Screening the Formulation of Minodronic Acid Tablets by Full Factorial Experimental Design and Investigation on Its Blend Uniformity

OBJECTIVE To screen the optimal formulation of minodronic acid tablets and confirm its blend uniformity. METHODS According to the formulation of the innovator products, Minitab 19 software was used to design and analyze the optimization experiment of the formulation dosage of each excipient, taking the dissolution and content uniformity as inspection indicators, the full factorial experimental design and analysis were carried out. According to ASTM E2709/E2810, stratified sampling was used, and the blend and content uniformity was statistically analyzed. RESULTS After screening, the optimal particle size distribution of active pharmaceutical ingredient was D90(11 to 15 μm), the optimal proportion of starch, lactose and hydroxypropyl cellulose was 9%, 79.5% and 10% respectively. The statistical analysis results of small and pilot production batches showed that uniformity of samples from blending process and from tabletting process were acceptable. CONCLUSION The screened formulation and process of minodronic acid tablets are feasible and can guarantee the dissolution and content uniformity of the tablets with small strength.