Sublingual and buccal film compositions
AssigneeMonosol Rx, LLC
InventorsGarry L. Myers, Samuel D. Hilbert, Bill J. Boone, B. Arlie Bogue, Pradeep Sanghvi, Madhusudan Hariharan
Life of this patent
Estimating the term…
Abstract
The present invention relates to products and methods for treatment of various symptoms in a patient, including treatment of pain suffered by a patient. The invention more particularly relates to self-supporting dosage forms which provide an active agent while providing sufficient buccal adhesion of the dosage form. Further, the present invention provides a dosage form which is useful in reducing the likelihood of diversion abuse of the active agent.
Claims65
A self-supporting film dosage composition comprising:
- a. A polymeric carrier matrix;
- b. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof;
- and
- c. a buffer sufficient to maximize the absorption of the agonist.
A self-supporting film dosage composition comprising:
- a. A polymeric carrier matrix;
- b. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof;
- c. A therapeutically effective amount of an antagonist or a pharmaceutically acceptable salt thereof;
- and
- d. A buffering system;
- wherein said buffering system comprises a buffer capacity sufficient to inhibit the absorption of said antagonist during the time which said composition is in the oral cavity of a user.
A method of treatment, comprising the steps of:
- a. Providing a film dosage composition comprising:
- i. A polymeric carrier matrix;
- ii. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof, and
- iii. A buffer in an amount sufficient to maximize the absorption of said agonist;
- and
- b. Administering said film dosage composition to a patient.
A method of treatment, comprising the steps of:
- a. Providing a film dosage composition comprising:
- i. A polymeric carrier matrix;
- ii. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof,
- iii. A therapeutically effective amount of an antagonist or a pharmaceutically acceptable salt thereof,
- iv. A first buffer in an amount sufficient to obtain a local pH of said agonist of about 4 to about 9;
- v. A second buffer in an amount sufficient to obtain a local pH of said antagonist of about 2 to about 4;
- and
- b. Administering said film dosage composition to a user.
A self-supporting film dosage composition comprising:
- a. A first region comprising:
- i. A first polymeric matrix;
- ii. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof, and
- iii. A first buffering system in an amount sufficient to optimize the absorption of said agonist;
- b. A second region comprising:
- i. A second polymeric matrix;
- ii. A therapeutically effective amount of an antagonist;
- and
- iii. A second buffering system in an amount sufficient to inhibit the absorption of said antagonist.
An orally dissolving film formulation comprising a first region comprising a therapeutically effective amount of an agonist and second region comprising a therapeutically effective amount of an antagonist, wherein said formulation provides an in vivo plasma profile having a Cmax of about 0.624-5.638 ng/ml for said agonist and an in vivo plasma profile having a Cmax of about 46.04-323.75 pg/ml for said antagonist.
A self-supporting film dosage composition comprising:
- a. A polymeric carrier matrix;
- b. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof;
- c. A therapeutically effective amount of an antagonist or a pharmaceutically acceptable salt thereof;
- and
- d. A buffering system sufficient to obtain a local pH of said antagonist of about 2 to about 4.
A self-supporting film dosage composition comprising:
- a. A polymeric carrier matrix;
- b. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof;
- c. A therapeutically effective amount of an antagonist or a pharmaceutically acceptable salt thereof;
- and
- d. A buffering system sufficient to inhibit absorption of said antagonist and optimize absorption of said agonist when said film dosage composition is placed in the mouth of a user.
A self-supporting film dosage composition comprising:
- a. A first region comprising:
- i. A first polymeric matrix;
- ii. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof, and
- iii. A first buffering system in an amount sufficient to optimize absorption of said agonist when said film dosage composition is placed in the mouth of a user;
- and
- b. A second region comprising:
- i. A second polymeric matrix;
- ii. A therapeutically effective amount of an antagonist;
- and
- iii. A second buffering system in an amount sufficient to inhibit absorption of said antagonist when said film dosage composition is placed in the mouth 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 an agonist or a pharmaceutically acceptable salt thereof,
- iii. A therapeutically effective amount of an antagonist or a pharmaceutically acceptable salt thereof, and
- iv. A buffer in an amount sufficient to optimize absorption of said agonist and sufficient to inhibit absorption of said antagonist when said film dosage composition is placed in the mouth of a user;
- and
- b. Drying said film-forming composition to form a self-supporting film dosage composition.
A method of treatment, comprising the steps of:
- a. Providing a film dosage composition comprising:
- i. A polymeric carrier matrix;
- ii. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof;
- iii. A therapeutically effective amount of an antagonist or a pharmaceutically acceptable salt thereof, and
- iv. A buffering system in an amount sufficient to provide an in vivo plasma profile having a Cmax of about 0.624-5.638 ng/ml for said agonist and an in vivo plasma profile having a Cmax of about 41.04-323.75 pg/ml for said antagonist;
- and
- b. Administering said film dosage composition to a user.
A self-supporting film dosage composition comprising:
- a. A first region comprising:
- i. A first polymeric matrix;
- ii. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof;
- and
- iii. A first buffering system in an amount sufficient to optimize the absorption of said agonist;
- b. A second region comprising:
- i. A second polymeric matrix;
- ii. A therapeutically effective amount of an antagonist;
- and
- iii. A second buffering system in an amount sufficient to inhibit the absorption of said antagonist
- wherein said second region dissolves at a faster rate when placed in the oral cavity of the user than said first region.
A process of forming a film dosage composition comprising the steps of:
- a. Casting a first film-forming composition, said first film-forming composition comprising:
- i. A polymeric carrier matrix;
- ii. A therapeutically effective amount of an agonist or a pharmaceutically acceptable salt thereof, and
- iii. A buffer in an amount sufficient to optimize absorption of said agonist when said film dosage composition is placed in the mouth of a user;
- b. Casting a second film-forming composition, said second film-forming composition comprising:
- i. A polymeric carrier matrix;
- ii. A therapeutically effective amount of an antagonist or a pharmaceutically acceptable salt thereof, and
- iii. A buffer in an amount sufficient to inhibit absorption of said antagonist when said film dosage composition is placed in the mouth of a user;
- and
- c. Laminating said first film-forming composition and said second film-forming composition together to form a self-supporting film dosage composition.
Dependencies are inferred from the claim text.