Atsushi Kambayashi , Masaki Iida , Makoto Ishihara , Yoshinori Takahashi , Bertil Abrahamsson , Naseem A. Charoo , Rodrigo Cristofoletti , Peter Langguth , Mehul Mehta , Alan Parr , James E. Polli , Vinod P. Shah , Jennifer Dressman
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引用次数: 0
摘要
本专论讨论了为含有拉替拉韦钾的速释药品提供基于 BCS 的生物豁免的可能性，拉替拉韦钾用于治疗人类免疫缺陷病毒（HIV）感染。雷特格韦钾可归入 BCS II 类或 IV 类，因为该化合物溶解度低，渗透性不确定。因此，根据 ICH M9 指导原则，不建议在批准拉替拉韦钾速释固体制剂时采用基于 BCS 的生物豁免，无论是新的仿制药，还是在产品成分和/或生产方法发生中度至重大变化时。
Biowaiver monograph for immediate-release solid oral dosage forms: Raltegravir potassium
The present monograph discusses the possibility of BCS-based biowaivers for immediate release pharmaceutical products containing raltegravir potassium, which is used to treat human immunodeficiency virus (HIV) infections. Raltegravir potassium can be assigned to BCS class II or IV since this compound has low solubility and uncertain permeability. Therefore, according to the ICH M9 guideline, it is not recommended to apply BCS-based biowaiver to approval of immediate release solid dosage forms of raltegravir potassium, either for new generic versions or when moderate to major changes in composition and/or the manufacturing method of the product are made.
期刊介绍：
The Journal of Pharmaceutical Sciences will publish original research papers, original research notes, invited topical reviews (including Minireviews), and editorial commentary and news. The area of focus shall be concepts in basic pharmaceutical science and such topics as chemical processing of pharmaceuticals, including crystallization, lyophilization, chemical stability of drugs, pharmacokinetics, biopharmaceutics, pharmacodynamics, pro-drug developments, metabolic disposition of bioactive agents, dosage form design, protein-peptide chemistry and biotechnology specifically as these relate to pharmaceutical technology, and targeted drug delivery.
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