Patent ID: 9687445
Date: 2017-06-27
CPC Classifications: A61K,A61P

Claim:
1. An oral film dosage comprising at least one layer formed from a controlled-release composition imparting intestinal release of a therapeutically effective amount of an opioid agonist and/or pharmaceutically acceptable salt thereof and a clinically effective amount of opioid antagonist and/or pharmaceutically acceptable salt thereof; said controlled-release composition formed from a coating mass comprising at least one controlled-release matrix polymer and enteric-release beads dispersed within said matrix polymer, wherein said enteric-release beads are formed from opioid agonist and said opioid antagonist and/or their respective salts suspended and/or dissolved directly within at least one enteric release polymer coating; wherein said enteric-release polymer dissolves to release at least 75 wt % of said opioid agonist and said opioid antagonist and/or their respective salts within 5 minutes in an aqueous solution at a pH of 7.4, said enteric-release polymer is polymethacrylate copolymer and the polymethacrylate copolymer is a mixture of (i)cationic copolymer derived from dimethylaminoethyl methacylate and/or other neutral methacrylic acid esters and (ii) anionic copolymer derived from methacrylic acid and acrylate, wherein the weight ratio of said cationic copolymer and said anionic copolymer is about 1:10 to 10:1, said controlled-release composition further comprising a pH adjuster in an amount effective to adjust the composition to a pH of about 2.0 to 3.0 pH units below the pKa of the opioid agonist, antagonist and their respective salts, and said controlled-release composition further optionally comprising one or more additives added to said coating mass selected from (i) one or more taste masking agents consisting of sweeteners, cooling sensation agents, taste receptor blockers, and flavors, (ii) emulsifiers, (iii) plasticizers, (iv) colorants, (v) antioxidants, (vi) microbial preservatives and (vii) permeation enhancers, said enteric-release beads further optionally comprising bead stabilizer.