SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
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.
1 . An orally dissolving film formulation comprising from about 2 to about 16 mg of buprenorphine and from about 0.5 to about 4 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 0.6 ng/ml and about 5.7 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 41 pg/ml to about 324 pg/ml for naloxone.
2 . The film formulation of claim 1 , comprising about 2 mg of buprenorphine and about 0.5 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 0.6 ng/ml and about 1.0 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 41 pg/ml to about 65 pg/ml for naloxone.
3 . The film formulation of claim 1 , comprising about 4 mg of buprenorphine and about 1 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 1.0 ng/ml and about 1.7 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 64 pg/ml to about 102 pg/ml for naloxone.
4 . The film formulation of claim 1 , comprising about 8 mg of buprenorphine and about 2 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 1.8 ng/ml and about 2.9 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 75 pg/ml to about 119 pg/ml for naloxone.
5 . The film formulation of claim 1 , comprising about 12 mg of buprenorphine and about 3 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 2.5 ng/ml and about 4.1 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 159 pg/ml to about 250 pg/ml for naloxone.
6 . The film formulation of claim 1 , comprising about 16 mg of buprenorphine and about 4 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 3.6 ng/ml and about 5.7 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 207 pg/ml to about 324 pg/ml for naloxone.
7 . An orally dissolving film formulation comprising from about 2 to about 16 mg of buprenorphine and from about 0.5 to about 4 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 0.7 ng/ml and about 6.9 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 40 pg/ml to about 405 pg/ml for naloxone.
8 . The film formulation of claim 7 , comprising about 2 mg of buprenorphine and about 0.5 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 0.7 ng/ml and about 1.2 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 40 pg/ml to about 64 pg/ml for naloxone.
9 . The film formulation of claim 7 , comprising about 4 mg of buprenorphine and about 1 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 1.2 ng/ml and about 2.0 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 72 pg/ml to about 113 pg/ml for naloxone.
10 . The film formulation of claim 7 , comprising about 8 mg of buprenorphine and about 2 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 2.1 ng/ml and about 3.4 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 104 pg/ml to about 163 pg/ml for naloxone.
11 . The film formulation of claim 7 , comprising about 12 mg of buprenorphine and about 3 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 3.3 ng/ml and about 5.3 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 196 pg/ml to about 308 pg/ml for naloxone.
12 . The film formulation of claim 7 , comprising about 16 mg of buprenorphine and about 4 mg of naloxone, wherein said formulation provides an in vivo plasma profile having a mean C max of between about 4.3 ng/ml and about 6.9 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 259 pg/ml to about 405 pg/ml for naloxone.
13 . An orally dissolving film formulation comprising buprenorphine and naloxone that is bioequivalent to a SUBOXONE® tablet containing from about 2 to about 16 mg of buprenorphine and from about 0.5 to about 4 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 0.6 ng/ml and about 5.7 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 41 pg/ml to about 324 pg/ml for naloxone.
14 . The film formulation of claim 13 wherein said film formulation comprising buprenorphine and naloxone is bioequivalent to a SUBOXONE® tablet containing about 2 mg of buprenorhphine and about 0.5 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 0.6 ng/ml and about 1.0 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 41 pg/ml to about 65 pg/ml for naloxone.
15 . The film formulation of claim 13 wherein said film formulation comprising buprenorphine and naloxone is bioequivalent to a SUBOXONE® tablet containing about 4 mg of buprenorhphine and about 1 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 1.0 ng/ml and about 1.7 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 64 pg/ml to about 102 pg/ml for naloxone.
16 . The film formulation of claim 13 wherein said film formulation comprising buprenorphine and naloxone is bioequivalent to a SUBOXONE® tablet containing about 8 mg of buprenorhphine and about 2 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 1.8 ng/ml and about 2.9 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 75 pg/ml to about 119 pg/ml for naloxone.
17 . The film formulation of claim 13 wherein said film formulation comprising buprenorphine and naloxone is bioequivalent to a SUBOXONE® tablet containing about 12 mg of buprenorhphine and about 3 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 2.5 ng/ml and about 4.1 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 159 pg/ml to about 250 pg/ml for naloxone.
18 . The film formulation of claim 13 wherein said film formulation comprising buprenorphine and naloxone is bioequivalent to a SUBOXONE® tablet containing about 16 mg of buprenorhphine and about 4 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 3.6 ng/ml and about 5.7 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 207 pg/ml to about 324 pg/ml for naloxone.
19 . An orally dissolving film formulation comprising buprenorphine and naloxone that is bioequivalent to a SUBOXONE® Film comprising from about 2 to about 16 mg of buprenorphine and from about 0.5 to about 4 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 0.7 ng/ml and about 6.9 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 40 pg/ml to about 405 pg/ml for naloxone.
20 . The film formulation of claim 19 wherein said film formulation comprising buprenorphine and naloxone is bioequivalent to a SUBOXONE® Film comprising about 2 mg of buprenorphine and about 0.5 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 0.6 ng/ml and about 1.0 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 41 pg/ml to about 65 pg/ml for naloxone.
21 . The film formulation of claim 19 wherein said film formulation comprising buprenorphine and naloxone is bioequivalent to a SUBOXONE® Film comprising about 4 mg of buprenorphine and about 1 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 1.2 ng/ml and about 2.0 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 72 pg/ml to about 113 pg/ml for naloxone.
22 . The film formulation of claim 19 wherein said film formulation comprising buprenorphine and naloxone is bioequivalent to a SUBOXONE® Film comprising about 8 mg of buprenorphine and about 2 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 2.1 ng/ml and about 3.4 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 104 pg/ml to about 163 pg/ml for naloxone.
23 . The film formulation of claim 19 wherein said film formulation comprising buprenorphine and naloxone is bioequivalent to a SUBOXONE® Film comprising about 12 mg of buprenorphine and about 3 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 3.3 ng/ml and about 5.3 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 196 pg/ml to about 308 pg/ml for naloxone.
24 . The film formulation of claim 19 wherein said film formulation comprising buprenorphine and naloxone is bioequivalent to a SUBOXONE® Film comprising about 16 mg of buprenorphine and about 4 mg of naloxone such that said formulation provides an in vivo plasma profile having a mean C max of between about 4.3 ng/ml and about 6.9 ng/ml for buprenorphine and an in vivo plasma profile having a mean C max of between about 259 pg/ml to about 405.00 pg/ml for naloxone.