Claims for Patent: 10,383,820

Summary for Patent: 10,383,820

Title:	Colchicine drug-to-drug interactions
Abstract:	The use of oral colchicine solutions in combination with other therapeutics, while minimizing toxic drug to drug interactions are described herein. Related compositions are also provided.
Inventor(s):	Muni; Indu (North Reading, MA), Vishnupad; Naomi (Reading, MA)
Assignee:	RxOMEG Therapeutics LLC (Woburn, MA)
Application Number:	16/155,571
Patent Claims:	1. A method of treating a colchicine sensitive disorder, comprising orally administering a liquid colchicine solution to a human subject having a colchicine sensitive disorder in an effective amount to treat the disorder, wherein the colchicine sensitive disorder is selected from gout, familial Mediterranean fever (FMF), pericarditis, Behcet's disease, atrial fibrillation, amyloidosis, calcium pyrophosphate deposition disease (pseudogout), cirrhosis of the liver, or sarcoid arthritis, wherein the liquid colchicine solution comprises a concentration of colchicine of 0.01-1.0 mg/ml, 0.1-0.3% w/v of anhydrous citric acid, 0.8-1.6% w/v of dibasic sodium phosphate heptahydrate, 0.1-0.2% w/v of a thickening agent, a preservative, glycols, and water, and wherein the liquid colchicine solution is stable for at least one month at refrigerated and ambient temperature conditions. 2. The method of claim 1, wherein the liquid colchicine solution further comprises one or more agents selected from the group consisting of propylene glycol, glycerin, benzyl alcohol, xanthan gum, sucralose, a dye, and a flavoring agent and/or taste enhancing agent. 3. The method of claim 1, wherein the liquid colchicine solution has a stable pH. 4. The method of claim 1, wherein the liquid colchicine solution has a viscosity in the range of 40-800 cps. 5. The method of claim 1, wherein the liquid colchicine solution has less than 5% of total impurities. 6. The method of claim 1, wherein the liquid colchicine solution has less than 0.5% of degradants. 7. The method of claim 6, wherein the degradants comprise .beta.-lumicolchicine, .gamma.-lumicolchicine, and/or colchiceine. 8. The method of claim 1, wherein the liquid colchicine solution is a 0.12 mg/ml solution. 9. A method of treating gout, comprising orally administering a liquid colchicine solution to a human subject in an effective amount to treat gout, wherein the liquid colchicine solution comprises a concentration of colchicine of 0.01-1.0 mg/ml, 0.1-0.3% w/v of anhydrous citric acid, 0.8-1.6% w/v of dibasic sodium phosphate heptahydrate, 0.1-0.2% w/v of a thickening agent, a preservative, glycols, and water, and wherein the liquid colchicine solution is stable for at least one month at refrigerated and ambient temperature conditions. 10. The method of claim 9, wherein the liquid colchicine solution is a 0.12 mg/ml solution.