Preparation and Quality Evaluation of Tamoxifen Citrate Tablets

OBJECTIVE To explore the preparation and process of tamoxifen citrate tablets and to evaluate the quality. METHODS The optimum formulation ratio and preparation process were screened by investigating the proportion of filler, binder concentration, amount of disintegrant, amount of lubricant, particle size and moisture content. Several batches of tamoxifen citrate tablets (1 000 tablets/batch) were prepared for quality evaluation of particle angle of repose, drug crystal form, tablet weight difference, hardness, disintegration time limit, content, etc. And multiple dissolution curves were established to evaluate the similarity of self-madness and reference formulation by similarity factor method. RESULTS The quality of tamoxifen citrate tablets prepared by using this prescription and process conditions was in accordance with the relevant quality requirements in the 2015 edition of the Chinese Pharmacopoeia; the similarity factor f₂ of the dissolution profiles in the four dissolution media was >50. CONCLUSION The homemade tablets of tamoxifen citrate and the reference preparation have in vitro dissolution consistency.