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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Comparison of bioavailability between the most available generic tablet formulation containing artemether and lumefantrine on the Tanzanian market and the innovator's product
Malaria Journal, Volume 12, No. 1, Article 174, Year 2013
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Description
Background: Existence of anti-malarial generic drugs with low bioavailability marketed on sub-Saharan Africa raises a concern on patients achieving therapeutic concentrations after intake of such products. This work compared bioavailability of one generic tablet formulation with innovator's product. Both were fixed dose combination tablet formulations containing artemether and lumefantrine. Methodology. The study was conducted in Dar Es Salaam, Tanzania, in which a survey of the most abundant generic containing artemether-lumefantrine tablet formulation was carried out in retail pharmacies. The most widely available generic (Artefan®, Ajanta Pharma Ltd, Maharashtra, India) was sampled for bioavailability comparison with Coartem® (Novartis Pharma, Basel, Switzerland) - the innovator's product. A randomized, two-treatment cross-over study was conducted in 18 healthy Tanzanian black male volunteers. Each volunteer received Artefan® (test) and Coartem® (as reference) formulation separated by 42 days of drug-free washout period. Serial blood samples were collected up to 168 hours after oral administration of a single dose of each treatment. Quantitation of lumefantrine plasma levels was done using HPLC with UV detection. Bioequivalence of the two products was assessed in accordance with the US Food and Drug Authority (FDA) guidelines. Results: The most widely available generic in pharmacies was Artefan® from India. All eighteen enrolled volunteers completed the study and both test and reference tablet formulations were well tolerated. It was possible to quantify lumefantrine alone, therefore, the pharmacokinetic parameters reported herein are for lumefantrine. The geometric mean ratios for Cmax, AUC 0-t and AUC0-∞ were 84% in all cases and within FDA recommended bioequivalence limits of 80% - 125%, but the 90% confidence intervals were outside FDA recommended limits (CI 49-143%, 53 - 137%, 52 - 135% respectively). There were no statistical significant differences between the two formulations with regard to PK parameters (P > 0.05). Conclusions: Although the ratios of AUCs and Cmax were within the acceptable FDA range, bioequivalence between Artefan® and Coartem® tablet formulations was not demonstrated due to failure to comply with the FDA 90% confidence interval criteria. Based on the observed total drug exposure (AUCs), Artefan® is likely to produce a similar therapeutic response as Coartem®. © 2013 Minzi et al.; licensee BioMed Central Ltd.
Authors & Co-Authors
Minzi, Omary Mashiku Sylivester
Tanzania, Dar es Salaam
Muhimbili University of Health and Allied Sciences
Marealle, Ignace A.
Tanzania, Dar es Salaam
Muhimbili University of Health and Allied Sciences
Shekalaghe, Seif Abdallah
Tanzania, Ifakara
Ifakara Health Institute
Juma, Omar Ali
Tanzania, Ifakara
Ifakara Health Institute
Ngaimisi, Eliford
Tanzania, Dar es Salaam
Muhimbili University of Health and Allied Sciences
Chemba, Mwajuma
Tanzania, Ifakara
Ifakara Health Institute
Rutaihwa, Mastidia
Tanzania, Ifakara
Ifakara Health Institute
Abdulla, Salim Mohammed K.
Tanzania, Ifakara
Ifakara Health Institute
Sasi, Philip Galula
Tanzania, Dar es Salaam
Muhimbili University of Health and Allied Sciences
Statistics
Citations: 9
Authors: 9
Affiliations: 2
Identifiers
Doi:
10.1186/1475-2875-12-174
e-ISSN:
14752875
Research Areas
Food Security
Health System And Policy
Study Design
Cross Sectional Study
Study Approach
Quantitative
Study Locations
Tanzania
Participants Gender
Male