Gastric Retention System

• US 20080107732A1
• Filed: 03/24/2005
• Published: 05/08/2008
• Est. Priority Date: 03/25/2004
• Status: Active Grant

• Current Assignee: Sun Pharma Advanced Research Company Limited (Shanghvi Finance Pvt Ltd.)
• Original Assignee: Sun Pharma Advanced Research Company Limited (Shanghvi Finance Pvt Ltd.)
• Inventors: Dharmadhikari, Nitin Bhalachandra, Zala, Yashoraj Rupsinh
• Granted Patent: US 9,439,851 B2
• Time in Patent Office: Days
• US Class Current: 424/482
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61K 9/0065 Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61K 9/2886 having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer of the type active core-drug layer-inactive layer A61K9/209
• CPC Class Codes: A61K 9/4891 Coated capsules; Multilayered drug free capsule shells with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents

Abstract

The present invention provides a novel gastric retention system in the form of a tablet or a capsule coated with an expandable coating, more particularly, with an expandable coating comprising a film-forming polymer and an expandable component.

Claims

1. A gastric retention system in the form of a coated tablet comprising:

(a) a core in the form of a tablet comprising an agent capable of generating internal pressure on the coat, and

(b) an expandable coating formed by applying a coating composition comprising a film-forming polymer and one or more expandable components on the tablet core to form a film capable of expanding and maintaining its physical integrity in the gastric milleu.

2. A gastric retention drug delivery system as claimed in claim 1 wherein the agent capable of generating internal pressure is selected from a group comprising gas generating agents, highly swellable polymers, superdisintegrants and mixtures thereof.

3. A gastric retention drug delivery system comprising a gastric retention system as claimed in claim 2 and one or more therapeutically active agents.

4. A gastric retention drug delivery system as claimed in claim 3 wherein one or more therapeutically active agents is present in an immediate release form and/or in a modified release form to provide an immediately releasing dose of one or more of the therapeutically active agents, and/or a modified release dose of the same or different therapeutically active agent(s).

5. A gastric retention drug delivery system as claimed in claim 4 wherein the system has a floatation time of less than 15 minutes, when placed in an aqueous medium.

6. A gastric retention system in the form of a coated tablet comprising:

(a) a core in the form of a tablet comprising an agent capable of generating internal pressure on the coat, and

(b) a second coating formed by applying a coating composition comprising a film-forming polymer and one or more expandable components on the first coating whereby the second coating forms a film capable of expanding and maintaining its physical integrity in the gastric milleu.

7. A gastric retention drug delivery system comprising a gastric retention system as claimed in claim 6 and one or more therapeutically active agents.

8. A gastric retention system in the form of a coated capsule, comprising:

(a) a core in the form of a capsule, the core comprising an agent capable of generating internal pressure on the coating, and

(b) an expandable coating formed by applying a coating composition comprising a film-forming polymer and one or more expandable components on the capsule core to form a film capable of expanding and maintaining its physical integrity in the gastric milleu.

9. A gastric retention system as claimed in claim 8 wherein the agent capable of generating internal pressure is selected from a group comprising gas generating agents, highly swellable polymers, superdisintegrants and mixtures thereof.

10. A gastric retention drug delivery system comprising a gastric retention system as claimed in claim 9 and one or more therapeutically active agents.

11. A gastric retention drug delivery system as claimed in claim 10 wherein one or more therapeutically active agents is present in an immediate release form and/or in a modified release form to provide an immediately releasing dose of one or more of the therapeutically active agents, and/or a modified release dose of the same or different therapeutically active agent(s).

12. A gastric retention drug delivery system as claimed in claim 10, wherein the system is capable of instantaneously floating, when placed in an aqueous medium.

13. (canceled)

14. (canceled)

15. A process for coating a tablet or capsule core comprising applying a coating composition comprising expandable components in a dry powder form or suspended in a non-solvent vehicle.