Abstract

Solubility and permeability plays an important role in development of dosage form. Benchmark for solubility and permeability is the Biopharmaceutics Classification System (BCS) which demonstrates four classes based on solubility and permeability. It enables the scientist to modify chemical structure of active pharmaceutical ingredient so as to optimize chemical properties. Oral dosage form have the rate limiting steps as dissolution and permeability for which BCS plays an important role. Biowaver can be given for some dosage forms based upon its BCS classification system. Dissolution number, dose number and absorption number are the fundamental basis for BCS classification. It is also a guideline for determining the conditions under which in vitro-in vivo correlations are expected. Solubility, permeability and dissolution are the class boundaries of the BCS. As per regulatory aspects during the process of generic drug development in vitro dissolution can replace bioequivalence studies.