In Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South-West Ethiopia

Background. Persistent postmarket quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces a biopharmaceutical and therapeutically equivalent list of the products to the prescribers and users of it. This in turn facilitates access to essential medicines by breaking the high-cost barrier imposed by a few expensive brands of the product. This study was aimed at determining the quality and evaluating the equivalence of doxycycline hyclate capsules and tablets in Jimma, Ethiopia. Methods. Ten brands of doxycycline hyclate capsules and tablets were tested for product identity, dosage uniformity, assay, and in vitro dissolution; and tablets were tested for friability and hardness. Results. All investigated brands of doxycycline complied with the USP for dosage uniformity, an assay of the active ingredient, and single-point dissolution tests. One brand, D09, failed both hardness and friability tests. Comparisons of dissolution profiles applying fit factors confirmed that only brands D04, D06, and D07 had similarities with the innovator. Ratio test approaches also showed that significant variability exists between test products and comparators. Weibull model was found to provide the best adjustment curve for all brands, from model-dependent approaches employed for explaining the overall release of drug from the dosage forms. Conclusions. Doxycycline is a biowaiver product. Hence, in vitro dissolution evaluation suffices its market approval. In this quality assessment study, however, the samples passed quality control tests, except D09 brand which failed friability; it has been revealed that five out of eight brands had problems with interchangeability. Only three doxycycline hyclate brands were found to be equivalent to the comparators.

Stability of Hydrocortisone Oral Suspensions Prepared from Tablets and Powder

Objective: To assess the stability, dosage uniformity, and clinical acceptability of hydrocortisone oral suspensions prepared from tablets and powder. Design: Hydrocortisone 2.5 mg/mL oral suspensions were stored in the dark for 91 days at 5, 25, and 40 °C. Dosage uniformity was assessed by repeated sampling of the formulation prepared from tablets at 5 and 25 °C. The formulation was clinically evaluated in 2 pediatric patients. Setting: A university pharmacy school and affiliated urban teaching hospital. Participants: A brother (4 y old) and sister (1 y old) with congenital adrenal hyperplasia maintained on a commercially available hydrocortisone cypionate suspension. Main Outcome Measures: Samples removed at 5 time points were analyzed for hydrocortisone to assess decomposition over 90 days. Dosage uniformity was evaluated by intra- and interday variability. Palatability was examined in the 2 children and urinary cortisol concentrations were measured in the boy before and 5 days after commencing the formulation prepared from tablets. Results: Decomposition of hydrocortisone was not significant except in the formulation that was prepared from tablets and stored at 40 °C. Dosage uniformity gave coefficients of variation less than 4.5%. The formulation was well-tolerated and resulted in satisfactory urinary Cortisol concentrations in the boy. Conclusions: The hydrocortisone oral suspensions supply a uniform dose and are chemically stable when stored in the dark at 5 and 25 °C for at least 30 days. They provide flexible and convenient dosage forms for pediatric patients.