Comparative in vitro dissolution study of carbamazepine immediate-release products using the USP paddles method and the flow-through cell system

The present study evaluated the ability of a modified flow-through method for predicting in vivo performance of immediate release (IR) and extended release (ER) formulations. In vitro dissolution of two model drugs, paracetamol IR tablets and felodipine ER tablets, was investigated under tuned conditions using the modified flow-through method and compared with the compendial quality control (QC) basket method. The in vivo absorption properties of paracetamol IR tablets and felodipine ER tablets were investigated in healthy volunteers. In vitro-in vivo correlation (IVIVC) analysis was performed based on the obtained in vitro and in vivo data. Our results demonstrated that the compendial QC method was not able to reflect in vivo actual absorption, while satisfactory discriminatory power and comparable in vitro dissolution/in vivo absorption were achieved for both paracetamol IR tablets and felodipine ER tablets by the modified flow-through method. This study indicated that the modified flow-through method is a potential tool to reflect in vivo performance of the IR and ER formulations.

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Formulation and Evaluation of Microbially- triggered tablets of Valdecoxib

International Journal of Drug Delivery Technology ◽

10.25258/ijddt.v2i1.8841 ◽

2010 ◽

Vol 2 (1) ◽

Author(s):

Surender Verma ◽

S. Singh ◽

D. Mishra ◽

Atul Gupta ◽

Rakesh Sharma

Keyword(s):

Phosphate Buffer ◽

Guar Gum ◽

Oral Route ◽

Matrix Tablets ◽

In Vitro Dissolution ◽

Wet Granulation ◽

Dissolution Study ◽

Caecal Content ◽

Model Drug

The objective of present study was to develop colon targeted drug delivery using bacterially triggered approach through oral route. Valdecoxib (COX-2 inhibitor) was chosen as a model drug in order to target it to colon which may prove useful in inflammatory bowel disease and related disorders. Matrix tablets of Valdecoxib were prepared by wet granulation technique utilizing different ratio of Guar gum and Sodium starch glycholate. The prepared matrix tablets were evaluated for uniformity of weight, uniformity of content, hardness and in vitro dissolution study in simulated gastric and intestinal fluid (Phosphate Buffer pH-1.2, pH-6.8 and pH-7.4), followed by Dissolution study in bio-relevant dissolution media Phosphate Buffer (pH-6.8) containing rat caecal content. The results revealed that the formulated batch had released lesser quantity of drug at pH 1.2 and pH 7.4 in 2 hors whereas in biorelevent dissolution media containing rat caecal content it released significantly higher amount of drug which was also significantly higher than the dissolution media of same pH without caecal content (microflora) and it was concluded that guar gum can be used as a potential carrier for targeting drugs to colon.

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In vivo and in vitro characterization of immediate release dosage forms containing n-acetylcysteine using the dynamic open flow-through test apparatus

10.26226/morressier.57d6b2b7d462b8028d88dd29 ◽

2016 ◽

Author(s):

Maximilian Sager

Keyword(s):

Immediate Release ◽

Dosage Forms ◽

Test Apparatus ◽

Open Flow ◽

In Vitro Characterization ◽

Flow Through

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In vitro dissolution method fitted to in vivo absorption profile of rivaroxaban immediate-release tablets applying in silico data

Drug Development and Industrial Pharmacy ◽

10.1080/03639045.2017.1411939 ◽

2017 ◽

Vol 44 (5) ◽

pp. 723-728 ◽

Cited By ~ 1

Author(s):

Nathalie R. Wingert ◽

Natália O. dos Santos ◽

Sarah C. Campanharo ◽

Elisa S. Simon ◽

Nadia M. Volpato ◽

...

Keyword(s):

In Silico ◽

Immediate Release ◽

In Vitro Dissolution ◽

Absorption Profile ◽

Dissolution Method ◽

In Vivo Absorption

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In Vitro Dissolution Testing with Flow-Through Method: A Technical Note

AAPS PharmSciTech ◽

10.1208/s12249-009-9339-6 ◽

2009 ◽

Vol 10 (4) ◽

Cited By ~ 16

Author(s):

Zongming Gao

Keyword(s):

Technical Note ◽

In Vitro Dissolution ◽

Dissolution Testing ◽

Flow Through

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COMPARISON OF THE IN VITRO DISSOLUTION PROFILES FOR A HIGH SOLUBILITY DRUG FROM IMMEDIATE RELEASE FORMULATIONS USING USP APPARATUSES 3 AND 4

FARMACIA ◽

10.31925/farmacia.2018.3.12 ◽

2018 ◽

Vol 66 (3) ◽

pp. 477-482 ◽

Cited By ~ 1

Author(s):

MONICA ARDELEAN

Keyword(s):

Immediate Release ◽

In Vitro Dissolution ◽

High Solubility

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

Journal of Pharmacy & Pharmaceutical Sciences ◽

10.18433/jpps32260 ◽

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.

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