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Physicochemical equivalence of some brands of Nifedipine
retard tablets available in Nigeria
Okoye, E. I.* and Iwuagwu, M. A.
Department of Pharmaceutics and Pharmaceutical Technology,
Faculty of Pharmacy, University of Benin, Benin City,
Nigeria.
*Corresponding author. E-mail:
ebypiaen@yahoo.com.
Tel: +23408052742521.
Accepted
9 November, 2009 |
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This
research evaluated the physicochemical equivalence of some
samples of Nifedipine 20 mg Retard Tablets available in
Nigeria. Seven samples were randomly procured from various
zones of the country and standard protocols applied to
evaluate their tablet weight uniformity, dimensions,
hardness, disintegration time, content of active Ingredient
and in vitro drug release profile. Results showed
that all the samples tested were chemically, but not
physically equivalent. Although within each sample,
compendial requirement for tablet weight uniformity was met,
there were significant differences in the mean tablet
weights, diameters and thickness of the samples studied (p <
0.05). Furthermore, tablet hardness and disintegration time
varied much among the samples, but not within each sample.
All the samples met the compendial requirement for content
of active ingredient and released more than 80% of the drug
within 4 h. It is therefore pertinent that manufacturers of
this product be advised to formulate tablets that are
equivalent in size, as different tablet sizes may impart
negative psychological effects on clinicians and their
patients when the need arises for switch over from one
product to another, since the availability of particular
products is never guaranteed at all times in Nigeria, a
largely import dependent nation.
Key
words:
Nifedipine 20 mg Retard tablets, physicochemical
equivalence, in-vitro drug release. |
