Dataset Information

Quality assessment of nine paracetamol 500 mg tablet brands marketed in Saudi Arabia.

ABSTRACT:

Objective

To evaluate in-vitro quality of paracetamol 500 mg tablet brands marketed in Saudi Arabia.

Results

Two reference (R1 and R2) and seven generic (G1-G7) brands were commercially available. Four brands were single-drug, containing paracetamol only (R1, G1-G3) and five contained additional active ingredients (R2, G4-G7). All brands were immediate-release. Weight variation (n = 20, range as percent difference from mean), active substance content (n = 20, mean (SD) as percent difference from label), breaking force (n = 10, mean (SD)), and friability (n = 20, as percent weight loss) ranged from 97 to 102%, 96.1% (2.9%) to 99.8% (1.1%), 9.9 (0.4) to 21.0 (0.9) kg, and 0.017% to 0.809%, respectively. Disintegration (water medium) time (n = 6, minute: second) ranged from 02:35-03:09 to 12:49-13:10. Dissolution (phosphate buffer, pH 5.8) profile showed a mean release at 30 min of 87% to 97% of label content, with seven brands passing stage-1 (≥ 85% for each of 6 test units) and two passing stage-2 (mean of 12 test units ≥ 85%) criteria. Despite statistically significant differences between R1 and R2 and some of their corresponding generic brands in active substance content, breaking force, and amount dissolved at 30 min, all nine brands met the pre-specified quality standards.

SUBMITTER: AlSwayeh R

PROVIDER: S-EPMC8247153 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionQuality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patients are exposed to chemical toxins and/or sub-therapeutic doses. This could lead to reduced treatment efficacy and promote development of drug resistance. Co-trimoxazole, a fixed dose combination of sulfamethoxazole and trimethoprim, is a broad spectrum for bacterial diseases and is also used as a prophylaxis for opportunistic infections in HIV infected individuals. This study evaluated quality of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.MethodsA total of 106 samples were collected, categorized into 15 brands and evaluated for active pharmaceutical ingredient content (API) and pH following United States Pharmacopeia. Assay for API was conducted using High Performance Liquid Chromatography. Results were compared with pharmacopeia references. Visual examination of labels and confirmation of retention status of the brands with Pharmacy and Poisons Board retention register was carried out.ResultsThe samples were primarily of local origin (86.7%). On October 23, 2019, retention status of six of the fifteen brands documented were no longer listed in the Pharmacy and Poisons Board retention register. Of the 106 samples tested 70.6% and 86.8% were compliant with United States Pharmacopeia (USP) specifications for pH and API respectively while 84.0% adhered to packaging and labelling requirements.ConclusionThis study has demonstrated that majority of co-trimoxazole suspensions tested were compliant with USP requirements. Additionally, it has provided evidence of poor quality co-trimoxazole medicines that could compromise treatment of infectious diseases in children. This emphasizes the need for regular quality assurance tests to ensure only quality medicines are in the market.

Project description:BackgroundWeight management apps may provide support and management options for individuals with overweight and obesity. Research on the quality of weight management mHealth apps among the Saudi population is insufficient despite frequent use.ObjectiveThe aims of this study were to explore user perceptions of weight management apps, explore reasons for starting and stopping app use, appraise the quality of weight management apps available in the App Store, and compare the features currently available within the app market and those that are most desirable to weight management app users.MethodsA web-based survey consisted of 31 open and closed questions about sociodemographic information, general health questions, app use, app user perceptions, and discontinuation of app use. The quality of the weight management apps available on the App Store was assessed using the Mobile App Rating Scale and evidence-based strategies. We also used six sigma evaluations to ensure that the quality measured by the tools consistently meets customer expectations.ResultsData from the survey were analyzed. Of the respondents, 30.17% (324/1074) had used a weight management app, 18.16% (195/1074) used the apps and stopped, and 51.68% (555/1074) had never used a weight management app. Of apps mentioned, 23 met the inclusion criteria. The overall average Mobile App Rating Scale quality of apps was acceptable; 30% (7/23) received a quality mean score of 4 or higher (out of 5), and 30% (7/23) did not meet the acceptability score of 3 or higher. Evidence-based strategy results showed that feedback was not observed in any of the apps, and motivation strategy was observed in only 1 app. The sigma results of evidence-based strategies reflect that most of the apps fail to pass the mean.ConclusionsApp users desired a feature that allows them to communicate with a specialist, which is a missing in the available free apps. Despite the large number and accessibility of weight management apps, the quality and features of most are variable. It can be concluded from six sigma results that passing the mean does not ensure that the quality is consistently distributed through all app quality properties and Mobile App Rating Scale and evidence-based strategies do not give developers an indication of the acceptance of their apps by mobile users. This finding stresses the importance of reevaluating the passing criterion, which is ≥50% for designing an effective app.

Dataset Information

Quality assessment of nine paracetamol 500 mg tablet brands marketed in Saudi Arabia.

Objective

Results

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