以聚乙醇为基础的囊外,通过注射成型制造,作为准备使用的防潮屏障,用于开发输送系统
Marco Uboldi1, Andrea Gelain2, Giuseppe Buratti2
1Sezione di Tecnologia e Legislazione Farmaceutiche "Maria Edvige Sangalli", Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, via G. Colombo 71, 20133 Milano, MI, Italy.
International journal of pharmaceutics
|June 23, 2024
概括
注塑成型成功制造了聚乙醇 (PVA) 囊. 这些新型药品囊提供可重复的质量,可调节的药物释放和防潮保护,为各种药物输送应用提供了多功能替代方案.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 材料科学是一种材料科学.
背景情况:
- 传统的囊制造方法有其局限性.
- 开发新的,多功能药物输送系统至关重要.
研究的目的:
- 为了证明使用注塑成型 (IM) 制造囊的可行性.
- 评估基于聚乙醇 (PVA) 的成型囊的性能和性能.
主要方法:
- 600微米厚的囊的原型使用药品级的低粘度PVA,有或没有填充剂,通过注射成型来制造.
- 描述包括重量和厚度的可重复性,穿孔行为,药物释放概况和防潮保护.
- 一种在线近红外光谱法被开发和验证用于湿度评估.
主要成果:
- 成功成型的PVA囊外具有可重复的重量 (CV < 2) 和厚度 (CV < 5).
- 证明了符合穿孔行为,可调节的释放动力学 (即时和脉冲),以及有效的防潮保护.
- 验证了一种在线近红外光谱法,用于评估防潮保护.
结论:
- PVA的注射成型为制造药品囊提供了一种多功能和可行的方法.
- 基于PVA的成型囊提供可复制的质量,可调节的药物释放和防潮屏障特性.
- 这些囊是现有选择的有希望的替代品,适合各种配方和施用途径 (口服,肺部).
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