System and method for fabrication of uniform polymer films containing nano and micro particles via continuous drying process
申请人:New Jersey Institute of Technology
公开号:US10646452B2
公开(公告)日:2020-05-12
The present disclosure provides improved stripfilm based pharmaceutical products (e.g., for enhancing dissolution and bioavailability). More particularly, the present disclosure provides improved systems/methods for fabricating stripfilm based pharmaceutical products by utilizing higher viscosity film forming precursors and drying methods that accomplish improved/faster drying and provide improved/excellent content uniformity of active pharmaceutical agents in the stripfilm based pharmaceutical products. Exemplary systems/methods advantageously use high viscosity, bio-compatible polymeric precursors, (optional use of surface modified drug powders), and convective drying for fabrication of thin films loaded with nano and/or micro sized particles of poorly water-soluble active pharmaceutical ingredients (APIs) to achieve improved active content uniformity and very fast dissolution from poorly water soluble actives, while accomplishing fast drying during the fabrication process. The present disclosure provides for the fast drying (e.g., via low temperature forced convection) of biocompatible polymer films loaded with poorly water-soluble drug nano-particles.
本公开提供了改进的基于条状薄膜的药物产品(例如,用于提高溶解度和生物利用度)。更具体地说,本公开提供了用于制造条状薄膜类药物产品的改进系统/方法,通过使用粘度更高的成膜前体和干燥方法,实现了改进/更快的干燥,并在条状薄膜类药物产品中提供了改进/出色的活性药剂含量均匀性。示例性系统/方法利用高粘度、生物相容性聚合物前体(可选择使用表面改性药物粉末)和对流干燥技术,在薄膜中添加纳米和/或微米大小的水溶性差的活性药物成分(API)颗粒,以提高活性成分的均匀性,并使水溶性差的活性成分快速溶出,同时在制造过程中实现快速干燥。本公开提供了快速干燥(例如,通过低温强制对流)装载有难溶于水药物纳米颗粒的生物相容性聚合物薄膜的方法。