MODIFIED RELEASE ORAL DOSAGE FORM USING CO-POLYMER OF POLYVINYL ACETATE

Abstract

Once a day modified release oral dosage form comprising of granules or pellets which are either compressed into tablet or filled inside the capsule, wherein the pellet has a core of active ingredient coated on non pareil seeds with a rate controlling functional coating of co-polymer of polyvinyl acetate optionally with an intermediate separating coating between the core and the functional coating layer.

Description

Claims

1. Once a day modified release oral dosage form of active pharmaceutical ingredient with copolymer of polyvinyl acetate and pharmaceutically acceptable excipients.

2. Once a day modified release oral dosage form as claimed in claim 1, wherein the active ingredient can be serotonin noradrenaline reuptake inhibitor, phenyl ethyl amines, benzimidazole class of proton pump inhibitor, or HMG-CoA reductase inhibitor.

3. The dosage form as claimed in claim 2, wherein the serotonin noradrenaline reuptake inhibitor is venlafaxine or its pharmaceutically acceptable salt, phenylethyl amine is bupropion or its pharmaceutically acceptable salt, benzimidazole class of proton pump inhibitor is lansoprazole or its pharmaceutically acceptable salt and HMG-CoA reductase inhibitor is pravastatin or its pharmaceutically acceptable salt.

4. The dosage form as claimed in claim 1, wherein granules or pellets are prepared which are either compressed into tablet or filled inside the capsule.

5. The dosage form as claimed in claim 4, wherein the pellets comprises of core and a release controlling functional coating optionally with an intermediate barrier/separating coating between the core and the functional coating.

6. The dosage form as claimed in claim 5, wherein the core comprises of non pareil seeds coated with active pharmaceutical ingredient and pharmaceutically acceptable excipients.

7. The dosage form as claimed in claim 5, wherein the functional coating comprises of hydrophilic polymer, plasticizer, and glidant.

8. The dosage form as claimed in claim 5, wherein the intermediate barrier/separating coating comprises of film former such as sodium alginate, glidant and opacifier.

9. The dosage form as claimed in claim 4, wherein the granules are prepared by dry granulation method or wet granulation method or melt granulation method.

10. Once a day modified release oral dosage form of venlafaxine or its pharmaceutically acceptable salt, comprising of non pareil seeds, venlafaxine hydrochloride, sodium alginate in the core coated with an intermediate barrier coating comprising of sodium alginate, glidant, opacifier and other pharmaceutically acceptable excipient and a final release controlling functional coating comprising of copolymer of polyvinyl acetate.

11. Once a day modified release oral dosage form of venlafaxine as claimed in claim 10, wherein the pellets are filled inside capsule or compressed to form tablet.

12. Once a day modified release oral dosage form of venlafaxine as claimed in claim 10, wherein the core comprises of 25-50% venlafaxine hydrochloride, 5-15% sodium alginate, the intermediate barrier coating comprises of 1-10% sodium alginate and the functional coating comprises of copolymer of polyvinyl acetate 5-25%.

13. The dosage form as claimed in claim 10, wherein the copolymer of polyvinyl acetate is Kollicoat SR 30 D.

14. Once a day modified release oral dosage form of bupropion or its pharmaceutically acceptable salt, wherein the dosage form is a tablet comprising bupropion hydrochloride (25-50%), co-polymer of polyvinyl acetate (5-25%), and other pharmaceutically acceptable excipients.

15. Once a day modified release oral dosage form as claimed in claim 1, wherein the dosage form is a tablet prepared by compressing the pellets and suitable excipients, wherein the pellets comprises of core of non pareil seeds, pravastatin sodium (5-50%), and hydroxyl propyl methyl cellulose (0.5-10%) with a rate controlling functional coating of copolymer of polyvinyl acetate (5-25%).

16. Once a day modified release oral dosage form as claimed in claim 1, having dissolution profile as below:

17. (canceled)

18. Once a day modified release oral dosage form as claimed in claim 10, having dissolution profile as below:

19. Once a day modified release oral dosage form as claimed in claim 14 having dissolution profile as below:

20. Once a day modified release oral dosage form as claimed in claim 15 having dissolution profile as below: