Claims for Patent: 10,525,053

Summary for Patent: 10,525,053

Title:	Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Abstract:	An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In a preferred embodiment, a drug is modified to increase its lipophilicity. In some embodiments the modified drug is homogeneously dispersed within spherical 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/or organic solvent insoluble. The abuse-deterrent composition retards the release 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 passes through the GI tract.
Inventor(s):	Rariy; Roman V. (Allston, MA), Fleming; Alison B. (North Attleboro, MA), Hirsh; Jane (Wellesley, MA), Klibanov; Alexander M. (Boston, MA)
Assignee:	Collegium Pharmaceutical, Inc. (Stoughton, MA)
Application Number:	15/727,134
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,525,053
Patent Claims:	1. An oral dosage form comprising a plurality of microparticles, wherein each microparticle comprises a homogenous single phase comprising: (a) oxycodone; (b) myristic acid; and (c) one or more carrier materials; wherein the weight ratio of myristic acid to oxycodone is about 5:1 to about 8:1 and the oxycodone is in the form of a myristic acid salt. 2. The oral dosage form of claim 1, wherein the one or more carrier materials comprise fats, fatty substances, waxes, wax-like substances or mixtures thereof. 3. The oral dosage form of claim 2, wherein the one or more carrier materials comprise beeswax, carnauba wax, or mixtures thereof. 4. The oral dosage form of claim 2, wherein the one or more carrier materials comprise beeswax, carnauba wax, mixtures of mono-, di- and tri-glycerides and mono- and di-fatty acid esters of polyethylene glycol, or mixtures thereof. 5. The oral dosage form of claim 1, wherein the oral dosage form is a capsule or a tablet. 6. The oral dosage form of claim 5, wherein the oral dosage form is a capsule. 7. The oral dosage form of claim 1, wherein the oral dosage form further comprises an antioxidant. 8. The oral dosage form of claim 7, wherein the antioxidant comprises butylated hydroxy toluene (BHT); ascorbic acid, its salts and esters; Vitamin E, tocopherol and its salts; sodium metabisulphite; cysteine; citric acid; propyl gallate; butylated hydroxyanisole (BHA); or combinations thereof. 9. The oral dosage form of claim 1, wherein the oral dosage form is a controlled-release oral dosage form. 10. The oral dosage form of claim 1, wherein each microparticle further comprises a pharmaceutically acceptable surfactant. 11. The oral dosage form of any of claims 1-10, wherein the microparticles are spherical. 12. The oral dosage form of claim 1, wherein the weight ratio of myristic acid to oxycodone is about 6:1 to about 8:1 and the oxycodone is in the form of a myristic acid salt.