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Abstract: Dissolution testing has been recognized as
an important element in drug development and quality
assessment of pharmaceutical products. In- vitro
dissolution testing is one of the primary USP/ NF test
that is performed to ensure that a drug product meet the
USP/NF standards of identity, strength, quality, purity,
stability and reproducibility. For drug products with
minor post-approval changes, the US FDA SUPAC (scale-up
and post-approval changes) guidelines indicate that
in-vitro dissolution testing with profile comparison can
be used as a surrogate for in-vivo bioequivalence
testing. In addition, the general bioavailability and
bioequivalence guidance allows biowaivers for lower
strength (s) of immediate release as well as modified
release drug products based on formulation
proportionality and dissolution profile comparison. The
comparison of dissolution profiles is considered to be
very critical test for assessing the performance of a
drug product. Dissolution profiles of two drug products
can be compared by various model independent methods
(i.e. mean dissolution time, similarity and difference
factor, sampling time) reported in literature. This
review article gives an overview of various model
independent approaches used for comparing dissolution
profiles with their merits, demerits and applications in
pharmaceutical industries.
Introduction
In vitro dissolution has been recognized for the past
two decades as an important tool both in drug
development and quality assessment of the pharmaceutical
dosage forms. Release of drug and its further
dissolution from the solid dosage forms often constitute
a determining step in the in vivo absorption process and
is thus used in conjunction with in-vivo/in-vitro
correlations to establish quality control parameters.
This is especially relevant in checking batch to batch
consistency in clinical trials, bioavailability and
routine production. In the development of a new product,
dissolution testing can aid in drug release modeling,
e.g. through selection of excipients, optimization of
the manufacturing process, scale-up, and formulation of
test products matching desired dissolution
characteristics. It may also be used to determine the
long term stability of a dosage form and assess the
impact of post-approval changes in the manufacturing
process.
The dissolution method and specification are set by
considering the solubility, permeability, dissolution,
and pharmacokinetic of drug substances. Three categories
of dissolution test specification for immediate release
dosage forms are described in the guidance provided by
the Centre for Drug Evaluation and Research (CDER) at
the Food and Drug Administration (FDA) (i) single point
specification, (ii) two-point specification, (iii)
dissolution profile comparison. Though the ‘point
estimates’ approach is suitable for drug product
containing substances with high solubility and high
permeability, it may not be adeq uate for drugs with low
solubility or products with modified release
characteristics. In these situations, sometimes the drug
products with inherently different dissolution profiles
may inadvertently lead to the declaration of similar
dissolutions. The dissolution profile comparison seems
to be more precise than the point estimate approach to
characterise the drug product.
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