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Claims for Patent: 8,475,832

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Claims for Patent: 8,475,832

Title:Sublingual and buccal film compositions
Abstract: The present invention relates to products and methods for treatment of narcotic dependence in a user. The invention more particularly relates to self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form.
Inventor(s): Myers; Garry L. (Kingsport, TN), Hilbert; Samuel D. (Jonesboro, TN), Boone; Bill J. (Johnson City, TN), Bogue; B. Arlie (New Carlisle, IN), Sanghvi; Pradeep (Schererville, IN), Hariharan; Madhusudan (Munster, IN)
Assignee: RB Pharmaceuticals Limited (Slough, GB)
Application Number:12/537,571
Patent Claims: 1. A film dosage composition comprising: a. A polymeric carrier matrix; b. A therapeutically effective amount of buprenorphine or a pharmaceutically acceptable salt thereof; c. A therapeutically effective amount of naloxone or a pharmaceutically acceptable salt thereof; and d. A buffer in an amount to provide a local pH for said composition of a value sufficient to optimize absorption of said buprenorphine, wherein said local pH is from about 3 to about 3.5 in the presence of saliva.

2. The composition of claim 1, wherein said film dosage composition provides a bioequivalent absorption of buprenorphine to that of a tablet having an equivalent amount of buprenorphine or a pharmaceutically acceptable salt thereof.

3. The composition of claim 1, wherein said polymeric carrier matrix comprises at least one polymer in an amount of at least 25% by weight of said composition.

4. The composition of claim 1, wherein said buffer is present in an amount of from about 2:1 to about 1:5 by weight of buffer to buprenorphine.

5. The composition of claim 1, wherein said polymeric carrier matrix comprises at least one self-supporting film forming polymer.

6. The film dosage composition of claim 1, wherein said buprenorphine is present in an amount of from about 2 mg to about 16 mg per dosage.

7. The film dosage composition of claim 1, wherein said buffer comprises sodium citrate, citric acid, and combinations thereof.

8. The film dosage composition of claim 1, wherein said buffer comprises acetic acid, sodium acetate, and combinations thereof.

9. A method of treating narcotic dependence of a user, comprising the steps of: a. providing a composition comprising: i. A polymeric carrier matrix; ii. A therapeutically effective amount of buprenorphine or a pharmaceutically acceptable salt thereof; iii. A therapeutically effective amount of naloxone or a pharmaceutically acceptable salt thereof; and iv. A buffer in an amount to provide a local pH of about 3 to about 3.5 for said composition of a value sufficient to optimize absorption of said buprenorphine and also sufficient to inhibit absorption of said naloxone; and b. administering said composition to the oral cavity of a user.

10. The composition of claim 9, wherein said method provides a bioequivalent absorption of buprenorphine to that of a tablet having an equivalent amount of buprenorphine or a pharmaceutically acceptable salt thereof.

11. The method of claim 9, wherein said film dosage composition is administered to the user through buccal administration, sublingual administration, and combinations thereof.

12. The method of claim 9, wherein said film dosage composition remains in the oral cavity of the user for a period of at least 1 minute.

13. The method of claim 9, wherein said film dosage composition remains in the oral cavity of the user for a period of between about 1 and 1.5 minutes.

14. The method of claim 9, wherein said film dosage composition remains in the oral cavity of the user for a period of up to 3 minutes.

15. An orally dissolving film formulation comprising buprenorphine and naloxone, wherein said formulation provides an in vivo plasma profile having a Cmax of between about 0.624 ng/ml and about 5.638 ng/ml for buprenorphine and an in vivo plasma profile having a Cmax of between about 41.04 pg/ml to about 323.75 pg/ml for naloxone.

16. The formulation of claim 15, wherein said formulation provides a mean AUC of between about 5.431 hrng/ml to about 56.238 hrng/ml for buprenorphine.

17. The formulation of claim 15, wherein said formulation provides a mean AUC of between about 102.88 hrpg/ml to about 812.00 hrpg/ml for naloxone.

18. The formulation of claim 15, wherein said formulation comprises about 2 to about 16 mg of buprenorphine or a salt thereof.

19. The formulation of claim 15, wherein said formulation comprises about 0.5 to about 4 mg of naloxone or a salt thereof.
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