Sublingual and buccal film compositions
AssigneeMonosol Rx, LLC
InventorsGarry L. Myers, Eric Dadey
Life of this patent
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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.
Claims30
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 chelator or antioxidant;
- wherein the ratio of said antagonist to said chelator or antioxidant is from about 40:1 to about 1:10 by weight.
A self-supporting 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 chelator or antioxidant;
- wherein the ratio of said naloxone or a pharmaceutically acceptable salt thereof to said chelator or antioxidant is from about 40:1 to about 1:10 by weight.
A self-supporting 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. ethylenediaminetetraacetic acid disodium salt (EDTA);
- wherein the ratio of said naloxone or a pharmaceutically acceptable salt thereof to said EDTA is from about 4:1 to about 1:2 by weight.
A self-supporting film dosage composition comprising:
- a. a polymeric carrier matrix;
- b. a therapeutically effective amount of buprenorphine hydrochloride;
- c. a therapeutically effective amount of naloxone hydrochloride;
- d. ethylenediaminetetraacetic acid disodium salt (EDTA);
- and
- e. citric acid;
- wherein the ratio of said naloxone hydrochloride to said EDTA is from about 4:1 to about 1:2 by weight.
Dependencies are inferred from the claim text.