Fighting fake medicines: Quality evaluation of seven brands of Albendazole tablets in Yemeni Market

Othman, Gamil

doi:10.20428/yjms.11.1.a7

Cited by 7 publications

(5 citation statements)

References 8 publications

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“…In this study, assessment of the weight uniformity revealed that four batches did not meet the criteria. In contrast to the finding of this study, absence of variation was reported by Othman [16] in Yemen. The difference may be related to the manufacturing practices.…”

Section: Discussioncontrasting

confidence: 99%

“…A relatively high prevalence of poor quality of albendazole was also reported in a separate study by Suleman et al [21] in Ethiopia. In Yemen, Othman [16] assessed the quality of seven brands of albendazole and found that only two brands fulfil the British Pharmacopeia quality control standards. The presence of counterfeit anthelminthic drugs was also reported by Khan et al [8] in Cambodia.…”

Section: Discussionmentioning

confidence: 99%

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Quality of albendazole tablets legally circulating in the pharmaceutical market of Addis Ababa, Ethiopia: physicochemical evaluation

Seifu

Kebede

Bacha

et al. 2019

BMC Pharmacol Toxicol

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Background Parasitic 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. Methods Ultraviolet–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. Results All 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. Conclusions All 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. Electronic supplementary material The online version of this article (10.1186/s40360-019-0299-5) contains supplementary material, which is available to authorized users.

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Section: Discussioncontrasting

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Quality of albendazole tablets legally circulating in the pharmaceutical market of Addis Ababa, Ethiopia: physicochemical evaluation

Seifu

Kebede

Bacha

et al. 2019

BMC Pharmacol Toxicol

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“…To be effective a drug should have the required physicochemical qualities and should be sterile. The quality of a drug might be affected by the storage conditions, humidity, packaging materials, transportation, formulation, the nature of the active ingredient, and the presence of microorganisms (Othman, 2017;WHO, 2019). The pharmaceutical products should constitute not only an adequate amount of API but also must be packed with proper packaging materials in the desired container, which protects environmental conditions that may affect the quality of the products.…”

Section: Discussionmentioning

confidence: 99%

Quality of injectable oxytetracycline circulating in legal markets of Addis Ababa, Ethiopia using physiochemical and sterility analysis

Nigussie¹,

Melaku²,

Tadese³

et al. 2021

Ethiop. Vet. J.

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This study was conducted to evaluate the quality of different brands of injectable oxytetracycline solutions circulating in the legal markets of Addis Ababa with respect to physicochemical characteristics and sterility. Nine brands of oxytetracycline with thirteen different batches were randomly purchased from veterinary drug stores in the city. The physical assessment was performed by using a checklist that was prepared based on the World Health Organization guidelines. The qualitative and quantitative analysis of active pharmaceutical ingredients (API) was performed by High-Performance Liquid Chromatography. The sterility test was assessed by using the direct inoculation method. All samples passed the identity, the assay, and the sterility tests. However, there were statistically significant differences (P<0.05) among brands in the quantity of API. The highest percentage of the API was recorded in brand G (112.12%± 1.86) while the lowest was seen in brand H (92.61%± 1.5). This study revealed that all brands passed both physicochemical and sterility tests except for the differences in the API level among brands. Strict regulation, monitoring, and wider-scale surveillance are required to assure sustainable control of substandard, unsterile, and falsified pharmaceutical products in the country.

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“…We know that the friability test is a quality test requirement for assuring the tablet's resistance to abrasion during packaging, handling, and transportation 39 . If the tablet is friable, the amount of API present in the formulation will be under the required amount and cause a problem of content uniformity in product 28 . All this will decrease the bioavailability of the drug and customer trust in the product 40 .…”

Section: Friability Testmentioning

confidence: 99%

“…Then 13.5 ml of sample solution from each glass beaker was taken and transferred into individual 25 ml volumetric flasks using a volumetric pipette. As a result, it was subjected to suitable dilution (adding a diluent to a volume of 25 ml) to get the accepted sample concentration of 0.015 mg/ml (125%) 28 and analyzed by using UV-Visible spectroscopy at the wavelength of 272 nm at which maximum absorbance appear under the test 24 . The absorbance of the sample was measured.…”

Section: Dissolution Testmentioning

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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Fighting fake medicines: Quality evaluation of seven brands of Albendazole tablets in Yemeni Market

Cited by 7 publications

References 8 publications

Quality of albendazole tablets legally circulating in the pharmaceutical market of Addis Ababa, Ethiopia: physicochemical evaluation

Quality of albendazole tablets legally circulating in the pharmaceutical market of Addis Ababa, Ethiopia: physicochemical evaluation

Quality of injectable oxytetracycline circulating in legal markets of Addis Ababa, Ethiopia using physiochemical and sterility analysis

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

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