Granted Patent B2

US 12,409,131 · App. 17/225,038 · Granted Sep 9, 2025

Inventors: Fotios M. Plakogiannis (Whitestone, NY); Tamanna Lather (Jersey City, NJ); Nisarg Modi (Jersey City, NJ); Marina Borovinskaya (East Brunswick, NJ)

Assignee: Pike Therapeutics USA, Inc.

A61K9/0014A61K9/0021A61K9/7084A61K31/352A61P1/08

Abstract

Claims (23)

1. A pharmaceutical composition in the form of a transdermal matrix patch comprising: dronabinol, wherein the concentration of the dronabinol is from about 1% to about 15% w/w;

wherein the pharmaceutical composition further comprises:

about 10% to about 17% w/w of a solvent comprising propylene glycol;

about 4% to about 10% w/w of a penetration enhancer comprising oleic acid;

about 50% to about 80% w/w of a silicone pressure sensitive adhesive;

at least one suspending agent comprising silicon dioxide;

an antioxidant comprising BHT,

wherein the transdermal matrix patch provides an average flux of the dronabinol of about 0.43 to about 0.93 μg/cm 2 /hr over at least 6 days.

2. The pharmaceutical composition of claim 1 , comprising no additional antiemetic drug.

3. The pharmaceutical composition of claim 1 , wherein dronabinol is in a form selected from the group consisting of co-crystals, amorphous, coated, crystalline, a salt, an isomer, a solid solution, a prodrug, an analog, a derivative, a metabolite, a solution, synthetic, an ethanol solution, and a naturally derived delta-9-tetrahydrocannabinol.

4. The pharmaceutical composition of claim 1 , wherein dronabinol is selected from a group consisting of amorphous dronabinol, crystalline dronabinol, co-crystals of dronabinol, coated dronabinol, and ethanolic solution of dronabinol in the range of 0.01%-95% w/w or w/v.

5. The pharmaceutical composition of claim 1 , wherein dronabinol is in a salt form.

6. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated as microneedles.

7. A method for the treatment of nausea and/or vomiting associated with cancer chemotherapy, comprising:

selecting a patient in need of treatment of nausea and/or vomiting associated with cancer chemotherapy; and

topically applying or instructing to topically apply the pharmaceutical composition of claim 1 , wherein the topically applying is performed at least once in a day.

8. The method of claim 7 , wherein the composition is a liquid formulation and/or a semisolid formulation, wherein the topically applying is done two to six times in a day, once in a day, once in two days, once in three days, once in four days, once in five days, once in six days, once in a week.

9. The method of claim 7 , wherein the composition is topically applied once in two days, once in three days, once in four days, once in five days, once in six days, once in a week, or once in ten days.

10. The method of claim 7 , wherein said topically applying provides a constant rate of delivery of the active components of the transdermal patch over a time period.

11. The method of claim 7 , wherein said topically applying provides a steady absorption rate of dronabinol over a time period.

12. The method of claim 7 , wherein said topically applying achieves a constant blood serum level of dronabinol over a time period.

13. The method of claim 7 , wherein said topically applying achieves a reduced variability in blood serum level of dronabinol over a time period relative to oral administration of a dronabinol over the time period.

14. The method of claim 7 , wherein said topically applying achieves a plasma concentration of dronabinol in a therapeutic range over a period of time.

Assignments (2)

Continuity (4)

References Cited (346)