BCS Classification System

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BCS classification

DEFINITION of BCS classification System

Pre-formulation: The study of the physical and chemical properties of drug substances prior to formulation is called pre-formulation.

Angle of repose: The internal angle between the surface of the pile and the horizontal surface is known as the angle of repose.

Solubility: It is defined as the amount of the drug (solute) that dissolves in a given solution (solvent) to obtain a saturated solution at constant temperature and pressure.

BCS classification system

Partition coefficient: It is defined as the ratio of unionized drug between organic (n-octanol) and aqueous (water) phase at equilibrium.

Dissolution: It is the process by which a solid substance enters the solvent phase to yield a solution so that body can absorb drug easily.

Polymorphism: It is defined as the ability of a drug substance to exist in more than one crystalline phases which have different arrangements and / or conformations of the molecules in the crystal lattice.

The Absorption number: It is the ratio of the mean residence time to the absorption time.

The Dissolution number: It is a ratio of mean residence time to mean dissolution time.

The Dose number: It is the mass divided by an uptake volume of 250ml and the drug‘s solubility.

BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS)

The biopharmaceutical classification system is a fundamental guideline for determining the conditions under which in vitro in vivo correlations are expected. It is also used as a tool to develop the in vitro dissolution specification. The classification is associated with the drug dissolution and absorption model. It identifies the key parameters that control drug absorption as a set of dimensionless numbers: absorption number, dissolution number, and dose number.

The Absorption number: It is the ratio of the mean residence time to the absorption time.

The Dissolution number: It is a ratio of mean residence time to mean dissolution time.

The Dose number: It is the mass divided by an uptake volume of 250ml and the drug’s solubility.

In the BCS classification system, a drug is classified in one of four classes based on its solubility and intestinal permeability;

Bio-pharmaceutics classification system

Sr.noClassDescriptionExamples
1Class IHigh solubility/High permeabilityMetoprolol
2Class IILow solubility/High permeabilityPhenytoin
3Class IIIHigh solubility/Low permeabilityCimetidine
4Class IVLow solubility/Low permeabilityChlorothiazide

Classes of BCS classification system

 Class I compounds such as metoprolol exhibit a high absorption and a high dissolution number. The rate-limiting step to drug absorption is drug dissolution or gastric emptying rate if dissolution is very rapid.

Class II drugs such as phenytoin have a high absorption number but a low dissolution number. The absorption for class II drugs is usually slower than class I and occurs over a longer period of time.

   

Class III drugs, permeability are the rate-controlling drug absorption. These drugs exhibit a high variability of rate and extent of drug absorbed.

Class IV drugs are low solubility and low permeability drugs. These class of drugs exhibit a lot of problems for effective oral administration.

   

Applications of BCS classification system

Dissolution testing are widely used in the pharmaceutical industry for formulation optimization and quality control.

a. It is useful in the pharmaceutical and biotechnology industry to formulate dosage forms.

b. It is also used to develop quality control specifications for manufacturing.

c. It is used to simulate food effect on bio availability.

d. It is used as a Surrogate for in vivo studies.

e. It is used to study In vitro in vivo correlations.

BIOASSAY OF INSULIN Notes Pharmacology

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