The College of Pharmacy discussed the PhD dissertation entitled “Cilnidipine Nanocrystals Oral Film: Preparation, Characterization, Ex-vivo and In-vivo Study” by Suray Abd Hazaa and the supervisor, Professor Dr. Nawal Ayash Rajab, at the Pharmaceutics Department. This study aimed to formulate cilnidipine as nanocrystals (CLD NCs) to improve drug solubility and dissolution rate, which would be capable of enhancing bioavailability, and then load formulated CLD NCs as oral films. The study included the preparation of cilnidipine as nanocrystals (NCs) using the solvent-anti-solvent technique. Different stabilizers were utilized to prepare many formulas with different drug-to-stabilizer ratios and particle sizes. Freeze-drying of the CLD NCs optimized formula was established. Further evaluations were done on the dry form of CLD NCs, such as content uniformity, release profile, compatibility study (fourier transform infrared spectroscopy FTIR), and for crystalline state evaluation, x-ray powder diffraction (XRPD) and differential scanning calorimetry (DSC) were performed. Results showed that F27* displayed the lowest particle size, composed of CLDNCs, Soluplus as stabilizer, and Tween 20 as co-stabilizer in a ratio of 1:0.25:0.5, respectively. Fourier transform infrared spectroscopy (FTIR) proved there was no chemical interaction between the CLD and other excipients used. FESEM was used to examine surface morphology and showed more uniformity in shape and fast dissolution behavior, with a more than 99% after 5 minutes, so F27* was selected as the best formula for further studies. The stability studies of CLD NC-loaded oral films were controlled for two months at two different temperatures (25 and 50 °C). The results indicated that the prepared films were stable for two months under these conditions, and the drug content of 93.713%) was achieved, which was an acceptable range. At last, it can be concluded that F27* was the best formula and was selected for incorporation into oral film to be formulated as a film (P4) showing the fastest in vitro release, better in vitro disintegration time, and good stability after a complete storage period.
