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Last Updated: October 22, 2019

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Claims for Patent: 9,345,771

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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.

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