聚合物特性用于在颗粒上涂层药物,使用新型融颗粒技术,MALCORE®
Ryota Kimata1,2, Naoki Yoshihara1,2, Yuya Tomita1
1School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-Ku, Shizuoka, 422-8526, Japan.
AAPS PharmSciTech
|April 10, 2024
概括
研究人员探索了用于MALCORE®化颗粒的新聚合物,发现聚烯 (PVP) 有效. 这扩大了制造含药颗粒 (DCP) 的聚合物选择,并保持了一致的质量.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
背景情况:
- 马尔科尔 (MALCORE) 是一种化颗粒技术,用于生产含药物颗粒 (DCP).
- 有效的聚合物选择对于MALCORE®中融粘度和颗粒性质至关重要.
- 氨基甲基烯酸合聚合物E (AMCE) 是迄今为止唯一使用的聚合物.
研究的目的:
- 为了确定用于MALCORE®化颗粒的替代聚合物.
- 了解聚合物对于这一过程的基本特性.
主要方法:
- 在酸 (SA) 溶解中研究了聚烯 (PVP) 的溶解性.
- 利用里叶变换红外光谱法 (FTIR) 来评估聚合物-SA相互作用.
- 采用相位图来确定液态的最佳混合比率和温度范围.
- 分析了聚合物数量和分子量对混合物粘度的影响.
主要成果:
- 聚烯利 (PVP) 在酸 (SA) 溶解中表现出可溶性.
- FTIR证实SA和PVP之间没有化学相互作用.
- 阶段图确定了液体SA-PVP混合物的特定混合比率和温度范围.
- 融化成分的粘度受到PVP度和分子重量的直接影响.
- 通过MALCORE®使用PVP制造的DCP显示了与AMCE制造的DCP相似的药物特性.
结论:
- 聚烯 (PVP) 是一种可行的替代聚合物用于MALCORE®化颗粒.
- 了解聚合物特性 (溶解度,分子量) 是优化MALCORE®制造的关键.
- 这项研究可以加强对温度和混合比率的控制,以实现一致的DCP生产.
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