Effect of Formulation and Technology on Blend Uniformity and Content Uniformity of Rosuvastatin Calcium Tablets

OBJECTIVE To study the influence of the excipients in formulation and technology on the blend uniformity and content uniformity of rosuvastatin calcium tablets. METHODS Used the powder direct compression technology, through single factor experiment, the types of lactose, the types of microcrystalline cellulose, the ratios of lactose to microcrystalline cellulose, the types of calcium salt and the dosages of crospovidone were investigated for the influence of the blend uniformity and content uniformity. The influence of blending process on the blend uniformity and the influence of tableting process on the content uniformity were studied. RESULTS There were good blend uniformity and content uniformity on types of lactose(T80, PW80, 315), types of microcrystalline cellulose(PH102, M102, 102), different ratios of lactose to microcrystalline cellulose(1:1, 3:1, 1:3), types of calcium saltcalcium phosphate(fine particles), dibasic calcium phosphate anhydrous(fine particles, fine powder), calcium carbonate(fine powder) and dosages of crospovidone, but a poor result on calcium phosphate(coarse particles). Added 50% lactose to the mixing container, added active pharmaceutical ingredient, microcrystalline cellulose, crospovidone and calcium phosphate, mixed at 10 r·min^-1 for 20-25 min; then added the remaining lactose and mixed at 10 r·min^-1 for 15-25 min, the blend uniformity was good. The content uniformity of gravity feeder and tableting speed(10-20 r·min^-1) was good, but a bad result on forced feeder and tableting speed(30 r·min^-1). CONCLUSION The types of lactose and microcrystalline cellulose, ratios of lactose to microcrystalline cellulose, types of calcium salt and dosages of crospovidone suitable for the powder direct compression process are selected through research. The range of blending process parameters is investigated, and the gravity feeder and tableting speed(10-20 r·min^-1) are optimized to obtain good blend uniformity and content uniformity.