经皮给药系统制造的最佳工艺设计

Hans-Michael Wolff
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引用次数: 30

摘要

在竞争日益激烈的医药市场中,与系统设计有关的评估标准越来越重要。对于传统剂型和给药系统(DDS)来说都是如此,因为制造商努力实现足够的患者便利性和依从性。同时,DDS制造的工艺设计必须符合现行的良好生产规范,并充分考虑相关的环境问题。相关问题必须在社会和安全压力下解决,而这些压力反过来又成为经济压力,例如控制方法的考虑。此外,系统设计和过程设计对产品成本以及与开发相关的复杂性或风险水平都有重大影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Optimal process design for the manufacture of transdermal drug delivery systems

In a pharmaceutical market characterized by increasing competition, assessment criteria related to system design are assuming greater importance. This is true for both conventional dosage forms and drug delivery systems (DDS), as manufacturers strive to achieve adequate patient convenience and compliance. At the same time, the process design for the manufacture of DDS must comply with current good manufacturing practices, and give sufficient consideration to associated environmental issues. Related problems must be solved under social and safety pressures, which, in turn, become economic pressures, such as the consideration of control methods. In addition, both the system design and the process design have a major impact on the cost of goods, as well as on the levels of complexity or risk associated with development.

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