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

Abstract

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.

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

“…In this study, 22.2% of the brands or 23.1% of batches didn't have leaflets or package inserts. The absence of leaflet was also reported by Seifu et al (2019) for albendazole in the same study area. This may lead to the inappropriate use of the drugs.…”

“…Hence, periodic assessment of drugs circulating in the market will make the quality control process complete and help to design systems or strategies to control the circulation of substandard drugs. The authors of this article conducted a quality test on albendazole, a quite commonly used drug to treat helminthic parasites, and found that 3 of the 10 batches contained a lower amount of albendazole per tablet than expected (Seifu et al, 2019). This finding initiates us to test the quality of other drugs like oxytetracycline which is quite commonly sold and used drug for the treatment of widespread infectious diseases in animals (Tufa et al, 2018).…”

<p>In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia</p>

“… 18 Seifu et al found that all batches of albendazole circulating in the market in Addis Ababa did not fulfill either physical or chemical quality standards. 19 These findings revealed that the Ethiopian health system could be endangered with poor quality medicines. Hence, there is the need for continuous assessment of the pharmaceutical quality of essential drugs circulating in the market to ensure the quality of these medicines.…”

Identification of environmental supply chain bottlenecks: a case study of the Ethiopian healthcare supply chain

“…The severe consequences for end customers as patients in taking counterfeit products are an additional societal burden. The process activities labelled CO, are those supply chain processes which, from the insight of the case study supported by Seifu et al (2019) and Suleman et al (2014), are possible gateways for counterfeited products into the legitimate chain. The tracing (Tr) and inventory management (IM) categories both affect efficiency.…”