Development and Evaluation of Proposed Pharmaceutical Formulations of Modified-Release Granules of Celecoxib for Use It in Preparation of Extended-Release Tablets

Abstract

Objective: Procedure a technological study for proposed pharmaceutical formulations for preparing prolonged release granules of celecoxib for reducing of chronic pain for use it in preparation other pharmaceutical 
dosage forms.
Materials and Methods: The research experiments were conducted by using materials and calibrated accurately devices according to the requirements of Good Manufacturing Practice (GMP). The technological properties of prepared pharmaceutical dosage forms as granules and tablets were determined by doing pharmacopoeial tests according to the requirements of the United States Pharmacopoeia USP 43 NF 38. Cellulose polymers as an auxiliary excipient, were selected to control the release of celecoxib. Six formulations of celecoxib granules were proposed and their technological properties and release rate were determined by dissolution test in Vitro. Their suitability for obtaining tablets with extended release as a final pharmaceutical dosage form was also determined.
Results: The results showed that 3 of the proposed formulations give promising results for manufacturing a prolonged-acting pharmaceutical dosage form of celecoxib for prolonged pain relief up to 20 hours, and clinical tests can be continued on these formulations.
Conclusion: This current study shed light on the possibility of preparing extended release tablets of celecoxib used as a newer generation selective non-steroidal anti-inflammatory for the treatment of chronic pain. These prepared pharmaceutical dosage forms are expected to reduce the severity of side effects with improving patient adherence to the treatment plan, also reducing the frequency of administration compared to conventional pharmaceutical forms, and reducing treatment costs.