Oral Film Containing Opiate Enteric-Release Beads
First 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 comprising at least one controlled-release matrix polymer and enteric-release beads dispersed within said matrix polymer, whereinsaid enteric-release beads are formed from an at least one enteric-release polymer having said opioid agonist and said opioid antagonist and/or their respective salts encapsulated therein;
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, andsaid controlled-release composition further optionally comprising one or more additives selected from taste masking agents, emulsifiers, plasticizers, colorants, antioxidants, microbial preservatives and permeation enhancers, said enteric-release beads further optionally comprising bead stabilizer.
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Accused Products
Abstract
A control release and abuse-resistant opiate drug delivery oral wafer or edible oral film dosage to treat pain and substance abuse is provided. The drug delivery oral wafer or edible oral film dosage includes a controlled release layer containing enteric-release beads dispersed in a polymer matrix. The enteric-release beads are formed from a therapeutic amount of an opioid agonist and/or pharmaceutically acceptable salt thereof and a sub-therapuetic amount of opioid antagonist and/or pharmaceutically acceptable salt thereof coated or encapsulated in an enteric-release polymer. The controlled release polymer matrix dissolves or disintegrates following administration or consumption of the oral wafer or edible oral film, releasing the enteric-release beads to be swallowed, with subsequent absorption of the active ingredients within the patient'"'"'s intestines.
18 Citations
34 Claims
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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;
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said controlled-release composition 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 an at least one enteric-release polymer having said opioid agonist and said opioid antagonist and/or their respective salts encapsulated therein; 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 selected from taste masking agents, emulsifiers, plasticizers, colorants, antioxidants, microbial preservatives and permeation enhancers, said enteric-release beads further optionally comprising bead stabilizer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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Specification