E-drug: Dissolution problems with generic drugs
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As a follow up to Richard Laing's request for further details about
the dissolution problems with generic drugs, the drug with which we have
specific experience is the sulfadoxine/pyrimethamine combination used
extensively as a treatment for malaria in Kenya. The products were both
locally produced and imported from India. The majority of the products
studied in this pilot market surveillance programme carried out in
collaboration with my colleague Prof. I.O. Kibwage of the Dept. of
Pharmaceutical Chemistry at the Faculty of Pharmacy, showed failure to
comply with the dissolution specification
of the USP, in some cases for sulfadoxine, in others for pyrimethamine and
still others both components. A paper is in preparation for publication giving
full details of the study outcomes. One can imagine the impact these substandard
products will have on the success of the Malaria Control Programme.
Following this pilot study a more extensive study of the quality of
antimalarials on the Kenyan market is to be undertaken by the National
Quality Control Laboratory in collaboration with other like-minded
institutions in the country. We think that a regional study in the same vein
would be very useful.
A number of the products studied were registered in the Kenyan market.
Others were samples that had been presented to the regulatory authority with
the registration application dossiers. We did not at the time of carrying
out the study check whether the WHO Certification Scheme certificates had
been submitted with the application or at the time of importation. This
information is
however, available with the Pharmacy and Poisons Board and will be included in
the paper.
I would be interested in hearing about the experiences of other colleagues from
Africa.
Dr. Elizabeth Ominde-Ogaja
Director
National Quality Control Laboratory
P.O. Box 29725
Nairobi
Kenya
Tel: +254-2-726963
Fax: +254-2-718073
EMail: afdran-nqcl@ken.healthnet.org
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