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*Abraham Mathew Saji, Zulkarnain Matbah, Abdul Rahman Dato’ Abdul Razak, Zainal Arif Tan Sri Mahmood

Royce Pharma Manufacturing Sdn Bhd, PT 1663 Nilai Industrial Estate, City: Nilai, State: Negeri Sembilan, Malaysia.


The Biopharmaceutical Classification System (BCS) was introduced in by1995 by Amidon and team with the primary aim to reduce the need for in vivo bioavailability studies in comparison to a reference product, in order to establish bioequivalence. BCS can help to utilize in vitro dissolution tests as a surrogate for in vivo bioavailability studies. The principles of BCS can be used for all new product development to its scale-up and post approval changes in drug product manufacturing. This can save significant amount of product development time and money of pharmaceutical drug product manufacturers. BCS is a tool that allows estimation of the contributions of three major factors namely, dissolution, solubility, and permeability, which affect drug absorption from immediate release (IR) solid oral products. Knowledge of BCS can help the pharmaceutical formulator to develop a suitable oral dosage form that can purport to be similar in effectiveness and efficiency of desired pharmacological activity as that of the reference product. This review article represents principle, goal & guidance of BCS and characteristics of various BCS class drugs. Various type of dissolution media for various BCS class drugs, their importance & methodology of dissolution, and various applications of BCS have been highlighted.

Keywords: BCS; Solubility; Permeability; Dissolution; Bioequivalence.

[Full Text Article]

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