Post-marketing sampling and testing programs for licensed medicinal products: a narrative review

Neves, Edvaldo Oliveira; Sales, Paloma Michelle de; Silveira, Dâmaris

doi:10.1590/s2175-97902022e19538

Cited by 1 publication

(1 citation statement)

References 13 publications

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“…1. Post-marketing quality control is one of the methods used to reduce the occurrence of low-quality drugs in the pharmaceutical market (13)(14)(15).…”

Section: Introductionmentioning

confidence: 99%

In-vitro quality assessment of commercially available Albendazole tablets marketed in Arbaminch town, SNNPR, Ethiopia

Wado,

Nuri,

Kashala

2023

Preprint

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Introduction: Albendazole is amongst the most used broad-spectrum anti-helminthic which is active against a wide range of intestinal parasites. The existence of poor-quality brands in the current drug market is posing a threat to optimizing the therapeutic use of this drug. Therefore conducting regular post-marketing quality control testing has enormous importance. Methods: This study was carried out on samples collected from Arbaminch town in Ethiopia. Product samples were collected by using a convenient sampling method from private drug retail outlets which are found in Arbaminch town and the quality assessment was done in Jimma University drug quality control laboratory. The collected drug samples were undergone a friability test, weight uniformity test, dissolution test, identification test, and assay test as per British and United States Pharmacopeia specifications. Result: Brand A3 (0.630) of Albendazole had the highest percentage of friability. None of the tested brands of Albendazole differ from the mean weight by more than 5% which is an acceptable limit. One brand of Albendazole tablets, A1(67.93), failed the dissolution test. Albendazole samples passed the identification test since the retention time of the samples and reference standard do not differ by more than 0.1 minutes. All three Albendazole brands are within the acceptance range of the assay test. Conclusion: This study of in-vitro quality assessment tests has revealed that all brands passed most quality parameters except one brand of the three tested Albendazole brands that failed the dissolution test. The quality of pharmaceuticals is very important for the ultimate therapeutic outcome.

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“…1. Post-marketing quality control is one of the methods used to reduce the occurrence of low-quality drugs in the pharmaceutical market (13)(14)(15).…”

Section: Introductionmentioning

confidence: 99%