Department of Pharmaceutics, College of Pharmacy, Umm Al-Qura University, Makkah, KSA.
Pharm Dev Technol. 2013 Nov-Dec;18(6):1355-60. doi: 10.3109/10837450.2012.700936. Epub 2012 Jul 11.
The objective of this work was to study the dissolution and mechanical properties of fast-dissolving films prepared from a tertiary mixture of pullulan, polyvinylpyrrolidone and hypromellose. Disintegration studies were performed in real-time by probe spectroscopy to detect the onset of film disintegration. Tensile strength and elastic modulus of the films were measured by texture analysis. Disintegration time of the films ranged from 21 to 105 seconds whereas their mechanical properties ranged from approximately 2 to 49 MPa for tensile strength and 1 to 21 MPa% for young's modulus. After generating polynomial models correlating the variables using a D-Optimal mixture design, an optimal formulation with desired responses was proposed by the statistical package. For validation, a new film formulation loaded with diclofenac sodium based on the optimized composition was prepared and tested for dissolution and tensile strength. Dissolution of the optimized film was found to commence almost immediately with 50% of the drug released within one minute. Tensile strength and young's modulus of the film were 11.21 MPa and 6, 78 MPa%, respectively. Real-time spectroscopy in conjunction with statistical design were shown to be very efficient for the optimization and development of non-conventional intraoral delivery system such as fast dissolving films.
本工作旨在研究普鲁兰、聚乙烯吡咯烷酮和羟丙甲纤维素三元混合物制备的速溶薄膜的溶解性能和力学性能。通过探针光谱学实时进行崩解研究，以检测薄膜崩解的起始。通过质地分析测量薄膜的拉伸强度和弹性模量。薄膜的崩解时间范围为 21 至 105 秒，而其力学性能范围为拉伸强度约 2 至 49 MPa 和杨氏模量约 1 至 21 MPa%。使用 D-最优混合物设计生成相关变量的多项式模型后，统计软件包提出了具有所需响应的最佳配方。为了验证，根据优化的组成制备并测试了载有双氯芬酸钠的新薄膜配方的溶出度和拉伸强度。发现优化后的薄膜的溶出度几乎立即开始，1 分钟内释放了 50%的药物。薄膜的拉伸强度和杨氏模量分别为 11.21 MPa 和 6,78 MPa%。实时光谱学与统计设计相结合，对于优化和开发非传统的口腔内给药系统（如速溶薄膜）非常有效。
