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THE PHARMA REVIEW (JAN 2010)

Endeavoring Biowaivers using BCS and IVIVC

Bhupinder Singh, Ashutosh Mohapatra, Shantanu Bandyopadhyay and Rishi Kapil

Abstract: The realm of drug delivery has endowed the pharmaceutical scientist with a newer look towards formulation development and subsequent patient therapy. Despite tremendous strides made in novel non-oral drug delivery systems, more than one-half of the drug formulations available commercially, across the globe today, are the oral ones. From the patient perspectives, it is primarily a consequent of the wide acceptability of this “natural” route, better safety vis--vis the parenteral route, low cost of therapy, ease and convenience of this non-invasive method of administration and high stability. Besides, the simple, flexible and inexpensive development and manufacturing of oral drug products, coupled with the unproblematic availability of raw materials, equipment and technology, and simple regulatory approval account for their popularity amongst the manufacturers too.

Introduction
Bioavailability & Bioequivalence Issues

Development of an oral formulation usually starts with the establishment of a theoretical drug release profile for the formulation based on desirable target blood concentration and pharmacokinetic characteristics of the drug. Accordingly, the term, “bioavailability” construes measurement of both true rate and total amount of drug that reaches the general circulation from an administered dosage form by absorption. The United States Food and Drug Administration (1989) defined bioavailability as “the rate and extent to which the active drug ingredient or therapeutic moiety is absorbed from a drug product and becomes available at the site of drug action”. Fig. 1 depicts the significance of rate as well as extent of drug absorption in elucidating the theory of bioavailability.

 

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