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Eur J Pharm Sci. 2013 Jan 23;48(1-2):240-8. doi: 10.1016/j.ejps.2012.11.003. Epub 2012 Nov 16.
Films of ethyl cellulose (EC) and water-soluble hydroxypropyl cellulose (HPC) can be used for extended release coatings in oral formulations. The permeability and microstructure of free EC/HPC films with 30% w/w HPC were studied to investigate effects of EC molecular weight. Phase separation during film spraying and subsequent HPC leaching after immersion in aqueous media cause pore formation in such films. It was found that sprayed films were porous throughout the bulk of the films after water immersion. The molecular weight affected HPC leaching, pore morphology and film permeability; increasing the molecular weight resulted in decreasing permeability. A model to distinguish the major factors contributing to diffusion retardation in porous films showed that the trend in permeability was determined predominantly by factors associated with the geometry and arrangement of pores, independent of the diffusing species. The film with the highest molecular weight did, however, show an additional contribution from pore wall/permeant interactions. In addition, rapid drying and increasing molecular weight resulted in smaller pores, which suggest that phase separation kinetics affects the final microstructure of EC/HPC films. Thus, the molecular weight influences the microstructural features of pores, which are crucial for mass transport in EC/HPC films.
乙基纤维素(EC)和水溶性羟丙基纤维素(HPC)薄膜可用作口服制剂的缓释包衣材料。研究了含有 30%w/w HPC 的 EC/HPC 自由薄膜的透气性和微观结构,以考察 EC 分子量的影响。在薄膜喷涂过程中的相分离以及随后在水性介质中的 HPC 浸出会导致此类薄膜中形成孔。结果发现,水浸后,喷涂薄膜在整个薄膜体积中都是多孔的。分子量影响 HPC 的浸出、孔形态和薄膜的渗透性;分子量增加导致渗透性降低。一个区分多孔膜中扩散延迟主要因素的模型表明,渗透性的趋势主要取决于与孔的几何形状和排列有关的因素,而与扩散物质无关。然而,分子量最高的薄膜确实显示出与孔壁/可渗透物质相互作用有关的额外贡献。此外,快速干燥和增加分子量会导致孔径变小,这表明相分离动力学会影响 EC/HPC 薄膜的最终微观结构。因此,分子量会影响孔隙的微观结构特征,这对于 EC/HPC 薄膜中的质量传递至关重要。