Bcs Class 2 Drug List Pdf

14.08.2019

Jump to navigationJump to search

Bcs Class 2 Drug List
Schedule 1 Drug List

Biopharmaceutics Classification System (BCS) is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver.

For other uses of the abbreviation BCS, see BCS (disambiguation).

The Biopharmaceutics Classification System is a system to differentiate the drugs on the basis of their solubility and permeability.^[1]

This system restricts the prediction using the parameters solubility and intestinal permeability. The solubility classification is based on a United States Pharmacopoeia (USP) aperture. The intestinal permeability classification is based on a comparison to the intravenous injection. All those factors are highly important because 85% of the most sold drugs in the United States and Europe are orally administered^{[citation needed]}.

BCS classes[edit]

According to the Biopharmaceutical Classification System (BCS) drug substances are classified to four classes upon their solubility and permeability:^[1]

Class I - high permeability, high solubility
- Example: metoprolol, paracetamol^[2]
- Those compounds are well absorbed and their absorption rate is usually higher than excretion.
Class II - high permeability, low solubility
- Example: glibenclamide, bicalutamide, ezetimibe, aceclofenac
- The bioavailability of those products is limited by their solvation rate. A correlation between the in vivo bioavailability and the in vitro solvation can be found.
Class III - low permeability, high solubility
- Example: cimetidine
- The absorption is limited by the permeation rate but the drug is solvated very fast. If the formulation does not change the permeability or gastro-intestinal duration time, then class I criteria can be applied.
Class IV - low permeability, low solubility
- Example: Bifonazole
- Those compounds have a poor bioavailability. Usually they are not well absorbed over the intestinal mucosa and a high variability is expected.

Definitions[edit]

The drugs are classified in BCS on the basis of solubility, permeability, and dissolution.

Jun 20, 2014 - I have the Bunker Hill Security - item#61229 and n. I have the Bunker Hill Security - item#61229 and need to download the software. Bunker hill security camera drivers. Nov 29, 2017 - I cant down load the drivers for my cameras. Hello, bunker hill security 62368. I intalled the driver but i cant find my cameras anywere. Dec 26, 2017 - bunker hill security h.264 dvr security system software Download. BUNKER HILL SECURITY 68332 Security Camera pdf manual download. Turn your WebCam into a Security Camera. No extra equipment needed. Just set the timer and leave the room. The camera will detect the first thing that moves.

Solubility class boundaries are based on the highest dose strength of an immediate release product. A drug is considered highly soluble when the highest dose strength is soluble in 250 ml or less of aqueous media over the pH range of 1 to 7.5. The volume estimate of 250 ml is derived from typical bioequivalence study protocols that prescribe administration of a drug product to fasting human volunteers with a glass of water.

Permeability class boundaries are based indirectly on the extent of absorption of a drug substance in humans and directly on the measurement of rates of mass transfer across human intestinal membrane. Alternatively non-human systems capable of predicting drug absorption in humans can be used (such as in-vitro culture methods). A drug substance is considered highly permeable when the extent of absorption in humans is determined to be 90% or more of the administered dose based on a mass-balance determination or in comparison to an intravenous dose.

For dissolution class boundaries, an immediate release product is considered rapidly dissolving when no less than 85% of the labeled amount of the drug substance dissolves within 15 minutes using USP Dissolution Apparatus 1 at 100 RPM or Apparatus 2 at 50 RPM in a volume of 900 ml or less in the following media: 0.1 N HCl or simulated gastric fluid or pH 4.5 buffer and pH 6.8 buffer or simulated intestinal fluid.

References[edit]

^ ^a^bMehta M (2016). Biopharmaceutics Classification System (BCS): Development, Implementation, and Growth. Wiley. ISBN978-1-118-47661-1.
^https://www.ema.europa.eu/documents/scientific-guideline/draft-paracetamol-oral-use-immediate-release-formulations-product-specific-bioequivalence-guidance_en.pdf

External links[edit]

BCS guidance of the U.S. Food and Drug Administration

Retrieved from 'https://en.wikipedia.org/w/index.php?title=Biopharmaceutics_Classification_System&oldid=884065387'

Categories:

Hidden categories:

Toshihide Takagi^†, Chandrasekharan Ramachandran^†, Marival Bermejo^‡, Shinji Yamashita^§, Lawrence X. Yu^‖^⊥, and Gordon L. Amidon*^†

College of Pharmacy, University of Michigan, Ann Arbor, Michigan 48109-1065, Department of Pharmacy and Technology, University of Valencia, Valencia, Spain, Faculty of Pharmaceutical Sciences, Setsunan University, Osaka, Japan, and Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857

DOI: 10.1021/mp0600182

Cite this:Mol. Pharm. 3, 6, 631-643

Abstract

Orally administered, immediate-release (IR) drug products in the top 200 drug product lists from the United States (US), Great Britain (GB), Spain (ES), and Japan (JP) were provisionally classified based on the Biopharmaceutics Classification System (BCS). The provisional classification is based on the aqueous solubility of the drugs reported in readily available reference literature and a correlation of human intestinal membrane permeability for a set of 29 reference drugs with their calculated partition coefficients. Oral IR drug products constituted more that 50% of the top 200 drug products on all four lists, and ranged from 102 to 113 in number. Drugs with dose numbers less than or equal to unity are defined as high-solubility drugs. More than 50% of the oral IR drug products on each list were determined to be high-solubility drugs (55−59%). The provisional classification of permeability is based on correlations of the human intestinal permeabilities of 29 reference drugs with the calculated Log P or CLogP lipophilicity values for the uncharged chemical form. The Log P and CLogP estimates were linearly correlated (r² = 0.79) for 187 drugs. Metoprolol was chosen as the reference compound for permeability and Log P or CLogP. A total of 62−69.0% and 56−60% of the drugs on the four lists exhibited CLogP and Log P estimates, respectively, greater than or equal to the corresponding metoprolol value and are provisionally classified as high-permeability drugs. We have compared the BCS classification in this study with the recently proposed BDDCS classification based on fraction dose metabolism. Although the two approaches are based on different in vivo processes, fraction dose metabolized and fraction dose absorbed are highly correlated and, while depending on the choice of reference drug for permeability classification, e.g., metoprolol vs cimetidine or atenolol, show excellent agreement in drug classification. In summary, more than 55% of the drug products were classified as high-solubility (Class 1 and Class 3) drugs in the four lists, suggesting that in vivo bioequivalence (BE) may be assured with a less expensive and more easily implemented in vitro dissolution test.

Keywords: BCS; solubility; dose number; permeability; partition coefficient; WHO essential drugs; top-selling US, European, Japanese drugs; BDDCS

Find Your Institution

Previously logged in from:

If you no longer have access with this institution, try logging in with your ACS ID.

Type part of your institution name for a list of matches. If your institution is not listed, please contact your librarian.

Unable to find the university or organization name. Please log in with your ACS ID, or get in contact with your librarian.

Press Enter to select the institution

Login with ACS ID

ACS members enjoy benefits including 50 free articles a year and reduced priced individual subscription. Learn More

ACOnet Identity Federation (Austria)

Institute of Science and Technology Austria
Johannes Kepler University Linz
University of Veterinary Medicine Vienna

German Higher Education (DFN-AAI)

Albert-Ludwigs-Universität Freiburg
Bielefeld University
Friedrich-Alexander-Universität Erlangen-Nürnberg
Hamburg University of Technology (TUHH)
Heinrich Heine University Duesseldorf
Hochschule Aschaffenburg - University of Applied Sciences
Hochschule Darmstadt
Hochschule Hamm-Lippstadt
Hochschule Harz (FH)
Hochschule Ostwestfalen-Lippe
Hochschule für Wirtschaft und Umwelt Nürtingen-Geislingen
Johann Wolfgang Goethe-Universität Frankfurt am Main
Julius-Maximilians-Universität Würzburg
Karlsruhe Institute of Technology (KIT)
Otto von Guericke University Magdeburg
Philipps-University Marburg
SLUB Dresden
San-Netz.de
Technical University of Munich (TUM)
Technische Universität Bergakademie Freiberg
Technische Universität Dortmund
UNIVERSITY OF VETERINARY MEDICINE HANNOVER, FOUNDATION
University of Applied Sciences Karlsruhe
University of Education Karlsruhe
University of Leipzig
University of Paderborn
University of Siegen
Universität Duisburg-Essen
Universität Greifswald
Universität Ulm

India: INFLIBNET Access Management Federation (INFED)

Alagappa University, Tamil Nadu
Avinashilingam University, Tamil Nadu
Bharathidasan University
Central University of Punjab
Central University of Tamilnadu
IIT Guwahati
INFLIBNET Staff [Parichay Identity Service]
Madurai Kamaraj University
Sikkim University
Thapar Institute of Engineering and Technology
University of Delhi
Vidyasagar University

Ireland - Edugate Federation Schedule 1 drug list

Athlone Institute of Technology
TU Dublin - Tallaght Campus
University of Limerick

Italy - IDEM GARR

Ca' Foscari University of Venice
Cagliari State University
Free University of Bolzano
Politecnico di Bari
Roma TRE University
Scuola Superiore Sant'Anna
University of Bologna
University of Camerino
University of Genoa
University of Messina
University of Naples Federico II
University of Padova
University of Palermo
University of Parma
University of Pavia
University of Perugia
University of Pisa
University of Rome Tor Vergata
University of Salerno
University of Siena
University of Verona

OpenAthens Federation

Agilent Technologies Inc
Agnes Scott College
Ajman University of Science and Technology
AkzoNobel
Aligarh Muslim University
Allegheny College
Anonymous Petcare
Aston University
Azusa Pacific (APU) & Los Angeles Pacific (LAPU) University
BP International
BRAC University
Bar-Ilan University
Baylor Health Sciences Library
Birkbeck College
Bridgend College
Bristol-Myers Squibb
Calico Life Sciences LLC
California University of Pennsylvania
Carson-Newman University
Case Western Reserve University
Celgene
Columbus State University
Coventry University
Cranfield University
DSM N.V.
Defence Science and Technology Group (DST)
Delaware Valley University
Deutsches Zentrum fur Neurodegenerative Erkrankungen
DuPont
East Tennessee State University
Eduserv Athens
Environment Agency
FL2811 Air Force Civil Engineer Center - Tyndall Research Site
Faulkner University
Fera Science Ltd
Ferring Pharmaceuticals
Gannon University
Georgia Institute of Technology
Georgia State University
Gilead Sciences, Inc
Glasgow Kelvin College
Hogskolan i Gavle
Honeywell International, Inc.
Howard Payne University
Incyte Corporation
Indian Institute of Science Education and Research Thiruvananthapuram
Indiana Wesleyan University
Inova Health System
Iowa State University
JKM Library
James Madison University
Jamia Millia Islamia University
Jawaharlal Nehru Centre for Advanced Scientific Research
Juniata College
Kutztown University
LEO Pharma A/S
LSU Health Sciences Center Library
La Roche University
LaGrange College
Lipscomb University
Liverpool John Moores University
London South East Colleges (LSEC)
Lycoming College
Macalester College
Maryville College
Mercer University
Millersville University
Ministry of Education (MOE) HQ Library
Mississippi State University
Mississippi Valley State University
Monsanto
National Health Research Institutes - NHRI 國家衛生研究院圖書館
Naval Surface Warfare Center
Naval Warfare Center Research Commons
Norfolk State University Lyman Beecher Brooks Library
Nutricia
ORT Braude College
Park University
PepsiCo
Philadelphia College of Osteopathic Medicine
Prairie State College
Provadis School of International Management and Technology AG
Punjab Technical University
Rothamsted Research
Royal Dutch Shell
Royal Phi
Savannah State University
Seattle Genetics, Inc.
Seton Hall University
Shippensburg University of Pennsylvania
Singapore Institute of Technology (SIT)
Solvay
South College
Southwest Baptist University
Southwestern University
Swansea University
Tennessee State University
Tennessee Wesleyan University
Teva Pharmaceutical Industries LTD
Texas Medical Center Library
The Centre For Environment and Aquaculture Science (Cefas)
The Sixth Form College, Farnborough
US Army Medical Research and Materiel Command
Universidad Nacional De Tres De Febrero
Universidade Federal Do Parana
Universiti Sains Malaysia -Perpustakaan Hamzah Sendut
Universiti Teknologi Petronas
University of Chester
University of Dallas
University of East Anglia (UEA)
University of Hertfordshire
University of Huddersfield Library
University of Leeds
University of Leicester
University of Lincoln
University of North Carolina at Charlotte
University of Pikeville
University of San Francisco
University of Toledo
University of Ulster
University of West Georgia
University of the Cumberlands
University of the South
Université de Moncton
Upstate Medical University and Medical Center
Verily Life Sciences
Victorian Government Library Service
Visva Bharati University
Waynesburg University
West Chester University
West College Scotland
Westmont College
anonymous institute

RCTSaai - Portuguese Federation

FCCN - Unidade da FCT I.P.
INL- International Iberian Nanotechnology Laboratory
ISCTE - Instituto Universitario de Lisboa
Instituto Politecnico de Portalegre
Instituto Politécnico de Bragança
Instituto Politécnico de Castelo Branco
Instituto Politécnico de Lisboa
Instituto Politécnico de Tomar
Instituto Politécnico de Viana do Castelo
Laboratorio Nacional de Energia e Geologia
Laboratório Nacional de Engenharia Civil
Polytechnic Institute of Beja
Polytechnic Institute of Cavado and Ave
Polytechnic Institute of Leiria
Polytechnic Institute of Porto
Polytechnic Institute of Santarém
Polytechnic Institute of Setubal
ULisboa - Campus UL
UNL - Rectory
Universidade Aberta
Universidade Autónoma de Lisboa
Universidade Católica Portuguesa - Porto
Universidade Portucalense Infante D. Henrique
Universidade da Madeira
Universidade dos Açores
Universidades Lusiada - Lisboa
University Fernando Pessoa
University of Algarve
University of Aveiro
University of Beira Interior
University of Coimbra
University of Minho
University of Porto
University of Trás os Montes e Alto Douro
University of Évora