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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-à-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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