Sublingual and buccal film compositions
AssigneeRB Pharmaceuticals Limited
InventorsGarry L. Myers, Samuel D. Hilbert, Bill J. Boone, Beuford A. Bogue, Pradeep Sanghvi, Madhusudan Hariharan
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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.
Claims24
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 Cmax of between about 0.6 ng/ml and about 5.7 ng/ml for buprenorphine and an in vivo plasma profile having a mean Cmax of between about 41 pg/ml to about 324 pg/ml for naloxone.
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 Cmax of between about 0.7 ng/ml and about 6.9 ng/ml for buprenorphine and an in vivo plasma profile having a mean Cmax of between about 40 pg/ml to about 405 pg/ml for naloxone.
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 Cmax of between about 0.6 ng/ml and about 5.7 ng/ml for buprenorphine and an in vivo plasma profile having a mean Cmax of between about 41 pg/ml to about 324 pg/ml for naloxone.
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 Cmax of between about 0.7 ng/ml and about 6.9 ng/ml for buprenorphine and an in vivo plasma profile having a mean Cmax of between about 40 pg/ml to about 405 pg/ml for naloxone.
Dependencies are inferred from the claim text.