scholarly journals In Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South-West Ethiopia

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Woldemichael Abraham ◽  
Habtamu Abuye ◽  
Selass Kebede ◽  
Sultan Suleman
Keyword(s):  
Quality Assessment ◽  
Single Point ◽  
Dosage Forms ◽  
Essential Medicines ◽  
In Vitro Dissolution ◽  
Ratio Test ◽  
Doxycycline Hyclate ◽  
Product Identity ◽  
Dosage Uniformity

Background. Persistent postmarket quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces a biopharmaceutical and therapeutically equivalent list of the products to the prescribers and users of it. This in turn facilitates access to essential medicines by breaking the high-cost barrier imposed by a few expensive brands of the product. This study was aimed at determining the quality and evaluating the equivalence of doxycycline hyclate capsules and tablets in Jimma, Ethiopia. Methods. Ten brands of doxycycline hyclate capsules and tablets were tested for product identity, dosage uniformity, assay, and in vitro dissolution; and tablets were tested for friability and hardness. Results. All investigated brands of doxycycline complied with the USP for dosage uniformity, an assay of the active ingredient, and single-point dissolution tests. One brand, D09, failed both hardness and friability tests. Comparisons of dissolution profiles applying fit factors confirmed that only brands D04, D06, and D07 had similarities with the innovator. Ratio test approaches also showed that significant variability exists between test products and comparators. Weibull model was found to provide the best adjustment curve for all brands, from model-dependent approaches employed for explaining the overall release of drug from the dosage forms. Conclusions. Doxycycline is a biowaiver product. Hence, in vitro dissolution evaluation suffices its market approval. In this quality assessment study, however, the samples passed quality control tests, except D09 brand which failed friability; it has been revealed that five out of eight brands had problems with interchangeability. Only three doxycycline hyclate brands were found to be equivalent to the comparators.

scholarly journals In-Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South Weast Ethiopia

2020 ◽  
Author(s):  
Woldemichael Abraham Leficho ◽  
Habtamu Abuye Lambore ◽  
Selass Kebede Olbemo ◽  
Sultan Suleman Wega
Keyword(s):  
Single Point ◽  
Essential Medicines ◽  
In Vitro Dissolution ◽  
Ratio Test ◽  
Doxycycline Hyclate ◽  
Dissolution Tests ◽  
Post Market ◽  
Access To Essential Medicines ◽  
Equivalence Problems

Persistent post market quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces biopharmaceutically and therapeutically equivalent list of the products to the prescribers and users of it. This in turn facilitates access to essential medicines by breaking the high cost barrier imposed by few expensive brands of the product. This study was aimed at determining the quality and evaluating equivalence of doxycycline hyclate capsules and tablets in Jimma, Ethiopia. Ten brands of doxycycline hyclate capsules and tablets were tested for physic-chemical parameters. All investigated brands of doxycycline complied with the USP for dosage unifor¬mity, assay of active ingredient and single-point dissolution tests. One brand, D09 failed both hardness and friabilty tests. Comparisons of dissolution profiles applying fit factors confirmed that only brands D04, D06 and D07 had similarity with innovator. Ratio test approaches also showed significant variability existence between test products and comparators. This may question the product’s being categorized as a <biowaiver> to mean in-vitro dissolution evaluation suffices its market approval. This work, however, found equivalence problems between ‘comparators’ and interchangeability issues among doxycycline different brands already distributed in the market.

Formulation and Evaluation of Bilayer Sustained Release Tablets of Salbutamol and Theophylline

2009 ◽  
Vol 2 (3) ◽  
pp. 638-646
Author(s):  
R. Nagaraju ◽  
Rajesh Kaza
Keyword(s):  
Ethyl Cellulose ◽  
Xanthan Gum ◽  
Dosage Forms ◽  
In Vitro Dissolution ◽  
Dissolution Studies ◽  
Sustained Release Tablets ◽  
Dissolution Apparatus ◽  
Single Dosage

Salbutamol and theophylline are available in conventional dosage forms, administered four times a day, leading to saw tooth kinetics and resulting in ineffective therapy. The combination of these two drugs in a single dosage form will enhance the patient compliance and prolong bronchodilation. Various polymers, such as hydroxy propyl methylcellulose K4M (HPMC- K4M), hydroxy propyl methylcellulose K100M (HPMC- K100M), xanthan gum, ethyl cellulose and hydroxy propyl methylcellulose phthalate (HPMC-P) were studied. HPMC-P and HPMC- K4M were found to be best in controlling the release. In-vitro dissolution studies were carried out for all the bi-layered tablets developed using USP dissolution apparatus type 2 (paddle). It was found that the tablet FB15-FW3 showed 50% release of salbutamol in first hour and the remaining was released for eight hours. However, theophylline was found to be released as per the USP specifications. The IR spectrum was taken for FB15-FW3 formulation and it revealed that there is no disturbance in the principal peaks of pure drugs salbutamol and theophylline. This further confirms the integrity of pure drugs and no incompatibility of them with excipients. Also, formulation of FB15-FW3 has shown required release pattern and complies with all the evaluated parameters and comparable to the marketed formulation.

scholarly journals The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing

2012 ◽  
Vol 2 ◽  
pp. 1-8 ◽  
Author(s):  
Mubarak Nasser Al Ameri ◽  
Nanda Nayuni ◽  
K.G. Anil Kumar ◽  
David Perrett ◽  
Arthur Tucker ◽  
...  
Keyword(s):  
Dosage Forms ◽  
In Vitro Dissolution ◽  
Dissolution Testing ◽  
Generic Medicines ◽  
Solid Dosage Forms ◽  
Solid Dosage

scholarly journals Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

2021 ◽  
Vol 24 ◽  
pp. 548-562
Author(s):  
Matthias Shona Roost ◽  
Henrike Potthast ◽  
Chantal Walther ◽  
Alfredo García-Arieta ◽  
Ivana Abalos ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
In Vitro Dissolution ◽  
Quantitative Composition ◽  
Modified Release ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less straightforward for modified release products than for immediate release products. There is consensus that modified release products should demonstrate bioequivalence not only in the fasted state but also in the fed state, but differences exist regarding the necessity of additional multiple dose studies. Fundamental differences between jurisdictions are revealed regarding requirements on the quantitative composition of different strengths and the differentiation of single and multiple unit dosage forms. Differences in terms of in vitro dissolution requirements are obvious, though these are mostly related to possible additional comparative investigations rather than regarding the need for product-specific methods. As with the requirements for immediate release products, harmonization of the various regulations for modified release products is highly desirable to conduct the appropriate studies from a scientific point of view, thus ensuring therapeutic equivalence.

Validation and Comparative In-vitro Dissolution Studies of Cefaclor in Their Powder for Oral Suspension Dosage Forms

2018 ◽  
Vol 8 (1) ◽  
pp. 88-103 ◽  
Author(s):  
Mahmoud A. Mohamed ◽  
Amr H. Ali ◽  
Abdelfatah M. Abdelfatah ◽  
Mahmoud O. Ahmed
Keyword(s):  
Dosage Forms ◽  
Oral Suspension ◽  
In Vitro Dissolution ◽  
Dissolution Studies

In vitro dissolution of sparingly water-soluble drug dosage forms

1995 ◽  
Vol 125 (1) ◽  
pp. 99-106 ◽  
Author(s):  
Vinod P. Shah ◽  
Assad Noory ◽  
Carol Noory ◽  
Bruce McCullough ◽  
Sanford Clarke ◽  
...  
Keyword(s):  
Drug Dosage ◽  
Dosage Forms ◽  
Water Soluble ◽  
In Vitro Dissolution ◽  
Water Soluble Drug

scholarly journals Non-compendial vs compendial analytical tests - a powerful tool for predicting in vitro similarity of highly viscous oral suspension

2019 ◽  
Vol 64 (02) ◽  
pp. 61-72
Author(s):  
Elena Kazandjievska ◽  
Iva Antova ◽  
Slavica Mitrevska ◽  
Aleksandar Dimkovski ◽  
Elena Dimov ◽  
...  
Keyword(s):  
Drug Release ◽  
Negative Impact ◽  
In Vitro Release ◽  
Active Pharmaceutical Ingredient ◽  
Pharmaceutical Products ◽  
Dosage Forms ◽  
Oral Suspension ◽  
In Vitro Dissolution ◽  
Dissolution Profile

In vitro dissolution profiles are increasingly used to evaluate drug release characteristics of pharmaceutical products. The dissolution methods is expected to be an appropriate tool for checking consistency of the pharmaceutical attributes by discriminating similarities and dissimilarities between different drug formulations. Expansion in development of novel “special” dosage forms, due to the manner in which these dosage forms release the active pharmaceutical ingredient, usually requires applying non-compendial dissolution strategy that differs from the traditional compendial recommendations. For demonstrating sameness in the dissolution profile, in vitro drug release comparison between test and reference product of highly viscous oral suspension by applying non-compendial peak vessel against conventional hemispheric vessel was demonstrated in this study. All reference batches exhibited high variability in dissolution data when using hemispheric vessel due to forming mound compact mass at the bottom of the vessel. Different strategies for samples manipulation, before and during dissolution period, were performed in order to eliminate additional variabilities. Modifications of conventional USP 2 apparatus such as using peak vessel provided with more reproducible and reliable result for distinguishing in vitro similarities between different formulations of oral suspensions. Misinterpretation of dissolution data can lead to negative impact on product development. Taking time to observe and evaluate what is happening to the product in the vessel during dissolution is of curtail consideration for proper selection of the dissolution strategy. Keywords: oral suspensions; in-vitro release; hydrodynamic variability; USP apparatus 2/ Paddle apparatus; peak vessel

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