Sublingual and buccal film compositions
AssigneeMonosol Rx, LLC
InventorsGarry L. Myers, Samuel D. Hilbert, Bill J. Boone, B. Arlie 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.
Claims31
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.
5 The composition of claim 1, wherein said polymeric carrier matrix comprises at least one polymer in an amount of at least 25% by weight of said composition.
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 sufficient to inhibit the absorption of said naloxone when administered orally.
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 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.
A method of treating narcotic dependence of a user, comprising the steps of:
- 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.
A process of forming a film dosage composition comprising the steps of:
- 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.
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.
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.
Dependencies are inferred from the claim text.