The developability classification system: application of biopharmaceutics concepts to formulation development

Journal of Pharmaceutical Sciences
James M Butler, Jennifer B Dressman

Abstract

A revised classification system for oral drugs was developed using the biopharmaceutics classification system (BCS) as a starting point. The revised system is designed to have a greater focus on drug developability. Intestinal solubility, the compensatory nature of solubility and permeability in the small intestine and an estimate of the particle size needed to overcome dissolution rate limited absorption were all considered in the revised system. The system was then validated by comparison with literature on the in vivo performance of a number of test compounds. Observations on the test compounds were consistent with the revised classification, termed the developability classification system (DCS), showing it to be of greater value in predicting what factors are critical to in vivo performance than the widely used BCS.

References

Sep 1, 1991·Therapeutic Drug Monitoring·P H Hinderling, D Hartmann
Apr 1, 1985·The Journal of Pharmacy and Pharmacology·F A OgunbonaO S Olawoye
Jan 1, 1986·European Journal of Clinical Pharmacology·B Beermann, C Midskov
Sep 1, 1986·Journal of Pharmaceutical Sciences·T HamaguchiN Mizuno
Jan 1, 1985·European Journal of Clinical Pharmacology·M Schäfer-KortingE Mutschler
Aug 1, 1984·The Journal of Pharmacy and Pharmacology·M KingsfordR J Shirkey
Jul 1, 1980·The Journal of Antimicrobial Chemotherapy·J W Van Der MeerJ Brugmans
May 1, 1983·Clinical Pharmacokinetics·O L Laskin
Jul 1, 1982·Journal of Pharmaceutical Sciences·V P ShahB E Cabana
Dec 1, 1994·Biopharmaceutics & Drug Disposition·T Gramatté
Mar 1, 1996·Journal of Clinical Pharmacology·J LavelleJ Connor
Dec 1, 1995·Journal of Pharmaceutical Sciences·D A AdkinI R Wilding
Nov 1, 1996·Inflammation Research : Official Journal of the European Histamine Research Society ... [et Al.]·A MukherjeeR Stein
Apr 2, 1998·Journal of Pharmaceutical Sciences·A L UngellH Lennernäs
May 9, 2001·The Journal of Pharmacy and Pharmacology·T TeraoH Shouji
Sep 21, 2001·Journal of Clinical Pharmacology·D JungA Dorr
Sep 29, 2001·Advanced Drug Delivery Reviews·C J Porter, W N Charman
May 15, 2002·European Journal of Medicinal Chemistry·Chengyue ZhuKin-Kai Hwang
Jun 5, 2002·Journal of Clinical Pharmacology·Marilyn N Martinez, Gordon L Amidon
Dec 14, 2002·Journal of Molecular Graphics & Modelling·Susanne WiniwarterAnders Karlén
Jan 28, 2003·Drug Discovery Today·Michael H AbrahamDerek P Reynolds
Feb 7, 2003·Journal of Medicinal Chemistry·Christel A S BergströmPer Artursson
Feb 21, 2003·International Journal of Pharmaceutics·Karl A LevisOwen I Corrigan
Apr 25, 2003·International Journal of Pharmaceutics·Kiyohiko SuganoYoshinori Aso
Feb 26, 2004·The Journal of Pharmacy and Pharmacology·Edmund S KostewiczJennifer B Dressman
Mar 18, 2004·The Journal of Pharmacy and Pharmacology·Manisha DevaniDuncan Q M Craig
Apr 22, 2004·The Journal of Pharmacy and Pharmacology·Maria VertzoniChristos Reppas
Jun 16, 2004·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Ching-Ling ChengChen-Hsi Chou
Jul 23, 2004·Journal of Medicinal Chemistry·Stefan WillmannJennifer B Dressman
May 17, 2005·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Maria VertzoniChristos Reppas
Jun 14, 2005·Journal of Clinical Pharmacology·Hartmut DerendorfWolfgang Eisert
Sep 2, 2005·Journal of Pharmaceutical Sciences·H PotthastD M Barends
Mar 21, 2006·European Journal of Medicinal Chemistry·L-P RuanS X Qiu
Jul 29, 2006·The Journal of Pharmacy and Pharmacology·Mariangeles Perez de la Cruz MorenoPatrick Augustijns
Oct 21, 2006·Pharmaceutical Research·Stefanie BendelsAlex Avdeef
Jan 24, 2007·Journal of Pharmaceutical Sciences·Jochem AlsenzElisabeth Haenel

❮ Previous
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Citations

Dec 12, 2012·Pharmaceutical Research·Maria M Posada, David E Smith
Feb 20, 2013·Clinical Pharmacokinetics·Frederik E StuurmanJan H M Schellens
Jul 31, 2013·International Journal of Pharmaceutics·Angela SprunkPeter Kleinebudde
May 1, 2012·Nature Reviews. Drug Discovery·Michael M Hann, György M Keserü
Jan 7, 2014·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Jung Hyun ChoHan-Gon Choi
Mar 13, 2014·International Journal of Pharmaceutics·Ulla Brinkmann-Trettenes, Annette Bauer-Brandl
Aug 26, 2014·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Asami Ono, Kiyohiko Sugano
Oct 15, 2014·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Valentina AnutaOctavian Tudorel Olaru
May 12, 2015·Expert Opinion on Drug Delivery·Federica Leone, Roberta Cavalli
Jul 20, 2013·Expert Opinion on Drug Discovery·Klara ValkoPeter Eddershaw
Sep 8, 2011·Expert Opinion on Drug Delivery·Peter van HoogevestAlfred Fahr
Jul 3, 2015·Drug Development and Industrial Pharmacy·Ignacio González-GarcíaMarival Bermejo
Jan 15, 2016·Expert Opinion on Drug Delivery·Maria MalamatariGraham Buckton
Jan 4, 2012·Journal of Pharmaceutical Sciences·Ann NewmanGeorge Zografi
Feb 26, 2015·Journal of Pharmaceutical Sciences·Kiyohiko Sugano, Katsuhide Terada
Aug 8, 2014·Journal of Pharmaceutical Sciences·William Wei Lim ChinRajeev Gokhale
Sep 27, 2014·Journal of Pharmaceutical Sciences·Arzu SelenJennifer B Dressman
Nov 19, 2015·Journal of Pharmaceutical Sciences·Dhaval A ShahRutesh H Dave
Jul 6, 2014·Journal of Pharmaceutical Sciences·Hywel D WilliamsUNKNOWN Communicated on Behalf of the LFCS Consortium
Feb 3, 2016·Advanced Drug Delivery Reviews·Paul D Leeson
Dec 25, 2012·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Martin Kuentz, Georgios Imanidis
Nov 6, 2012·International Journal of Pharmaceutics·David Elder, René Holm
Sep 25, 2012·International Journal of Pharmaceutics·Jan P Möschwitzer
Mar 16, 2012·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Veronika RozehnalJuergen Mueller
Dec 25, 2015·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·David P ElderRené Holm
Dec 22, 2015·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Martin KuentzDavid P Elder
Oct 16, 2015·International Journal of Pharmaceutics·Sophia Yui Kau FongAnnette Bauer-Brandl
Mar 10, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Uwe MuensterAndreas Ohm
Jul 29, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Joseph P O'SheaBrendan T Griffin
Sep 1, 2015·Therapeutic Delivery·Jonas H Fagerberg, Christel As Bergström
Oct 13, 2012·The Journal of Pharmacy and Pharmacology·Sarah Maud FischerGert Fricker
Jun 6, 2014·Pharmaceutical Development and Technology·Elisabeth LenzSusanne Page
Apr 4, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Constantinos MarkopoulosChristos Reppas
Feb 28, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·M VogtherrC Saal
Jan 11, 2014·International Journal of Pharmaceutics·Andreas Niederquell, Martin Kuentz
Feb 4, 2014·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Yasuhiro TsumeGordon L Amidon
Oct 1, 2013·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Line Hagner NielsenAnette Müllertz
Nov 6, 2013·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·H LennernäsB Abrahamsson
Aug 31, 2013·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Hans Lennernäs
May 15, 2013·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Hannah K BatchelorUNKNOWN European Paediatric Formulation Initiative

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