Sublingual and buccal film compositions

CAFC
  • US 9,687,454 B2
  • Filed: 01/06/2016
  • Issued: 06/27/2017
  • Est. Priority Date: 08/07/2009
  • Status: Active Grant
First Claim
Patent Images

1. An oral, self-supporting, A mucoadhesive film comprising:

  • (a) about 40 wt % to about 60 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 Cmax 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 Cmax 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.

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