Pharmacognosy

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Browsing Pharmacognosy by Subject "Antibacterial"

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    Post-marketing Quality Surveillance of Selected Antibacterial Agents Marketed in Setit Humera and west Gondar Zones, North West Ethiopia.
    (Addis Ababa University, 2023) Denekew,Tewodros; Ashenef,Ayenew(Ass.Prof.); Eticha,Tadele(Ass.Prof.)
    Background: The presence of low-quality medicines is becoming increasingly problematic in many parts of the world, particularly in developing countries. Antibiotics are among the most common anti-infective medicines that are falsified. Objective: The purpose of this study was to assess the quality of selected antibacterials that are marketed in Setit Humera and west Gondar Zones, North West Ethiopia. Methods: Seventy-one samples of the antibacterials were collected from six sites in Setit Humera and west Gondar Zones, North West Ethiopia. A mystery shopper collection system was used for sample collection. Visual inspection and confirmation of the registration status were carried out using the WHO/FIP/USP checklist and the EFDA's MRIS database, respectively. Then Pharmacopeial methods (USP, BP) were employed to assess the physicochemical parameters. Results: From 71 samples, 25.35% (18/71) were not registered and 15.49% (11/71) were registered but the license period was expired i.e not in line with the EFDA’s specification. Some (74.65% (53/71) observed samples) did not meet the visual inspection criteria outlined in the joint WHO/FIP/USP checklists. The physicochemical evaluation showed that all the samples studied met the quality specification with respect to the identification and hardness test. From 71 samples tested with regard to assay, dissolution, uniformity of dosage units, disintegration and friability tests, 27.49% (23/71), 16.9%, and 14.08% (10/71), 2.82% (2/71) and 8.57% (3/35) of samples were found to be substandard respectively. Overall, 56.33 % (40/71) of the samples tested were of poor-quality. Conclusion: The results indicated that some (56.33 %) antibacterial medicines circulating in the market did not meet the required quality. Therefore, the regulatory body (EFDA) should focus on enforcing the necessary measures to ensure that antibacterial drugs on the market meet the required mandatory standards