Development of Celecoxib Granules for Manufacturing of Prolonged Release Celecoxib Capsules and Tablets

Introduction. To reduce frequency of taking celecoxib dosage forms, as a highly effective drugs of the latest generation for the treatment of inflammatory diseases of the musculoskeletal system, it is advisable to develop pharmaceutical dosage form with modified release, which will reduce side effects and costs treatment. Aim. The purpose of this study was to develop formulations of prolonged release celecoxib granules. Materials and methods. Experiments were carried out with materials and equipments of the scientific laboratories of the company LEM pharma (Hama, Syria). The physico-chemical and technological properties of the experimental samples of granules and tablets of celecoxib were determined according to the methods of the American Pharmacopoeia USP 41 NF 36 edition. Results and discussion. The choice of excipients, in particular, cellulosic polymers to control releasing celecoxib was carried out. The compositions of six model samples of celecoxib granules were proposed. The technological characteristics of the samples of granules (index Hausner, Carr ratio, Particle size distribution and moisture content) have been determined, using a dissolution test, their suitability for obtaining capsules and matrix tablets of prolonged release has been established. Conclusion. The compositions of granules celecoxib with modified release are developed, which can be used to obtain capsules, as well as matrix tablets as the final pharmaceutical form. © 2022, Center of Pharmaceutical Analytics. All rights reserved.