Heng Paul W S, Chan L W, Ong K T
Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore.
J Pharm Pharm Sci. 2003 Sep-Dec;6(3):334-44.
To investigate the influence of storage conditions and types of plasticizers on the properties and stability of ethylcellulose and polymethacrylate films and to elucidate the mechanism for the changes observed.
Films were prepared from Surelease, Aquacoat and Eudragit L 30D dispersions by the casting method. The effects of different plasticizers on the morphology, transparency, mechanical property and water vapour permeability of the prepared films were studied. The film samples were exposed to storage conditions of 30 degrees C and 50 or 75 %RH. Samples were removed at pre-determined time intervals for mechanical testing and analysis of plasticizer content in the films.
It was found that films prepared from aqueous ethylcellulose dispersions were relatively weaker and more brittle than acrylate films. Acrylate films did not show any significant change in mechanical property when stored at high humidity. However, the properties of ethylcellulose films stored at high humidity varied depending on the type of plasticizers present.
The changes in mechanical property of ethylcellulose films on storage were mainly attributed to the loss of plasticizers during storage, causing further coalescence of ethylcellulose films and to a smaller extent, reduction in moisture content of the film.
研究储存条件和增塑剂类型对乙基纤维素和聚甲基丙烯酸酯薄膜性能及稳定性的影响,并阐明所观察到变化的机制。
通过流延法由Surelease、Aquacoat和Eudragit L 30D分散体制备薄膜。研究了不同增塑剂对所制备薄膜的形态、透明度、机械性能和水蒸气透过率的影响。将薄膜样品置于30℃、50%或75%相对湿度的储存条件下。在预定的时间间隔取出样品进行机械性能测试和薄膜中增塑剂含量分析。
发现由乙基纤维素水分散体制备的薄膜比丙烯酸酯薄膜相对更脆弱且更脆。丙烯酸酯薄膜在高湿度储存时机械性能未显示任何显著变化。然而,在高湿度下储存的乙基纤维素薄膜的性能因存在的增塑剂类型而异。
乙基纤维素薄膜储存时机械性能的变化主要归因于储存期间增塑剂的损失,导致乙基纤维素薄膜进一步聚结,且在较小程度上归因于薄膜水分含量的降低。