Yamazaki N, Iizuka R, Miyazawa S, Wada Y, Shimokawa K, Ishii F
Department of Pharmaceutical Sciences, Meiji Pharmaceutical University, Tokyo, Japan.
Drug Discov Ther. 2012 Oct;6(5):263-8.
Changes in the hardness, dissolution, and the disintegration time of brand name and generic preparations (6 preparations) of famotidine orally disintegrating tablets were investigated. Tablets had been stored in a thermo-hygrostat-controlled environment set to simulate the home conditions of patients up to 8 weeks after unit-dose packaging. Among the tablets in unit-dose packaging prepared immediately after blister packs (BP) were opened, one generic had decreased hardness to less than 2.0 kg after 1 week, 55.1% of its initial hardness value, and a shorter disintegration time of about 1/5 of its initial disintegration time. Generics met the standard for dissolution 8 weeks after unit-dose packaging. The decrease in hardness after unit-dose packaging is presumed to be associated with additives, and particularly the types and amounts of binding agents, but evidence of this association was lacking. The hardness noted in drug interview forms (IFs) and the state of sales of bulk tablet packages must be determined to facilitate the selection of generics that remain hard even after unit-dose packaging.
对法莫替丁口腔崩解片的品牌制剂和仿制药制剂（6种制剂）的硬度、溶出度及崩解时间变化进行了研究。片剂在模拟患者家庭条件的温湿度控制环境中储存，直至单剂量包装后8周。在泡罩包装（BP）打开后立即制备的单剂量包装片剂中，有一种仿制药在1周后硬度降至2.0 kg以下，为其初始硬度值的55.1%，崩解时间缩短至初始崩解时间的约1/5。仿制药在单剂量包装8周后符合溶出标准。单剂量包装后硬度降低被认为与添加剂有关，尤其是粘合剂的类型和用量，但缺乏这种关联的证据。必须确定药品访谈表（IFs）中记录的硬度以及散装片剂包装的销售状态，以便于选择即使在单剂量包装后仍保持坚硬的仿制药。
