Malaria is a disease affecting millions of people in 109 malarious countries and
territories, causing approximately one million deaths annually. In 2004 one of the
parasites causing human malaria, Plasmodium falciparum, was among the leading
global causes of death from a single infectious agent, especially in Africa (WHO,
2008:23).
Treatment of this disease with single active pharmaceutical ingredients has led to the
emergence of resistant P. falciparum parasites, resulting in the most severe form of
this illness. Alarmingly, the poor quality of commercially available antimalarial
products, especially in Africa, has increasingly been reported as a major cause of
resistance to antimalarials. In Pakistan it was found that a P. falciparum epidemic
that initially was attributed to drug resistance, was actually caused by substandard
sulfadoxine/pyrimethamine products, causing a 50 times higher incidence of malaria
in these areas than elsewhere (Leslie et al., 2009:1758). Other results indicated that
up to 10% of sulfadoxine/pyrimethamine tablets, sampled in six African countries,
failed the assay test, whilst up to 40% failed the USP dissolution test. Furthermore,
the World Health Organization (WHO) reported that 20 - 90% of products failed
quality requirements during 1999 and 2000 in seven African countries (WHO,
2003:263).
Cases like these have raised the awareness of the vast number of inferior products
that are being distributed. The subsequent need for establishing mechanisms to proactively
detect substandard medicines, specifically antimalarials, easily and
effectively had indirectly led to the origin of this study, long before it was formally
undertaken.
Testing monographs for pharmaceutical products are developed to formalise, or
standardise, the regulation of pharmaceutical dosage forms. Problems have,
however, been reported with regards to the inadequacy of existing antimalarial
monographs in assuring quality medicines, fit for their intended use. The WHO had requested the Research Institute for Industrial Pharmacy,
incorporating the Centre for Quality Assurance of Medicines (RIIP®/CENQAM®), both
operating at the Potchefstroom Campus of the North–West University, to develop
monographs for three immediate–release antimalaria dosage forms, namely
amodiaquine tablets, sulfadoxine/pyrimethamine fixed–dose combination tablets and
mefloquine tablets. The undertaking of these projects, to develop specifications for
the quality control of these pharmaceutical products, formed the object of this
research study.
Data had been accumulated since 2000, as a result of continuous requests by the
WHO to help solve problems that had been experienced with analytical test
methods, especially from manufacturers. These requests either led to the refinement
of existing methods, or to the development of new ones. The success with
which these outcomes were implemented worldwide, finally led to the decision to
publish these research findings under the umbrella of this project.
The proud product is a comprehensive package of tests for three commercial
antimalarial products, the outcomes of which are hoped to contribute towards the
combat against resistance formation to these important disease fighters. / Thesis (Ph.D. (Pharmaceutics))--North-West University, Potchefstroom Campus, 2011.
| Identifer | oai:union.ndltd.org:netd.ac.za/oai:union.ndltd.org:nwu/oai:dspace.nwu.ac.za:10394/4920 |
| Date | January 2010 |
| Creators | Wessels, Johanna Christina |
| Publisher | North-West University |
| Source Sets | South African National ETD Portal |
| Detected Language | English |
| Type | Thesis |
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