BCS classification of some drugs
Assignment of Biopharmaceutics I
BCS Classification of Some Drugs
Faculty- Dr. Rajib Bhattacharjee
BY
Shoaib –UL–Islam
0910783046
The Biopharmaceutical Classification System-
The Biopharmaceutics Classification System is a guide for predicting the intestinal drug absorption provided by the U.S. Food and Drug Administration. It was developed primarily in the context of immediate release (IR) solid oral dosage forms. It is the scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability. It is a drug development tool that allows estimation of the contributions of three major factors, dissolution, solubility and intestinal permeability that affect oral drug absorption from immediate release solid oral dosage forms. The interest in this classification system is largely because of its application in early drug development and then in the management of product change through its life cycle. It was first introduced into regulatory decision-making process in the guidance document on Immediate Release Solid Oral Dosage Forms: Scale Up And Post Approval Changes.
Purpose of the BCS Guidance:
Expands the regulatory application of the BCS and recommends methods for classifying drugs.
Explains when a waiver for in vivo bioavailability and bioequivalence studies may be requested based on the approach of BCS.
Goals of the BCS Guidance:
To improve the efficiency of drug development and the review process by recommending a strategy for identifying expendable clinical bioequivalence tests.
To recommend a class of immediate-release (IR) solid oral dosage forms for which bioequivalence may be assessed based on in vitro dissolution tests.
To recommend methods for classification according to dosage form dissolution, along with the solubility and permeability characteristics of the drug substance.
Classification:
According to BCS, drug substances are classified as (Figure 3):
Class I : High Solubility – High
BCS Classification of Some Drugs
Faculty- Dr. Rajib Bhattacharjee
BY
Shoaib –UL–Islam
0910783046
The Biopharmaceutical Classification System-
The Biopharmaceutics Classification System is a guide for predicting the intestinal drug absorption provided by the U.S. Food and Drug Administration. It was developed primarily in the context of immediate release (IR) solid oral dosage forms. It is the scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability. It is a drug development tool that allows estimation of the contributions of three major factors, dissolution, solubility and intestinal permeability that affect oral drug absorption from immediate release solid oral dosage forms. The interest in this classification system is largely because of its application in early drug development and then in the management of product change through its life cycle. It was first introduced into regulatory decision-making process in the guidance document on Immediate Release Solid Oral Dosage Forms: Scale Up And Post Approval Changes.
Purpose of the BCS Guidance:
Expands the regulatory application of the BCS and recommends methods for classifying drugs.
Explains when a waiver for in vivo bioavailability and bioequivalence studies may be requested based on the approach of BCS.
Goals of the BCS Guidance:
To improve the efficiency of drug development and the review process by recommending a strategy for identifying expendable clinical bioequivalence tests.
To recommend a class of immediate-release (IR) solid oral dosage forms for which bioequivalence may be assessed based on in vitro dissolution tests.
To recommend methods for classification according to dosage form dissolution, along with the solubility and permeability characteristics of the drug substance.
Classification:
According to BCS, drug substances are classified as (Figure 3):
Class I : High Solubility – High
References: 1 http://www.pharmainfo.net/reviews/biopharmaceutical-classification-drugs 2 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm128219.htm 3 United States Pharmacopoeia 30 – National Formulary 25 4 www.wikipedia.org