Formula comprising a hypolipidemic agent
The present invention relates to the stable pharmaceutical composition of a suitable hypolipidemic agent. Preferably, the present invention discloses novel formulations of the compound of formula (I), or pharmaceutically acceptable salts of compounds of formula (I). More particularly the present invention relates to the stable pharmaceutical composition of compounds of formula (I) comprising compounds of formula (I) or its pharmaceutically acceptable salts, wherein the pH of the formulation is maintained above 7. formula (I).
1. A stable pharmaceutical composition comprising a compound of formula (Ia):
wherein:
the pH of the composition is above 7, and the composition comprises
an alkalinizer or pH modifying agent which maintains the pH of the pharmaceutical composition above 7, wherein the alkalinizer or pH modifying agent is light or heavy magnesium oxide; and
optionally a stabilizer and one or more other pharmaceutically acceptable excipients.
2. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises a binder.
3. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises microcrystalline cellulose.
4. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises povidone.
5. The pharmaceutical composition of claim 3 , wherein the pharmaceutical composition comprises povidone.
6. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises a glidant.
7. The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition comprises a glidant.
8. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises talc.
9. The pharmaceutical composition of claim 4 , wherein the pharmaceutical composition comprises talc.
10. The pharmaceutical composition of claim 5 , wherein the pharmaceutical composition comprises talc.
11. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises a lubricant.
12. The pharmaceutical composition of claim 7 , wherein the pharmaceutical composition comprises a lubricant.
13. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises magnesium stearate.
14. The pharmaceutical composition of claim 5 , wherein the pharmaceutical composition comprises magnesium stearate.
15. The pharmaceutical composition of claim 10 , wherein the pharmaceutical composition comprises magnesium stearate.
16. The pharmaceutical composition of claim 1 , wherein the alkalinizer or pH modifying agent is light magnesium oxide.
17. The pharmaceutical composition of claim 5 , wherein the alkalinizer or pH modifying agent is light magnesium oxide.
18. The pharmaceutical composition of claim 15 , wherein the alkalinizer or pH modifying agent is light magnesium oxide.
19. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises:
3.08% w/w compound of formula Ia;
6.15% w/w light magnesium oxide;
23.07% w/w lactose anhydrous;
50.00% w/w microcrystalline cellulose;
9.23% w/w croscarmellose sodium;
3.85% w/w povidone K-30;
1.54% w/w purified talc;
1.54% w/w colloidal silicon dioxide; and
1.54% w/w magnesium stearate.
20. A tablet or caplet, comprising a pharmaceutical composition of claim 1 .
21. A tablet or caplet, comprising a pharmaceutical composition of claim 5 .
22. A tablet or caplet, comprising a pharmaceutical composition of claim 18 .
23. A tablet or caplet, comprising a pharmaceutical composition of claim 19 .