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US 7,771,707 B2Granted
Abuse-deterrent drug formulations
AssigneeCollegium Pharmaceutical, Inc.
InventorsJane C. Hirsh, Alison B. Fleming, Roman V. Rariy, Alexander M. Klibanov
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AssigneeCollegium Pharmaceutical, Inc.
InventorsJane C. Hirsh, Alison B. Fleming, Roman V. Rariy, Alexander M. Klibanov
Estimating the term…
An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred 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, preferably two to ten times the molar amount of the active agent. In one embodiment the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble. The abuse-deterrent composition prevents the immediate release of a substantial portion of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) 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.
A solid orally administrable abuse-deterrent pharmaceutical composition of a pharmaceutically active agent prone to abuse, the composition comprising:
A method of manufacturing a solid, orally administrable abuse-deterrent pharmaceutical formulation of a drug prone to abuse, the method comprising mixing together a therapeutically effective amount of a pharmaceutically active agent prone to abuse and one or more fatty acids or fatty amines present in molar excess relative to the pharmaceutically active agent wherein the active agent comprises an effective amount of a fatty acid or fatty amine salt of the active agent prone to abuse, wherein the mixture forms a single phase when heated to a temperature above the melting point of the one or more fatty acids or fatty amines but below the melting point of the active agent.
Dependencies are inferred from the claim text.