ABUSE-DETERRENT DRUG FORMULATIONS
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Accused Products
Abstract
An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In one embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent. The abuse-deterrent composition prevents the immediate release of a substantial portion of drug, even if the physical integrity of the formulation is compromised and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.
23 Citations
49 Claims
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1-29. -29. (canceled)
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30. A method for the management of pain comprising administering to a patient in need thereof a therapeutically effective pharmaceutical composition comprising solid microparticles, wherein the microparticles comprise:
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a) an active agent, b) one or more fatty acids, and c) one or more carrier materials selected from the group consisting of waxes or wax-like substances and mixtures thereof; wherein the active agent comprises a fatty acid salt of oxycodone, and the one or more fatty acids are present in an amount ranging from 6.9 to 15 times the molar amount of the active agent. - View Dependent Claims (32, 34, 36, 38, 40, 42, 44, 46, 48)
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- 31. The method of claim 31, wherein the molar concentration of the one or more fatty acids in the microparticle is 6.9 to 10 times the molar amount of the active agent.
Specification