与乳糖载体的无形含量有关的复杂性
Pauline H M Janssen1,2, Lorina M N Bisharat2,3, Marly Bastiaansen2
1Department of Pharmaceutical Technology and Bio pharmacy, University of Groningen, Antonius Deusinglaan 1, Groningen 9713 AV, the Netherlands.
International journal of pharmaceutics: X
|November 13, 2023
概括
乳糖中的无形含量虽然很小,但显著影响干粉吸入配方. 控制这种无形含量对于产品性能和监管合规性至关重要.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 乳糖中的无形含量,尽管存在少量,但可以显著影响干粉吸入 (DPI) 配方的性能.
- 配方者和监管机构认识到需要控制无形含量,因为它与最终产品的性能有关.
研究的目的:
- 详细阐述与控制DPI配方中乳糖中的无形含量相关的挑战和复杂性.
- 审查无形乳糖的定义和量化方法.
- 讨论热力学不稳定性的挑战以及关于无形乳糖的监管格局.
主要方法:
- 对现有关于乳糖无形含量定义和量化文献的审查.
- 对影响无形乳糖的热力学不稳定因素的分析.
- 检查与无形内容控制有关的当前监管专著和立场论文.
主要成果:
- 乳糖中无形含量的存在,即使在低水平,也给DPI配方的性能带来了重大挑战.
- 准确地定义和量化无形乳糖是复杂的,需要仔细考虑.
- 无形乳糖的热力学不稳定性使其控制更加复杂.
结论:
- 控制乳糖中的无形含量对于确保一致的DPI配方性能至关重要.
- 建议对无形含量进行强有力的控制策略,特别是当其对性能的影响在特定的过程阶段被证明时.
- 对管理无形内容及其稳定性的进一步研究是先进的DPI开发的必要条件.
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