Comparison of dissolution profile of extended-release oral dosage forms - two one-sided equivalence test

The aim of this work is to present the two one-sided test (TOST) as an alternative approach to compare dissolution profiles of extended-release dosage forms. The dissolution profiles of oxycodone extended-release tablets containing 10 mg, 20 mg and 40 mg (reference and generic) were evaluated according to the requirements described in United States Pharmacopeia. These dissolution profiles were compared using the conventional similarity factor (f2) and the proposed TOST as an equivalence test. TOST is a simple and alternative approach to compare dissolution profiles of extended-release dosage forms. It allows us to identify the time-point (or time-points) that did not show similarity. We concluded that the two one-sided test performed at a significance level of 5% and defined as D = 10 showed results comparable to those obtained by the conventional similarity factor (f2).

O objetivo deste trabalho é apresentar o teste uni-caudal duplo (TOST) como uma abordagem alternativa na comparação do perfil de dissolução de formas farmacêuticas de liberação prolongada. Os perfis de dissolução de comprimidos de liberação prolongada de oxicodona contendo 10 mg, 20 mg e 40 mg (genérico e referência) foram avaliados de acordo com os requisitos descritos na Farmacopeia Americana. Estes perfis de dissolução foram comparados empregando-se o fator de semelhança convencional (f2) e o método TOST como teste de equivalência. TOST é uma abordagem simples e alternativa para a comparação de perfis de dissolução de formas farmacêuticas de liberação prolongada. Este permite identificar o ponto (ou pontos) que não apresentou semelhança. Considerando-se D = 10, concluímos que o teste uni-caudal duplo num nível de significância de 5% apresenta resultados comparáveis àqueles obtidos com o fator de semelhança convencional (f2).

Sedative and hypnotic effects of oil of spine date seeds from different extraction technologies in mice / 西安交通大学学报(医学版)

Objective To study the sedative and hypnotic effects of oil of spine date seeds by different extraction technologies(compression and supercritical CO2 extraction,OSDSE and OSDSS) in mice.Equivalence test was used to test the effects.Methods Spontaneous activity and tolerance were observed by photoelectric counting method after long-term intragastric administration of OSDSE and OSDSS in mice.The sleeping time and delitescence induced by above threshold dose of pentobarbital sodium and sleeping number induced by below threshold dose of pentobarbital sodium were utilized to observe the hypnotic effect of OSDSE and OSDSS in mice.Diazepam was applied as a positive control drug.Results OSDSE and OSDSS could obviously reduce spontaneous activity,increase sleeping time and sleeping number in mice,while the sleeping delitescence was shortened.All the effects induced by OSDSE and OSDSS were equivalent.The inhibitory effect of spontaneous activity was enhanced following repeated administration,while the effect of diazepam was reduced.Conclusion Both oils of spine date seeds can induce sedative and hypnotic effects without tolerance.They have equivalent effects on sedation and hypnosis.