Farinha A, Bica A, Pais J P, Toscano M C, Tavares P
Laboratório de Estudos Farmacêuticos, Rua Alto do Duque 67, 1400 Lisbon, Portugal.
Eur J Pharm Sci. 1999 Mar;7(4):311-5. doi: 10.1016/s0928-0987(98)00043-8.
Omeprazole, a proton pump inhibitor, effectively suppresses the gastric acid secretion in the parietal cells of the stomach. Several previously published papers focus on the pharmacokinetics of the drug and its interactions with physiological aspects or with other drugs. The increasing number of omeprazole containing products available in the market, raises questions of therapeutic equivalence and/or generic substitution. The bioequivalence evaluation between two or more formulations provides information about in vivo performance. In a favorable decision regarding bioequivalence, the products are considered to have a similar therapeutic efficacy when used under the same therapeutic conditions. This paper reports the design, results and some important aspects involved in a bioequivalence study between two solid oral formulations from different manufacturers. Some important findings were the high intra-subject variability observed for Cmax and the variability observed between subject profiles, probably caused by the multi-unit type of formulations studied.
奥美拉唑是一种质子泵抑制剂，能有效抑制胃壁细胞的胃酸分泌。此前发表的几篇论文聚焦于该药物的药代动力学及其与生理因素或其他药物的相互作用。市场上含奥美拉唑产品的数量不断增加，引发了治疗等效性和/或仿制药替代的问题。两种或更多剂型之间的生物等效性评估可提供有关体内性能的信息。若生物等效性判定良好，则这些产品在相同治疗条件下使用时被认为具有相似的治疗效果。本文报告了来自不同制造商的两种固体口服制剂生物等效性研究的设计、结果及一些重要方面。一些重要发现包括观察到的Cmax的高个体内变异性以及个体曲线间的变异性，这可能是由所研究的多单元剂型导致的。
