Composition and method of use of colchicine oral liquid

• US 9,907,751 B2
• Filed: 11/22/2016
• Issued: 03/06/2018
• Est. Priority Date: 03/10/2016
• Status: Active Grant

• Current Assignee: RxOMEG Therapeutics LLC
• Original Assignee: RxOMEG Therapeutics LLC
• Inventors: Muni, Indu, Vishnupad, Naomi
• Primary Examiner(s): Kim, Jennifer M
• Application Number:
  US15/358,621
• Publication Number:
  US 20170258715A1
• Time in Patent Office: 469 Days
• Field of Search: 514625
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006

Abstract

Oral liquid colchicine formulations are described herein. Methods of using the oral liquid colchicine formulations are also provided.

Claims

1. A liquid solution suitable for oral administration comprising colchicine and a pharmaceutically acceptable solvent system comprised of water, buffering agents, and one or more agents selected from the group consisting of glycols, sweeteners, flavoring agents, preservatives, thickening agents, and dyes, wherein

the liquid solution is stable for 30 days to 24 months at ambient and refrigerated temperature conditions, wherein the liquid solution is comprised of the following components:

2. The liquid solution of claim 1, wherein the pharmaceutically acceptable solvent system is comprised of one or more agents selected from the group consisting of water, propylene glycol, glycerin, benzyl alcohol, dibasic sodium phosphate heptahydrate, citric acid anhydrous, xanthan gum, sucralose, a dye, and a flavoring agent and/or taste enhancing agent.

3. The liquid solution of claim 1, wherein the pharmaceutically acceptable solvent system is comprised of the following components:

4. The liquid colchicine solution of claim 1, wherein the solution is stable for 3 months to 12 months at accelerated conditions.

5. The liquid colchicine solution of claim 1, wherein the solution has a stable pH.

6. The liquid colchicine solution of claim 1, wherein the solution has a viscosity in the range of 40-800 cps.

7. The liquid colchicine solution of claim 1, wherein the solution is volume packaged 60 mL-473 mL.

8. The liquid colchicine solution of claim 1, wherein the pH is range is 6.2-7.2.

9. The liquid colchicine solution of claim 1, wherein the solution has less than 5% of total impurities.

10. The liquid colchicine solution of claim 1, wherein the solution has less than 0.5% of degradants.

11. The liquid colchicine solution of claim 1, wherein the degradants comprise β

-lumicolchicine, γ

-lumicolchicine, and/or colchiceine.