Department of Pharmaceutics and Pharmaceutical Technology, L. M. College of Pharmacy, Navrangpura, Ahmedabad-380009, India.
Curr Drug Deliv. 2009 Oct;6(5):486-94. doi: 10.2174/156720109789941696.
The aim of the present investigation was to prepare and optimize the formulation of mouth dissolving film of salbutamol sulphate by applying experimental design technique. The films were prepared using hydroxypropyl methylcellulose, polyvinyl pyrrolidone and polyvinyl alcohol by solvent evaporation technique. Simplex lattice design and desirability function were adopted for the preparation of film possessing desirable and optimized characteristics. Tensile strength, elastic modulus, percentage strain, load at yield, and percentage drug release were selected as dependent variables. Regression equations and contour plots were used to relate the dependent and independent variables. The concept of similarity factor S(d) was used to prove similarity of dissolution between distilled water and simulated saliva (pH = 6.8). The polymers greatly influenced the mechanical properties and % drug release from the film. From the computed value of desirability function, it was determined that the film containing hydroxypropyl methylcellulose and polyvinyl alcohol was the best batch. The experimental design serves to be a useful tool for the formulation development of mouth dissolving film.
本研究旨在通过应用实验设计技术制备和优化硫酸沙丁胺醇口溶膜的配方。采用溶剂蒸发法，以羟丙甲纤维素、聚乙烯吡咯烷酮和聚乙烯醇为成膜材料制备薄膜。采用单纯形格子设计和适宜性函数来制备具有理想和优化特性的薄膜。选择拉伸强度、弹性模量、应变率、屈服载荷和药物释放百分比作为因变量。回归方程和等高线图用于关联因变量和自变量。相似因子 S(d)的概念用于证明水和模拟唾液（pH=6.8）之间的溶出度相似性。聚合物对薄膜的机械性能和药物释放百分比有很大影响。从适宜性函数的计算值可以确定，含有羟丙甲纤维素和聚乙烯醇的薄膜是最好的一批。实验设计是口溶膜制剂开发的有用工具。
