Influence of manufacturing practices on quality of pharmaceutical products manufactured in Kenya

Objective: To establish the quality of pharmaceutical products manufactured by the respective industries in Kenya and determine the effect of manufacturing practices on the quality of these products. Design: Cross-sectional study. Setting: Industries examined are in Nairobi, Kenya. Laboratory analysis was carried out using available facilities at Kenya Medical Research Institute and University of Nairobi, Faculty of Pharmacy. Interventions: Structured Questionnaires were administered to examine how the code of good manufacturing practices has been used in the production of each pharmaceutical product by respective companies. Questionnaires designed to evaluate the distribution and carry out limited post-market surveillance study were administered to community pharmacy outlets. Drugs were sampled and analyzed for their quality according to the respective monographs. Main Outcome Measures: The questionnaires administered to the industry included the source of raw materials, quarantine procedure before and after manufacture, manufacturing procedure, quality audit, quality assurance procedure, equipment, and staff. That administered to the pharmacy outlet included availability, affordability and acceptability of locally manufactured pharmaceutical products. Quality analysis of products involved the establishment of the chemical content, dissolution profile, friability, uniformity of weight and identity. For antibiotic suspensions the stability after reconstitution was also determined. Results: There were 15 respondents and two non-respondents from the industry and six out of nine respondents from the pharmacy outlets. The ratio of qualified staff to product range produced seemed to influence product quality. Industries producing several products with only limited number of pharmaceutical staff had more products failing to comply with pharmacopoeia specifications compared to those producing only few products. Nevertheless, all companies are well equipped with quality control equipment, in accordance with type of product manufactured. Private pharmacies stocked few of the locally manufactured products. The reason, they said, was due to low doctor and/or patient acceptance. Compliance with quality specifications as set out in respective monographs was overall 76%. Conclusion: Although the local pharmaceutical industries have adopted good manufacturing practices leading to many good quality products currently in commerce, these manufacturing practices are not comprehensive and measures need to be taken to continue improving them. East African Medical Journal Vol.81(6) 2004: 287-29

In vitro anti-viral activity of aqueous extracts of Kenyan Carissa edulis Prunus africana and Melia azedarach against human cytomegalovirus.

The aqueous extracts of three medicinal plants, Carissa edulis (Forssk.) Vahl (Apocynaceae), Prunus africana (Hook.f.) Kalkm (Rosaceae) and Melia azedarach L. (Meliaceae) have shown significant reduction in the replication of human cytomegalovirus (HCMV) in human embryonic lung (HEL) fibroblasts cells in vitro. Using the plaque inhibition assay for the determination of anti-viral activity, the HEL fibroblast cells cultured in 24 well plates were infected with 1 x 102 PFU 91S HCMV and treated with various concentrations of the extracts. The plaques formed were counted after 7 days incubation at 370C in 5% CO2 and the percent plaques inhibited were calculated against infected untreated control. The effective concentrations inhibiting plaque formation by 50% (EC50) was found between 40 to 80 μg/ml for all the extracts. The cell cytotoxic concentrations (CC50) for each of the three extracts, by the trypan blue exclusion test, gave a safe therapeutic index. These results have demonstrated the potential anti-viral activities of the extracts of the three medicinal plants at non-cytotoxic concentrations. African Journal of Health Sciences Vol. 14 (3-4) 2007: pp. 143-14

The anti-viral effect of Acacia mellifera, Melia azedarach and Prunus Africana, extracts against herpes simplex virus type 1 infection in mice

Aqueous extracts from the stem barks of Prunus africana(Hook.f.) Kalkm, Acacia mellifera (Vahl.) Benth. and Melia azedarach L. were evaluated for in vivo antiviral activity in Balb/C mice following a cutaneous wild type strain 7401H herpes simplex virus type 1 (HSV-1) infection. A significant therapeutic effect was observed when the infected mice were orally treated with the extracts of Prunus africana and Acacia mellifera at a dose of 500 mg/kg. A delayed onset of skin lesions, slowed progression of infection and a prolonged mean survival time was expressed as opposed to the untreated infected control (p ≤0.05). Treatment with the Melia azedarach extract at a dose of 500 mg/kg was acutely toxic to mice, however a reasonable antiviral activity was exhibited at a lower dose of 250 mg/kg. No acute toxicity was presented in mice treated withP. africana and A. mellifera at the therapeutic dose. The results suggest the presence of anti-HSV agents in these medicinal plant extracts that can be exploited as possible antivirals. Keywords: Prunus africana, Acacia mellifera, Melia azedarach, HSV-1, antiviral activity, medicinal plants Journal of Tropical Microbiology and Biotechnology Vol. 2(1) 2006: 3-