.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 8,628,799

« Back to Dashboard

Claims for Patent: 8,628,799

Title:Coated tablet formulation and method
Abstract: A coated tablet formulation is provided which includes a medicament such as the DPP4-inhibitor, saxaglipitin ##STR00001## 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: Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:13/094,379
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 about 1 mg to about 100 mg of a coating polymer formulation comprising a polyvinyl alcohol; and c) a second coating layer coated on the inner seal coating layer of the drug tablet, wherein the second coating layer comprises about 0.2 mg to about 140 mg saxagliptin ##STR00006## or a pharmaceutically acceptable salt thereof and about 2 mg to about 140 mg of a coating polymer formulation comprising a polyvinyl alcohol; and d) an outer protective coating layer coated on the second coating layer of the drug tablet, wherein the outer protective coating layer comprises about 1 mg to about 100 mg of a coating polymer formulation comprising a polyvinyl alcohol; wherein the drug tablet is other than saxagliptin or a pharmaceutically acceptable salt thereof.

2. The combination formulation as defined in claim 1, wherein said second coating layer is comprised of from about 0.1 to about 70% by weight saxagliptin or a pharmaceutically acceptable salt thereof and from about 30 to about 99.5% by weight coating polymer formulation, based on the weight of the second coating layer.

3. The combination formulation as defined in claim 1, wherein the coating polymer formulation in the second coating layer is at least about 2 mg with a 200 mg drug tablet, and the saxagliptin or a pharmaceutically acceptable salt thereof is at least about 0.2 mg.

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

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

6. The combination formulation as defined in claim 1, wherein the inner seal coating layer comprises about 40% polyvinyl alcohol, and further comprises about 20% polyethylene glycol, about 15% talc, and about 25% titanium dioxide.

7. The combination formulation as defined in claim 1, wherein the coating polymer formulation of the second coating layer further comprises polyethylene glycol.

8. The combination formulation as defined in claim 1, wherein the coating polymer formulation of the second coating layer comprises about 40% polyvinyl alcohol, and further comprises about 20% polyethylene glycol, about 15% talc, and about 25% titanium dioxide.

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

10. The combination formulation as defined in claim 1, wherein the outer protective coating layer comprises about 40% polyvinyl alcohol, and further comprises about 20% polyethylene glycol, about 15% talc, and about 25% titanium dioxide.

11. The combination formulation as defined in claim 1, wherein the inner seal coating layer consists essentially of the coating polymer formulation in an amount in the range of 2 mg to 6 mg; the second coating layer consists essentially of the saxagliptin in free base or HCl salt form in an amount in the range of 0.5 mg to 140 mg, and the coating polymer formulation in an amount in the range of 2 mg to 100 mg; and the outer protective coating layer consists essentially of the coating polymer formulation in an amount in the range of 2 mg to 10 mg.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc