SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
First Claim
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1. A method for treating an opioid narcotic dependence in a patient in need thereof comprising sublingually or buccally administering a mucoadhesive film to a sublingual or buccal mucosal tissue of the patient to treat the opioid narcotic dependence;
- wherein the film comprises a polymeric matrix, about 2 mg to about 16 mg buprenorphine or a pharmaceutically acceptable salt thereof, naloxone or a pharmaceutically acceptable salt thereof, and a buffer;
wherein absorption of the buprenorphine through the sublingual or buccal mucosal tissue is maximized to produce a Cmax from about 0.624 ng/ml and about 5.638 ng/ml and an AUC from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml in the patient; and
wherein absorption of the naloxone or the pharmaceutically acceptable salt thereof through the sublingual or buccal mucosal tissue is minimized or inhibited.
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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.
7 Citations
10 Claims
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1. A method for treating an opioid narcotic dependence in a patient in need thereof comprising sublingually or buccally administering a mucoadhesive film to a sublingual or buccal mucosal tissue of the patient to treat the opioid narcotic dependence;
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wherein the film comprises a polymeric matrix, about 2 mg to about 16 mg buprenorphine or a pharmaceutically acceptable salt thereof, naloxone or a pharmaceutically acceptable salt thereof, and a buffer; wherein absorption of the buprenorphine through the sublingual or buccal mucosal tissue is maximized to produce a Cmax from about 0.624 ng/ml and about 5.638 ng/ml and an AUC from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml in the patient; and wherein absorption of the naloxone or the pharmaceutically acceptable salt thereof through the sublingual or buccal mucosal tissue is minimized or inhibited. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method for treating an opioid narcotic dependence in a patient in need thereof comprising sublingually or buccally administering a mucoadhesive film to a sublingual or buccal mucosal tissue of the patient to treat the opioid narcotic dependence;
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wherein the film comprises at least 25 wt % of a water-soluble polymer, about 2 mg to about 16 mg buprenorphine or a pharmaceutically acceptable salt thereof, about 0.5 mg to about 4 mg naloxone or a pharmaceutically acceptable salt thereof, and a buffer; wherein the water-soluble polymer is polyethylene oxide, pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth guam, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, or combinations thereof; wherein absorption of the buprenorphine through the sublingual or buccal mucosal tissue is maximized to produce a Cmax from about 0.624 ng/ml and about 5.638 ng/ml and an AUC from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml in the patient; and wherein absorption of the naloxone or the pharmaceutically acceptable salt thereof through the sublingual or buccal mucosal tissue is minimized or inhibited.
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Specification