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首页> 外文期刊>Journal of pharmaceutical sciences. >Biowaiver monographs for immediate release solid oral dosage forms: amitriptyline hydrochloride.
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Biowaiver monographs for immediate release solid oral dosage forms: amitriptyline hydrochloride.

机译：速释固体口服剂型的生物豁免专论：盐酸阿米替林。

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摘要

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing amitriptyline hydrochloride are reviewed. Its therapeutic uses, its pharmacokinetic properties, the possibility of excipient interactions and reported BE/bioavailability (BA) problems are also taken into consideration. Literature data indicates that amitriptyline hydrochloride is a highly permeable active pharmaceutical ingredient (API). Data on the solubility according to the current Biopharmaceutics Classification System (BCS) were not fully available and consequently amitriptyline hydrochloride could not be definitively assigned to either BCS Class I or BCS Class II. But all evidence taken together, a biowaiver can currently be recommended provided that IR tablets are formulated with excipients used in existing approved products and that the dissolution meets the criteria defined in the Guidances.
机译：文献资料与决定放弃体内生物等效性（BE）测试以批准含有阿米替林盐酸盐的速释（IR）固体口服剂型有关。还应考虑其治疗用途，药代动力学特性，赋形剂相互作用的可能性以及已报道的BE /生物利用度（BA）问题。文献数据表明阿米替林盐酸盐是一种高渗透性的活性药物成分（API）。根据当前生物制药分类系统（BCS）的溶解度数据尚不完全可用，因此不能将盐酸阿米替林确定地分配给BCS I类或BCS II类。但是综合考虑所有证据，如果IR片剂与现有批准产品中使用的赋形剂一起配制并且溶出度符合指南中定义的标准，则目前可以推荐生物豁免。

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