Abstract
Background The availability of poor-quality drugs on the drug market might favor the ineffectiveness of the drug and/antimicrobial resistance. Aim To evaluate the quality of similar batches of ethambutol hydrochloride tablets available in different governmental health facilities of Jimma town, southwest Ethiopia. Methods The World Health Organization checklist was used to inspect the storage area of health facilities and check medicines for the sign of counterfeit. The test was conducted as per the United States Pharmacopeia on six similar batches of ethambutol hydrochloride sampled from different governmental health facilities. Data were analyzed using SPSS version 20, and one-way ANOVA was used for comparing the dissolution profile and weight variation of batches. Results Three health facilities did not comply with the storage area specifications for pharmaceuticals. No batches have shown any sign of counterfeit. All of the tablet batches tested complied with USP specifications for weight variation, percentage purity, and dissolution test. Conclusions and Recommendation. The entire tablet batches complied with the World Health Organization specification for packaging and labelling of pharmaceuticals. All tablet batches complied with the test for weight variation, purity of drug substance, and dissolution. Since some health facilities did not comply with at least one specification for storage of pharmaceuticals, regulatory agencies and stack holders are advised to inspect the health facilities to ensure appropriate storage of pharmaceuticals in health facilities.
Highlights
Background. e availability of poor-quality drugs on the drug market might favor the ineffectiveness of the drug and/antimicrobial resistance
Introduction e quality of pharmaceutical products are affected by many factors; from those factors are stability of drug substance/s, the potential interaction between drug substance/s and excipients, manufacturing process, dosage form, packaging system, environmental conditions encountered during transport, storage and use, and length of time between manufacture and usage
Storage of the Drug in Health Facilities Included in the Study. e storage area of each of the governmental health facilities included in the study was inspected by using the World Health Organization (WHO) checklist for inspection of storage area for pharmaceuticals, and three of the facilities (F4, F5, and F6) failed to comply with WHO guidelines for at least two parameters for storage of pharmaceuticals (Table 2)
Summary
Background. e availability of poor-quality drugs on the drug market might favor the ineffectiveness of the drug and/antimicrobial resistance. Aim. To evaluate the quality of similar batches of ethambutol hydrochloride tablets available in different governmental health facilities of Jimma town, southwest Ethiopia. Ree health facilities did not comply with the storage area specifications for pharmaceuticals. All of the tablet batches tested complied with USP specifications for weight variation, percentage purity, and dissolution test. E entire tablet batches complied with the World Health Organization specification for packaging and labelling of pharmaceuticals. All tablet batches complied with the test for weight variation, purity of drug substance, and dissolution. Class III drugs exhibit high variability in rate and extent of absorption, but if dissolution is fast such that 85% of the drug dissolves in 15 minutes, the variation could be attributed to gastrointestinal transit, luminal contents, and membrane permeation rather than dosage form factors [9]
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