Claims for Patent: 9,687,454

Summary for Patent: 9,687,454

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; Beuford Arlie (Valparaiso, IN), Sanghvi; Pradeep (Valparaiso, IN), Hariharan; Madhusudan (Munster, IN)
Assignee:	Indivior UK Limited (Slough, GB)
Application Number:	14/989,669
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,687,454
Patent Claims:	1. An oral, self-supporting, A mucoadhesive film comprising: (a) about 40 wt % to about 60 wt % of a water-soluble polymeric matrix; (b) about 2 mg to about 16 mg of buprenorphine or a pharmaceutically acceptable salt thereof; (c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable salt thereof; and (d) an acidic buffer; wherein the film is mucoadhesive to the sublingual mucosa or the buccal mucosa; wherein the weight ratio of (b):(c) is about 4:1; wherein the weight ratio of (d):(b) is from 2:1 to 1:5; and wherein application of the film on the sublingual mucosa or the buccal mucosa results in differing absorption between buprenorphine and naloxone, with a buprenorphine C.sub.max from about 0.624 ng/ml to about 5.638 ng/ml and a buprenorphine AUC from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml; and a naloxone C.sub.max from about 41.04 pg/ml to about 323.75 pg/ml and a naloxone AUC from about 102.88 hr*pg/ml to about 812.00 hr*pg/ml. 2. The film of claim 1, wherein the weight ratio of (d):(b) is from about 1:1 to 1:5. 3. The film of claim 1, wherein the weight ratio of (d):(b) is from about 1.4:1 to about 1:3. 4. The film of claim 3, wherein the acidic buffer is citric acid. 5. The film of claim 1, wherein the weight ratio of (b):(a) is from about 1:3 to about 1:11.5. 6. The film of claim 5, wherein the weight ratio of (b):(a) is about 1:3. 7. The film of claim 1, wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water soluble polymeric matrix. 8. The film of claim 7, wherein the film comprises about 48.2 wt % of the water soluble polymeric matrix. 9. The film of claim 1, wherein the water-soluble polymeric matrix comprises a polyethylene oxide polymer alone or in combination with a hydrophilic cellulosic polymer. 10. The film of claim 9, wherein the hydrophilic cellulosic polymer is hydroxypropyl cellulose, hydroxypropylmethyl cellulose, or a combination thereof. 11. The film of claim 10, wherein the hydrophilic cellulosic polymer is hydroxypropylmethyl cellulose. 12. The film of claim 1, wherein the weight ratio of (d):(b) is from about 1:1 to 1:5; wherein the weight ratio of (b):(a) is from about 1:3 to about 1:11.5; and wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water soluble polymeric matrix. 13. A method for treating opioid dependence in a patient in need thereof comprising sublingually or buccally administering the mucoadhesive film of claim 1 to a sublingual or buccal mucosal tissue of the patient to treat the opioid dependence. 14. The film of claim 1, wherein the weight ratio of (d):(b) is from 2:1 to 1:1.