Sublingual and buccal film compositions
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.
1. An oral, self-supporting, mucoadhesive film comprising:
(a) at least 25 wt % of a water-soluble polymeric matrix;
(b) about 2 mg to about 16 mg of buprenorphine or a pharmaceutically acceptable salt thereof;
(c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable salt thereof; and
(d) an acidic buffer;
wherein the film is mucoadhesive to the sublingual mucosa or the buccal mucosa;
wherein the weight ratio of (b):(c) is about 4:1;
wherein the weight ratio of (d):(b) is from 2:1 to 1:5; and
wherein application of the film on the sublingual mucosa or the buccal mucosa results in differing absorption between buprenorphine and naloxone, with a buprenorphine C max from about 0.624 ng/ml to about 5.638 ng/ml and a buprenorphine AUC from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml; and a naloxone C max from about 41.04 pg/ml to about 323.75 pg/ml and a naloxone AUC from about 102.88 hr*pg/ml to about 812.00 hr*pg/ml.
2. The film of claim 1 , wherein the weight ratio of (d):(b) is from about 1:1 to 1:5.
3. The film of claim 1 , wherein the weight ratio of (d):(b) is from about 1.4:1 to about 1:3.
4. The film of claim 1 , wherein the acidic buffer is citric acid.
5. The film of claim 1 , comprising at least 50 wt % of the water-soluble polymeric matrix.
6. The film of claim 1 , wherein the water-soluble polymeric matrix comprises a polyethylene oxide polymer alone or in combination with a hydrophilic cellulosic polymer.
7. The film of claim 6 , wherein the hydrophilic cellulosic polymer is hydroxypropyl cellulose, hydroxypropylmethyl cellulose, or a combination thereof.
8. The film of claim 7 , wherein the hydrophilic cellulosic polymer is hydroxypropylmethyl cellulose.
9. A method for treating opioid dependence in a patient in need thereof comprising sublingually or buccally administering the mucoadhesive film of claim 1 to a sublingual or buccal mucosal tissue of the patient to treat the opioid dependence.