Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V
Marc LindenbergJennifer B Dressman

Abstract

Since its inception in 1995, the biopharmaceutical classification system (BCS) has become an increasingly important tool for regulation of drug products world-wide. Until now, application of the BCS has been partially hindered by the lack of a freely available and accurate database summarising solubility and permeability characteristics of drug substances. In this report, orally administered drugs on the Model list of Essential Medicines of the World Health Organization (WHO) are assigned BCS classifications on the basis of data available in the public domain. Of the 130 orally administered drugs on the WHO list, 61 could be classified with certainty. Twenty-one (84%) of these belong to class I (highly soluble, highly permeable), 10 (17%) to class II (poorly soluble, highly permeable), 24 (39%) to class III (highly soluble, poorly permeable) and 6 (10%) to class IV (poorly soluble, poorly permeable). A further 28 drugs could be provisionally assigned, while for 41 drugs insufficient or conflicting data precluded assignment to a specific BCS class. A total of 32 class I drugs (either certain or provisional classification) were identified. These drugs can be further considered for biowaiver status (drug product approval based on ...Continue Reading

References

Nov 1, 1976·Clinical Pharmacokinetics·K M Das, R Dubin
Jan 1, 1977·Clinical Pharmacokinetics·E Iisalo
Sep 1, 1979·European Journal of Clinical Pharmacology·P J PentikäinenA Penttilä
Nov 1, 1979·British Journal of Clinical Pharmacology·C GraffnerO Rönn
Mar 1, 1978·Clinical Pharmacology and Therapeutics·B F JohnsonC Bye
Jan 1, 1976·Clinical Pharmacokinetics·D J GreenblattJ Koch-Weser
Apr 20, 1977·European Journal of Clinical Pharmacology·M D RawlinsA R Hijab
Sep 1, 1976·Cardiovascular Research·M SchomerusM Eichelbaum
Jan 1, 1976·European Journal of Clinical Pharmacology·T Talseth
Feb 1, 1976·Australian and New Zealand Journal of Medicine·R O DayG G Graham
Aug 1, 1975·Clinical Pharmacology and Therapeutics·D E DugganF G McMahon
Feb 1, 1976·Clinical Pharmacology and Therapeutics·R GuglerD L Azarnoff
Feb 1, 1976·Clinical Pharmacology and Therapeutics·A KarimM Dooley
Jul 1, 1976·Clinical Pharmacology and Therapeutics·E H Nauta, H Mattie
Sep 1, 1992·The Journal of Infectious Diseases·M N DudleyK Mayer
May 1, 1992·The Annals of Pharmacotherapy·M J SheltonG D Morse
Jan 1, 1992·Journal of Toxicology. Clinical Toxicology·P E McKinneyW A Watson
May 1, 1992·Antimicrobial Agents and Chemotherapy·J T LettieriA H Heller
Jul 1, 1992·Arthritis and Rheumatism·G D KozloskiJ B Johnson
Jan 1, 1992·European Journal of Clinical Pharmacology·K PerssonA Rane
Jan 1, 1991·Developmental Pharmacology and Therapeutics·S ItoH Yoshioka
Sep 1, 1991·Therapeutic Drug Monitoring·P H Hinderling, D Hartmann
Jun 1, 1991·Clinical Pharmacokinetics·A E Balant-GorgiaL P Balant
Mar 1, 1990·Reviews of Infectious Diseases·K W BrammerJ K Faulkner
Dec 1, 1990·Clinical Pharmacokinetics·K Vance-BryanJ C Rotschafer
Jun 1, 1990·Journal of Clinical Pharmacology·W J SandbornR M Strong
Feb 1, 1989·Clinical Pharmacokinetics·M R Holdiness
Dec 1, 1989·Clinical Pharmacokinetics·J S FroemmingC M Davis
Feb 1, 1989·Journal of Pharmaceutical Sciences·R A HermanD E Furst
Mar 1, 1989·Journal of Clinical Pharmacology·F KellerG Offermann
Jul 1, 1989·British Journal of Clinical Pharmacology·D R RobertsonC F George
Apr 1, 1985·The Journal of Pharmacy and Pharmacology·F A OgunbonaO S Olawoye
Aug 1, 1985·The Journal of Pharmacy and Pharmacology·M R HirjiJ C Mucklow
Nov 1, 1985·Clinical Pharmacokinetics·D M Paton, D R Webster
Apr 1, 1987·The Journal of Pharmacy and Pharmacology·R DahlanV B Sunderland
Aug 1, 1988·Clinical Pharmacokinetics·G Edwards, A M Breckenridge

❮ Previous
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Citations

Mar 3, 2010·European Journal of Clinical Pharmacology·Juan José TorradoAlfredo García-Arieta
Oct 19, 2006·Pharmaceutical Research·M-L ChenA S Hussain
Jul 28, 2013·International Journal of Pharmaceutics·Sushant PatilVandana Patravale
May 5, 2009·Transactions of the Royal Society of Tropical Medicine and Hygiene·J Russell StothardDavid Rollinson
Dec 15, 2010·Journal of Chemical Information and Modeling·Taiji OashiAlexander D Mackerell
Nov 13, 2008·The AAPS Journal·Filippos Kesisoglou, Yunhui Wu
Nov 19, 2008·AAPS PharmSciTech·Praveen S Hiremath, Ranendra N Saha
Nov 27, 2008·AAPS PharmSciTech·Sandra Klein, Vinod P Shah
Feb 2, 2010·Chemical & Pharmaceutical Bulletin·Shahla Soltanpour, Abolghasem Jouyban
May 1, 2013·PloS One·Thanyanan ChaowanachanKim A Woodrow
Oct 12, 2012·International Journal of Nanomedicine·Lidiane M MonteiroLucio M Cabral
Apr 6, 2006·Clinical Pharmacokinetics·Ekarat JantratidJennifer B Dressman
Dec 18, 2007·Clinical Drug Investigation·Hossein AminiAbolhassan Ahmadiani
Sep 1, 2008·Indian Journal of Pharmaceutical Sciences·S ChandranNeelima Mantha
Oct 4, 2011·Journal of Pharmacy & Bioallied Sciences·Hetal Paresh ThakkarSneha Piyush Thakkar
Mar 13, 2014·Carbohydrate Polymers·Cui ZhangFeng-Qing Yang
Jan 7, 2014·The Journal of Antimicrobial Chemotherapy·Piero OlliaroJennifer Keiser
Nov 23, 2013·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Moran ZurArik Dahan
Feb 26, 2014·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·H KortejärviM Yliperttula
Aug 15, 2013·AAPS PharmSciTech·Thiago da Silva HonórioLucio Mendes Cabral
May 31, 2014·Journal of Pharmaceutical and Biomedical Analysis·Norbert RadacsiRita Ambrus
Sep 10, 2014·International Journal of Pharmaceutics·Eva Julia LaukampJoerg Breitkreutz
May 27, 2014·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Anjali SethChristine Ménager
Jul 11, 2014·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·A VervaeckC Vervaet
Oct 5, 2013·Phytomedicine : International Journal of Phytotherapy and Phytopharmacology·André de Lima AiresMônica Camelo Pessôa de Azevedo Albuquerque
May 25, 2012·International Journal of Hyperthermia : the Official Journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group·Anna Yudina, Chrit Moonen
Feb 7, 2016·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Manuel IbarraPietro Fagiolino
Sep 27, 2014·International Journal of Molecular Sciences·Jahamunna A A BarbosaArnóbio A da Silva-Júnior
May 28, 2011·Drug Development and Industrial Pharmacy·Venugopal P MarasanapalleBhaskara R Jasti
Mar 16, 2006·Drug Development and Industrial Pharmacy·N PatelJ Murray
Jul 20, 2013·Expert Opinion on Drug Discovery·Klara ValkoPeter Eddershaw

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