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Claims for Patent: 8,163,306

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Claims for Patent: 8,163,306

Title:Oral drug delivery system
Abstract: An oral drug delivery system comprising a coated tablet having one or more surfaces. The coated tablet further comprises a core and a coating surrounding the core. The core comprises an active ingredient composition comprising at least one active ingredient and a pharmaceutically acceptable excipient and a composition selected from a swellable composition and a reactive composition located in an immediate vicinity of one or more preselected surfaces. The coating is operable to be reliably removed fully from the one or more of the preselected surfaces of the tablet upon contact with an aqueous environment, but not removed from at least one of the surfaces.
Inventor(s): Dharmadhikari; Nitin Bhalachandra (Mumbai, IN), Zala; Yashoraj Rupsinh (Mumbai, IN), Singh; Amarjit (Mumbai, IN)
Assignee: Sun Pharma Advanced Research Company (Andheri (E), Mumbai, IN)
Application Number:10/572,502
Patent Claims: 1. An orally administerable drug delivery system comprising: (1) a core comprising one or more active ingredient composition layers and one or more separate swellable composition layers, the one or more active ingredient composition layers comprising at least one pharmaceutically active ingredient and one or more pharmaceutically acceptable excipients, wherein in at least one active ingredient composition layer, at least one pharmaceutically acceptable excipient is a rate controlling excipient, and (2) a water insoluble polymer coating surrounding the core; wherein one or more of the swellable composition layers is located in an immediate vicinity of one or more preselected portions of the coating in order to be in communication with said preselected portions of the coating, and the one or more active ingredient composition layers are in the vicinity of another portion of the coating; wherein the water insoluble polymer coating comprises one or more passageways through the preselected portions of the coating, said one or more passageways penetrating to at least one swellable layer; and wherein the at least one or more preselected portions of the coating that is in communication with the swellable layer and has a passageway is removed after contact with an aqueous environment and wherein the remaining portion of the coating is not removed.

2. The orally administerable drug delivery system as claimed in claim 1, wherein the coating is impermeable to the pharmaceutically active ingredient.

3. The orally administerable drug delivery system as claimed in claim 1, wherein the active ingredient in any one of the active ingredient composition layers may be the same or different from the active ingredient in any of the other active ingredient composition layers.

4. The orally administerable drug delivery system as claimed in claim 1, wherein the swellable composition comprises a swelling agent.

5. The orally administerable drug delivery system as claimed in claim 4, wherein the swelling agent is selected from a swellable excipient, a gas generating agent, or mixtures thereof.

6. The orally administerable drug delivery system as claimed in claim 1, wherein the swellable composition comprises one or more wicking agents.

7. The orally administerable drug delivery system as claimed in claim 1, wherein the swellable composition comprises one or more osmogents.

8. The orally administerable drug delivery system as claimed in claim 1, wherein the active ingredient is released without a substantial delay after the tablet contacts the aqueous environment.

9. The orally administerable drug delivery system as claimed in claim 1, further comprising an outer coating including a pH-dependent polymer.

10. The orally administerable drug delivery system of claim 1, wherein one or more swellable composition layers is in the form of an in-lay.
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