HOW IS TORCETRAPIB/ATORVASTATIN TABLET MADE?
Based on Pfizer’s patent application, the process of preparation for this atorvastatin/torcetrapib combo tablet may be as follows: [1] They dissolved 12% hydroxypropyl methylcellulose acetate succinate and 4% torcetrapib in 84% acetone and then spray-dried the solution at high temperature. After the drying of the polymer and drug, they got a solid amorphous dispersion of torcetrapib in hydroxypropyl methylcellulose acetate succinate. [2] They blended 48% torcetrapib solid amorphous dispersion, 23% polyoxy, 23% xylitol, 5% sodium starch glycolate and 1% magnesium stearate to form the drug-containing composition (drug layer). They also blended 75% sodium croscarmellose, 24.4% silicified-microcrystalline cellulose, 0.5% magnesium stearate and 0.1% red lake#50 to form the water-swellable (push-layer) composition. They then compress these two compositions together into a bilayer-tablet (13/32 inch standard round concave; weight 500 mg, hardness 16 Kp). [3] They then coated the tablet with a
