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Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market.

ABSTRACT: OBJECTIVE:We previously reported the pharmaceutical quality of eight brands of 50 mg enteric-coated diclofenac sodium tablet available on the Saudi market. Here, we assess the quality of reference (R1) and four generic (G1-G4) brands of 50 mg immediate-release diclofenac potassium tablet and of reference (R2) and generic (G5) brands of 100 mg sustained-release diclofenac sodium tablet. RESULTS:Weight variation (range as % difference from mean), active substance content (mean (SD) as % difference from label), breaking force [mean (SD)], and friability (as % weight loss) were 95-104% and 99-102%, 100.9% (3.4%) and 105.6 (4.2%), 12.2 (1.3) and 12.9 (1.8) kg, and 0.0014% and 0.0012%, for R1 and R2, respectively. For G1-G5, they were???±?2%, 98.8% (2.7%) to 109.2% (3.8%), 6.4 (0.6) to 13.3 (1.0) kg, and 0.0007% to 0.0261%, respectively. R1 and G1-G4 disintegrated within 04:50-17:20 min: seconds and released a mean of 89-100% of label active substance content by 60 min in buffer (pH 6.8). R2 and G5 did not disintegrate or dissolve in 0.1 N HCl for 2 h, disintegrated in buffer (pH 6.8) in 01:58-02:15 h: minutes, and fulfilled dissolution criteria (pH 7.5) for both United States Pharmacopoeia test-1 and test-2. Thus all seven brands met pre-specified quality criteria.

SUBMITTER: Hammami MM

PROVIDER: S-EPMC7694918 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market.

Hammami Muhammad M MM AlSwayeh Reem R Hussein Rajaa F RF

BMC research notes 20201126 1

<h4>Objective</h4>We previously reported the pharmaceutical quality of eight brands of 50 mg enteric-coated diclofenac sodium tablet available on the Saudi market. Here, we assess the quality of reference (R1) and four generic (G1-G4) brands of 50 mg immediate-release diclofenac potassium tablet and of reference (R2) and generic (G5) brands of 100 mg sustained-release diclofenac sodium tablet.<h4>Results</h4>Weight variation (range as % difference from mean), active substance content (mean (SD) ...[more]

PMID: 33243292

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Project description:BackgroundParasitic diseases are the main challenge of livestock production in the world. They are mainly controlled by the use of anthelmintic drugs. To be effective, the drugs should contain the appropriate amount of active pharmaceutical ingredient (API) and have the required physical characteristics. In this study, qualitative and quantitative assessments were performed to evaluate the quality of different brands of albendazole tablets legally circulating in pharmaceutical markets of Addis Ababa, Ethiopia.MethodsUltraviolet-Visible Spectroscopy (UVS), Fourier Transform Infrared Spectroscopy (FTIR) and High-Performance Liquid Chromatography (HPLC) were used for identification. Quantitative analysis was performed by HPLC. United States Pharmacopeia standard was used as a control to evaluate the identity and content of the API in the samples. A total of 10 batches of albendazole tablets from six different brands were collected and evaluated.ResultsAll brands of albendazole tablets, except one, had acceptable physical characteristics. There was gross contamination in one batch, weight variation in 4 (40%) batches, and absence of package insert in 2 (20%) batches. All three methods of evaluation (UVS, FTIR and HPLC) confirmed that all batches passed the identity test. Quantitative analysis showed that no batch had API above the acceptable limit. However, 30% of batches from three different brands contained lower amount of API per tablet than the acceptable limit.ConclusionsAll batches of albendazole circulating in the market in Addis Ababa did not fulfil either physical or chemical quality standards. The most important finding of this research was the presence of drugs with lower level of API than the acceptable limit. This can lead to treatment failure and favour the emergence of parasites that are resistant to drugs. Therefore, there should be a thorough evaluation of drugs before approval. The study also revealed the importance of occasional assessment of drugs circulating even in the legal market.

Project description:BackgroundDrug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination.ObjectiveThis study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe.MethodsThe case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses.ResultsA total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were 'change in administration setting to hospital' (374%, p<0.0001), 'addressing unmet needs' (69%, p<0.05), 'reformulations belonging to Group 3'-that is, change in administration route (117%, p<0.001), and being a repurposed product with the 'same brand name' as the original product (65%, p<0.05).ConclusionWe found that the ability of the repurposed product to address unmet needs, a reformulation where the target product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in the USA, in particular. Although a change of administration from ambulatory to hospital setting seemed to be significantly correlated with a price increase for the target product, only one case was retrieved for this parameter; as such, it was not possible to infer a firm correlation between this parameter and a change in price.

Dataset Information

Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market.

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Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market.

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