The chemical and pharmaceutical equivalence of sulphadoxine/pyrimethamine tablets sold on the Tanzanian market

Abstract

This study investigated chemical and pharmaceutical equivalence of 11 brands of pyrimethamine-sulphadoxine combination tablets sold on the Tanzanian market. Physical and chemical tests were performed for all the 11 brands. These tests included hardness test, friability, disintegration, dissolution, weight uniformity and assay for the active components. All the brands passed all the quality specifications of the United States Pharmacopoeia (USP) and British Pharmacopoeia (BP) in terms of hardness, friability, disintegration, assay and dissolution test, except for three brands that failed the hardness, disintegration or friability tests. One brand failed both the hardness and disintegration test; one failed the hardness test, whereas another one failed the friability test. The percentage content of pyrimethamine in the brands was in the range of 91.04-100.20% whereas that of sulphadoxine ranged from 91.53% to 99.88%. There were no major differences between the different brands of tablets containing pyrimethamine and sulphadoxine and the innovator product (Fansidar), and all brands were physically and chemically equivalent. The results indicate that the post-market surveillance and registration process in Tanzania is having an impact on product quality as there was no brand which could be considered of very poor quality. Impurity profiling of all the locally produced brands indicated that they all contained the same sulphadoxine impurity, which was absent in the innovator product, suggesting a common source of generic raw material.

Post Marketing Surveillance of Anti-malarial Medicines in Tanzania

“…The samples were also tested for other quality indicating parameters and one brand failed hardness and disintegration tests, another brand failed hardness test while the third one failed friability test. Likewise, out of 304 antimalarial products tested for quality, 12.2% which included antifolate anti-malarials, quinine tablets, amodiaquine formulations and 23.8% SP were found to be substandard [23].…”

Quality Assessment of the Commonly Prescribed Antimicrobial Drug, Ciprofloxacin Tablets, Marketed in Tigray, Ethiopia

“…These could be the widespread counterfeiting of medicines, decomposition of the active ingredient in drug dosage form due to high temperature and humidity of the storage condition, and inadequate quality assurance systems during the manufacture of pharmaceutical products (Risha et al, 2003;Kaymba et al, 2004;Hebron et al, 2005).…”

Anti-malarial medicine quality field studies and surveys: a systematic review of screening technologies used and reporting of findings

“…Three studies sampled from the highest level of the distribution chain such as wholesalers and central medical stores (in addition to hospitals, pharmacies etc.) [30, 52, 53]. In the included studies, a broad range of anti-malarial medicines were sampled and analysed for quality.…”

“…USP guidelines for medicine sampling state that a minimum of 30 dosage units per location be collected, sufficient to carry out testing for identity and content of SAPI and dissolution [19]. Yet overall, 10/39 (26%) studies based their findings on a sample size of less than 30 [32, 35, 37–41, 47, 49, 52]. …”

“…The GPHF MiniLab ® manual provides guidelines to standardize visual inspection. In this review 9/39 (23%) studies did not state undertaking a visual assessment [31, 32, 46, 47, 52, 70–72]. Of those studies that did undertake visual inspection, 12 mentioned referring to MiniLab ® guidelines [5, 28, 29, 34, 43, 45, 48, 66, 73–76].…”