Literature DB >> 15236445

Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and atenolol.

H Vogelpoel1, J Welink, G L Amidon, H E Junginger, K K Midha, H Möller, M Olling, V P Shah, D M Barends.   

Abstract

Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapamil hydrochloride, propranolol hydrochloride, and atenolol in the form of BCS-monographs. Data on the qualitative composition of immediate release (IR) tablets containing these active substances with a Marketing Authorization (MA) in the Netherlands (NL) are also provided; in view of these MA's the assumption was made that these tablets were bioequivalent to the innovator product. The development of a database with BCS-related data is announced by the International Pharmaceutical Federation (FIP). Copyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 93:1945-1956, 2004

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Year:  2004        PMID: 15236445     DOI: 10.1002/jps.20131

Source DB:  PubMed          Journal:  J Pharm Sci        ISSN: 0022-3549            Impact factor:   3.534


  13 in total

1.  Disintegration of highly soluble immediate release tablets: a surrogate for dissolution.

Authors:  Abhay Gupta; Robert L Hunt; Rakhi B Shah; Vilayat A Sayeed; Mansoor A Khan
Journal:  AAPS PharmSciTech       Date:  2009-04-23       Impact factor: 3.246

Review 2.  Clinical relevance of dissolution testing in quality by design.

Authors:  Paul A Dickinson; Wang Wang Lee; Paul W Stott; Andy I Townsend; John P Smart; Parviz Ghahramani; Tracey Hammett; Linda Billett; Sheena Behn; Ryan C Gibb; Bertil Abrahamsson
Journal:  AAPS J       Date:  2008-08-07       Impact factor: 4.009

3.  Permeation of four oral drugs through human intestinal mucosa.

Authors:  Erina Pretorius; Patrick J D Bouic
Journal:  AAPS PharmSciTech       Date:  2009-03-12       Impact factor: 3.246

4.  Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds.

Authors:  Marija Tubic-Grozdanis; Michael B Bolger; Peter Langguth
Journal:  AAPS J       Date:  2008-04-02       Impact factor: 4.009

5.  Comparison of drug permeabilities and BCS classification: three lipid-component PAMPA system method versus Caco-2 monolayers.

Authors:  Zeynep S Teksin; Paul R Seo; James E Polli
Journal:  AAPS J       Date:  2010-03-12       Impact factor: 4.009

6.  Modeling of In Vitro Dissolution Profiles of Carvedilol Immediate-Release Tablets in Different Dissolution Media.

Authors:  Duygu Yilmaz Usta; Tuba Incecayir
Journal:  AAPS PharmSciTech       Date:  2022-07-26       Impact factor: 4.026

7.  Fast dissolving strips: A novel approach for the delivery of verapamil.

Authors:  S Kunte; P Tandale
Journal:  J Pharm Bioallied Sci       Date:  2010-10

8.  Investigating Halloysite Nanotubes as a Potential Platform for Oral Modified Delivery of Different BCS Class Drugs: Characterization, Optimization, and Evaluation of Drug Release Kinetics.

Authors:  Tazeen Husain; Muhammad Harris Shoaib; Farrukh Rafiq Ahmed; Rabia Ismail Yousuf; Sadaf Farooqi; Fahad Siddiqui; Muhammad Suleman Imtiaz; Madiha Maboos; Sabahat Jabeen
Journal:  Int J Nanomedicine       Date:  2021-03-01

Review 9.  Self-Emulsifying Granules and Pellets: Composition and Formation Mechanisms for Instant or Controlled Release.

Authors:  Ioannis Nikolakakis; Ioannis Partheniadis
Journal:  Pharmaceutics       Date:  2017-11-03       Impact factor: 6.321

10.  Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin.

Authors:  Navid Goodarzi; Ahmadreza Barazesh Morgani; Bertil Abrahamsson; Rodrigo Cristofoletti; D W Groot; Peter Langguth; Mehul U Mehta; James E Polli; Vinod P Shah; Jennifer B Dressman
Journal:  J Pharm Sci       Date:  2016-03-05       Impact factor: 3.534

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