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US 10,646,485 B2Granted
Process of making stable abuse-deterrent oral formulations
AssigneeCollegium Pharmaceutical, Inc.
InventorsSaid Saim, Alison B. Fleming, Ravi K. Varanasi
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Abstract
The present disclosure relates to cured pharmaceutical compositions designed to reduce the potential for improper administration of drugs that are subject to abuse, the process of curing such composition in order to improve the dissolution stability, method of using the same for treatment of pain.
Claims67
A pharmaceutical composition comprising solid microparticles or formulated microparticles prepared by:
- (a) preparing a mixture at a temperature sufficient to form a melt comprising:
- (i) oxycodone, myristic acid, beeswax and carnauba wax, or
- (ii) oxycodone in the form of a myristic acid salt, beeswax and carnauba wax;
- (b) forming solid microparticles from the melt;
- (c) optionally further formulating the solid microparticles with additional pharmaceutically acceptable excipients to provide formulated microparticles, and
- (d) curing the solid microparticles or the formulated microparticles at one or more curing temperatures from 26° C. to 38° C., for a minimum of about 48 hours to provide cured solid microparticles or cured formulated microparticles.
3 more elements
Dependencies are inferred from the claim text.