与乳糖载体无定形含量有关的复杂性

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY International Journal of Pharmaceutics: X Pub Date : 2023-10-23 DOI:10.1016/j.ijpx.2023.100216
Pauline H.M. Janssen , Lorina M.N. Bisharat , Marly Bastiaansen
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引用次数: 0

摘要

虽然乳糖中的无定形含量很低,但它对干粉吸入配方性能的影响可能很大。许多配方师和监管机构认为,一旦与最终产品性能有关系,就应该控制非晶态含量的水平。然而,这并不是一件容易的事。本文详细阐述了乳糖中非晶含量控制的多重挑战和复杂性。综述了非晶乳糖的定义和定量方法,以及与热力学不稳定性相关的挑战。此外,本文还讨论了当前的专著和最近考虑到这一参数的立场文件,以提供监管格局的概述。建议制定控制策略,前提是在工艺的特定时刻,非晶含量已显示对干粉吸入器的性能有影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Complexities related to the amorphous content of lactose carriers

Although the amount of amorphous content in lactose is low, its impact on the performance of a dry powder inhalation formulation might be high. Many formulators and regulatory agencies believe that the levels of amorphous content should be controlled once there is a relationship with the final product performance. This is however not an easy task. The current paper elaborates on multiple challenges and complexities that are related to the control of the amorphous content in lactose. The definition and quantification methods of amorphous lactose are reviewed, as well as challenges related to thermodynamic instability. Additionally, current monographs and recent position papers considering this parameter are discussed to provide an overview of the regulatory landscape. Development of a control strategy is recommended, provided that the amorphous content at a specific moment in the process has shown to have an impact on the performance of the dry powder inhaler.

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来源期刊
International Journal of Pharmaceutics: X
International Journal of Pharmaceutics: X Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
6.60
自引率
0.00%
发文量
32
审稿时长
24 days
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