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Evaluation of the quality of amodiaquine and sulphadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar Es Salaam Tanzania.
J Clin Pharm Ther. 2003 Apr; 28(2):117-22.JC

Abstract

OBJECTIVE

There are several independent reports in Tanzania of treatment failures with commercially available sulphadoxine/pyrimethamine (SP) and amodiaquine (AQ) brands. The aim of this work was to assess the quality of SP and AQ tablets marketed by wholesale pharmacies in Dar Es Salaam, Tanzania.

METHODS

All eight wholesale pharmacies authorized to import medicines and located in Dar Es Salaam were included in the study. From each pharmacy, samples of all SP and AQ brands available at the time of sampling were bought, provided they had a shelf-life of at least 1 year. A sample was either an intact box of 100 tablets or a sealed tin of 100 tablets. To ensure blinding, 30 tablets of each sample were removed from their original containers, coded and sent to the quality control laboratory for analysis. The name, strength, batch number, manufacturer and the expiry dates of the tablets were recorded. In total 15 AQ and 18 SP samples were collected. Identity, assay for content of active ingredients and dissolution assay were performed as described in the United States Pharmacopoeia (USP).

RESULTS

All samples passed the identity test. Among the AQ samples collected, two of 15 (13%) failed the dissolution test but all passed the assay for content, whereas two of 18 (11%) and eight of 18 (44%) SP samples failed the assay for content and dissolution tests, respectively. None of the pharmacies stocked all AQ and SP brands.

CONCLUSION

This work reveals the availability of poor quality antimalarial drugs on the Tanzanian market. Use of substandard drugs could have serious clinical consequences to patients. The results support the need for continuous monitoring of the quality of marketed drugs to ensure safety and efficacy of these products in the treatment of malaria in endemic areas.

Authors+Show Affiliations

Clinical Pharmacology Department, Faculty of Medicine, Muhimbili University College of Health Sciences (MUCHS), Dar Es Salaam, Tanzania. ominzi@muchs.ac.tzNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12713608

Citation

Minzi, O M S., et al. "Evaluation of the Quality of Amodiaquine and Sulphadoxine/pyrimethamine Tablets Sold By Private Wholesale Pharmacies in Dar Es Salaam Tanzania." Journal of Clinical Pharmacy and Therapeutics, vol. 28, no. 2, 2003, pp. 117-22.
Minzi OM, Moshi MJ, Hipolite D, et al. Evaluation of the quality of amodiaquine and sulphadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar Es Salaam Tanzania. J Clin Pharm Ther. 2003;28(2):117-22.
Minzi, O. M., Moshi, M. J., Hipolite, D., Massele, A. Y., Tomson, G., Ericsson, O., & Gustafsson, L. L. (2003). Evaluation of the quality of amodiaquine and sulphadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar Es Salaam Tanzania. Journal of Clinical Pharmacy and Therapeutics, 28(2), 117-22.
Minzi OM, et al. Evaluation of the Quality of Amodiaquine and Sulphadoxine/pyrimethamine Tablets Sold By Private Wholesale Pharmacies in Dar Es Salaam Tanzania. J Clin Pharm Ther. 2003;28(2):117-22. PubMed PMID: 12713608.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the quality of amodiaquine and sulphadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar Es Salaam Tanzania. AU - Minzi,O M S, AU - Moshi,M J, AU - Hipolite,D, AU - Massele,A Y, AU - Tomson,G, AU - Ericsson,O, AU - Gustafsson,L L, PY - 2003/4/26/pubmed PY - 2003/8/13/medline PY - 2003/4/26/entrez SP - 117 EP - 22 JF - Journal of clinical pharmacy and therapeutics JO - J Clin Pharm Ther VL - 28 IS - 2 N2 - OBJECTIVE: There are several independent reports in Tanzania of treatment failures with commercially available sulphadoxine/pyrimethamine (SP) and amodiaquine (AQ) brands. The aim of this work was to assess the quality of SP and AQ tablets marketed by wholesale pharmacies in Dar Es Salaam, Tanzania. METHODS: All eight wholesale pharmacies authorized to import medicines and located in Dar Es Salaam were included in the study. From each pharmacy, samples of all SP and AQ brands available at the time of sampling were bought, provided they had a shelf-life of at least 1 year. A sample was either an intact box of 100 tablets or a sealed tin of 100 tablets. To ensure blinding, 30 tablets of each sample were removed from their original containers, coded and sent to the quality control laboratory for analysis. The name, strength, batch number, manufacturer and the expiry dates of the tablets were recorded. In total 15 AQ and 18 SP samples were collected. Identity, assay for content of active ingredients and dissolution assay were performed as described in the United States Pharmacopoeia (USP). RESULTS: All samples passed the identity test. Among the AQ samples collected, two of 15 (13%) failed the dissolution test but all passed the assay for content, whereas two of 18 (11%) and eight of 18 (44%) SP samples failed the assay for content and dissolution tests, respectively. None of the pharmacies stocked all AQ and SP brands. CONCLUSION: This work reveals the availability of poor quality antimalarial drugs on the Tanzanian market. Use of substandard drugs could have serious clinical consequences to patients. The results support the need for continuous monitoring of the quality of marketed drugs to ensure safety and efficacy of these products in the treatment of malaria in endemic areas. SN - 0269-4727 UR - https://www.unboundmedicine.com/medline/citation/12713608/Evaluation_of_the_quality_of_amodiaquine_and_sulphadoxine/pyrimethamine_tablets_sold_by_private_wholesale_pharmacies_in_Dar_Es_Salaam_Tanzania_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0269-4727&date=2003&volume=28&issue=2&spage=117 DB - PRIME DP - Unbound Medicine ER -