Akademik Veri Yönetim Sistemi
JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY, 2024 (SCI-Expanded)
Amlodipine besylate (AML) and rosuvastatin calcium (ROS) are commonly used in the treatment of cardiovascular diseases such as hypertension, dyslipidemia, and coroner artery disease. Orodispersible films (ODFs) have received considerable attention in pharmaceutical development studies as they significantly improve patient compliance. The aim of this study was to develop an ODF formulation containing AML and ROS simultaneously as an electrospun fiber fixed dose preparation. Polymer solutions were evaluated for surface tension, viscosity, and conductivity properties. Preformulation studies were conducted to optimize the electrospinning process. Two different formulations, designated ODF-1 and ODF-2 were the focus of this study. Fiber characterization studies, such as scanning electron microscopy (SEM), Fourier transform-infrared spectroscopy (FT-IR), mechanical properties were performed to assess these two formulations. Furthermore, ODF characterizations, such as disintegration and wetting time, homogeneity of contents, and in vitro dissolution studies were carried out. All formulations exhibited suitable mechanical properties, facilitating easy storage and handling. ODF characterizations revealed rapid disintegration and wetting times for all formulations with over 90 % dissolution in 5 min for both AML and ROS. The overall evaluation of all experiments suggests that ODF-1 may more desirable mechanical properties and a more stable dissolution profile compared to ODF-2. Furthermore, individual ODFs loaded with AML or ROS (AML-ODF-1 and ROS-ODF-1) were prepared by ODF-1 preparation method and then characterized to compare the results with fixed dose ODF results. In conclusion, a promising formulation strategy has been developed to obtain an electrospun fiber ODF formulation containing AML and ROS that is reproducible and suitable for industrial production.