Claims for Patent: 9,345,771

Summary for Patent: 9,345,771

Title:	Oral 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 DEVELOPMENT COMPANY, INC. (Chandler, AZ)
Application Number:	13/644,283
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,345,771
Patent Claims:	1. An oral pharmaceutical solution consisting essentially of 0.1 to 5% w/w of dronabinol, 25-33% w/w water, 15-65% w/w solvent, a cosolvent consisting of 5.5% w/w propylene glycol and 12% w/w polyethylene glycol, and an excipient selected from the group consisting of butylated hydroxyanisole (BHA), butylated hydroxytoulene (BHT), disodium ethylenediaminetetracetic acid (EDTA), a paraben and a combination thereof wherein said oral pharmaceutical solution is stable for at least eighteen months at room or refrigerated temperatures, has an in vivo absorption variability of less than 50%, and a 5 mg dose of dronabinol provides a pharmacokinetic profile of C.sub.max of 2.4+/-1.30 (ng/mL), AUC (0-t) of 4.23+/-1.97 (h*ng/mL) or a T.sub.max of 0.25-4.00 (h) following oral administration and wherein the solution is a liquid for oral consumption. 2. The oral pharmaceutical solution of claim 1 consisting essentially of 50% solvent. 3. The oral pharmaceutical solution of claim 2, wherein said solvent is ethanol. 4. The oral pharmaceutical solution of claim 3 in sublingual spray form. 5. An oral pharmaceutical solution consisting essentially of the solution of claim 1 having a 5 mg dose of dronabinol and having a pharmacokinetic profile of C.sub.max of 2.4+/-1.30 (ng/mL), AUC (0-t) of 4.23+/-1.97 (h*ng/mL) and a T.sub.max of 0.25-4.00 (h). 6. The oral pharmaceutical solution of claim 1 wherein the solution has a pharmacokinetic profile of AUC (inf) of 4.48.+-.1.94 (h*ng/mL) or t1/2 (h) of 7.51.+-.5.70 or .lamda.z (h.sup.-1) of 0.12353.+-.0.0624 following oral administration. 7. The oral pharmaceutical solution of claim 1 consisting essentially of 5% w/w dronabinol. 8. The oral pharmaceutical solution of claim 1 consisting essentially of 30-33% w/w water. 9. An oral pharmaceutical solution consisting essentially of 5% w/w dronabinol, 12% w/w polyethylene glycol 400, 5.5% w/w propylene glycol, 30-33% w/w water, and 50% w/w alcohol. 10. The oral pharmaceutical solution of claim 1 consisting essentially of 5% w/w dronabinol, 12% w/w polyethylene glycol 400, 5.5% w/w propylene glycol, 30-33% w/w water, 50% w/w alcohol, butylated hydroxyl anisole, sucralose, methyl paraben, and propyl paraben. 11. The oral pharmaceutical solution of claim 1 consisting essentially of 0.01% w/w BHA or EDTA. 12. The oral pharmaceutical solution of claim 1 consisting essentially of 0.05% w/w sweetener.