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杜塔胺液态固体片剂的配方开发和扩大规模
Krzysztof Woyna-Orlewicz1, Grzegorz Huszcza2, Edyta Pesta3
1Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, Krakow, Poland.
Drug development and industrial pharmacy
|January 25, 2025
概括
这项研究使用工业规模的设备成功开发了液态固体 (LS) 片剂,用于溶解不良的杜塔斯特 (DTS). 这种LS方法改善了药物溶解和含量统一性,证明了它对低剂量配方的工业可行性.
科学领域:
- 制药技术 制药技术 制药技术
- 药物输送系统 药物输送系统
- 配方科学科学 配方科学
背景情况:
- 液化 (LS) 技术提高了水溶性较差的药物的溶解和含量均性,特别是在低剂量时.
- 对于药物配方的LS技术的工业规模应用仍未得到充分研究.
- 杜塔斯特 (DTS) 是一种不溶于水的药物,通常需要先进的配方策略.
研究的目的:
- 开发和试验规模的含有0.5毫克杜塔斯特 (DTS) 的LS片.
- 评估LS技术在工业制药生产中的可行性.
- 评估关键的平板电脑质量属性,包括溶解和稳定性.
主要方法:
- 两个阶段的研究:安慰剂配方的开发,其次是试点规模的LS平板电脑生产与DTS.
- 使用高剪切颗粒机混合机与喷雾系统进行LS配方.
- 制造的药片进行全面的测试:质量均性,粉碎强度,分解,溶解,稳定性和杂质分析.
主要成果:
- 一个标准的高剪切颗粒机混合机证明了LS配方开发和试点规模转移的有效性.
- 成功将LS系统压缩成符合所需测试,内容均性和机械强度规格的片.
- 达到了杜塔斯特LS片所需的溶解配置.
结论:
- 高剪切颗粒机混合机促进了高效的LS配方开发和扩展.
- LS技术是一种可行的工业规模的方法,用于生产强效的低剂量药片.
- 单工艺方法提高了高强度化合物的制造安全性.
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