乳制品行业侧流乳糖用于药片制造 - - 概念验证研究
Anssi-Pekka Karttunen1, Atte Junnila1, Eetu Myöhänen1
1Drug Research Program, Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
International journal of pharmaceutics
|June 19, 2024
概括
使用乳制品侧流乳糖作为辅助剂对可持续的药物制造和供应链安全有很大希望. 虽然冷干燥乳糖表现出良好的可分片性,但对于最佳的药物释放,需要提高纯度.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 化学工程是化学工程的重要组成部分.
背景情况:
- 药物短缺凸显了对制药辅助剂有弹性的供应链的需要.
- 乳糖是一种广泛使用的片剂辅助剂,是从乳制品中衍生出来的,这为利用副作用产品提供了机会.
- 在供应链中断期间,确保国内有乳糖等关键原材料的可用性至关重要.
研究的目的:
- 评估从乳制品侧流中提取的乳糖作为直接压缩片剂的可持续替代辅助剂.
- 为了比较喷雾干燥和冷干燥的研究乳糖与商业参考的性能.
- 评估侧流乳糖对配方流动性,可分片性,分解性和药物释放性的影响.
主要方法:
- 从乳制品侧流中制备了两种形式的试验乳糖 (喷雾干燥和冷干燥).
- 配方是通过混合乳糖与微晶纤维素,滑剂和滑动剂以不同的比例来创建的.
- 描述了配方的流动性,可分片性,分解时间和药物释放概况.
主要成果:
- 喷雾干燥的乳糖,尽管具有良好的可分片性,但由于其无形性和小颗粒大小,其流动性较差.
- 与商业参考相比,冷干燥乳糖显示出足够的流量和优越的可分片性.
- 试验中乳糖配方的分解和药物释放速度较慢,这归因于剩余的牛奶蛋白质,特别是素.
结论:
- 乳制品侧流乳糖具有作为直接压缩的可持续辅助剂的潜力,增强供应链的弹性.
- 来自侧流的冷干燥乳糖在流量和可表达性方面提供了竞争力的性能.
- 进一步净化试验中的乳糖是必要的,以克服分解和药物释放的局限性,确保最佳的药物性能.
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