Salamanca Constain H, Barrera-Ocampo Alvaro, Lasso Juan C, Camacho Nathalia, Yarce Cristhian J
Departamento de Ciencias Farmacéuticas, Facultad de Ciencias Naturales, Universidad Icesi, Calle 18 No. 122-135, Cali 760031, Colombia.
Pharmaceutics. 2018 Sep 5;10(3):148. doi: 10.3390/pharmaceutics10030148.
This study aimed to evaluate and compare, using the methodology of Franz diffusion cells, the ketoprofen (KTP) releasing profiles of two formulations: A gel and a conventional suspension. The second aim was to show that this methodology might be easily applied for the development of semi-solid prototypes and claim proof in pre-formulation stages. Drug release analysis was carried out under physiological conditions (pH: 5.6 to 7.4; ionic strength 0.15 M; at 37 °C) for 24 h. Three independent vertical Franz cells were used with a nominal volume of the acceptor compartment of 125 mL and a diffusion area of 2.5 cm². Additionally, two different membranes were evaluated: A generic type (regenerated cellulose) and a transdermal simulation type (Strat-M). The KTP permeation profiles demonstrated that depending on the membrane type and the vehicle used, the permeation is strongly affected. High permeation efficiencies were obtained for the gel formulation, and the opposite effect was observed for the suspension formulation. Moreover, the permeation studies using Strat-M membranes represent a reproducible methodology, which is easy to implement for pre-formulation stage or performance evaluation of semi-solid pharmaceutical products for topical or transdermal administration.
本研究旨在使用弗兰兹扩散池方法评估和比较两种制剂（一种凝胶剂和一种传统混悬剂）的酮洛芬（KTP）释放曲线。第二个目的是表明该方法可轻松应用于半固体原型的开发，并在制剂前阶段提供证据支持。在生理条件下（pH：5.6至7.4；离子强度0.15 M；37°C）进行24小时的药物释放分析。使用三个独立的垂直弗兰兹池，接受室的标称体积为125 mL，扩散面积为2.5 cm²。此外，评估了两种不同的膜：一种通用型（再生纤维素）和一种透皮模拟型（Strat-M）。KTP渗透曲线表明，根据膜的类型和所用的载体，渗透受到强烈影响。凝胶制剂获得了高渗透效率，而混悬剂则观察到相反的效果。此外，使用Strat-M膜进行的渗透研究是一种可重复的方法，易于在制剂前阶段或用于局部或透皮给药的半固体药品的性能评估中实施。
