Prescription Optimization and in Vitro Dissolution Evaluation of Self-Made Etoricoxib Tablets
Objective To optimize the prescription of self-made Etoricoxib Tablets,and to evaluate their in vitro dissolution.Methods With the Etoricoxib Tablets reference(trade name:Arcoxia,specification:120 mg per tablet)as the development goal,the content of etoricoxib in the prescription was determined by the high-performance liquid chromatography method,the dissolution was calculated,and the dissolution profile was plotted.The particle size of active pharmaceutical ingredients(APIs)and dosages of microcrystalline cellulose SH-101,anhydrous calcium hydrogen phosphate,magnesium stearate added in the prescription were optimized with the similarity factor(f2)of the dissolution profile in four different media(pH 1.0 hydrochloric acid solution,pH 4.5 acetate solution,pH 6.8 phosphate solution and water)as the evaluation standard.Results The pH 4.5 acetate solution was selected as the dissolution medium.The optimal preparation of Etoricoxib Tablets was as follows:the particle size of APIs was greater than 10 μm but smaller than 50 μm,the dosages of microcrystalline cellulose SH-101,anhydrous calcium hydrogen phosphate and magnesium stearate added were 125 mg,140 mg,3 mg per tablet respectively.With pH 4.5 acetate solution,pH 6.8 phosphate solution and water as the dissolution media,the f2 of the final self-made preparation was 79,68,78 respectively,and the dissolution of the reference and self-made preparations with pH 1.0 hydrochloric acid solution as the dissolution medium was no lower than 85%in 15 min.Conclusion The in vitro dissolution profile of determined self-made Etoricoxib Tablets is basically consistent with that of the reference preparation,which can provide a reference for the study of its bioequivalence.