Microbiological Assay of Two Selected Products of Ceftriaxone Powder for Injection from Pharmaceuticals' Market in Sudan

Background: Different techniques have classically been used to evaluate and assure the quality of medicines circulated on the market; one of the commonly uses is chemical analysis. However, some evidence has shown that there are other important indicators (e.g. bioequivalence, relative potency, etc.) that should also be considered when evaluating the quality of pharmaceutical products.Materials and Methods: A microbiological assay was conducted to compare the relative potency of two Ceftriaxone products (with a third one used as standard product) from the market using 3 reference bacteria including Streptococcus pneumoniae, Klebsiella pneumoniae and Staphylococcus aureus. Serial dilutions were made with the corresponding 1, 4, 8, 16 and 32-fold Minimum Inhibitory Concentration (MIC) of Ceftriaxone against the bacteria under investigation.Results: The relative potency of one product compared to the standard product was estimated to be within the acceptable range of bioequivalence (89.6%), while the other product showed unacceptable relative potency (72.3%).Conclusions: The microbiological assay is an effective and simple method for comparing the equivalency of injectable products. A complaint reporting system about quality and effectiveness problems needs to be considered as a priority source of such information to inform decision-makers.Keywords: Microbiological assay, Ceftriaxone, quality assurance, relative potency and genericmedicines

Interchangeability and Comparative Effectiveness between Micronized and Non-micronized Products of Glibenclamide Tablets

Background: During the last few years there was wide debate about the interchangeability and effectiveness between circulated products containing Glibenclamide in the market.Objectives: This study aimed to compare the effectiveness of this product “non-micronized” to the originator’s product of Glibenclamide tablets “of micronized” sulfonylurea.Methods: 12 volunteers received a dose of 5mg of Glibenclamide (from test and standard products) under fasting conditions in two separate sessions using randomized crossover design. Blood glucose level for the volunteers was monitored to avoid the development of hypoglycemia. Plasma samples were collected over 24 hours and analyzed using HPLC.Results: The maximum concentration Cmax for the test and reference products were 2.508 ± 0.104 and 3.526 ± 0.118 (ìg/ml) respectively and the area under the curve AUC0-[ were 3.511 ± 0.153 4.572 ± 0.202 (ìg.h/ml) for these products respectively, with a difference of about 24% between the test and reference products in its AUC.Conclusions: The results indicate that the test product is not bioequivalent to reference product. The difference in formulation between micronized product and non-micronized product of Glibenclamide tablets has impact on clinical outcomes.Key words:sulfonylurea,Blood glucose,hypoglycemia