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1
Babita Himmatrao More, Vaibahavi Pradeep Shirke, Aditya Sanjeev Bhambure, and Rupali Rajesh Tasgaonkar. "Duocapsule and alternative shell material to gelatin: Advancement in capsule formulation." World Journal of Biology Pharmacy and Health Sciences 13, no. 2 (2023): 221–27. http://dx.doi.org/10.30574/wjbphs.2023.13.2.0076.
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Owing to broad advantages like self-medication, unit dosage form, and patient compliance, cost effective, limited interaction with the excipients and possibility of mask the unpleasant taste, capsules are the most extensively recognized conventional solid dosage form after Tablet. In the world of Novel drug delivery system to overcome the disadvantages of conventional delivery system modifications are made in the capsule to develop a product of higher selectivity for medical treatment like the capsules that facilitates the controlled drug delivery, sustained and targeted release profiles with its own benefits as conventional dosage form. The advancement in capsules has led to the formation of different types of capsule formulations such as tablets in capsules, pellets in capsule and the capsule in another capsule, liquid in capsule products and pellets in capsule formulations. This article aims to highlights the advancement in the capsule system, particularly Duocapsules and capsules with capsule shell prepared with alternative shell material to gelatin. The Duo capsule is also called as capsule in capsule formulation as it contains two capsules one with the bigger size containing the smaller sized capsule inside it with different or same formulations in various forms such as liquids, solids, powders, tablets, pellets etc. The article mainly focuses on the different applications, advantages, formulation consideration, and applicable drugs of duo capsules. Considering the challenges invovled in manufacturing the gelatin shell and unstability of in different climatic conditions, the present article also emphasizes on the formulation development in capsule system with alternative polymers to the gelatin like HPMC, starch and PVA copolymer capsule shells.
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Babita, Himmatrao More, Pradeep Shirke Vaibahavi, Sanjeev Bhambure Aditya, and Rajesh Tasgaonkar Rupali. "Duocapsule and alternative shell material to gelatin: Advancement in capsule formulation." World Journal of Biology Pharmacy and Health Sciences 13, no. 2 (2023): 221–27. https://doi.org/10.5281/zenodo.8026808.
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Owing to broad advantages like self-medication, unit dosage form, and patient compliance, cost effective, limited interaction with the excipients and possibility of mask the unpleasant taste, capsules are the most extensively recognized conventional solid dosage form after Tablet. In the world of Novel drug delivery system to overcome the disadvantages of conventional delivery system modifications are made in the capsule to develop a product of higher selectivity for medical treatment like the capsules that facilitates the controlled drug delivery, sustained and targeted release profiles with its own benefits as conventional dosage form. The advancement in capsules has led to the formation of different types of capsule formulations such as tablets in capsules, pellets in capsule and the capsule in another capsule, liquid in capsule products and pellets in capsule formulations. This article aims to highlights the advancement in the capsule system, particularly Duocapsules and capsules with capsule shell prepared with alternative shell material to gelatin. The Duo capsule is also called as capsule in capsule formulation as it contains two capsules one with the bigger size containing the smaller sized capsule inside it with different or same formulations in various forms such as liquids, solids, powders, tablets, pellets etc. The article mainly focuses on the different applications, advantages, formulation consideration, and applicable drugs of duo capsules. Considering the challenges invovled in manufacturing the gelatin shell and unstability of in different climatic conditions, the present article also emphasizes on the formulation development in capsule system with alternative polymers to the gelatin like HPMC, starch and PVA copolymer capsule shells.
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Sonar, Shivani, Sheetal Gondkar, and Ravindranath B. Saudagar. "Liquid Filled Hard Gelatin Capsule." Journal of Drug Delivery and Therapeutics 9, no. 3-s (2019): 832–35. http://dx.doi.org/10.22270/jddt.v9i3-s.2794.
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Novel dosage forms emerges more and more in recent years. One of them is liquid-filled hard gelatin capsules, which have gelatin or the hydroxypropyl methyl cellulose (HPMC) as capsule shell. The liquid-filled hard gelatin capsule is gradually getting attention because of its new-concept dosage form design, which bring liquid drugs by solid form. The paper mostly presents application, pharmaceutical manufacturing, quality assessment, vision of liquid-filled hard gelatin capsules and emphases on the application and pharmaceutical manufacturing of liquid-filled capsule. It is recommended that the capsule is suitable for many liquid or semi-solid natural plant extract and achieve different release profiles. The preparation adopted liquid-filled hard capsules technology. The impact factors concluded property of shell and device of filling. The quality was frequently evaluated by moisture content of capsule shell, dissolution rate. At the same time, it was pointed out that the new dosage form has remarkable marketing prospect and bring profits for enterprises. Keywords: Liquid filled capsule, Capsule Shell, Gelatin, HPMC, Dissolution rate.
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Pervaiz, Fahad, Sana Ali Zahra, Fariah Qaiser, Syeda Komal Fatima, and Rabbia Mazhar Khan. "Characterization and Evaluation of Capsules and Study of QC tests for Capsules." Global Pharmaceutical Sciences Review III, no. I (2018): 7–18. http://dx.doi.org/10.31703/gpsr.2018(iii-i).02.
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Using the capsule as a dosage form dates back to the early pharmacy days; from those days, the capsule preparation process is greatly evolved in order to meet the current needs of patients and the pharmaceutical industry. Currently, all pharmaceutical industries are making a dynamic change in the specifications of particular dosage forms such as capsules. It has become more difficult to obtain the higher valued drug product from the dosage form, along with the potential for improved delivery that can improve clinical outcomes. In addition, the capsules have played a significant role in drug development because of the hand filling or the production of semiautomatic capsular formulations, which have fewer requirements, and can be developed easily. The article will discuss different tests like Universal tests and specific tests, particularly for capsules, performed prior to the release of the batch to ensure efficacy and safety.
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S.G.Gavande, R.O.Sonwane A.D.Pichkewar S.S.Dorik. "REVIEW ON IMMEDIATE RELEASE DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 04 (2019): 8509–18. https://doi.org/10.5281/zenodo.2652693.
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<em>Most popular immediate release dosage forms such as tablet, capsule and pellet.</em><em> Because of its convenience of self-administration, and simple to the manufacturing. The type of dosage from is some advantages such as improved stability of formulation. Improved bioavablity of Product. Rapid onset action and cost effective as compare to other dosage formulation. They disintegrant are selected as type of dosage and physical characteristics of drugs. </em><em>The basic approach used in development tablets, capsule and pellet as the use of some excipient like superdisintegrants, Bulking agent, Emulsifying agent, Binders, Lubricants, Flavouring and Sweetening agent As a drug entity nears the end of its patent life, it is common for pharmaceutical manufacturers to develop a given drug entity in a latest and improved dosage form.</em> <em>The manufacturing of Immediate release tablet, capsule and pellet they using various method such as, Tablet Modling, Wet Granulation, Direct Compression, Solid Dispersion. capsule Direct filling, wet Granulation, and pellets Extrusion, Sphronization, Globulation, Spray Drying, Spray congealing, Compression.</em> <strong>Key Words</strong>:- <em>Immediate Release, Superdisintigrent, Conventional Techniques.</em>
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Semchenko, K. V., and L. I. Vyshnevska. "Methodological approaches to the development of the capsules «Phytohelmin» composition." Farmatsevtychnyi zhurnal, no. 6 (December 9, 2020): 78–85. http://dx.doi.org/10.32352/0367-3057.6.20.08.
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The existing range of medicines is represented by a variety of dosage forms. Among them a significant proportion takes oral solid dosage forms, in particular capsules. The introduction of active pharmaceutical ingredients in the capsule composition does not require the addition of flavouring agents and requires a significantly lower amount of excipients compared to the formation of tablet dosage forms.
 In the development of dosage forms based on extracts of medicinal plants, the rational choice of the dosage form is important. The use of capsules allows making a composition of several extracts, providing the proper consumer characteristics of the finished product.
 The aim of the workis to study methodological approaches to the development of the drug «Phytohelmin», proposed for use in the 3rd phase of the treatment of helminthiasis of the digestive system.
 As the objects of research scientific works of domestic and foreign authors, databases and own findingswere selected. When conducting the own research, we used methods of bibliosemantic analysis, systematization and generalization of data.
 Capsules are characterized as a dosage form: the definition, classification, features, advantages and disadvantages are presented. When developing a medicine for the treatment of helminthiases of the digestive system in phase III (eliminating the consequences of the disease and restoring the functions of the gastrointestinal tract), we selected the solid capsule dosage form. We present a decision tree for 6 stages of choosing the medicinal plant material to justify the capsule composition under the conditional name «Phytohelmin».
 7 Degrees of the general algorithm for pharmaceutical development of capsules are described and solutions for each stage directly for the capsules of the proposed composition are given.
 Based on the results obtained, the main methodological approaches to the development of drugs in the form of capsules are formulated, in particular, capsule characteristics and classification are given, and the advantages and disadvantages of this dosage form are analyzed. The tree of decisions on the choice of medicinal plant materials in the development of medicines and the final composition of the capsules «Phytohelmin», obtained on the basis of its application, is given. The general algorithm for the pharmaceutical development of capsules and the corresponding solutions for the development of «Phytohelmin» capsules based on it in accordance with the requirements of Guide 42-3.1: 2004 «Quality Guide. Medications. Pharmaceutical Development» is described.
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Kotov, S.A., and T.M. Gontova. "Standardization of the dosage form for the combined herbal medicine with anti-allergic activity." Annals of Mechnikov Institute, no. 4 (December 14, 2022): 42–51. https://doi.org/10.5281/zenodo.7436777.
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<strong>Introduction</strong>. The creation of a combined herbal preparation with anti-allergic action is an urgent task, it is supported by a wide base of herbal drugs for the creation of the future medicine, a wide range of biologically active substances in their original form, low toxicity and the practical absence of side effects. Such an object is the developed combined plant extract based on the composition of herbal drugs – bur-marigod herb, calendula flowers and hawthorn leaves and flowers - in a ratio of 6:3:1. <strong>The aim of the work</strong> was to standardize the dosage form of a combined herbal medicine (hard gelatine capsules), to develop methods of their quality control. <strong>Materials and methods. </strong>The combined herbal preparation of anti-allergic action with a filler of 50% microcrystalline cellulose was developed according to the utility model patent. Samples of capsules containing the combined drug were obtained using a manual capsule machine. The capsule mass was placed in a hard gelatine capsule, size #0, cylindrical in shape with a transparent body and a transparent lid. Study of flowability, bulk density and tapped density of the capsule mass was carried out according to the methods of State Pharmacopeia of Ukraine (SPhU<em>), 2.9.16, 2.9.34</em>. Analytical scales ES225M-DR manufactured by «Preisa Gravimetrics AG», Switzerland and a drying cabinet 2B-151 manufactured by «Odessa Medical Laboratory Technology» were used to determine the loss on drying. Determination of the dissolution of capsules was carried out on a dissolving device for tablets and capsules SOTAX AT-7 (Switzerland). Qualitative analysis was carried out using the method of thin-layer chromatography according to the national monographs of the SPhU "Bur-marigold herb" and "Calendula flowers". As external standards, pharmacopoeial standard samples (caffeic acid, hyperoside, chlorogenic acid, rutin, luteolin, luteolin-7-glycoside, calendulosides), as well as extracts of bur-marigold, calendula, hawthorn and combined dry extract were used. The total content of polyphenolic compounds was determined using a modified Folin–Ciocalteu reactive spectrophotometry method. Pyrogallol was used as a standard sample, which the content of polyphenols was calculated. Validation studies of quantitative determination method were carried out in accordance with the requirements of the general article SPhU 2.4, <em>5.3.N.2</em> "Validation of analytical methods and tests<strong>". Results & discussion. </strong>The loss on drying of the obtained capsule mass was 4.89+0.03% which ensured satisfactory flowability of the capsule mass and its stability during storage. During the study of the technological characteristics of the obtained capsule mass, the following results were obtained: bulk density - 0.571 g/cm<sup>3</sup>; tapped density - 0.714 g/cm<sup>3</sup>; compressibility index (Carr Index) – 20%; the Hausner ratio – 1.25; flowability – 11.11 g/s, which met the requirements of the SPhU <em>2.9.16. 2.9.34. 2.9.36.</em> The identification of capsules was carried out by TLC method, using for this purpose the capsule mass obtained by determining the average mass of the contents of the capsules. When conducting a TLC test in the conditions of the national monograph "Bur-marigold herb" to detect the zones of flavonoids and hydroxycinnamic acids, characteristic zones of the extracts of bur-marigold, calendula and hawthorn were found in the chromatogram of the capsule mass. During the identification of triterpene compounds in the capsule mass under the conditions of Identification method D of the national monograph "Calendula flowers", 2 purple zones were found, which coincided in color and location with the corresponding zones on the chromatogram of the reference standard solution of calendulosides. It was found that the average weight of the capsules was 0.609734 ± 0.0102 g, the deviation from the average weight was in the range from 0.18% to 2.75%, the maximum deviation during the analysis of the tested capsules was 2.75%, which met the requirements of the SPhU, <em>2.9.5</em>. Determination of dissolution was carried out on a device with a basket, the speed of rotation of the basket - 100 revolutions/min, 500 ml of water was used as a dissolution medium, the temperature of the medium was (37 ± 0.5) °С. 6 capsules were placed in the device, after 45 minutes, 10 ml of the solution was taken from each vessel, filtered, discarding the first 5 ml and then quantitative determination of polyphenols was carried out. As a result, it was found that the amount of active substance released into the dissolution medium within 45 minutes was at least 93% (average for 6 capsules – 96.5%), which met the requirements of the SPhU, <em>2.9.3</em>. Quantitative determination of polyphenols was carried out by the spectrophotometric method (SPhU, <em>2.2.25</em>). The development and validation tests were carried out on the capsule mass obtained by determining the content of 20 capsules. During the validation studies, the following metrological characteristics were checked: specificity, linearity, accuracy, precision and intra-laboratory precision. It was found that the method of quantitative determination of polyphenols met the requirements of SPhU 2.4, <em>5.3.N.2</em> according to all the studied validation characteristics. The content of total polyphenols in the preparation, in terms of pyrogallol, is regulated to be at least 12 mg in one capsule. <strong>Conclusions. </strong>The parameters of standardization of the dosage form for the combined herbal medicine with antiallergic activity have been developed. The pharmaco-technological characteristics of the capsule mass and capsules were studied according to the indicators that are mandatory and regulated by the requirements of the SPhU. A complex of physico-chemical methods of analysis has been developed, which allows systematic support for the pharmaceutical development of developed capsules. The validation characteristics of the method for the quantitative determination of polyphenols in accordance with the requirements of the SPhU were studied.
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Hussein, Ali N., Ahmed M. J. Jehan Yin, and Murtada M. Hasan. "Determination of Tetracycline in Capsule Dosage Form." International Journal of Drug Delivery Technology 10, no. 03 (2020): 465–67. http://dx.doi.org/10.25258/ijddt.10.3.28.
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Background: Tetracycline antibiotic is widely prescribed that encourages the finding of rapid and reliable protocol for the determination of tetracycline hydrochloride in hard gelatine capsules. Recently, the standard addition method is used commonly with the aid of a UV-visible (UV-vis) spectrophotometer for such purpose. In this work, the authors aim to quantify the percent assay of Apcycline-250 capsules utilizing the standard addition protocol. Methods: Twenty filled and emptied capsules were weighed and an equivalent amount of 50 mg of tetracycline hydrochloride was diluted, filtered, and an appropriate standard was spiked and prepared for assay. Results: The λmax was found to be 348 nm and the absorbance vs. concentration standard addition curve was plotted for tetracycline hydrochloride capsules. This curve shows good linearity (R2 = 0.9994). The limit of detection (LoD) and limit of quantification (LoQ) were observed as 0.007937 and 0.02646, respectively. While the percent assay was 103.2%. Conclusion: The authors conclude that the standard addition technique is a reliable method to conduct rapid, economical, and validated day-by-day analyses work of tetracycline hydrochloride hard gelatine capsules.
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Shah, Dimal A., Akash Patel, Sunil L. Baldania, Usmangani K. Chhalotiya, and Kashyap K. Bhatt. "Simultaneous Estimation of Pantoprazole Sodium and Levosulpiride in Capsule Dosage Form by Simultaneous Equation Spectrophotometric Method." ISRN Spectroscopy 2013 (May 9, 2013): 1–4. http://dx.doi.org/10.1155/2013/459820.
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A simple, accurate, and precise spectrophotometric method was developed for simultaneous estimation of pantoprazole sodium and levosulpiride in capsule dosage form. Simultaneous equation was developed at 290 and 232 nm. The method was found to be linear in the range of 4–12 μg/mL for pantoprazole sodium and 8–20 μg/mL for levosulpiride while accuracy of the method was confirmed by recovery studies of capsule dosage form and was found to be 100.23–100.99% and 100.51–100.94% for pantoprazole sodium and levosulpiride, respectively, in their capsule dosage form. The proposed method was validated and found to be accurate and precise. The method was successfully applied for the estimation of pantoprazole sodium and levosulpiride from their capsule dosage form.
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Gupta, Shallini, Kanika Khajuria, Niraj Kumar, and Vijay Khajuria. "Evaluation of capsule labelling for its wall contents as gelatin or non gelatin." International Journal of Basic & Clinical Pharmacology 7, no. 7 (2018): 1387. http://dx.doi.org/10.18203/2319-2003.ijbcp20182687.
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Background: Capsules are the most commonly used solid drug dosage form and are made up of gelatin or non gelatin. Currently the gelatin based capsules drug formulations are more used. However, current issue of vegetarian and non vegetarian capsules has come up due to recent Indian government initiative to promote vegetarian capsules.Methods: There were 100 capsule dosage forms were examined for the gelatin or HPMC wall contents and nature of medicine contained in capsules, whether ayurvedic or allopathic.Results: Out of 100 capsules studied 55 had gelatin wall base while 25 had HPMC and 20 capsule labels did not mention the nature of capsule wall constituent. Out of 55 gelatin capsules 30 were of allopathic while 25 capsules were of ayurvedic medicines. Among HPMC, 15 were ayurvedic while 10 allopathic. 20 capsules had no mention of its constituent and among these non labelled capsule formulations had 11 from ayurvedic and 9 from allopathic medicines.Conclusions: The current study revealed that gelatin capsules forms bulk in Indian market. Even the gelatin capsules contained ayurvedic medicines while 10% of HPMC capsules contained allopathic medicines. Non labelled capsules formed 20% of total capsules. These findings suggest wider scope for promotion of HPMC based capsules.
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Abolin, Craig, Dar-Shong Hwang, and Frank Mazza. "Bioavailability of Temazepam: Comparison of Four 7.5-mg Capsules with a Single 30-mg Capsule." Annals of Pharmacotherapy 27, no. 6 (1993): 695–99. http://dx.doi.org/10.1177/106002809302700602.
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OBJECTIVE: To compare the bioavailability of four temazepam 7.5-mg capsules (Restoril, Sandoz Pharmaceuticals) with that of a single temazepam 30-mg capsule. DESIGN: Single-dose, open-label, two-period, crossover (replicated Latin square). SETTING: Domiciled environment for clinical testing. PARTICIPANTS: Twenty-six healthy male volunteers aged 18–40 years; 25 completed the study. INTERVENTIONS: Subjects randomly received either four temazepam 7.5-mg capsules or one temazepam 30-mg capsule. Blood samples were drawn at various time points after each period (0-48 h), and analyzed for plasma concentration of temazepam. The washout period between doses was five days. MAIN OUTCOME MEASUREMENTS: Five parameters of both dosage forms were compared: (1) area under curve (AUC), (2) peak concentration (Cmax), (3) time to peak concentration (Tmax), (4) apparent rate constant for absorption, and (5) lag time for appearance of drug in plasma. Statistical procedures included ANOVA, power analysis, and confidence limits. RESULTS: The mean AUC for the four 7.5-mg capsules and one 30-mg capsule differed by less than 2 percent and the mean Cmax differed by less than 14 percent for the two dosage strengths; neither of these differences reached statistical significance (p>0.05). The 7.5-mg capsules reached peak plasma concentrations significantly faster than the 30-mg dosage form (mean Tmax 1.18 and 1.73 h, respectively; p=0.01). CONCLUSIONS: The two formulations of temazepam were bioequivalent with respect to the extent of bioavailability. Regarding the rate of absorption, however, the 7.5-mg capsules reached peak plasma concentrations significantly faster than the 30-mg dosage form.
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Prabahar, A. Elphine, B. Thangabalan, R. Kalaichelvi, and P. Vijayaraj Kumar. "UV Spectrophotometric Estimation of Acipimox inBulk and Capsule Dosage Form." E-Journal of Chemistry 6, no. 4 (2009): 1117–20. http://dx.doi.org/10.1155/2009/790531.
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A new simple, rapid, accurate, sensitive and precise spectrophotometric method in ultra violet region has been developed for determination of acipimox (ACX) in bulk and capsule dosage form. Acipimox exhibited maximum absorbance at 231 nm with apparent molar absorptivity of 1.5104 × 104in distilled water. Beer’s law was found to be obeyed in the concentration range 1-10 μg mL-1. Correlation coefficient was found to be 0.9998. The developed method was validated respect to linearity, precision, accuracy. The proposed method is useful for the routine estimation of ACX in bulk and capsule dosage form.
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Mahrous, Mohamed S., Magdi M. Abdel-Khalek, and Mohamed E. Abdel-Hamid. "Colorimetric determination of two fenamates in capsule dosage form." Talanta 32, no. 8 (1985): 651–53. http://dx.doi.org/10.1016/0039-9140(85)80161-2.
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Sonar, S. P., S. B. Gondkar, and R. B. Saudagar. "Formulation and Evaluation of Liquid Filled Hard Gelatin Capsule of Febuxostat." Journal of Drug Delivery and Therapeutics 9, no. 5 (2019): 105–9. http://dx.doi.org/10.22270/jddt.v9i5.3579.
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Liquid filled hard gelatin capsule are well recognized as a solid dosage form for convenient administration of drugs orally in a liquid form. This liquid composition available help the most challenging drug compounds in capsules has increased significantly in recent years. The drugs which have low solubility, poor bioavailability, low melting point, critical stability are the perfect candidate for liquid filling in capsule. The current study presents the formulation aspects, filling and sealing aspects of capsule, evaluation parameters of the liquid filled hard gelatin capsule using Febuxostat as drug, oils (Arachis oil, Coconut oil, Olive oil) as solvents, Glyceryl monostearate as solubilizing agent, Butylated hydroxy toluene as antioxidant, Methyl paraben & Propyl paraben as preservatives. A capsule formed F3 formulation shows maximum drug release and drug content among all the formulations.
 Keywords: Liquid filled hard gelatin capsule, Febuxostat, Arachis oil, Coconut oil, Olive oil, Glyceryl monostearate, Butylated hydroxy toluene, Methyl paraben, Propyl paraben.
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Rushikesh, B. Gadekar. "A Comprehensive Review On: Capsule." International Journal in Pharmaceutical Sciences 2, no. 10 (2024): 307–20. https://doi.org/10.5281/zenodo.13895858.
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Capsules are a popular dosage form due to their stability, ease of administration, attractiveness, and compounding capabilities. They can be customized to meet individual patient needs and can incorporate multiple drugs. Special capsules can be prepared outside the norm of powders. Gelatine is widely used as a capsule shell material for hard and soft gelatine capsules. However, due to its animal origin and cross-linking properties, other non-animal materials like hydroxyl propyl methyl cellulose, starch, and poly vinyl alcohol copolymer are needed to meet the dietary and cultural needs of vegetarian patients and comply with regulatory requirements.
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Palwinder, Singh* and Rajeev Garg. "FAST DISSOLVING ORAL FILMS: A NOVEL TREND IN DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 05 (2018): 4571–78. https://doi.org/10.5281/zenodo.1256824.
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Oral routes are most commonly preferred route for drug delivery. Commonly used oral dosage forms are tablet and capsules. But many patients such as geriatric, paediatric and dysphasic patients find difficulty in swallowing conventional tablet and capsule. To overcome the problems related to swallowing, Fast dissolving Tablets (FDTs) were designed in early 19th century and hence further advancement has led to development of Fast Dissolving Oral Films (FDOFs). Many pharmaceutical groups are focusing their research on rapid dissolving technology. FDOFs technology is gaining much attention. This technology has been used for local action as well as rapid release products. The fast dissolving oral films may compose of various Active pharmaceutical ingredients (API), film forming polymers, plasticizer, flavours, colours and sweeteners. Now a day, such types of films became a novel and widely accepted technology for delivering OTC and prescription medication too. Keywords: Introduction, Advantages, Disadvantages, Formulation Ingredients, Method Of Preparation, Patented Technologies
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Putri, Syakirah Yasmin, Dewi Isadiartuti, M.Si., Apt., Isnaeni Isnaeni, et al. "The Effectiveness of Vitamin E Soft Capsules as an Antioxidant." Berkala Ilmiah Kimia Farmasi 11, no. 1 (2024): 5–11. http://dx.doi.org/10.20473/bikfar.v11i1.51902.
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Antioxidants inhibit the oxidation of other molecules and play an important role in maintaining a healthy body. Antioxidants are found in fruits, vegetables, all parts of plants, and are present in the body as enzymes or products of metabolism. Vitamin E refers to a large number of natural or synthetic compounds, with alpha-tocopherol being the most active and widely distributed form in nature. Alpha-tocopherol is the most active antioxidant form of vitamin E and serves as the primary lipophilic antioxidant in plasma, membranes, and tissues. The most important function of vitamin E is its antioxidant capability, counteracting free radical attacks that can damage cells and cause various degenerative diseases. Additionally, antioxidants help reduce the effects of photoaging on the skin, potentiate anti-aging and anti-inflammatory activity, increase the rate of wound healing, and help maintain healthy eyes and the immune system. One form of vitamin E dosage form is a soft capsule which has several advantages, including the ease of filling the Active Pharmaceutical Ingredient (API) in liquid form, higher production capacity and formulation uniformity compared to gelatin tablets or hard capsules. Soft capsule preparations also have rapid API release, which can result in achieving therapeutic blood levels more quickly and achieving greater bioavailability. This study aims to evaluate soft capsule dosage forms in enhancing the effectiveness of vitamin E as an antioxidant. The research utilizes review articles sourced from national and international journals, as well as scientific journals. The results show that vitamin E supplementation in soft capsules can increase its effectiveness as an antioxidant.
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Sutiswa, Shandra Isasi, and Asep Abdul Rahman. "Celery (Apium graviolens L.) Herba Extract Capsule Formulation as Anti-Ulcer." JURNAL INFO KESEHATAN 18, no. 2 (2020): 105–12. http://dx.doi.org/10.31965/infokes.vol18.iss2.314.
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The use of medicinal plants for medicine has been prevalent since ancient times and various plants are used for public health. One of the plants that is often used in herbal medicine is celery, either directly in the form of vegetables or as an extract from the Apium graveolens L plant. Celery extract has previously been given to white mice, and can significantly protect the gastric mucosa and suppress gastric acid secretion. Traditional medicine derived from plant extracts is generally more desirable in tablet or capsule dosage forms. The objective of this study is to determine the best filler in the celery herb extract capsule formulation. This study used a pure experimental method using celery herb extracts which were formulated in capsule dosage forms. The powder fillers used in this formulation are Avicel 101, Avicel 102, and Amylum maydis. The extract capsules were then evaluated for uniformity of weight and disintegration time. Based on the evaluation results, the capsules formulated with Avicel 102 filler gave the best results with an average weight uniformity of 380.98 ± 4.41 mg and disintegration time of 2.64 ± 0.31 minutes. It is advisable to continue the evaluation of the dissolution test for the capsule preparation which gives the best result.
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Salve, Priyanka M., Shital V. Sonawane, Mayuri B. Patil, and Rajendra K. Surawase. "Dissolution and Dissolution Test Apparatus: A Review." Asian Journal of Research in Pharmaceutical Sciences 11, no. 3 (2021): 229–36. http://dx.doi.org/10.52711/2231-5659.2021.00037.
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Dissolution is an official test. These used by pharmacopeias for evaluating drug release of solid and semisolid dosages forms. The application of the dissolution testing ensures consistent product quality and to predict in vivo drug bioavailability. The dissolution test, in its simplest form, placing the formulation in a dissolution apparatus containing suitable dissolution medium, allowing it to dissolved specified period of time and then using appropriate rational method to determine the amount of drug. Dissolution test are probative and analysis like drug degradation profile, shelf-life studies, stability, physical and mechanical testing of dosage forms. The present review outlines findings on various dissolution apparatus, various methods and their modification. Dissolution testing the of various dosage form like Delayed release dosage form, Immediate release dosage form, Extended-release dosage form, Powders, Chewable tablets, Transdermal delivery system, Buccal tablets, Soft gelatin capsule, Chewing gums, Suppositories, Aerosols and others semisolids. This article goal of the description of the all-official dissolution testing apparatus.
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Chaganti, Soujanya, Sree Vibha Vangala, Swathi Naraparaju, Pani Kumar Durga Anumolu, and Karuna Devi Barla. "Spectrophotometric Method for Determination of Oseltamivir in Capsule Dosage Form." Scholars Academic Journal of Pharmacy 12, no. 07 (2023): 172–78. http://dx.doi.org/10.36347/sajp.2023.v12i07.002.
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Objectives: Study was aimed to establish and vindicate a simple, accurate and precise spectrophotometric method for the quantification of oseltamivir in API and capsule dosage form. Materials and Methods: The green coloured chromogen complex absorbance which was formed by the oxidative coupling with loss of two electrons and a proton of oseltamivir with MBTH in presence of FeCl3 was measured at 640nm. The amount of oseltamivir labelled in the marketed formulation (Fluvir) was determined without any interference owed with excipients. Results: A correlation coefficient of 0.999 was observed within the concentration range of 10-110μg/mL. The method was aided by various validation parameters such as LOD, LOQ and percentage relative standard deviation values (3.75 μg/mL, 9.86 μg/mL and 0.999 respectively). The percentage assay in capsule dosage form was found to be 97.6, which in conformance with ICH guidelines. Conclusion: Results were found to be within the permissible limits. Present method was verified statistically in consonance with ICH Q2R (1) guidelines. Based on above remarks, developed method may be successfully employed in regular analysis of oseltamivir in various pharmaceutical dosage forms.
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Bhilegaonkar, Shilpa P., Siya Kunde, and Mrunmayee V. Naik. "CAPSULE IN CAPSULE DOSAGE FORM WITH MINI TABLETS FOR THE TREATMENT OF HELICOBACTER PYLORI." International Research Journal Of Pharmacy 9, no. 4 (2018): 29–34. http://dx.doi.org/10.7897/2230-8407.09456.
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Benke, Edit, Patrícia Varga, Piroska Szabó-Révész, and Rita Ambrus. "Stability and In Vitro Aerodynamic Studies of Inhalation Powders Containing Ciprofloxacin Hydrochloride Applying Different DPI Capsule Types." Pharmaceutics 13, no. 5 (2021): 689. http://dx.doi.org/10.3390/pharmaceutics13050689.
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In the case of capsule-based dry powder inhalation systems (DPIs), the selection of the appropriate capsule is important. The use of gelatin, gelatin-PEG, and HPMC capsules has become widespread in marketed capsule-based DPIs. We aimed to perform a stability test according to the ICH guideline in the above-mentioned three capsule types. The results of the novel combined formulated microcomposite were more favorable than those of the carrier-free formulation for all capsule types. The use of HPMC capsules results in the greatest stability and thus the best in vitro aerodynamic results for both DPI powders after six months. This can be explained by the fact that the residual solvent content (RSC) of the capsules differs. Under the applied conditions the RSC of the HPMC capsule decreased the least and remained within the optimal range, thus becoming less fragmented, which was reflected in the RSC, structure and morphology of the particles, as well as in the in vitro aerodynamic results (there was a difference of approximately 10% in the lung deposition results). During pharmaceutical dosage form developments, emphasis should be placed in the case of DPIs on determining which capsule type will be used for specific formulations.
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Majeed, Saad M., Mohammed K. Al-Shaheen, Radhwan Nidal Al-Zidan, and Sameer M. Mahmood. "Multiple Unite Pellet Systems (MUPS) as Drug Delivery model." Journal of Drug Delivery and Therapeutics 10, no. 6 (2020): 231–35. http://dx.doi.org/10.22270/jddt.v10i6.4389.
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Multiparticulate drug delivery systems are mainly oral dosage form, consist of small discrete units that exhibit different characteristics especially in release pattern and drug bioavailability. These systems are represented by granules, pellets, microspheres, microcapsules, and minitablets. Pellets offer high flexibility in the design, formulation, and development of oral dosage forms such as sachet, suspension, capsule, and tablet. Multiparticulate tablets manufactured by compaction of multiple unite pellets is one of the latest and, yet, challenging technologies. Multiparticulate tablets combine the benefits of both a tablet and a pellet-filled capsule in one dosage form but their manufacturing experience many difficulties. The oral multiparticulate products consist of polymer-coated subunits or pellets, which are embedded in an inert excipients’ matrix, formulated to overcome the difficulty in administering capsules and improve the physicochemical stability of suspension and offer predictable release and uniform distribution in the gastro-intestinal tract compared to the plain tablet. This review discusses the advantages and drawbacks of MUPS, the properties of an ideal MUPS, various pharmaceutical applications of MUPS, the challenges and key variables that to be considered in the tableting process for successful production of MUPS
 Keywords: MUPS®, Pellets, Multiparticulate tablets.
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Shchukin, V. M., N. E. Kuz’mina, O. A. Matveeva, Yu N. Shvetsova, and E. S. Zhigilei. "Determination of Elemental Impurities in Gelatine Capsules by Inductively Coupled Plasma Mass Spectrometry." Safety and Risk of Pharmacotherapy 12, no. 2 (2024): 230–40. http://dx.doi.org/10.30895/2312-7821-2024-12-2-230-240.
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INTRODUCTION. Gelatine capsules are an essential dosage form used for many medicinal products. Gelatine capsules are subject to quality control in accordance with the requirements of the general monograph on capsules of the State Pharmacopoeia of the Russian Federation. This monograph does not standardise the content of elemental impurities, as these impurities are controlled at the raw material level. However, the equipment and excipients used in the production of gelatine capsule shells may be additional sources of impurities. Preliminary screening for chemical elements will help to assess the need for limiting elemental impurities in gelatine capsule shells.AIM. This study aimed to identify the chemical elements that contribute to gelatine capsule shell contamination the most by inductively coupled plasma mass spectrometry, to list the elements requiring specification, and to limit their content from a risk-based pharmaceutical quality control perspective.MATERIALS AND METHODS. The study used 18 samples of hard gelatine capsules by different national and international manufacturers. The elemental analysis was performed using an Agilent 7900 inductively coupled plasma mass spectrometer (Agilent Technologies).RESULTS. The As, Ba, Co, Cr, Cu, Li, Mo, Ni, Pb, Sb, and V content in gelatine capsule shells did not exceed the permitted daily exposure (PDE) thresholds for oral dosage forms specified in the State Pharmacopoeia of the Russian Federation. Ag, Au, Cd, Hg, Ir, Os, Pd, Pt, Rh, Se, Sn, or Tl were not detected in any of the samples within the established detection limits. The Fe content in 67% of the tested shell samples was above the safety-based PDE for medical gelatine.CONCLUSIONS. The greatest contributors to gelatine capsule shell contamination are Al, Fe, and Zn. The lack of established PDE thresholds for these elements presents a challenge in assessing the risks of adverse effects associated with ingesting these elements with gelatine capsules.
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Fathi, Mona, Sohrab Kazemi, Farbod Zahedi, Mohamad Reza Shiran, and Ali Akbar Moghadamnia. "Comparison of oral bioavailability of acetaminophen tablets, capsules and effervescent dosage forms in healthy volunteers." Current Issues in Pharmacy and Medical Sciences 31, no. 1 (2018): 5–9. http://dx.doi.org/10.1515/cipms-2018-0001.
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AbstractA wide variety of acetaminophen dosage forms have been administered to relieve mild to moderate pain and fever, so far. The purpose of this study was to compare the oral bioavailability in healthy volunteers, of three of these dosage forms. We included healthy volunteers in our study and divided replace with placed them into three groups: tablet, capsule and effervescent. Each dosage form contained 500 mg of acetaminophen as active material. Blood samples were taken at 0.5, 1, 2, 4 and 8-hour intervals after receiving the dose. Acetaminophen blood levels were measured using HPLC method. Data were fit in a “one-compartment PK model”, using P-Pharm 1.5 software and analyzed under statistical tests. The maximum concentrations of acetaminophen in blood samples were measured at 1h after taking the drug (6.61±3.19 μg/ml, 11.29±3.94 μg/ml and 15.25±2.54 μg/ml in groups receiving capsule, tablet and effervescent, respectively). Pharmacokinetic (PK) data analysis & modeling from the three groups showed that the half-life of acetaminophen was 140.72 min in the tablet group, 140.29 min in capsule and 132.08 min in effervescent. The area under the blood levels curve were 47.04, 40.62 and 53.11 μgmin/ml, in tablet, capsule, and effervescent groups, respectively. Statistically significant differences in PK parameters were recorded as the study replace with we compared effervescent with tablets and capsule dosage forms (p < 0.05). According to the results, the effervescent form creates better PK parameters compared with tablet and capsule forms, therefore, it is suggested replace with we suggested that this form should be administer in cases of pain and fever to achieve quick drug efficacy.
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Srinivasu, K., J. Venkateswara Rao, N. Appala Raju, and K. Mukkanti. "A Validated RP-HPLC Method for the Determination of Atazanavir in Pharmaceutical Dosage Form." E-Journal of Chemistry 8, no. 1 (2011): 453–56. http://dx.doi.org/10.1155/2011/812879.
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A validated RP HPLC method for the estimation of atazanavir in capsule dosage form on YMC ODS 150 × 4.6 mm, 5 μ column using mobile phase composition of ammonium dihydrogen phosphate buffer (pH 2.5) with acetonitrile (55:45 v/v). Flow rate was maintained at 1.5 mL/min with 288 nm UV detection. The retention time obtained for atazanavir was at 4.7 min. The detector response was linear in the concentration range of 30 - 600 μg/mL. This method has been validated and shown to be specific, sensitive, precise, linear, accurate, rugged, robust and fast. Hence, this method can be applied for routine quality control of atazanavir in capsule dosage forms as well as in bulk drug.
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Kute, Vaibhav Ghansham, Rajeshwari Satish Patil, Vaishnavi Ghansham Kute, and Priti Dilip Kaluse. "Immediate-release dosage form; focus on disintegrants use as a promising excipient." Journal of Drug Delivery and Therapeutics 13, no. 9 (2023): 170–80. http://dx.doi.org/10.22270/jddt.v13i9.6217.
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Disintegrants are materials or mixtures of substances added in the drug formulations, which make easier dispersion or breakup of tablets and ingredients of capsules in small-scale particles for fast dissolution then it comes in contact with water in the GI tract. Immediate drug release dosage forms disintegrate rapidly after administration with an enhanced rate of dissolution. The superdisintegrants provide instantaneous disintegration of tablets after administration in the stomach. In this field, immediate-release liquid dosage forms and parenteral dosage forms have also been introduced for treating patients. The oral route is the most convenient route for the administration of solid dosage form, about 85% of solid dosage is administered by the oral route because of its advantages over others. The therapeutic activity of these formulations is obtained through a typical manner like disintegration followed by dissolution. Hence disintegration has a major role in facilitating drug activity. Diverse categories of superdisintegrants such as synthetic, semi-synthetic, natural, co-processed blends, multifunctional superdisintegrants, etc. have been employed to develop effectual orodispersible tablets and to overcome the limitations of conventional tablet dosage forms. The objective of the present review article is to highlight the various kinds of traditional, Natural crude drugs containing gum and mucilage, Co-processed, semisynthetic and synthetic disintegrants along with a concentration in tablet and capsule disintegration and effect on drug release, which are being used in the formulation to provide the safer, effective drug delivery with patient compliance. Also highlights the mechanism and use of disintegrants in the immediate release dosage form.
 Keywords: Disintegrants, Natural, Co-processed, Immediate release
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Liu, Xing, Jun-Li Huo, Ting-Ting Li, Hao-Kai Peng, Jia-Horng Lin, and Ching-Wen Lou. "Investigation of the Shear Thickening Fluid Encapsulation in an Orifice Coagulation Bath." Polymers 11, no. 3 (2019): 519. http://dx.doi.org/10.3390/polym11030519.
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The orifice coagulation bath method is proposed to encapsulate shear thickening fluid (STF) to form STF capsules, in an attempt to improve the combination of STF and the matrix as well as strengthen the flexibility and stability of the STF composites. By varying the calcium chloride concentration (10, 20 mg/ml), sodium alginate concentration (5, 7, 10 mg/ml) and the surfactant dosage (10%, 20%, 30%), optimal preparation conditions were studied, considering the capsule strength and encapsulation rate. The capsules were also characterized using a scanning electron microscope (SEM), Fourier transform infrared spectroscopy (FTIR) and a thermogravimetric analyzer (TGA). The results show that the optimal solution for the preparation of the capsules is composed of 30% surfactant, 10 mg/ml mass concentration of CaCl2, and 10 mg/ml mass concentration of sodium alginate. The rough surface and porous interior was observed by SEM. The average diameter of the capsules was 1.93 mm. The TGA curves indicate an improvement on the capsule thermal stability. This study thus provides a promising STF capsule preparation method.
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Joshi, Sameer, Rajnish Sahu, Vida A. Dennis, and Shree R. Singh. "Nanofiller-Enhanced Soft Non-Gelatin Alginate Capsules for Modified Drug Delivery." Pharmaceuticals 14, no. 4 (2021): 355. http://dx.doi.org/10.3390/ph14040355.
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Capsules are one of the major solid dosage forms available in a variety of compositions and shapes. Developments in this dosage form are not new, but the production of non-gelatin capsules is a recent trend. In pharmaceutical as well as other biomedical research, alginate has great versatility. On the other hand, the use of inorganic material to enhance material strength is a common research topic in tissue engineering. The research presented here is a combination of qualities of alginate and montmorillonite (MMT). These two materials were used in this research to produce a soft non-gelatin modified-release capsule. Moreover, the research describes a facile benchtop production of these capsules. The produced capsules were critically analyzed for their appearance confirming resemblance with marketed capsules, functionality in terms of drug encapsulation, as well as release and durability.
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Sadraei, Hassan, Amir Hossein Rasouli-Amirabadi, Afsaneh Yekdaneh, and Naser Tavakoli. "Bioassay standardization of drug dosage form prepared from hydroalcoholic extract of Dracocephalum kotschyi ." Journal of Herbmed Pharmacology 11, no. 3 (2022): 435–43. http://dx.doi.org/10.34172/jhp.2022.50.
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Introduction: Zaringiah (Dracocephalum kotschyi) is a famous Iranian herbal plant with anti-inflammatory and spasmolytic activities. There is no standard drug dosage form for the D. kotschyi extract on the market. The objective of this project was to design a suitable oral dosage form for the hydroalcoholic extract of D. kotschyi. Methods: Standard granules were prepared using the moist granulation technique. Physical properties of the granules were determined before filling the capsule with fixed doses of the drug (25 mg and 50 mg). Syrup was prepared in sucrose solution at 5 mg/mL concentration. Bioactivity and phytochemical assays were used for dosage form stability and uniformity evaluations before and after 3- and 6- months incubation. Pharmacological bioassay method was designed to determine the bioactivity of the products before and after incubation. Pharmacological effects of the prepared capsule and syrup were determined on rat isolated ileum and intestinal meal transit, respectively. Results: In this study, D. kotschyi extract was effectively formulated as capsule and syrup for oral consumption. Environmental and aging factors had no significant effect on the total flavonoid or phenolic contents or bioactivity of the manufactured products. Furthermore, the ingredients used in the formulation had no effect on the bioactivity of the active substances in the extract. Conclusion: The standard oral dosage forms prepared from D. kotschyi extract can be used for clinical trials. In addition, we introduced a reliable bioassay technique, which might be applied for the evaluation of herbal medicines with antispasmodic activities.
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Sherje, AP, AV Kasture, KN Gujar, and PG Yeole. "Simultaneous spectrophotometric determination of lansoprazole and domperidone in capsule dosage form." Indian Journal of Pharmaceutical Sciences 70, no. 1 (2008): 102. http://dx.doi.org/10.4103/0250-474x.40343.
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Lin, Jian, Chunchan Zhang, Yaoxiang Gao, Xiaojun Zhao, and Xican Li. "A Validated HPLC Method for Determining Melatonin in Capsule Dosage Form." Spatula DD - Peer Reviewed Journal on Complementary Medicine and Drug Discovery 2, no. 3 (2012): 147. http://dx.doi.org/10.5455/spatula.20120906112559.
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Behera, Anindita, Swapan Kumar Moitra, Sudam Chandra Si, and Dannana Gowri Sankar. "Spectrophotometric method for determination of atazanavir sulfate in capsule dosage form." Química Nova 34, no. 8 (2011): 1349–53. http://dx.doi.org/10.1590/s0100-40422011000800010.
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Rump, Adrian, Marie-Luise Kromrey, Eberhard Scheuch, et al. "In Vivo Evaluation of a Gastro-Resistant HPMC-Based “Next Generation Enteric” Capsule." Pharmaceutics 14, no. 10 (2022): 1999. http://dx.doi.org/10.3390/pharmaceutics14101999.
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Many orally dosed APIs are bioavailable only when formulated as an enteric dosage form to protect them from the harsh environment of the stomach. However, an enteric formulation is often accompanied with a higher development effort in the first place and the potential degradation of fragile APIs during the coating process. Ready-to-use enteric hard capsules would be an easily available alternative to test and develop APIs in enteric formulations, while decreasing the time and cost of process development. In this regard, Lonza Capsugel® Next Generation Enteric capsules offer a promising approach as functional capsules. The in vivo performance of these capsules was observed with two independent techniques (MRI and caffeine in saliva) in eight human volunteers. No disintegration or content release in the stomach was observed, even after highly variable individual gastric residence times (range 7.5 to 82.5 min), indicating the reliable enteric properties of these capsules. Seven capsules disintegrated in the distal part of the small intestine; one capsule showed an uncommonly fast intestinal transit (15 min) and disintegrated in the colon. The results for this latter capsule by MRI and caffeine appearance differed dramatically, whereas for all other capsules disintegrating in the small intestine, the results were very comparable, which highlights the necessity for reliable and complementary measurement methods. No correlation could be found between the gastric residence time and disintegration after gastric emptying, which confirms the robust enteric formulation of those capsules.
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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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Dhaval, Mori, Jalpa Makwana, Ekta Sakariya, and Kiran Dudhat. "Drug Nanocrystals: A Comprehensive Review with Current Regulatory Guidelines." Current Drug Delivery 17, no. 6 (2020): 470–82. http://dx.doi.org/10.2174/1567201817666200512104833.
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Drug nanocrystals offer an attractive approach for improving the solubility and dissolution rate of poorly soluble drugs which accounts for nearly 40 % newly discovered drug molecules. Both methods for manufacturing drug nanocrystals have high industrial acceptability for being simple and easy to scale which is evident from the number of approved products available in the market. Ability to modify multiple aspects of dosage form like bioavailability, release pattern and dosage form requirement along with flexibility in choosing final dosage form starting from the tablet, capsule, suspension to parenteral one, have made nanocrystal technology one of the very promising and adaptable technology for dosage form design.
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Raihan, Roshaan, Azimullah Wafa, Aqa Mohammad Zhakfar, and Sudhakar CK. "Oral Disintegrating Films: A Review." Journal of Natural Science Review 2, no. 2 (2024): 60–74. http://dx.doi.org/10.62810/jnsr.v2i2.42.
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The oral route stands out as a preferred method for drug administration due to its cost-effectiveness and ease, contributing to enhanced patient compliance. Some individuals, particularly the geriatric and pediatric populations, encounter difficulties swallowing conventional tablets and hard gelatin capsules. To address this, oral disintegrating drug delivery systems are established as substitutes for tablets, capsules, and syrups. Notably, fast-dissolving oral thin films offer a practical solution for patients such as those in pediatric, bedridden, or developmentally disabled categories, as well as the geriatric population who struggle with a tablet or hard gelatin capsule ingestion. This innovative dosage form involves the creation of thin films consuming water-soluble polymers that quickly disintegrate and dissolve in the mouth cavity. It serves as a substitute stage for those particles that undergo significant metabolism of drugs in the liver. This study provides an overview of numerous dosage form-formulations, preparation approaches, and quality control measures related to fast-disintegrating films.
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Onokala, Lillian, Garrard Baker, and Bisrat Hailemeskel. "Price Comparison of Moringa in the Greater District of Columbia Area, United States of America." Advances in Food Technology and Nutrition Sciences – Open Journal 8, no. 1 (2022): 14–19. http://dx.doi.org/10.17140/aftnsoj-8-175.
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Introduction Moringa oleifera (MO) is a nutritional herbal supplement that grows in many subtropical and tropical regions of the world including India, Africa, North and South America, and Asia. The purpose of this study is to review recent clinical studies regarding the health benefits of MO as well as investigate the availability and relative pricing of MO among retail local and online stores for the various Moringa dosage forms. Method In this study, price variations and availability of MO in 18 retail companies that serve the District of Columbia, Maryland, and Virginia region were investigated. Price comparisons of the three major formulations of MO-powder, capsules, and tea-were performed through store-to-store and online searches. Results This investigation on retail selling pricing of Moringa has shown that Moringa is a very affordable and accessible product in the greater District of Columbia, Maryland, Virginia region. However, we found a major gap and range in prices among the dosage forms and among the 18 stores included in our study. The average selling price per day for all dosage forms is $0.39, ranging from $0.31 to $0.55. The powder is the most commonly carried dosage form of the supplement, and also has the greatest variation in pricing among the stores. In addition, it was noted that the capsule is the most expensive dosage form ($0.55 vs. $0.31 for the powder and tea forms) for daily dosing. A comparison of cost per gram per day dosing was done and shows that there are significant differences in the selling price among the three dosage forms with a p-value of less than 0.05. Discussion MO has many health benefits and is an excellent value as a nutritional supplement. Numerous studies have shown Moringa to have excellent anti-inflammatory, antioxidant, and antimicrobial activity. In the evaluation of dosage price per day, it was found that for over half of the stores (56%; n=16) the Moringa powder was under $0.50, while for three-fourths of the stores (75%; n=12) it was under $1.00. Moringa is readily available in most stores. Over two-thirds (67%; n=11) of the stores carry all three dosage forms. However, there is a major gap range in the price per day and the daily dose quantity of the herb for each dosage form. The powder dosage form was found to be the most readily available form of the supplement and the least expensive. Conclusion It was found that Moringa is relatively inexpensive and is a great value for the health benefits obtained. The powder dosage form is the most readily available form while the capsule is the most expensive dosage form. It is important to emphasize in pharmacist counseling sessions that patients should shop around and compare prices when choosing their desired Moringa product.
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Huynh, Thi My Duyen, Thanh Sil Nguyen, Kien Tuong Ta, and Thi Minh Ngoc Le. "RESEARCH ON FORMULATION OF HARD CAPSULES CONTAINING EXTRACTS OF HOUTTUYNIA CORDATA THUMB (SAURURACEAE), MORUS ALBA L. (MORACEAE), AND CARICA PAPAYA L. (CARICACEAE)." Tạp chí Y Dược học Cần Thơ, no. 6 (October 20, 2023): 150–58. http://dx.doi.org/10.58490/ctump.2023i6.1227.
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Background: previous studies have demonstrated that Houttuynia cordata Thumb (Saururaceae), Morus alba L. (Moraceae), and Carica papaya L. (Caricaceae) are effective against various viruses, especially the SARS-CoV-2 virus. In Vietnam, even though the three of these plant species are grown quite popularly and are pretty commonly consumed by residents regularly, there have not been any applications to the dosage forms to promote their full potential effects and make these dosage forms easy to use and preserve. Furthermore, no research has been conducted on a capsule form that combines all three of these medicinal herbs. Objectives: the research focuses on the composition of a hard capsule formula containing the extracts of Houttuynia cordata, Morus alba, and Carica papaya as well as the development of testing standards for prepared hard capsules. Materials and methods: the ratio of adsorbents and fillers in the formula was investigated so that the granules had low moisture, a suitable flow rate, and the appropriate apparent density for packaging; standards for testing capsules were developed according to current regulations. Results: the selected adsorbent was light MgCO3, with a ratio of plant extract: filler: adsorbent of 10: 5: 0.5 and a ratio of Avicel: Starch 1500 of 1: 3. Conclusions: a hard capsule containing medicinal plant extract was formulated with a moisture content of < 5% and well-flowing granules that had the suitable apparent density for packing the capsule size of 0. Capsules met standards in terms of appearance, weight uniformity, disintegration, heavy metal and microorganisms, with a quercetin content of 74.45 ± 0.23 mg. The result of the study is considered one of the most essential bases for further research on determining the effectiveness of medicines derived from medicinal plants and applied to support the treatment of COVID-19, which is still happening in a quite complicated way at the moment.
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Singh, Rajnish Kumar, Naveen Kumar Choudhary, and Ankit Anand Kharia. "Formulation Development and Release Profile of Levomilnacipran Extended Release Capsules using Principles of Quality by Design." Asian Pacific Journal of Health Sciences 9, no. 4 (2022): 214–16. http://dx.doi.org/10.21276/apjhs.2022.9.4s1.39.
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The study’s goal was to use Quality By Design (QbD) principles to design an Extended Release dosage form of levomilnacipran and evaluate its in vitro release profile. Doses of levomilnacipran extended release capsules (LERC) ranging from 20 mg to 120 mg. QbD was employed in this work to design LERC capsule formulation and production, which ensures LERC safety and efficacy. To create the LERC, wurster coating was applied to non-pariel seeds, which were then filled with capsules. To provide prolonged absorption, a polymer derived from ethylcellulose was chosen. Extensive release capsules are made up of four main components: (1) Drug layering, (2) extended release coating, (3) lubricant application, and finally (4) capsule filling. Results revealed that there was no significant difference in release profile LERC in different doses; however, the highest release of drug was seen at 120 mg, that is, 93%. The present formulation may be used as an effective treatment therapy against major depressive disorder.
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Tzakri, Theodora, Lara Rehenbrock, Stefan Senekowitsch, et al. "Determination of Gastric Water Emptying in Fasted and Fed State Conditions Using a Compression-Coated Tablet and Salivary Caffeine Kinetics." Pharmaceutics 15, no. 11 (2023): 2584. http://dx.doi.org/10.3390/pharmaceutics15112584.
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Because of the importance of gastric emptying for pharmacokinetics, numerous methods have been developed for its determination. One of the methods is the salivary tracer technique, which utilizes an ice capsule containing caffeine as a salivary tracer. Despite the ice capsule’s advantage in labeling ingested fluids with caffeine for subsequent salivary detection, its risk of premature melting before swallowing, and its complicated storage and preparation, limit its application, particularly in special populations (e.g., older people). For this reason, here, a compression-coated tablet was developed and validated against the ice capsule in a cross-over clinical trial. The two dosage forms were administered simultaneously to 12 volunteers in an upright position under fasted and fed state conditions. To distinguish the caffeine concentrations in saliva from each dosage form, regular type of caffeine (12C) was added to the tablet, while for the ice capsule 13C3 labelled caffeine was used. The salivary caffeine concentrations showed no statistically significant differences for the pharmacokinetic parameters tmax and AUC0→60 (p > 0.05). Thus, the new formulation is a useful tool for determining gastric emptying that can also be used in special populations.
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Robson, J., G. Snow, J. Y. Park, R. C. Moretz, H. O. Krenkel, and A. Angel. "Microscopic evaluation of structural changes in brittle, hydrated, gelatin capsules." Proceedings, annual meeting, Electron Microscopy Society of America 50, no. 1 (1992): 780–81. http://dx.doi.org/10.1017/s0424820100124306.
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Gelatin capsules are a commonly used dosage form for prescription medications. Storage conditions as well as drug formulation can directly affect capsule integrity over time. Often, capsule brittleness following storage can be related to water loss. In this report an encapsulated drug formulation containing 77% anhydrous citric acid became brittle following two years of storage at 25° C/60% RH. However, Thermogravimetric data showed that capsule brittleness did not result from changes in water content. Both normal(without drug formulation) and brittle capsules contained 12% water. Microscopy was then applied to examine capsule walls to determine if the change in physical integrity could be related to a structural change.LM of normal capsules showed both the interior and exterior walls to be smooth, without indentations. SEM examination of the interior wall of the normal capsules revealed fairly smooth walls (Fig. 1). Sections of normal capsules examined with the TEM revealed intact walls with little variation between sections or capsules (Fig. 2). Examination of capsules stored for one year revealed interior surfaces stippled with particulate identified as active ingredient(AI) and citric acid. The particulate was not fused to the interior wall and no morphological changes were observed for the Al or citric acid when compared to known active/excipient morphology. In contrast, the interior wall of capsules stored for two years showed striking morphological changes. LM presented an eroded interior wall indicating a loss or redistribution of gelatin. TEM further illustrated that the structure of the capsule had been altered; subsurface pockets were seen throughout the section of the capsule (Fig. 3). TiO2 particles, a whitener used in the capsules, were redistributed in the areas where degradation was apparent. SEM presented irregular interior surfaces with abundant particulate fused to the capsule wall (Fig. 4). The fused particulate presented structure which contrasted with the known morphology of the citric acid and Al starting materials indicating that dissolution and recrystallization had taken place. Comparable crystal structure was determined when Al and citric acid were dissolved in water and allowed to recrystallize at room temperature.
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Shaikh, Siddiqua, and Prerana Jadhav. "RP-HPLC Method Development and Validation for the Simultaneous Estimation of Amitriptyline Hydrochloride and Pantoprazole Sodium in Bulk and Capsule Dosage Form." Journal of Drug Delivery and Therapeutics 9, no. 4 (2019): 37–42. http://dx.doi.org/10.22270/jddt.v9i4.2978.
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A simple, rapid, accurate and precise isocratic reversed phase high performance liquid chromatographic method has been developed and validated for Simultaneous Estimation of Pantoprazole Sodium (PNT) and Amitriptyline Hydrochloride in Bulk and Capsule Dosage Form. In RP-HPLC method, the analyte were resolved by using isocratic program, methanol and phosphate buffer (80:20v/v) was used as mobile phase, at a flow rate of 0.8 ml/min. on HPLC system containing UV-visible detector with Workstation software and cosmosil 18 (250 mm × 4.6 mm,5 μm) column. The detection was carried out at 244nm. The retention times were 3.21 minutes and 4.20 minutes for Amitriptyline Hydrochloride and Pantoprazole Sodium respectively. Calibration plots were linearity was found 0.9995 and 0.9997 for Amitriptyline Hydrochloride and Pantoprazole Sodium. The method was validated for linearity, precision, accuracy, ruggedness and robustness. The proposed method was successfully used for simultaneous estimation of Amitriptyline Hydrochloride and Pantoprazole Sodium in capsule dosage form. Validation studies revealed that the proposed method is specific, rapid, reliable and reproducible. The high % recovery and low % RSD confirms the suitability of the proposed method for routine quality control analysis of Amitriptyline Hydrochloride and Pantoprazole Sodium in bulk and capsule dosage forms. Keywords: RP-HPLC, Amitriptyline Hydrochloride and Pantoprazole Sodium, methanol, phosphate buffer.
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Klinger, Janosch, and Rolf Daniels. "Assessing a Mass-Based Method for the Preparation of Low-Dosed Paediatric Capsules with Baclofen and Spironolactone." Pharmacy 9, no. 1 (2021): 56. http://dx.doi.org/10.3390/pharmacy9010056.
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Despite the steadily improving medical care situation in pediatrics, some drugs are still not available in a suitable dose or dosage form and thus need to be prepared extemporaneously. Capsules can be easily compounded at the hospital and public pharmacies, offering an alternative to liquid formulations. This study aims at testing a mass-based approach for the extemporaneous preparation of low-dose pediatric capsules and investigating systematically the API loss during this procedure. A total of 54 capsule batches were prepared with baclofen and spironolactone as pediatric-relevant drugs. The hard capsules were prepared using three different bulking agents consisting of either mannitol, lactose-monohydrate and microcrystalline cellulose mixed with 0.5% colloidal silica. Capsules were tested according to Ph. Eur. method “2.9.40 Content Uniformity” as well as for occurring powder loss and mass uniformity. The results reveal that the mass-based approach, in general, allows the preparation of low-dose pediatric capsules of appropriate quality. However, absolute quality is highly dependent on the homogeneity of the powder mixture and the use of defined parameters for capsule preparation.
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NK, Shinde, and Mane DV. "Development and Evaluation of Antifungal Drug Product by Solid Dispersion Technique using Drug Coating and Seal Coating Approach (Itraconazole Capsules 100 mg)." INTERNATIONAL JOURNAL OF DRUG DELIVERY TECHNOLOGY 14, no. 04 (2024): 1116–23. https://doi.org/10.25258/ijddt.14.4.28.
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A very important stage in developing and preserving the quality of any pharmaceutical drug product is validation. Drug product validation creates the written proof that offers a high level of certainty that a manufacturing process will reliably provide a product with predefined standards and quality features. Studying the process performance certification of the drug product Itraconazole Capsules 100 mg Immediate Release Capsule dosage form was the primary goal of my research. The research conducted here guarantees that the production process is appropriate for the intended use and that the final product continuously satisfies predefined requirements and quality standards. Sifting, dry mixing, wet granulation, drying, sizing, blending, lubrication, capsule filling, packing, and analysis of in-process tests and final product are only a few of the processes in the production process that are covered in depth. This study used developmental research to identify Critical Process Parameters (CPPs) that were involved in sifting, dry mixing, wet granulation, drying, sizing, blending, and capsule filling. The CPPs were then assessed during the process validation study. All of the critical quality attributes (also known as critical control parameters) were monitored during this process, including blend uniformity (BU), water content, blend physical characteristics, capsule physical parameters, description, water content (final product), dissolution, dosage unit uniformity, assay, degradation products, and microbiological examination. Following discussion and analysis of the analytical data, it may be said that this manufacturing process can reliably produce a product that satisfies its predefined specifications and quality features. As a result, the medicinal product's manufacturing method has been verified and is suitable for regular production of 100 mg Itraconazole Capsules.
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Jha, Preeta, Rabea Parveen, Suroor A. Khan, Ozair Alam, and Sayeed Ahmad. "Stability-Indicating High-Performance Thin-Layer Chromatographic Method for Quantitative Determination of Omeprazole in Capsule Dosage Form." Journal of AOAC INTERNATIONAL 93, no. 3 (2010): 787–91. http://dx.doi.org/10.1093/jaoac/93.3.787.
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Abstract A novel HPTLC method has been developed and validated for quantitative determination of omeprazole (OPZ) in capsule dosage form. The method was validated according to the International Conference on Harmonization guidelines for accuracy, precision, linearity, specificity, and robustness. HPTLC aluminum sheets precoated with silica gel 60F254 were used as the stationary phase and chloroformmethanol (9 + 1) as the mobile phase. The mobile phase was found to give compact bands for OPZ (Rf value of 0.39 0.12) in densitometric analysis in the absorbance mode at 302 nm. The linear regression analysis data for the calibration plots showed good linearity (r2 = 0.997) with respect to peak area in the concentration range 503000 ng/band. The mean values of the slope and intercept were 9.896 0.0753 and 1870.761 16.866, respectively. The method was also applied for stability testing of OPZ in different stress conditions and found to be accurate, linear, precise, robust, specific, and stability indicating. The method proposed can be used for QC and stability testing of different dosage forms such as tablets and capsules, as well as for bulk drug analysis of OPZ.
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Xu, Xiaohui, and J. T. Stewart. "MEKC DETERMINATION OF GUAIFENESIN, PSEUDOEPHEDRINE, AND DEXTROMETHORPHAN IN A CAPSULE DOSAGE FORM." Journal of Liquid Chromatography & Related Technologies 23, no. 1 (2000): 1–13. http://dx.doi.org/10.1081/jlc-100101431.
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Abed Al- Rahman, Issraa Rasheed, Alaa A. A.Rasool, and Fatima A. Tawfiq. "A Modified Organic Method for Preparation of Ibuprofen Microcapsules As a Sustained Release Solid Dosage Form." Iraqi Journal of Pharmaceutical Sciences ( P-ISSN: 1683 - 3597 , E-ISSN : 2521 - 3512) 14, no. 1 (2017): 1–11. http://dx.doi.org/10.31351/vol14iss1pp1-11.
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ABSTRACT:Microencapsulation is used to modify and retard drug release as well as to overcome the unpleasant effect(gastrointestinal disturbances) which are associated with repeated and overdose of ibuprofen per day.So that, a newly developed method of microencapsulation was utilized (a modified organic method) through amodification of aqueous colloidal polymer dispersion method using ethylcellulose and sodium alginate coating materials toprepare a sustained release ibuprofen microcapsules.The effect of core : wall ratio on the percent yield and encapsulation efficiency of prepared microcapsules was low, whereas, the release of drug from prepared microcapsules was affected by core: wall ratio ,proportion of coating material andpresence of additive(PEG4000). The 2:1 core : wall ratio was compared (in weight equivalent to 300mg and 600mg drug)with Fenbid® spansule capsule 300mg and Balkaprofen® tablet 600mg respectively. It was found that the release of drugfrom selected ratio and Balkaprofen® tablet was more or less similar(P 0.05) .This sustained release ratio wasencapsulated in weight equivalent to 300mg drug to be administered once daily (600mg) as two capsules as the reference.The capsules were stable within 6 months of storage at room temperature.
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Nerdy, Nerdy, Linda Margata, Nilsya Febrika Zebua, et al. "Development and Validation of Fast and Simple Fourier Transform Infrared Spectrophotometric Method for Analysis of Thiamphenicol in Capsule Dosage Form." Science and Technology Indonesia 8, no. 3 (2023): 344–52. http://dx.doi.org/10.26554/sti.2023.8.3.344-352.
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The development of a method for identification and determination of thiamphenicol by Fourier Transform Infrared will provide convenience to developers because it is fast and easy for analysis. The research was carried out by utilizing the solubility of thiamphenicol in methanol with three stages, namely method development, sample analysis, and method validation. The method development stage showed that the specific peak of thiamphenicol was at a peak with a wavenumber of 1694.1 cm−1; this specific peak of thiamphenicol was used for qualitative analysis and quantitative analysis of thiamphenicol in the capsule dosage form. The sample analysis showed that all analyzed thiamphenicol in capsule dosage form showed good results both qualitatively and quantitatively. Qualitatively all the samples analyzed showed a specific peak at specific positions and specific wavenumbers. These results meet the requirements for containing thiamphenicol in the dosage form. Quantitatively all the samples analyzed ranged from 97.97% to 102.24% by peak height and peak area. These results meet the requirements for active substance levels in general preparations within 90.0% to 110.0%. The method validation for peak height and peak area showed that the accuracy parameter had a recovery percentage of 100.28% and 100.41% (between 98.0% to 102.0%), the precision parameter with a relative standard deviation of 0.31% and 0.37% (not more than 2.0%), and the linearity parameter with a correlation coefficient of 0.9999 and 0.9997 (not less than 0.99). The limit of detection value was 0.2971 mg/mL and 0.5338 mg/mL, the limit of quantitation value was 0.9004 mg/mL and 1.6176 mg/mL, the range for both was 80% to 120%, and the specificity for both met the requirement. The Fourier Transform Infrared method has been successfully developed, applied, and validated for qualitative analysis and quantitative analysis of thiamphenicol in capsule dosage form.
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Muno, Francis J. "Broadening Utility of Tablet and Capsule Imprints." Journal of Pharmacy Practice 13, no. 2 (2000): 130–40. http://dx.doi.org/10.1177/089719000001300204.
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From a strategic 1962 article cataloging the imprints on tablets, capsules and softgels, the art of identification of solid medication dosage form has proceeded to where all prescription medications, including controlled substance, over-the-counter (OTC) drugs, veterinary and homeopathic drug products must be imprinted. Imprints may be comprised of logos, numerical and/or alphabetical information. Imprints are electronically searchable by two computer programs, one of which provides graphics of logos. The public and health, law enforcement and teaching professionals have a need to know when a "stray" tablet or capsule is found what it is with a high degree of accuracy. Imprints may soon be on prescription labels and searchable through various websites on the internet.