In Vitro Comparative Study of Different Brands of Pantoprazole  Sodium Enteric Coated Tablets Marketed in Addis Ababa, Ethiopia

Nigatu, Muluken; Mohammed, F. Aisha; Temesgen, Abrham

doi:10.22270/ajprd.v7i1.467

Cited by 6 publications

(4 citation statements)

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“…The uniformity in the thickness of tablets was pivotal for tablets' packaging and consumers' requirements [21]. Our findings showed that the variation of tablets' thickness was within the accepted limit; ±5%, where it was ranged between±0.01 and 0.10%.…”

Section: Discussionmentioning

confidence: 50%

Comparative Study of Seven Brands of Levofloxacin 500 Mg Film-Coated Tablet Marketed in Yemen

et al. 2021

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Objective: The objective of the current study was to evaluate the quality control parameters of seven brands of levofloxacin 500 mg film-coated tablet available in the Yemeni market. Methods: Physicochemical parameters assay was performed for seven brands of levofloxacin 500 mg film-coated tablet. Each brand was subjected to official and unofficial in vitro quality control tests, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity assay by High-Performance Liquid Chromatography (HPLC). Results: Out of seven, six brands of levofloxacin 500 mg film-coated tablet passed official specified assay tests according to the United States Pharmacopeia (USP) specifications. They showed a similar profile of thickness ranged between±0.01 and 0.10%, friability ranged between 0.01% and 0.34%, disintegration time ranged between 3.00 and 15.00 min, dissolution percentage ranged between 90.650 and 103.05 and content uniformity ranged between 93.62 and 107.12%. Regarding weight variation and hardness, six brands passed the weight variation test and only three brands showed optimum range (10-20 kg) of hardness test. Only one brand failed to pass the weight variation test, and four brands failed to pass the optimum range (10-20 kg) of hardness. Conclusion: There are no remarkable differences between the seven brands regarding in vitro quality control tests of content uniformity, thickness, friability, disintegration, and dissolution. Even though four brands were above the optimum range of hardiness, they showed complete disintegration and dissolution within the acceptable limit. Regular assessment of marketed drugs is required to ensure bioequivalent to their innovators.

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Section: Discussionmentioning

confidence: 50%

Comparative Study of Seven Brands of Levofloxacin 500 Mg Film-Coated Tablet Marketed in Yemen

et al. 2021

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“…Table 3 shows the most common problems reported by these studies concerning substandard or falsified antimicrobial drugs. The determination of API content was the most examined quality control parameter most examined, being determined by all of the studies except one [41]…”

Section: Quality Control Parameters and Stated Issues Of Substandard/...mentioning

confidence: 99%

Substandard and falsified antimicrobials in selected east African countries: A systematic review

Tegegne,

Feissa,

Godena

et al. 2024

PLoS ONE

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Background Globally, millions of people have been affected by fraudulent pharmaceutical products, particularly those in developing countries. Although the problem of falsified and substandard drugs is acknowledged, the extent of the issue is ever-changing, has a dynamic nature, and should be quantified and captured in a recent snapshot. Objective This systematic review seeks to examine the data that can quantify and provide a current snapshot of the prevalence of SF antimicrobials in selected east Africa countries. Methods Scientific studies on antimicrobial quality were searched in PubMed, Embase, Scopus, and Google Scholar from 2017 to February 2023. The search strategy focused on scientific articles published in peer-reviewed scientific journals written in English and the studies exclusively done in any of the selected countries of east Africa. The articles were carefully reviewed by two individuals for inclusion independently, first by title followed by abstract and the full-text retrieval. To minimize bias associated with the methodology used for data collection, the quality of the studies was assessed for quality according to the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). The reporting of this systematic review was done following Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA). Results Fifteen studies that estimated the prevalence of poor-quality antimicrobial medicines in selected four east African countries were included. The overall percentage of samples of antimicrobials that failed at least one quality test was 22.6% (151/669) with each class’s prevalence of 17% in antibiotics (73/432), 24% in antimalarial (41/171), and 56% in anthelmintics (37/66). Quality control parameters of API content were the most commonly examined in the included studies, accounting for 14/15 (93%) studies. Fifty (33.1%) of the failing samples failed assay API- content determination, while 26.5% (n = 40) failed the visual inspection and packaging analysis; 19.2% (29) failed dissolution; 14% (n = 21) flawed hardness or friability; 4%(n = 6) failed uniformity, as well as 3.2% (n = 5) failed disintegration test of the quality control parameter. Conclusion It was found that this review was general in these selected east African countries and was a catalyst for combating the menace of poor-quality medications that affect millions of lives.

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“…In this study brands NF3, NF5, NF7, and NF9 had a disintegration time of less than one minute. According to the study done by (Nigatu et al 2019), the kind, amount of excipients used in tablet formulation, and the manufacturing method, are all factors that might influence tablet disintegration time 41 . Based on this, brands NF3, NF5, and NF9 had too short disintegration time may be due to low compression force because the hardness value of those brands from those products is less than the minimum requirement of hardness value (39.23 N).…”

Section: Disintegration Time Testsmentioning

confidence: 99%

In vitro Comparative Quality Assessment of Different Brands of Hydrochlorothiazide Tablets Marketed in Northeast Ethiopia

Teshome,

Kassahun,

Said

et al. 2023

Preprint

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Background This study aimed to evaluate the quality and physicochemical bioequivalence of commercially available brands of hydrochlorothiazide 25mg tablets in community pharmacies in Dessie town, Northeast Ethiopia.Methods Experimental-based cross-sectional study design was applied using disintegration, identification, friability, uniformity, hardness, and assay test methods as described in the USP. Difference (f1) and similarity (f2) factor values were calculated to assess in vitro bioequivalence of generic products with the comparator.Result The study revealed that all investigated brands of hydrochlorothiazide tablets contain a genuine active pharmaceutical ingredient (API) in their formulations. The friability test result was concordant with the USP (< 1%) in eight of the investigated brands. Whereas the result of the hardness limit was concordant (39.23N, USP 2019) in only six of those brands. The weight variation test result indicated that all samples complied with USP specification limits. The quantitative assay result of API was within the limit of USP (90% up to 110%). Similarly, all samples meet the disintegration time limit (i.e, ≤ 30 minutes) and drug-releasing tolerance limit (API released more than 60% within 60 minutes). The f2 values were > 50 & f1 values were ˂15 for all sampled brands of hydrochlorothiazide tablet formulations.Conclusion The majority of sampled brands of hydrochlorothiazide 25 mg tablets met the quality requirements as per USP official test specifications limit. From similarity factor (f2) and difference factor (f1) values, all studied brands were equivalent to the comparator and can interchangeably use in the clinical area.

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In Vitro Comparative Study of Different Brands of Pantoprazole Sodium Enteric Coated Tablets Marketed in Addis Ababa, Ethiopia

Cited by 6 publications

References 0 publications

Comparative Study of Seven Brands of Levofloxacin 500 Mg Film-Coated Tablet Marketed in Yemen

Comparative Study of Seven Brands of Levofloxacin 500 Mg Film-Coated Tablet Marketed in Yemen

Substandard and falsified antimicrobials in selected east African countries: A systematic review

In vitro Comparative Quality Assessment of Different Brands of Hydrochlorothiazide Tablets Marketed in Northeast Ethiopia

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