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BCS CLASSIFICATION .pptx

The Biopharmaceutical Classification System (BCS) classifies drugs based on solubility and intestinal permeability, which are essential for drug discovery and lead optimization. BCS offers a regulatory framework for requesting biowaivers for certain drug classes, specifically Class I and some Class III compounds, under specific conditions related to solubility, permeability, and dosage form composition. The document outlines the significance of these parameters in predicting in vivo pharmacokinetics and the therapeutic performance of oral immediate-release drug products.

Health & Medicine◦
INTRODUCTION:- Biopharmaceutical Classification System (BCS) system allows restricting the prediction using the parameters solubility and intestinal permeability. The tenets of biopharmaceutics, solubility and permeability, are of pivotal importance in new drug discovery and lead optimization.
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.
Biowaiver are based on the Biopharmaceutics (BCS) classification of the active ingredient. Currently BCS class I and some class III compounds are eligible for biowaivers.  The drug substance should be highly soluble and highly permeable.
 An immediate release drug product should be rapidly dissolving.  The drug should not be a narrow therapeutic index drug.  Excipients used in the dosage form should have been used previously in FDA approved IR solid dosage forms.
1. The Biopharmaceutical Classification System has been developed to provide a scientific approach to allow for to prediction in vivo pharmacokinetics of oral immediate release (IR) drug product by classifying drug compound based on their, SOLUBILITY PERMEABILIT DISSOLUTION
The Maximum Amount of solute dissolved in a given solvent under standard conditions of temperature, pressure and pH. Solubility is the ability of the drug to be solution after dissolution.  The higher single unit dose is completely soluble in 250 ml at pH 1- 6.8 ( 37˚C ).
 Permeability of the drug to pass the biological membrane which is the lipophilic. Permeability is indirectly based on the extent of absorption of a drug substance. Drug substance is considered to be highly permeable, when the extent of absorption in human determined to be 90%.
It is process in which solid substance solubilises in given solvent i.e mass transfer from solid surface to liquid phase. Using USP apparatus I at 100 rpm or USP apparatus II at 50 rpm.  Dissolution Media [900 ml], 1. 0.1N HCl or simulated gastric fluid (pH 1.2) without enzyme. 2. pH 4.5 buffer & pH 6.8 buffer. 3. Simulated intestinal fluid without enzyme.
CLASS SOLUBILITY PERMEABILITY EXAMPLES Class-I High High Metoprolol , Propranolol Class-II low High Nifedipine, naproxen Class-III High Low Cimitidine, Metformin Class-IV Low Low Taxol, Clorthiazole
Ideal for oral route administration. Drug absorbed rapidly. Drug dissolved rapidly. Rapid therapeutic action. Bioavailability problem not expected for immediate release drug product. e.g. Metoprolol , Propranolol, Diltiazem.
Oral route for administration. Drug absorb rapidly. Bioavailability is controlled by dosage form and rate of release of the drug substance. e. g. Nifedipine, naproxen.
Oral route for administration. Drug absorbance is limited. Drug dissolve rapidly. e. g. Cimitidine, Metformin, Insulin.
Poorly absorbed by orally administration. Both solubility & permeability limitation. Low dissolution rate. Slow or low therapeutic action. e. g. Taxol, Chlorthiazole, Cefexime Trihydrate.
 To use in biowaiver considerations.  Aid in earliest stages of drug discovery research.  Applications in both the preclinical and clinical drug development processes.  To predict in vivo performance of drug product using solubility and permeability measurements.