Pharmaceutical composition
The invention relates to pharmaceutical compositions containing rosuvastatin calcium of formula (I) and processes for their manufacture.
1. A process for formation of a pharmaceutical formulation comprising a rosuvastatin calcium containing layer, said process comprising
a) coating a tablet, pellet or granule core with a sub-coating layer of a hydroxypropyl methylcellulose/polyethylene glycol (HPMC/PEG) coating polymer; and
b) spray coating a solution comprising rosuvastatin calcium and an HPMC/PEG polymer in water onto the coated tablet, pellet or granule core to provide the rosuvastatin calcium containing layer;
wherein the core contains an active ingredient which is not selected from any one or more of: niacin or a niacin analogue, a fibrate, metformin, a CETP inhibitor and aspirin; and
wherein the rosuvastatin calcium containing layer comprises rosuvastatin calcium and the HPMC/PEG polymer in a ratio of approximately 1:1.
2. The process as claimed in claim 1 , further comprising:
c) coating the rosuvastatin calcium containing layer with an outer coating comprising a third coating polymer.
3. The process as claimed in claim 1 wherein the tablet, pellet or granule core comprises an active ingredient which is not rosuvastatin calcium.
4. The process as claimed in claim 3 , wherein the core comprises an active ingredient which is selected from the group consisting of:
sulfonylureas, thiazolidinediones, DPP-4 inhibitors, SGLT-2 inhibitors, aldose reductase inhibitors, phosphodiesterase-5 inhibitors, phosphodiesterase-3 inhibitor, platelet aggregation inhibitors, Factor Xa inhibitors, dipyridamole, peripheral calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, direct thombin inhibitors, coenzyme Q-10, vitamin D2 (ergocalciferol), vitamin D3 (cholecalciferol), GPR40 agonists and antiobesity drugs.
5. The process as claimed in claim 1 wherein the first coating polymer further comprises a stabilization agent.
6. The process as claimed in claim 5 wherein the stabilization agent is calcium acetate or BHA.
7. The process as claimed in claim 5 wherein the stabilization agent is calcium acetate.
8. The process as claimed in claim 2 wherein the outer coating also contains ferric oxide.
9. The process as claimed in claim 1 wherein the core is a tablet core.
10. The process as claimed in claim 1 wherein the core is a pellet or granule core.
11. The process as claimed in claim 10 wherein the coated pellet or granule core is further processed to form a pharmaceutical product.
12. A pharmaceutical formulation prepared according to the method of claim 1 .