SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
First Claim
Patent Images
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 of said composition of a value sufficient to optimize absorption of said buprenorphine.
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Accused Products
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.
113 Citations
31 Claims
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1. A film dosage composition comprising:
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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 of said composition of a value sufficient to optimize absorption of said buprenorphine. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A film dosage composition comprising:
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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 sufficient to inhibit the absorption of said naloxone when administered orally. - View Dependent Claims (12, 13, 14)
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15. A film dosage composition comprising:
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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 buffering system; wherein said buffering system comprises a buffer capacity sufficient to maintain the ionization of naloxone during the time which said composition is in the oral cavity of a user. - View Dependent Claims (16)
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17. A method of treating narcotic dependence of a user, comprising the steps of:
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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 said composition of a value sufficient to optimize absorption of said buprenorphine; and b. administering said composition to the oral cavity of a user. - View Dependent Claims (18, 19, 20, 21, 22, 23)
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24. A process of forming a film dosage composition comprising the steps of:
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a. casting a film-forming composition, said film-forming 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 said composition of a value sufficient to optimize absorption of said buprenorphine; and b. drying said film-forming composition to form a self-supporting film dosage composition. - View Dependent Claims (25)
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26. A film dosage composition comprising a therapeutically sufficient amount of buprenorphine or a pharmaceutically acceptable salt thereof and a therapeutically sufficient amount of naloxone or a pharmaceutically acceptable salt thereof, said film dosage composition having a bioequivalent release profile as a tablet containing about 2 times the amount of buprenorphine or a pharmaceutically acceptable salt thereof.
- 27. 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.
Specification
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Current AssigneeIndivior UK Limited (Indivior Plc)
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Original AssigneeMonosol Rx LLC (Kuraray Company Limited)
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InventorsMyers, Garry L., Sanghvi, Pradeep, Boone, Bill J., Bogue, B. Arlie, Hilbert, Samuel D., Hariharan, Madhusudan
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current424/484
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CPC Class CodesA61K 2300/00 Mixtures or combinations of...A61K 31/4355 the heterocyclic ring syste...A61K 31/46 8-Azabicyclo [3.2.1] octane...A61K 31/485 Morphinan derivatives, e.g....A61K 47/10 Alcohols; Phenols; Salts th...A61K 47/12 Carboxylic acids; Salts or ...A61K 47/22 Heterocyclic compounds, e.g...A61K 47/26 Carbohydrates, e.g. sugar a...A61K 47/32 Macromolecular compounds ob...A61K 47/34 Macromolecular compounds ob...A61K 47/38 Cellulose; Derivatives thereofA61K 9/0056 Mouth soluble or dispersibl...A61K 9/006 Oral mucosa, e.g. mucoadhes...A61K 9/7007 Drug-containing films, memb...A61P 25/30 for treating abuse or depen...A61P 25/36 Opioid-abuse
