The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Sep. 19, 2017

Filed:

Jan. 03, 2014
Applicant:

Collegium Pharmaceutical, Inc., Canton, MA (US);

Inventors:

Jane Hirsh, Wellesley, MA (US);

Alison Fleming, Mansfield, MA (US);

Roman Rariy, Philadelphia, PA (US);

Alexander Klibanov, Boston, MA (US);

Assignee:
Attorney:
Primary Examiner:
Int. Cl.
CPC ...
A61K 31/485 (2006.01); A61K 47/12 (2006.01); A61K 47/44 (2017.01); A61K 9/14 (2006.01); A61K 9/26 (2006.01); A61K 9/50 (2006.01); A61P 25/36 (2006.01); A61K 9/16 (2006.01); A61K 9/20 (2006.01); A61K 9/48 (2006.01); A61K 31/13 (2006.01); A61K 31/20 (2006.01); A61K 45/06 (2006.01);
U.S. Cl.
CPC ...
A61K 9/1617 (2013.01); A61K 9/145 (2013.01); A61K 9/1664 (2013.01); A61K 9/2013 (2013.01); A61K 9/4858 (2013.01); A61K 9/5015 (2013.01); A61K 31/13 (2013.01); A61K 31/20 (2013.01); A61K 31/485 (2013.01); A61K 45/06 (2013.01); A61K 47/12 (2013.01);
Abstract

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.


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