Sublingual and buccal film compositions
DC CAFC
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 for said composition of a value sufficient to optimize absorption of said buprenorphine, wherein said local pH is from about 3 to about 3.5 in the presence of saliva.
10 Assignments
Litigations
4 Petitions
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.
195 Citations
19 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 for said composition of a value sufficient to optimize absorption of said buprenorphine, wherein said local pH is from about 3 to about 3.5 in the presence of saliva. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. 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 about 3 to about 3.5 for said composition of a value sufficient to optimize absorption of said buprenorphine and also sufficient to inhibit absorption of said naloxone; and b. administering said composition to the oral cavity of a user. - View Dependent Claims (10, 11, 12, 13, 14)
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- 15. 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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Litigation Data
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Current AssigneeIndivior UK Limited (Indivior Plc)
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Original AssigneeReckitt Benckiser North America Incorporated (Reckitt Benckiser Group PLC)
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InventorsMyers, Garry L., Hilbert, Samuel D., Boone, Bill J., Bogue, B. Arlie, Sanghvi, Pradeep, Hariharan, Madhusudan
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Primary Examiner(s)EPPS -SMITH, JANET L
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Application NumberUS12/537,571Publication NumberTime in Patent Office1,425 DaysField of SearchNoneUS Class Current424/435CPC 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
