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Claims for Patent: 9,339,472

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Claims for Patent: 9,339,472

Title:Coated tablet formulation and method
Abstract: A coated tablet formulation is provided which includes a medicament such as the DPP4-inhibitor, saxaglipitin ##STR00001## or its HCl salt, which is subject to intra-molecular cyclization, which formulation includes a tablet core containing one or more fillers, and other conventional excipients, which tablet core includes a coating thereon which may include two or more layers, at least one layer of which is an inner seal coat layer which is formed of one or more coating polymers, a second layer of which is formed of medicament which is the DPP4-inhibitor and one or more coating polymers, and an optional, but preferable third outer protective layer which is formed of one or more coating polymers. A method for forming the coated tablet is also provided.
Inventor(s): Desai; Divyakant S. (Princeton, NJ), Li; Bing V. (Princeton, NJ)
Assignee: AstraZeneca AB (Sodertalje, SE)
Application Number:14/150,331
Patent Claims: 1. A combination formulation comprising, a) a drug tablet; b) an inner seal coating layer coated on the drug tablet, wherein the inner seal coating layer comprises a coating layer polymer comprising 0.5 to 50% by weight of the drug tablet, wherein the coating layer polymer comprises polyvinyl alcohol; c) a second coating layer coated on the inner seal coating layer, wherein the second coating layer comprises saxagliptin ##STR00006## or a pharmaceutically acceptable salt thereof and a coating layer polymer, a plasticizer, and a glidant, wherein the saxagliptin or a pharmaceutically acceptable salt thereof comprises 0.1 to 70% by weight of the drug tablet, and the coating layer polymer, plasticizer, and glidant comprise 1 to 70% by weight of the drug tablet, and wherein said coating layer polymer comprises polyvinyl alcohol; and d) a third outer protective coating layer coated on the second coating layer, wherein the third outer protective coating layer comprises a coating layer polymer comprising 0.5 to 50% by weight of the drug tablet, wherein the coating layer polymer comprises polyvinyl alcohol; wherein the drug tablet comprises a drug other than saxagliptin or a pharmaceutically acceptable salt thereof.

2. The combination formulation as defined in claim 1, wherein the saxagliptin is present as a hydrochloride salt.

3. The combination formulation as defined in claim 1, wherein the inner seal coating layer further comprises polyethylene glycol.

4. The combination formulation as defined in claim 1, wherein the second coating layer comprises polyethylene glycol.

5. The combination formulation as defined in claim 1, wherein the third outer protective coating layer further comprises polyethylene glycol.

6. A combination formulation comprising, a) a drug tablet; b) an inner seal coating layer coated on the drug tablet, wherein the inner seal coating layer comprises a coating layer polymer comprising about 10 to about 95% by weight of the inner seal coating layer, wherein the coating layer polymer comprises polyvinyl alcohol; c) a second coating layer coated on the inner seal coating layer, wherein the second coating layer comprises saxagliptin ##STR00007## or a pharmaceutically acceptable salt thereof and a coating layer polymer, where the saxagliptin or the pharmaceutically acceptable salt thereof comprises about 0.25 to about 70% by weight of the second coating layer, and wherein the coating layer polymer comprises about 30 to about 99.5% by weight of the second coating layer, wherein the coating layer polymer comprises polyvinyl alcohol; and d) a third outer protective coating layer coated on the second coating layer, wherein the third outer protective coating layer comprises a coating layer polymer comprising about 10 to about 95% by weight of the third outer protective coating layer, wherein the coating layer polymer comprises polyvinyl alcohol; wherein the drug tablet comprises a drug other than saxagliptin or a pharmaceutically acceptable salt thereof.

7. The combination formulation as defined in claim 6, wherein the saxagliptin is present as a hydrochloride salt.

8. The combination formulation as defined in claim 6, wherein the inner seal coating layer further comprises polyethylene glycol.

9. The combination formulation as defined in claim 6, wherein the second coating layer further comprises polyethylene glycol.

10. The combination formulation as defined in claim 6, wherein the third outer protective coating layer further comprises polyethylene glycol.

11. The combination formulation as defined in claim 6, wherein the coating layer polymer in the inner seal coating layer comprises about 20 to about 90% by weight of the inner seal coating layer.

12. The combination formulation as defined in claim 6, wherein the polyvinyl alcohol comprises about 40% by weight of the inner seal coating layer.

13. The combination formulation as defined in claim 12, wherein the inner seal coating layer further comprises about 20% polyethylene glycol, about 15% talc, and about 25% titanium dioxide.

14. The combination formulation as defined in claim 6, wherein the saxagliptin or the pharmaceutically acceptable salt thereof comprises about 20 to about 50% by weight of the second coating layer.

15. The combination formulation as defined in claim 6, wherein the second coating layer comprises a coating material comprising the coating layer polymer, a plasticizer, a glidant, and an opacifying agent.

16. The combination formulation as defined in claim 15, wherein the coating material comprises about 40% by polyvinyl alcohol.

17. The combination formulation as defined in claim 16, wherein the coating material further comprises about 20% polyethylene glycol, about 15% talc, and about 25% titanium dioxide.

18. The combination formulation as defined in claim 6, wherein the coating layer polymer in the third outer protective coating layer comprises about 20 to about 90% by weight of the third outer protective coating layer.

19. The combination formulation as defined in claim 6, wherein the polyvinyl alcohol comprises about 40% by weight of the third outer protective coating layer.

20. The combination formulation as defined in claim 19, wherein the third outer protective coating layer further comprises about 20% polyethylene glycol, about 15% talc, and about 25% titanium dioxide.
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