal of Pharmaceutical Sciences 109, no. 12 (2020): 3590–97. http://dx.doi.org/10.1016/j.xphs.2020.08.021.
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Saurabh, Swami* Shubham Tikait Swati Deshmukh. "Formulation And Evaluation of Ayurvedic Solid Dosage Form of Vati." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 1908–22. https://doi.org/10.5281/zenodo.15387758.
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The present research focuses on the formulation and evaluation of an Ayurvedic solid dosage form Vati, using Triphala (a classical combination of Haritaki, Bibhitaki, and Amla) and jaggery (Gud). Triphala is known for its rejuvenating, digestive, and antioxidant properties, while jaggery acts as a natural binder and sweetener with additional nutritional benefits. The study involves standardizing raw materials, preparing the Vati by traditional methods, and evaluating its physicochemical properties such as hardness, friability, weight variation, and disintegration time. The formulation exhibited acceptable results across all evaluation parameters, indicating good stability, uniformity, and patient compliance. This study supports the integration of traditional Ayurvedic knowledge with modern pharmaceutical evaluation techniques for enhancing therapeutic efficacy and standardization of herbal dosage forms.
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Sonawane, Abhijeet A., Akhil A. Shinde, Pooja K. Phalke, et al. "Simultaneous estimation of simvastatin and labetalol in bulk and solid dosage form." Journal of Drug Delivery and Therapeutics 9, no. 2-s (2019): 383–86. http://dx.doi.org/10.22270/jddt.v9i2-s.2532.
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A simple, accurate, precise, sensitive, and highly selective ultra violet spectrometer method has been developed for the simultaneous estimation of simvastatin and labetalol in bulk and solid dosage form. The estimation of simvastatin was carried out at 239 nm while labetalol was estimated at 222.4 nm. The developed method was validated for linearity range, precision, recovery studies and interference study for mixture, all these parameter showed the adaptability of the method for the method quality analysis of the drug in bulk and combination formulation. Keywords: Simvastatin, Labetalol, UV Spectrophotometric, Dosage form.
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Garg, Ram Ishwar, Gladson David Masih, and Bikash Medhi. "Nanoformulation and Fixed Dose Combination." International Journal of Pharmaceutical Sciences and Nanotechnology(IJPSN) 18, no. 2 (2025): 7897–901. https://doi.org/10.37285/ijpsn.2024.18.2.1.
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Nanoformulation refers to the design of drug delivery systems at the nanoscale to enhance solubility, stability, and bioavailability. According to the U.S. Food and Drug Administration (FDA), nanoformulation refers to the design and development of drug delivery systems with components in the nanoscale range (typically 1-100 nanometers), where the unique physiochemical properties at this scale are leveraged to enhance therapeutic efficacy, improve bioavailability, and enable targeted delivery1. FDC (Fixed-Dose Combination) combines two or more drugs in a single dosage form. As defined by the Central Drugs Standard Control Organization (CDSCO) of India, FDCs are pharmaceutical products containing two or more active pharmaceutical ingredients (APIs) in a fixed ratio of doses, formulated into a single dosage form2. Combining nanoformulation with FDC ensures improved therapeutic efficacy, reduced dosing frequency, and better patient adherence3. Nanoformulation and fixed-dose combinations (FDCs) are a revolutionary area of frontier therapeutics, providing new approaches toward overcoming age-old issues in drug delivery and compliance of patients.
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Fatema, Kaniz, BK Sajeeb, KM Yasif Kayes Sikdar, ASM Monjur Al Hossain, and Sitesh C. Bachar. "Evaluation of the Formulation of Combined Dosage Form of Albendazole and Mebendazole through In vitro Physicochemical and Anthelmintic Study." Dhaka University Journal of Pharmaceutical Sciences 21, no. 2 (2022): 153–63. http://dx.doi.org/10.3329/dujps.v21i2.63116.
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In the current study, the combination of albendazole and mebendazole was analyzed as a potential anthelmintic agent against Lumbricus terrestris (commonly known as earthworms). The in vitro analysis showed the combination of 400 mg albendazole and 300 mg mebendazole had more significant therapeutic activities (mean paralysis time 58 minutes and mean death time 97.33 minutes) than the others. Then the combinations were formulated as tablet using different ratios of excipients where formulation-D performed excellent flow properties (Carr’s index: 14.04±0.27, Hausner’s ratio: 1.19 ± 0.03, Angle of repose: 40.22 ± 0.73). The dosage form prepared from formulation-D had better hardness of 9.40 ± 0.34 kg-N and loss of weight of 0.003 mg compared to other formulations. In terms of disintegration and dissolution studies, formulation-D exhibited excellent properties. The tablet was disintegrated fully within 8.94 ± 0.37 minutes in phosphate buffer (pH 8.3) and dissolution analysis showed R2 of 0.995 for albendazole and 0.991 for mebendazole which were statistically significant. The postformulation anthelmintic study showed that the prepared tablet dosage form was therapeutically effective because it paralyzed and killed all the earthworms within 56 and 85 minutes, respectively. Finally, the tablet was subjected to the scanning electron microscopy (SEM) analysis which confirmed better surface morphology and drug-drug compatibility within the dosage form. The next stage of the work will focus on in vivo analysis for market preparation. Dhaka Univ. J. Pharm. Sci. 21(2): 153-163, 2022 (December)
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Borkar, Dinesh P., Anup Barsagade, Nobel CP James, Suruchi Thakare, and Susmita Mandal. "Analytical Method Developement and Validation of Beclomethasone, Clotrimazole, Ofloxacin, Lidocaine by RP-HPLC in Combination Dosage Form." Journal of Pharmaceutical Research International 36, no. 11 (2024): 163–73. http://dx.doi.org/10.9734/jpri/2024/v36i117609.
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A rapid and precise method (in accordance with ICH guidelines) is required for the quantitative simultaneous determination of drugs in a combined pharmaceutical dosage form. The pursuit of desired quality is a continual challenge for pharmaceutical industries, necessitating a meticulous approach known as validation. Sensitive and specific RP-HPLC method involving UV detection was carried for determination and quantification of various drug in combination dosage form. The aim is "Analytical Method developement and Validation of Beclomethasone, Clotrimazole, Ofloxacin, Lidocaine by RP- HPLC In Combination Dosage Form " as per ICH guidelines. The developed method was validated for various parameters as per ICH guidelines like system suitability, specificity, linearity, system precision, method precision, accuracy, ruggedness and robustness. The separation method was carried out by using a mobile phase A consisting of Potassium dihydrogen phosphate buffer (0.05M): Methanol 45:55 v/v) pH 3.5 ± 0.1 and Mobile phase B comprises Acetonitrile in the ratio of 50:50 v/v. The detection was carried out by using UV detector at 300nm. The column was Agilent C 18 (250X4.6mm) 5µ. The flow rate was selected as 1.5 ml/min. The retention time of Ofloxacin, Lidocaine, Beclomethasone, and Clotrimazole, was found to be 5.67, 9.44, 18.29, and 21.85 respectively.
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H. Jaber, Saba, Zainab T.Salih, and Hiba M. Salmo. "Formulation of Azithromycin Suspension as an Oral Dosage Form." Iraqi Journal of Pharmaceutical Sciences ( P-ISSN 1683 - 3597 E-ISSN 2521 - 3512) 21, no. 1 (2017): 61–69. http://dx.doi.org/10.31351/vol21iss1pp61-69.
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Azithromycin is the drug of choice in the treatment of several bacterial infections, most often those causing middle ear infection, bronchitis, pneumonia, typhoid and sinusitis. It’s also effective against certain urinary tract infections and venereal diseases. This study was carried out to prepare an acceptable suspension either as dry physical mixture powder or granules to be reconstituted, through studying the effect of various type and concentration of suspending agent (xanthan gum, hydroxypropyl methylcellulose (HPMC), either alone or in combination) on the release profile of the drug. The best prepared suspension formulas (H& III) were selected depending on the dissolution profile of each formulas and then compared with the reference suspensions (Zithromax and Azi-once).The viscosity, sedimentation volume, Resuspendability and expiration date were evaluated for the chosen formulas (H&III) and compared with references ZithromaxÒ and Azi-onceÒ.The result indicated that the chosen formula – H had better dissolution rate compared with references suspensions, Also it was less viscous than them.While other chosen formula – III had lower dissolution rate compared with ZithromaxÒ and higher dissolution rate than AZi – once, also it was less viscous than both references.It was found that the dry physically mixed powder (formula – H) was more stable than the granular suspension (Formula III) since the expiration date for formula H and formula III were 3.24 and 2.7 years respectively. 
 Key words: Azithromycin, suspending agent, suspension.
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B., Patel Khushbu, and Barot Riya V. "A Review on Analytical Methods for Estimation of Azelnidipine and Chlorthalidone in Pharmaceutical Dosage Form." Der Pharma Chemica 14, no. 9 (2022): 6. https://doi.org/10.4172/0975-413X.14.9.6-11.
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High blood pressure, also called hypertension, is a common condition that is characterized by having a higher amount of pressure in your blood vessels than normal. Hypertension (HT) is a very common disorder, particularly past middle age. It is not a disease in itself, but is an important risk factor for cardiovascular mortality and morbidity. For improvement activity of hypertension, Azelnidipine and Chlorthalidone newer combination in market, which is effective in Hypertension. This combination was developed to improve medication for Stage II Hypertension. Azelnidipine is Ca2+ channel blocker and chemically 3- [1- (Benzyldrylazetidin-3-yl] 5-isopropyl- 2- amino6methyl-4-(3- nitrophenyl)-1, 4- dihydropyridine-3,5dicarboxylate. Chlorthalidone is a diuretic used to treat hypertension or edema caused by heart failure, renal failure, hepatic cirrhosis, estrogen therapy, and other conditions and Chemically 2-chloro-5-(1-hydroxy-3-oxo- 2H-isoindol-1-yl) benzenesulfonamide. This Review focuses on recent development in analytical method development for Azelnidipine and Chlorthalidone, and there was no any method reported for this combination. It provides information about different analytical method development like UV spectrophotometry, HPLC, HPTLC, LC-MS methods reported for Azelnidipine and Chlorthalidone for individual and other drug combination.
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Afonso Urich, Jesús Alberto, Viktoria Marko, Katharina Boehm, et al. "Stability-Indicating UPLC-PDA-QDa Methodology for Carvedilol and Felodipine in Fixed-Dose Combinations Using AQbD Principles." Scientia Pharmaceutica 92, no. 2 (2024): 22. http://dx.doi.org/10.3390/scipharm92020022.
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The development of analytical procedures, in line with the recent regulatory requirements ICH Q2 (R2) and ICH Q14, is progressing, and it must be able to manage the entire life cycle of the methodology. This is also applicable to and especially challenging for combinations of drug substances and dosage form. A reliable and efficient, stability-indicating, MS-compatible, reverse-phase ultra-performance liquid chromatographic (UPLC®) method was developed for the determination of carvedilol and felodipine in a combination oral dosage form. The development of the method, performed using analytical quality by design (AQbD) principles, was in line with the future regulatory requirements. Furthermore, the fixed-dose combination dosage forms are a clear solution to the polypharmacy phenomenon in the elderly population. The main factors evaluated were the mobile phase buffer, organic modifier, column, flow, and column temperature. The optimum conditions were achieved with a Waters Acquity HSS T3 (100 × 2.1 mm i.d., 1.8 µm) column at 38 °C, using ammonium acetate buffer (5 mM, pH 4.5) (Solution A) and MeOH (Solution B) as mobile phases in gradient elution (t = 0 min, 10% B; t = 1.5 min, 10% B; t = 12.0 min, 90% B; t = 13.0 min, 10% B; t = 15.5 min, 10% B) at a flow rate of 0.2 mL/min and UV Detection of 240 and 362 nm for carvedilol (CAV) and felodipine (FLP), respectively. The linearity was demonstrated over concentration ranges of 30–650 µg/mL (R2 = 0.9984) (CAV) and 32–260 µg/mL (R2 = 0.9996) (FLP). Forced degradation studies were performed by subjecting the samples to hydrolytic (acid and base), oxidative, and thermal stress conditions. Standard solution stability was also performed. The proposed validated method was successfully used for the quantitative analysis of bulk, stability, and fixed-dose combination dosage form samples of the desired drug product. Using the AQbD principles, it is possible to generate methodologies with improved knowledge, leading to high-quality data, lower operation costs, and minimum regulatory risk. Furthermore, this work paves the way for providing a platform of robust analytical methods for the simultaneous quantification of innovative on-demand new dose combinations.
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Marakhova, A. I., and A. M. Kulikova. "Development and validation of the dissolution test method for a combination of lamivudine and zidovudine adapted to the requirements of the EAEU pharmacopoeia." Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology), no. 2 (April 5, 2023): 8–15. http://dx.doi.org/10.33920/med-13-2302-01.
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The dissolution test is intended to determine the amount of a medicinal substance, which should be released into the dissolution medium from a solid dosage form over a certain period of time under the conditions specified in the pharmacopoeial article for the drug. Developing the method indicated for the combination of antiretroviral drugs lamivudine and zidovudine in a dosage form is crucial as this will allow, along with the assessment of pharmaceutical equivalence, at least an approximate assessment of the bioequivalence of the drug/
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Tiple, Rupali H., Shamli R. Jamane, Deepak S. Khobragade, and Dharmendra R. Mundhada. "Formulation of Herbal Topical Dermatological Dosage Form by Quality by Design Approach." INTERNATIONAL JOURNAL OF DRUG DELIVERY TECHNOLOGY 13, no. 04 (2023): 1448–53. http://dx.doi.org/10.25258/ijddt.13.4.50.
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Objective: The study developed an optimized dosage form by quality by design (QbD) approach containing Azadirachta indica (Neem) leaf extract and a combination of selected herbal oils viz. A. indica oil, Eucalyptus citriodora oil and Cymbopogon martini oil and assessed for its antifungal efficacy, stability and dermal safety. Methods: Ointment was prepared using the fusion method from an extract of neem leaves with a combination of herbal oils viz. A. indica, E. citriodora, C. martini, bees wax and soft-paraffin. Utilizing the Box-Behnken Design (BBD), the variables such as the percentage of soft paraffin, beeswax and melting temperature were optimized in relation to the output variables such as viscosity, spreadability, and finally the antifungal efficacy, which was further quantified. Wistar albino rats were used (n = 5/test, positive and negative control) to evaluate the acute dermal toxicity test of the formulated ointment. Stability studies were assessed at 25 ± 2℃/ 60 ± 5% RH and 40 ± 2℃/ 75 ± 5% RH. Results: Melting point and percentage of beeswax significantly affect viscosity and spreadability. Optimal viscosity was obtained at 5.4% beeswax and 89.6% soft-paraffin when melted at 58℃. No dermal toxicity was observed by the ointment when comparable to petroleum jelly, both differed significantly with negative control. The absence of new spots on chromatograms, a prominent zone on agar plates, and negligible changes in spreadability (p = 0.112) all suggested physical stability, chemical stability, and antifungal efficacy, respectively. Conclusion: Neem leaf extract and a blend of selected herbal oils; A. indica, E. citrodora, and C. martini, when combined to formulate ointment, proved reliable and stable dosage form with significant anti-fungal efficacy. The formulated ointment might be helpful tool for dermatophytes management.
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Battula, Shireesha, and Anusha Shivaraj. "RP-HPLC Method for the Simultaneous Estimation of Ampicillin and Cloxacillin in Capsule Dosage Form." INTERNATIONAL JOURNAL OF APPLIED PHARMACEUTICAL SCIENCES AND RESEARCH 2, no. 03 (2017): 93–98. http://dx.doi.org/10.21477/ijapsr.v2i03.8255.
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Combination formulation of ampicillin and cloxacillin sodium is β-lactam antibiotic. They are amino penicillin–isoxazyl penicillin combination drugs. In HPLC method development was carried out with acetonitrile: phosphate buffer pH 5 (35:65), hypersil C18, 250X4.6mm, 5μm column, UV detector at 254nm and flow rate of 1ml/min. Ampicillin retention time is 3.130min and cloxacillin retention time is 7.907min. In capsule brand no.:1. ampicillin content is found to be 250.29mg i.e. 100.1% and cloxacillin content is found to be 252.01mg. i.e. 102.75%. Validation results obtained are satisifactory for accuracy, precision, limit of detection, limit of quantification, linearity, system suitability, ruggedness and robustness parameters.
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Purvasha, S. Khot* Jaymin Ghanshyambhai Patel Bhumi Rajdevbhai Patel. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF LERCANIDIPINE HYDROCHLORIDE AND ENALAPRIL MALEATE IN COMBINATION." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 3144–51. https://doi.org/10.5281/zenodo.1237984.
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Stability indicating RP-HPLC method for simultaneous estimation of Lercanidipine Hydrochloride and Enalapril Maleate in their Combined Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Lercanidipine HCl and Enalapril Maleate in their combined dosage form. The separation was achieved by column C18 (250mm x 4.6 mm) Hypersil BDS and Buffer (pH 5.0): Methanol (30:70 % v/v) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 233 nm. Retention time of Lercanidipine HCl and Enalapril Maleate were found to be 4.057 min and 6.470 min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Lercanidipine HCl 10-30 μg/ml and for Enalapril Maleate 20-60 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Lercanidipine HCl and Enalapril Maleate In Their Combined Dosage Form Keywords: Lercanidipine HCl, Enalapril Maleate, Stability indicating RP-HPLC Method, Validation Method.
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M T, Ranjitha, and C. N. Somashekhar. "PREPARATION AND EVALUATION OF MEFENAMIC ACID AND DICYCLOMINE HYDROCHLORIDE AS ORAL DISINTEGRATING TABLET BY DIRECT COMPRESSION METHOD." Journal of Pharmaceutical and Scientific Innovation 10, no. 4 (2021): 94–101. http://dx.doi.org/10.7897/2277-4572.104211.
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A new dosage form, Oral disintegrating tablets (ODT’s) as a replacement to conventional oral dosage forms. ODT’s are dosage forms they disintegrate in mouth offering various advantages such as better mouth feel, dose accuracy, improved stability and convenient dosing as compared to oral liquids. So, there is need to designed oral disintegrating tablet to release the medicaments with an enhanced rate. Mefenamic acid is an anti- inflammatory drug while Dicyclomine HCl is anti-cholinergic drug. The combination of Mefenamic acid & Dicyclomine HCl controls pain very effectively, also relaxes bodily spasm which commonly arises during menstruation or intestinal colic spasm. This combination gives the quick onset of action and fast relief than conventional dosage form. For preparation of oral disintegrating tablet nine formulations were designed using Croscarmellose sodium and Crospovidone as superdisintegrants in varying concentration. All the formulations were prepared by direct compression method. Thus, all the formulations of Mefenamic acid and Dicyclomine HCl oral disintegrating tablets were investigated, in which F9 formulation was optimized. The % drug release of, Oral disintegrating tablet batch F9 has shown 96.98% of Mefenamic acid and 94.02 % of Dicyclomine HCl in 18 min, disintegration time in 40 sec and wetting time in 25sec.
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Bahr, Matthew Nathan, Dimple Modi, Sarsvatkumar Patel, Gossett Campbell, and Gregory Stockdale. "Understanding the Role of Sodium Lauryl Sulfate on the Biorelevant Solubility of a Combination of Poorly Water-Soluble Drugs Using High Throughput Experimentation and Mechanistic Absorption Modeling." Journal of Pharmacy & Pharmaceutical Sciences 22 (June 20, 2019): 221–46. http://dx.doi.org/10.18433/jpps30347.
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This study investigates the influence of surfactant sodium lauryl sulfate (SLS) on the solubility of poorly-water soluble drug substances, model Compound X and Compound Y, used in a fixed dose combination oral solid dosage form. To determine the impact of SLS concentration on the solubility of compounds X and Y, we experimentally determined the critical micelle concentration (CMC) of SLS in water, simulated gastric fluid (SGF), and fed state simulated intestinal fluid (FeSSIF) in the presence of Compound X and Compound Y using UV/Visible spectrophotometry at 25°C. The aggregation of SLS was characterized by calculating the standard Gibbs free energy of micellization in all the media investigated. To enhance the understanding of SLS aggregation, high throughput experiments and in-vivo mechanistic modelling were used to determine the effect of increasing levels of SLS on the solubility of compounds X and Y as both single agent and combination products to be formulated into a suitable oral solid dosage form. Micellar formation of SLS is a spontaneous process as shown by the negative values of the standard free energy of micellization. The CMC of SLS in the various media investigated in the presence of compounds X and Y decreases in the following order: water> FeSSIF> SGF. However, the aggregation of SLS in the various media is overall more spontaneous in the following order: SGF>FeSSIF>water. Using high throughput experimentation and in-vivo mechanistic modelling, it was determined that a combination oral solid product of compounds X and Y will have optimum solubility and in-vivo absorption if 2 mg of SLS was used in the oral solid dosage form. The results obtained from this study will help broaden the understanding of the micellization process involving SLS and poorly-water soluble drugs used in combination oral solid dosage forms.
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Rao A, Venkateswara. "SIMPLE AND RAPID LIQUID CHROMATOGRAPHIC METHOD FOR REAL-TIME QUANTIFICATION OF NAPROXEN / ESOMEPRAZOLE MAGNESIUM COMBINATION TABLETS." Journal of Applied Pharmacy 6 (2014): 42. http://dx.doi.org/10.21065/19204159.6.42.
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In this present investigation a simple, rapid and accurate reverse phase- liquid chromatographic method for the real- time quantification of naproxen and esomeprazole magnesium in tablet dosage form has been developed and validated.
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H. Tizkam, Hussam, Alaa A. Abdul Rassol, and Ahmed A. Hussain. "Preparation of a New Dosage Form of Metoclopramide Hydrochloride as Orodispersible Tablet." Iraqi Journal of Pharmaceutical Sciences ( P-ISSN: 1683 - 3597 , E-ISSN : 2521 - 3512) 18, no. 1 (2017): 38–48. http://dx.doi.org/10.31351/vol18iss1pp38-48.
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Metoclopramide HCl (MTB) is a potent antiemetic drug used for the treatment of nausea and vomiting. Many trials were made to prepare a satisfactory MTB orodispersible tablet using direct compression method.Various super disintegrants were used in this study which are croscarmellose sodium (CCS), sodium starch glycolate (SSG) and crospovidone (CP). The latter was the best in terms of showing the fastest disintegration time in the mouth.Among the different diluents utilized, it was found that a combination of microcrystalline cellulose PH101 (MCC 101), mannitol, dicalcium phosphate dihydrate (DPD) and Glycine was the best in preparing MTB orodispersible tablet with fastest disintegration time in the mouth.The physical parameters of the prepared MTB orodispersible tablet were satisfactory as hardness (4 Kg), friability (0.5%) and mouth disintegration (23 sec).The overall results suggest that the prepared formula of MTB as orodispersible tablet could be utilized as a new dosage form for the oral administration.
 Key words: Orodispersible, metoclopramide, super disintegrant
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Muni, Maniza, B. K. Sajeeb, Sumaiya Sharmin Mou, Adeeba Jaheen Faruqui, and Md Elias Al Mamun. "Feasibility Study for the Development of Combination Dosage Form Containing Aspirin and Omeprazole for Treating Cardiovascular and Cerebrovascular Events." Bangladesh Pharmaceutical Journal 28, no. 1 (2025): 105–13. https://doi.org/10.3329/bpj.v28i1.79470.
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Cardiovascular and cerebrovascular diseases are two of the major reasons of morbidity and mortality worldwide, hence require proper treatment and secondary prevention. Aspirin is a first line treatment option for the patients suffering from aforementioned issues and is usually co-administered with omeprazole to lessen the gastrointestinal side effects. A survey was done among patients, doctors, pharmaceuticals and retailers to explore the feasibility of developing a combination bilayer dosage form of aspirin and omeprazole so that the complications of co-administration can be minimized. Data were collected through direct interview and online questionnaire and statistical significance was determined using independent sample t-test. The study showed that drug utilization pattern of 85% of patients contain aspirin and omeprazole in the same prescription. Statistical data supported that both doctors and patients prefer the dose to be 75 mg for aspirin and 20 mg for omeprazole. More than 60% of each stakeholder showed their preference for the combination dosage form. Almost 50% of the doctors and patients preferred it for ease of consumption while retailers and manufactures considered the sales aspect. Moreover, ease of remembering, lesser number of pills consumption and lower price of the combination than the individual formulations came out to be the reasons for expecting availability of the combination among 68.82% of patients. As the demand of the combination and the market prediction of the pharmaceuticals matched, so introduction of fixed dose aspirin-omeprazole bilayer combination in Bangladesh can be beneficial overall. Bangladesh Pharmaceutical Journal 28(1): 105-113, 2025 (January)
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Jerad Suresh, A., A. Mohan Kumar, T. Suyaraj, and D. Vinod. "Determination of Stability and Degradation Rate for Combination Containing Amoxicillin and Dicloxacillin in Capsule Dosage Form." Journal of Pharmaceutical Research 11, no. 1 (2012): 1. http://dx.doi.org/10.18579/jpcrkc/2012/11/1/79326.
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Beludari, Mohammed Ishaq, Karanam Vanitha Prakash, and Ghanta Krishna Mohan. "RP-HPLC method for simultaneous estimation of Rosuvastatin and Ezetimibe from their combination tablet dosage form." International Journal of Chemical and Analytical Science 4, no. 4 (2013): 205–9. http://dx.doi.org/10.1016/j.ijcas.2013.04.006.
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Solanki, Dhavalsinh P., Krunal H. Solanki, Jaineel V. Desai, Dimal A. Shah, and Usmangani K. Chhalotiya. "HPTLC-Densitometric Estimation of Anti-hypertensive Drug Combination Azilsartan Medoxomil and Cilnidipine in Combined Dosage Form." Analytical Chemistry Letters 13, no. 1 (2023): 82–94. http://dx.doi.org/10.1080/22297928.2023.2195862.
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Sudarshan, Mirgal* Dr. Bharat Tekade Dr. Mohan Kale. "Enhancing Drug Delivery: Formulation and Evaluation of Novel Effervescent Tablets for Optimal Bioavailability." International Journal of Scientific Research and Technology 2, no. 1 (2025): 205–9. https://doi.org/10.5281/zenodo.14644713.
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Gastro-effervescent tablets have emerged as an innovative pharmaceutical dosage form designed to provide rapid and efficient drug delivery, particularly for medications requiring enhanced absorption in the stomach. This study focuses on the formulation, development, and evaluation of gastro-effervescent tablets, with the aim of improving patient compliance and therapeutic efficacy. The tablet formulation includes a combination of an active pharmaceutical ingredient (API), citric acid, and sodium bicarbonate, creating an effervescent reaction upon contact with water. This review paper aims to provide valuable insights into the development of gastro-effervescent tablets as a viable drug delivery system, offering potential advantages in terms of patient convenience, rapid onset of action, and improved absorption. Gastro-effervescent tablets have the potential to revolutionize the field by providing a convenient, fast-acting, and effective means of administering medications.
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Behera, A., D. G. Sankar, S. K. Moitra, and S. C. Si. "Development, Validation and Statistical Correlation of RP–LC Methods for Determination of Atazanavir Sulfate in Capsule Dosage Form." E-Journal of Chemistry 9, no. 4 (2012): 1778–87. http://dx.doi.org/10.1155/2012/402970.
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To study the effective therapeutic bioavailability of Atazanavir Sulfate (ATV), administered singly or in combination with Ritonavir, a cost effective and rapid method is required. In order to assess an in-depth study, it is primarily thought prudent to develop an effective analytical method for estimation of ATV in marketed dosage forms. The present work is to develop a simple and precise analytical method for in depth evaluation of therapeutic efficacy of ATV. The novelty of the method shows linearity in the concentration range of 10-100 µg/mL at two wavelengths, i.e. 254 nm and 284 nm respectively. The chromatographic system consists of HiQSil C18HS column; an isocratic mobile phase consisted of methanol and tetrahydrofuran (95:5 v/v). The developed method is validated according to ICH guidelines in capsule dosage form. Validation of the developed method shows good result in range, linearity, accuracy and precision. Student’st–test was used to correlate the two methods and applied to raw materials and capsule dosage form.
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Solgalova, S. A., T. V. Glukhova, I. A. Znamenskaya, and I. B. Romanova. "The experience of a comprehensive assessment of the effectiveness of antihypertensive therapy in clinical practice." Medical Herald of the South of Russia 10, no. 3 (2019): 62–71. http://dx.doi.org/10.21886/2219-8075-2019-10-3-62-71.
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Objective: to study the antihypertensive efficacy of a new dosage form of perindopril A — tablets dispersed in the oral cavity — in the group of patients with arterial hypertension (AH) on an outpatient basis.Material and methods: the study included 30 patients (mean age 53.8 ± 0.9 years) with the presence of arterial hypertension, diagnosed initially, or with no control of blood pressure at the background of previous antihypertensive therapy. All investigators were administered perindopril A in the form of a dispersible form in a dose of 10 mg in monotherapy or in combination with indapamide – in case of failure to achieve target blood pressure after 2 weeks of observation. The total duration of the study is 3 months.Results: by the end of the observation, the SBP / DBP decreased by 35.6 ± 2.3 / 16.5 ± 1.0 mm Hg. Correction of therapy with the addition of indapamide-retard was required in 6 (20%) patients. Effective antihypertensive therapy was accompanied by a significant decrease in daily (according to ICBP data), intravisit, and visit-to-visit variability of the SBP, which was 4.4 mm Hg in terms of standard deviation by the end of the observation. The use of a new dosage form of perindopril A was accompanied by a significant increase in adherence to therapy.Conclusion: the use of a new dosage form of perindopril A — tablets dispersed in the oral cavity — in monotherapy or in combination with indapamide-retard can improve the treatment of patients with hypertension who do not have target BP values.
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Gaikwad, Sarita. "A Derivative Spectrophotometric Method for the Vierordt’s Detection of Terbinafine and Itraconazole in Topical Dosage Form." INTERANTIONAL JOURNAL OF SCIENTIFIC RESEARCH IN ENGINEERING AND MANAGEMENT 08, no. 06 (2024): 1–5. http://dx.doi.org/10.55041/ijsrem36225.
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The goal of the current work was to simultaneously estimate the dosage forms of pharmaceutical topical dosage form and bulk itraconazole and terbinafine HCl by developing and validating a novel and straight forward UV spectrophotometric approach. As of right now, no reports of this medication combination for simultaneous UV spectrophotometric analysis exist. Acetonitrile was utilized as a solvent in the UV Shimadzu 1800 model, which was employed to test the developed approach. For Terbinafine HCl, the wavelength at which the λmax was measured was 235 nm, while for itraconazole, it was 263 nm. It was discovered that the percent RSD of both the system and technique precision for itraconazole and terbinafine HCl was less than 2%. In summary, a new and straightforward UV spectrophotometric technique was created and verified for the simultaneous measurement of terbinafine HCl and itraconazole in pharmaceutical topical dosage form and bulk dose forms. The created approach was determined to be precise, accurate, linear, and stable because the results were found to be within the given range. KEYWORDS Itraconazole, Terbinafine HCl, UV spectrophotometric, Validation, Simultaneous estimation method, vierordt’s method
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Singh, N., P. Bansal, M. Maithani, and Y. Chauhan. "Development and validation of a stability-indicating RP-HPLC method for simultaneous determination of dapagliflozin and saxagliptin in fixed-dose combination." New Journal of Chemistry 42, no. 4 (2018): 2459–66. http://dx.doi.org/10.1039/c7nj04260d.
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Naik Desai Prabhat Prabhaker and Kapupara Pankaj. "Development and Validation of RP-HPLC Method for the estimation of Sofosbuvir and Ledipasvir in combined dosage form." International Journal of Research in Pharmaceutical Sciences 12, no. 1 (2021): 523–29. http://dx.doi.org/10.26452/ijrps.v12i1.4112.
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Nowadays scientists aim at developing generic and specific methods for drugs in combined pharmaceutical dosage forms. The main aim was to develop and carry out validation using precision and accuracy for Sofosbuvir and Ledipasvir by applying RP-HPLC method. The dosage form in fixed combination of Sofosbuvir-Ledipasvir helps in effective treatment of genotypes of chronic hepatitis C virus. This combination of Sofosbuvir-Ledipasvir was the first FDA approved direct acting antiviral to treat hepatitis C. Both the drugs were optimized using mobile phase as acetonitrile: 0.1% orthophosphoric acid (55:50v/v) with pH 3.0. The mobile phase was optimized at maximum wavelength of 283nm. The separation was achieved using C18 Cosmosil (4.6 x 250mm) column with a particle size of 5µ. The method was specific eluting retention times of 3.7 for Sofosbuvir and 6.0 for Ledipasvir. Intra and interday precision was carried and %RSD was found to be less than 2%. The results were found to be accurate with percentage recovery of 99.76% and 99.10% for Sofosbuvir and Ledipasvir respectively. Linearity was carried out in the concentration ranging from 40-200µg/mL and 9-45µg/mL for Sofosbuvir and Ledipasvir respectively. Both the drugs showed the regression coefficient of 0.999. Deliberate changes in flow rate, pH and wavelength were made and found that method was robust. The developed method was found to be accurate, simple, specific, robust and precise for the simultaneous estimation of Sofosbuvir and Ledipasvir in tablet dosage form.
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Krushi, Dadhaniya* Dr. Vikram Pandya. "A Review on Development and Validation of Analytical Methods for Simultaneous Estimation of Dapagliflozin, Linagliptin and Metformin in Pharmaceutical Dosage Form." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 4750–65. https://doi.org/10.5281/zenodo.15545251.
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A chronic metabolic disease called diabetes mellitus is typified by high blood glucose levels brought on by deficiencies in either insulin action or production, or both. It is still one of the most common and difficult worldwide health problems, and in order to obtain the best glycemic control, combination medication is frequently needed. Dapagliflozin (an SGLT2 inhibitor), linagliptin (a DPP-4 inhibitor), and metformin (a biguanide) are three pharmacological alternatives that have drawn a lot of attention because of their complimentary mechanisms of action and better patient outcomes when taken in combination therapy. Numerous analytical techniques for estimating these medications separately in pharmaceutical dosage forms and bulk have been reported. Additionally, many studies have utilized techniques like high-performance liquid chromatography (HPLC), UV-visible spectrophotometry, and high performance thin-layer chromatography (HPTLC) to describe validated methods for their binary combinations, such as dapagliflozin with metformin, linagliptin with metformin, and dapagliflozin with linagliptin. Nevertheless, a thorough examination of the literature shows that no analytical technique has been created or approved as of yet for the simultaneous measurement of metformin, linagliptin, and dapagliflozin in a single formulation. The published analytical techniques for both individual and binary mixes of these antidiabetic drugs are critically compiled and assessed in this study. The article also emphasizes the need and potential for creating a new, trustworthy, and strong analytical technique for their simultaneous measurement. Regular quality control, the development of fixed-dose combination (FDC) products, and regulatory compliance would all greatly benefit from such a technique. Future studies aimed at creating and validating a single analytical technique for this promising triple-drug combination in the management of type 2 diabetes mellitus will be built upon the results of this review.
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Sa'adah, Hayatus. "OPTIMASI FORMULA EKSTRAK JAHE MERAH (Zingiber officinale) DENGAN METODE KEMPA LANGSUNG MENGGUNAKAN ANALISIS SIMPLEX LATTICE DESIGN." Jurnal Ilmiah Manuntung 1, no. 1 (2017): 47. http://dx.doi.org/10.51352/jim.v1i1.11.
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Processing of medicinal plants into the appropriate dosage form can ensure security during use. It is a motivation in making acceptable dosage form which is easy and convenient to use, especially the manufacture of ethanol extract red ginger tablets using a combination of starch 1500 and amprotab.The study begins with the manufacture of dry extract of red ginger. Optimization of making tablets using a combination of starch 1500 and disintegrator with simplex lattice design using three formulas is done by direct compaction method. Further testing on the tablet hardness, friability and disintegration time.The results showed starch 1500 has a greater influence increase hardness and disintegration time of tablets, as well as lowering the fragility of the tablet. While the interaction of starch 1500 and disintegrator has no effect on the physical tablet. The optimum proportion of the combination of starch 1500 and disintegrator meet the physical requirements of tablets with a ratio of 4: 6 with 7.99 kg hardness, the friability of 0.32% and disintegration time of 2.42 minutes
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Davydova, V. V., E. F. Stepanova, A. M. Shevchenko, A. S. Chiriapkin, A. S. Pleten, and A. A. Prokopov. "Development of technology and study of combination tablets of prednisolone and loratadine with modified release." Russian Journal of Biotherapy 23, no. 2 (2024): 85–92. http://dx.doi.org/10.17650/1726-9784-2024-23-2-85-92.
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Background. Allergies are a global medical and social problem. According to international statistics, the number of allergic diseases has increased dramatically in recent decades. In recent years, the largest increase in the incidence of bronchial asthma, pollinosis and dermatoses has been noted. Currently, significant success has been achieved in understanding the causes and mechanisms of allergic inflammation and in forming approaches to the treatment of allergic diseases. Among second-generation antihistamines, loratadine, an effective antiallergic drug, is excreted. However, in the pharmaceutical market, the range of its dosage forms is small – the drug is available in the form of tablets, capsules and syrup. Prednisolone is a drug that quickly copes with an allergic reaction and helps prevent unwanted complications. In this regard, it is proposed to develop a tablet dosage form of a combined composition. Combined technology was used in the development of model compacted tablet formulations. The release and assay of active ingredients from model tablets of different compositions were determined using the Dissolution test and by high performance liquid chromatography, respectively.Aim. Development of loratadine and prednisolone tablets of the combined structure.Materials and methods. Combined technology was used in the development of model compacted tablet formulations. The release of the active ingredients from the tablets was confirmed by the Dissolution test in HCl dissolution medium (0.1 M). The assay of the active ingredients in the formulation was determined by high performance liquid chromatography.Results. The conducted studies made it possible to determine the composition of the combined tablets, which ensures the initial release of prednisolone and the subsequent release of loratadine. In the Dissolution test, the chosen model composition of tablets No. 1 provided release of 84.4 % prednisolone and 81.5 % loratadine, respectively, at the 10th and 30th minutes.Conclusion. The possibility of preparing a tablet dosage form providing a sequence of release of active substances has been demonstrated.
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Fares, R., L.A Bobritskaya, T.P Osolodchenko, and V.I. Grytsenko. "STUDY OF ANTIMICROBIAL ACTION OF COMBINED DOSAGE FORM FOR THE TREATMENT OF INTESTINAL INFECTIONS." Annals of Mechnikov Institute, no. 4 (December 2, 2016): 112–16. https://doi.org/10.5281/zenodo.192331.
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Intestinal infection (II) of various etiologies is among to the most widespread diseases in the world. The treatment regimen bacterial etiology involves the suppression of pathogenic and conditionally pathogenic with the restoration of the normal intestinal microflora. For effective antibiotic pharmacotherapy of intestinal infections are widely used drug combinations with the additionof nifuroxazide, as well as enzymatic and normalizing bowel motility broad-spectrum drugs. Intestinal antiseptics nifuroxazide characterized by broad spectrum of antibacterial action against Staphylococcus spp, Clostridium spp, E. coli, Salmonella spp, Shigellaspp, Proteus spp, Klebsiellaspp, Enterobacter spp, V. cholerae, H. pylori, Yersinia spp, and also the lack of effect on the normal intestinal flora, high safety profile. Recently, for the treatment of intestinal infections nifuroxazide often combined with pre- and probiotics for complex correction of the intestinal microflora disorders. For complex therapy of intestinal infections, we have developed an original combined medicine "Diaplant", in the form of capsules, comprising as active ingredients nifuroxazide (200 mg) in combination with plant substance plantaglucide (200 mg). Plantaglucide drug obtained from Plantago major has spasmolytic, antimicrobial and anti-inflammatory activity, normalizes bowel peristalsis, while reducing the tone of smooth muscles of the stomach and intestines, reduces swelling folds of the gastric mucosa, and contained therein polysaccharides in the form of pectins have properties of prebiotic and have immunostimulatory effects. Aim of the work – study of antibacterial action of combined drug "Diaplant" containing nifuroxazide and plantaglucide in regard to test strains and clinical strains of microorganisms allocated from patients with bacterial diarrhea. Materials and methods. Estimation of antimicrobial activity was performed under conditions in vitro by method of serial dilutions. The object of research is a combined drug " Diaplant ", a reference drug"Enterofuril" manufacture of ("Bosnalijek" Bosnia and Herzegovina). For the evaluation of drugs samples activity used the following test strains: Staphylococcus aureus ATCC 25923, Escherichia coli ATCC 25922, Basillus subtilis ATCC 6633, Proteus vulgaris ATCC 4636, Pseudomonas aeruginosa АТСС 27853, Candida albicans ATCC 885/653. Clinical material comes from the Center of medical and environmental research to the bacteriological laboratory. Was allocated and identified 109 strains of conditionally pathogenic microorganisms. Results and its discussion. For clinical and test strains S. aureus MIC indicators for combined drug «Diaplant" were 15.0 mg / l, whereas the reference drug "Enterofuril" MIC equaled 30.0 mg / l. For E. coli - MIC indicators for combined drug «Diaplant" was 7.5 mg / l, for an "Enterofurila" - 15.0 - 30 mg \ l. MIC for combined drug "Diaplant" against different clinical strains of Enterobacteriaceae species ranged from 15.0 mg / l to 30.0 mg / l in comparison with "Enterofurilom", where the MIC was 30mg / l - 60mg / l. For yeasts and clinical strains C.albicans MIC combination drug "Diaplant" product is 15.0 mg / l, whereas equal to 30.0 mg / l for the control drug "Enterofuril" MIC. For test strains, such as P. aeruginosa ATCC 27853, P. vulgaris ATCC 4636, MIC "Diaplant" drug was 100.0 mg / l, whereas control drug "Enterofuril" MIC was above > 100.0 mg / l. For clinical strains of P. mirabilis and P. vulgaris MIC "Diaplant" was 30.0 mg / l, whereas the MIC "Enterofuril" equal to 60.0 mg / l. For clinical P. aeruginosa strains MIC "Diaplant" was 100.0 mg / l, whereas control drug "Enterofuril" MIC was above > 100.0 mg / l. It has been established that 80-95% of clinical microbial strains showed sensitivity to combined preparation "Diaplant". The highest index of sensitivity has next strains: S. aureus - 92,8% of strains, S. epidermidis - 100% of the strains, E. coli (lactose-negative) - 100% of the strains, K. pneumoniae, and K. mobilis 85-87% of the strains. Conclusions. 1. As a result of the conducted research was found, that the combined drug "Diaplant", containing as active ingredients nifuroxazide in combination with herbal substances plantaglucide, has a pronounced antibacterial activity against the reference strains and clinical strains of microorganisms, the main pathogens of bacterial diarrhea. 2. Plantaglucide substance which is part of the capsules is enhances the antimicrobial effect nifuroxazide at the expense of its own antibacterial properties of phenolic compounds, polysaccharides and their possible synergies.
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Rollando Rollando, Mauren Engracia, Eva Monica, and Siswadi Siswadi. "Immunomodulatory Activity Test of Syrup Dosage Form of Combination Phyllantus niruri Linn. And Sterculia quadrifida R.Br. Extract." International Journal of Research in Pharmaceutical Sciences 11, no. 1 (2020): 191–99. http://dx.doi.org/10.26452/ijrps.v11i1.1806.
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Meniran (Phyllantus niruri Linn.) is used generally as an immunomodulator and hepatoprotector. Empirically, bark of faloak (Sterculiaqudrifida R.Br.) is used as a medicinal plant to cure diseases such as hepatitis, gastroentritis, and diabetes. The combination of meniran extract and bark of faloak extract has the potential as a natural immunomodulatory agents. Immunomodulators are compositions of either recombinant, synthetic, or natural, which can restore the immune system. Therefore it is necessary to optimize the optimal formula in obtaining syrup preparations which have optimal immunomodulatory activity. The aim of this study was to find out the optimal syrup combination of meniran extract and faloak bark extract to produce optimal response values in the in vitro immunomodulatory activity test with TNF-α and NF-κB parameters, and immunomodulatory activity tests in vivo with activity parameters macrophages. The extract was obtained through reflux extraction. The results of the extract were formulated and approved to determine their ability to induce TNF-α and NF-κB, and in the test of mice balb/b (Mus musculus L.) orally for 21 days. The lymph organs were isolated, rinsed with an RPMI-1640 solution, and analyzed using ELISA reader 450 nm. The determination of optimal formulas is done by using Rstudio v.3.5.3 software with ANOVA test parametric test and using Design Expert v.11 software using the Simplex Lattice Design (SLD) method. The results showed that the formula for the preparation of combination syrup to produce results induced TNF-α and NF-κB, and macrophage activity, namely the formula using meniran and faloak 0.96993: 0.0300704.
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S. Jabbar, Mohammed, and Yehia I. Khalil. "Formulation of Metoprolol Bilayer Tablets as an Oral Modified Release Dosage Form." Iraqi Journal of Pharmaceutical Sciences ( P-ISSN: 1683 - 3597 , E-ISSN : 2521 - 3512) 19, no. 1 (2017): 21–30. http://dx.doi.org/10.31351/vol19iss1pp21-30.
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Metoprolol is a β1 adrenergic blocker used in treatment of heart diseases. Metoprolol (100mg) tablets was formulated as a modified release oral system utilizing the concept of bilayer system, first layer contained (30mg) as immediate release and the other (70mg) in the sustained release matrix. The immediate release layer consisted of lactose or microcrystalline cellulose as diluents with sodium starch glycolate or sodium croscarmellose as disintegrants. The result showed that the layer contains microcrystalline cellulose and 2% sodium starch glycolate gave disintegration time similar to that of conventional metoprolol tartrate tablet. This result was subjected in the subsequent preparation of the bilayer tablet. The sustained release layer was prepared using three polymers: ethylcellulose (EC), Hydroxypropyl methylcellulose (HPMC) and hydroxyl ethylcellulose (HEC) as retardant materials. It was found that the combination of EC with HPMC in ratio of 2:1 in F11 was best formula because of it’s release profile and the tablet integrity and dimensions were conserved for the period of the test, but according to similarity factor (f Â2Â), F15 (which contained EC:HPMC in ratio 2:1 with polyvinyl pyrrolidone (PVP) as a binder) was the best formula showed higher (f2Â) among all other formulas and equals to 72.3 comparing to reference product.
 Key words: Metoprolol, Bilayer tablet, Immediate release, Sustained release.
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Hertrampf, A., R. M. Sousa, J. C. Menezes, and T. Herdling. "Semi-quantitative prediction of a multiple API solid dosage form with a combination of vibrational spectroscopy methods." Journal of Pharmaceutical and Biomedical Analysis 124 (May 2016): 246–53. http://dx.doi.org/10.1016/j.jpba.2016.03.003.
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Chhalotiya, Usmangani K., Kashyap K. Bhatt, Dimal A. Shah, Gautam R. Chauhan, and Sunil L. Baldania. "Development of LC Method for the Simultaneous Determination of Antidepressant Drug Combination Melitracen Hydrochloride and Flupentixol Dihydrochloride in their Combined Dosage Form." Chromatography Research International 2011 (June 16, 2011): 1–6. http://dx.doi.org/10.4061/2011/632820.
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A simple, specific and stability-indicating reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of melitracen hydrochloride and flupentixol dihydrochloride in tablet dosage form. A Brownlee C-18, 5 μm column having 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.025 M potassium dihydrogen phosphate: methanol (10 : 90, v/v; pH 7.3) was used. The flow rate was 1.0 mL/min, and effluents were monitored at 230 nm. The retention times of melitracen hydrochloride and flupentixol dihydrochloride were 7.75 min and 5.50 min, respectively. The linearity for melitracen hydrochloride and flupentixol dihydrochloride were in the range of 0.5–60 μg/mL. The recoveries obtained for melitracen hydrochloride and flupenthixol dihydrochloride was 99.81–100.77% and 99.42–100.12%, respectively. Both the drugs were subjected to acid and alkali hydrolysis, chemical oxidation, and dry heat degradation and photodegradation. The proposed method was validated and successfully applied to the estimation of melitracen hydrochloride and flupentixol dihydrochloride in combined tablet dosage form.
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Faizan, Khorajiya* Dr. Khushbu Patel Khushbu Patel Dr. C. N. Patel. "Review Of the Combination Dosage Form of Sitagliptin Phosphate Monohydrate and Dapagliflozin Propanediol Monohydrate as an Anti-Diabetic Agent." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 2020–27. https://doi.org/10.5281/zenodo.15391282.
Full textAbstract:
Sitagliptin acting as Anti-Diabetic agent (Dipeptidyl peptidase-4 inhibitor) which boosts post prandial insulin release decreases Glucagon secretion and lower mean time as well as fasting blood glucose in type 2 diabetes mellitus. There is a strong rationale for combining a DPP-4i and a SGLT2i in patients with T2D because the two drugs exert different and complementary glucose-lowering effects. Dual therapy (initial combination or stepwise approach) is more potent than either monotherapy in patients treated with diet and exercise or already treated with metformin. This agent is used in combination with other oral hypoglycemic agents. Dapagliflozin acts as Sodium Glucose cotransporter-2(SGLT2) inhibitor. This agent is used in combination with diet and exercise to improve glycemic control in adult with type -2 diabetes mellitus. SGLT2 is major transporter of glucose whose inhibition induces glycosuria and lower blood sugar in type 2 diabetes mellitus. [2] According to the clinical trial Study of World Evidence with SGLT2 and DPP4 in Type2 diabetes mellitus patients in Spain which shows beneficial positive effect on patient of Diabetes Mellitus (Type-2) at the close level of 5-10 mg of Dapagliflozin and 50-100 mg of Sitagliptin. Cardiovascular disease remains the leading cause of mortality in patients with diabetes. Sodium-glucose cotransporter 2 inhibitors and dipeptidyl peptidase-4 inhibitors reported to have positive CV outcomes; especially, combination therapy with dapagliflozin and sitagliptin seem to be suitable therapeutic option. This review discusses introduction, chemistry, pharmacology, pharmacokinetic, rationale and clinical utility of combination therapy with dapagliflozin and sitagliptin in improving glycemic control and reducing cardiovascular events in patients with type 2 diabetes mellitus with multiple cardiovascular risk factors.
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W. Ameen, Dina. "Development and in vitro Evaluation of Bioadhesive Vaginal Tablet using Econazole Nitrate as a Model Drug." Iraqi Journal of Pharmaceutical Sciences ( P-ISSN: 1683 - 3597 , E-ISSN : 2521 - 3512) 20, no. 1 (2017): 57–65. http://dx.doi.org/10.31351/vol20iss1pp57-65.
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In this study, a bioadhesive dosage form of eoconazole nitrate for vaginal delivery was designed using a combination of bioadhesive polymers: Carbopol 941 p and sodium carboxymethylcellulose or methylcellulose in different ratios. The bioadhesive strength was evaluated by measuring the force required to detach the tablet from sheep vaginal mucosal membrane. It was found that the bioadhesive force was directly proportional to Carbopol 941 p content in the different formulae. The formulae were tested for their swelling behavior using agar gel plate method. The results showed that formulae containing a combination of Carbopol 941 p and sodium carboxymethylcellulose had greater swelling index than those containing a combination of Carbopol 941 p and methylcellulose. In vitro drug release study showed that the release of eoconazole nitrate from Formulae containing sodium carboxymethylcellulose was faster than its release from those containing methylcellulose.The dissolution profiles of the formula containing Carbopol 941 p alone and those conaining various combinations of Carbopol 941 p and methylcellulose could be considered similar since their calculated similarity factor values were >50. Formula F3 composed of CP/NaCMC in a ratio 1:1 showed moderate swelling, good bioadhesion and retardation of drug release. Thus, it may be considered a good candidate for vaginal bioadhesive dosage forms.
 Key words: Bioadhesive, econazole nitrate, vaginal tablet
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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.