`
`l.
`
`A film dosage form for trans-mucosal medication-assisted treatment for opioid addiction,
`
`the film dosage form comprising:
`
`a) an amount of buprenorphine, or an equivalent amount of a pharmaceutically
`
`acceptable salt thereof, sufficient to provide an average buprenorphine Cmax of less than
`
`about 7 ng/mland an average buprenorphine AUCo4of less than 40 (hrs*ng)/ml;
`
`b) naloxone or a pharmaceutically acceptable salt thereof; and
`
`c) at
`
`least one non-gelatin polymeric film-forming material
`
`in which the
`
`buprenorphine or the equivalent amount of the pharmaceutically acceptable salt thereof
`
`and the naloxone or the pharmaceutically acceptable salt
`
`thereof, are dissolved or
`
`homogeneously dispersed;
`
`the buprenorphine or the equivalent amount of the pharmaceutically acceptable
`
`salt thereof and the naloxone or the pharmaceutically acceptable salt
`
`thereof being
`
`present in the film dosage form in a weightratio of from 1:1 to 10:1;
`
`wherein, the film dosage form releases substantially all of the buprenorphine or
`
`the pharmaceutically acceptable salt thereof and approximately substantially all of the
`
`naloxone or the pharmaceutically acceptable salt thereof into contact with a mucosal
`
`surface of the oral cavity within less than 5 minutes after contacting the mucosalsurface.
`
`‘Lhe film dosage form of claim 1, wherein the film dosage form further comprises a pH
`
`modifier.
`
`-24-
`
`
`
`The film dosage form of claim 2, wherein the pH modifier is selected from the group
`
`consisting of citric acid,
`
`tartaric acid, phosphoric acid, hydrochloric acid, and maleic
`
`acid.
`
`The film dosage form of claim 1, wherein the film dosage form is mucoadhesive.
`
`The film dosage form of claim 1, wherein the non-gelatin polymeric film-forming
`
`material is a modified cellulose material.
`
`The film dosage form of claim 5, wherein the modified cellulose material is a cellulose
`
`ether.
`
`The film dosage form of claim 6, wherein the cellulose ether is selected from the group
`
`consisting of hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose (HPC),
`
`hydroxyethylmethylcellulose (HEMC), hydroxyethylcellulose (HEC), methylcellulose
`
`(MC), and carboxymethylcellulose (CMC).
`
`The film dosage form of claim 1, wherein the amount of buprenorphine is from 2 mg to
`
`16 mg.
`
`Thefilm dosage form of claim 8, wherein the amount of buprenorphine is 2 mg, 4 mg, 8
`
`mg, or 16 mg.
`
`10.
`
`Thefilm dosage form of claim 1, wherein the weightratio is 2:1 to 8:1.
`
`11.
`
`The film dosage form of claim 1, wherein the film dosage form further comprisesat least
`
`one of sodium dihydrogen or disodiumhydrogen phosphate, sodium tartrate, sodium
`
`ascorbate, citric acid, tartartic acid, adipinic acid, ascorbic acid,acetic acid, orlactic acid.
`
`-25-
`
`
`
`The film dosage form of claim 1, wherein the film dosage form exhibits a tmax from
`
`approximately 45 to approximately 90 minutes.
`
`The film dosage form of claim 1, further comprising a flavoring agent.
`
`14.
`
`The film dosage form of claim 13, wherein the flavoring agent is selected from the group
`
`consisting of mint, raspberry, licorice, orange, lemon, grapefruit, caramel, vanilla, cherry,
`
`grape, and combinationsthereof.
`
`8219591_2
`
`-26-
`
`
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