PREPARATION AND OPTIMIZATION OF CILOSTAZOL NANOEMULSION ORAL LIQUID DOSAGE FORM

Objective: Cilostazol has poor water solubility and low oral bioavailability. Therefore, the formulation of cilostazol as a nanoemulsion may enhance its solubility and improve oral bioavailability. Hence, the aim of this study was to formulate and characterize an oil-in-water (o/w) nanoemulsion of cilostazol as an oral liquid dosage form. Methods: Pseudo-ternary phase diagrams were constructed using the aqueous titration method. Formulations of pseudo-ternary phase plots consisting of oil, various weight ratios of S mix (mixture of surfactant and co-surfactant), and deionized water were made. Different characterization studies, droplet size measurement, polydispersity index, drug content, zeta potential measurement, and in vitro release, have been conducted to choose the optimized formula. Results: The characterization studies have demonstrated that the optimized formula is (F-6), consisting of 20 % S mix (3:1), 10% ginger oil, and 70% deionized water. This formula had the following characteristics; droplet size (72.9-110 nm), polydispersity index (0.22), percentage of drug content (99.8%), and in vitro release of cilostazol nanoemulsion was significantly higher (P<0.05) in comparison with other formulations. A Scanning probe microscopy (SPM) study has revealed that the droplet size of F-6 was at the nano-scale. Conclusion: In conclusion, the optimized cilostazol formula (F-6) is a promising formula, which may have the capability of improving the oral bioavailability of cilostazol

A A COMPARATIVE STUDY OF QUALITY CONTROL TESTING ON CANDESARTAN CILEXETIL CONVENTIONAL TABLETS IN IRAQ

Objective: The present study was performed to compare the quality of conventional tablets loaded with candesartan cilexetil. The selected candesartan cilexetil tablets were commercialized in the Iraq market and produced by different companies.  Methods: Different batches of candesartan cilexetil oral tablets (the concentration of candesartan was 8 mg) were subjected to quality control tests. Tests included weight variation, friability, hardness, drug content, disintegration time and in vitro release study. The protocols of these tests were performed according to USP pharmacopeia. Results: The results, in this study, revealed that all the used batches of candesartan cilexetil oral tablets complied with the specification of USP pharmacopeia for weight uniformity, friability value (% loss) was<1. Hardness results of the tablets were 4.9-6.6 Kg/cm2, which was within the required limits (i.e. 4-8 Kg/cm2). Disintegration time was<15 min in both Simulated Gastric Fluid (SGF) and Simulated Intestinal Fluid (SIF). The percentage of drug content in all marketed tablets was found between 96.2 % and 99.8 %, reflecting compliance with the pharmacopeia limits (i.e. 85-115 %). An in vitro release study indicated that the release of all marketed tablets exceeds 80 % within 15 min. Conclusion: All the studied tablets, loaded with candesartan cilexetil, were produced within the standard criteria of tablet production. The quality control analysis of the selected tablets, in this study, revealed satisfactory pharmaceutical properties (including safety and effectiveness) that comply within the limits of USP pharmacopeia