Claims for Patent: 8,222,292

Summary for Patent: 8,222,292

Title:	Liquid cannabinoid formulations
Abstract:	Oral cannabinoid formulations, including an aqueous-based oral dronabinol solution, that are stable at room or refrigerated temperatures and may possess improved in vivo absorption profiles with faster onset and lower inter-subject variability.
Inventor(s):	Goskonda; Venkat R. (Phoenix, AZ), Chavan; Ashok (Chandler, AZ), Kokate; Amit (Englewood, NJ), Gill; Howard (Scottsdale, AZ)
Assignee:	Insys Therapeutics, Inc. (Phoenix, AZ)
Application Number:	13/222,989
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,222,292
Patent Claims:	1. An oral pharmaceutical solution consisting essentially of dronabinol, 30-33% w/w water, about 50% w/w alcohol, 0.01% w/w butylated hydroxylanisole (BHA) or 0.1% w/w ethylenediaminetetraacetic acid (EDTA) and 5-21% w/w co-solvent, having a combined total of 100%, wherein said co-solvent is selected from the group consisting of propylene glycol, polyethylene glycol and combinations thereof, and wherein said oral pharmaceutical solution is stable for at least eighteen months at room or refrigerated temperatures and has in vivo absorption variability of less than 50%. 2. The oral pharmaceutical solution of claim 1 consisting essentially of 0.1 to 5% w/w of dronabinol, about 50% w/w alcohol, 5.5% w/w propylene glycol, 12% w/w polyethylene glycol and 30-33% w/w water. 3. The oral pharmaceutical solution of claim 2, wherein said alcohol is ethanol. 4. An oral pharmaceutical solution consisting essentially of about 0.1% to 1% w/w synthetic dronabinol, about 50% w/w alcohol, 5.5% w/w propylene glycol, 12% w/w polyethylene glycol, 30-33% w/w water, 0.01% w/w butylated hydroxyanisole, having a combined total of 100%, and wherein said oral pharmaceutical solution is stable for at least eighteen months at room or refrigerated temperatures and has in vivo absorption variability of less than 50%. 5. The oral pharmaceutical solution of claim 4 in sublingual spray form. 6. An oral pharmaceutical solution comprising 0.54% w/w dronabinol, 31.9% w/w water, 12% w/w polyethylene glycol 400, 5.5% w/w propylene glycol, 0.01% w/w butylated hydroxyanisole, 0.05% w/w sucralose, and 50% w/w alcohol.