Fresenius Kabi USA, Melrose Park, IL, USA.
School of Basic Pharmaceutical & Toxicological Sciences, College of Pharmacy, University of Louisiana Monroe, Monroe, LA, USA.
Pharm Dev Technol. 2021 Dec;26(10):1102-1109. doi: 10.1080/10837450.2021.1993912. Epub 2021 Oct 21.
The objective of the present study was to investigate the feasibility of formulating and loading Curcumin SEDDS (Self-Emulsified Drug Delivery Systems) into films made from Soluplus as the film-forming polymer. Films with up to 30% of Curcumin SEDDS were prepared by the solvent casting technique and analyzed for their mechanical and dissolution properties. A nine-run, two-factor, three-level factorial design was utilized to investigate the effect of SEDDS load (10, 20, and 30% w/w) and film thickness (10, 25, and 40 mils) on the tensile strength, elongation, and adhesiveness of the films. The dissolution profile of the films was also investigated by a USP Type 1 method. SEDDS loading was found to plasticize Soluplus and to yield transparent films of good mechanical properties. Increasing SEDDS load, however, was found to reduce the tensile strength of the films, while increasing their adhesiveness and elongation. On the other hand, while an increase in film thickness was found to increase the tensile strength of the films, it reduced the elongation capacity of the films. Loading SEDDS into Soluplus films was also found to sustain their release over 6 h, where a significant delay in release was found at lower SEDDS loads. This study demonstrated that Soluplus can be used not only to formulate SEDDS into polymeric films but also to sustain their release over an extended time.
本研究旨在探讨将姜黄素 SEDDS(自乳化药物传递系统)制成 Soluplus 薄膜的配方和载药量的可行性。通过溶剂浇铸技术制备了高达 30%姜黄素 SEDDS 的薄膜,并对其机械性能和溶解性能进行了分析。采用九次运行、双因素、三水平析因设计,研究了 SEDDS 载药量(10%、20%和 30%w/w)和薄膜厚度(10、25 和 40 密耳)对薄膜拉伸强度、伸长率和粘附性的影响。还通过 USP 类型 1 方法研究了薄膜的溶解曲线。结果表明,SEDDS 载药使 Soluplus 增塑,并得到具有良好机械性能的透明薄膜。然而,SEDDS 载药量的增加会降低薄膜的拉伸强度,同时增加其粘附性和伸长率。另一方面,薄膜厚度的增加会增加薄膜的拉伸强度,但会降低薄膜的伸长能力。将 SEDDS 载入 Soluplus 薄膜中也被发现可以持续释放 6 小时以上,在较低的 SEDDS 载药量下,释放明显延迟。本研究表明,Soluplus 不仅可以用于将 SEDDS 制成聚合物薄膜,还可以延长其释放时间。