Granted Patent B2

US 12,268,699 · App. 18/773,898 · Granted Apr 8, 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 Inc.

A61K31/658A61K9/7084A61K47/02A61K47/10A61K47/12A61K47/32

Abstract

Claims (30)

1. A pharmaceutical composition comprising tetrahydrocannabinol (THC), in a dosage form for transdermal delivery wherein the pharmaceutical composition comprises:

a concentration of THC selected from the group consisting of about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, and about 15% w/w;

about 5% to about 20% w/w of a solvent comprising propylene glycol;

about 1% to about 20% w/w of a penetration enhancer comprising oleic acid;

about 0.1% to about 0.7% w/w of butylated hydroxytoluene;

about 2% to about 15% w/w of at least one suspending agent comprising silicon dioxide;

about 0.1% to about 20% w/w of polyvinylpyrrolidone; and

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

wherein the pH of the composition is maintained at approximately 4.0 to 8.0, wherein the pharmaceutical composition is in the form of a transdermal matrix patch,

further wherein the pharmaceutical composition provides a constant rate of delivery of the active components of the transdermal matrix patch in a therapeutic range in a patient over 7 days.

2. The pharmaceutical composition of claim 1 further comprising carriers or ingredients selected from the group consisting of gelling agents, polymers, emollients, skin irritation reducing agents, buffering agents, pH stabilizers, solubilizers, dispersing agents, stabilizers, plasticizers, surfactants, antioxidants, oxidants, and combinations thereof.

3. The pharmaceutical composition of claim 1 further comprising carriers or ingredients selected from the group consisting of gelling agents, polymers, emollients, skin irritation reducing agents, buffering agents, pH stabilizers, solubilizers, dispersing agents, stabilizers, plasticizers, surfactants, antioxidants, oxidants, and combinations thereof in the range of 0.01%-95% w/w or w/v.

4. The pharmaceutical composition of claim 1 which is formulated as a transdermal matrix patch formulation which can be administered in a dosage regimen selected from the group consisting of once in a week, once in about 8 to about 13 days, once in two weeks, once in about 15 days to about 30 days.

5. The pharmaceutical composition of claim 1 wherein said THC is produced by a synthetic route.

6. A method for the treatment of pain and/or inflammation comprising: selecting a patient in need of treatment of pain and/or inflammation; topically applying a pharmaceutical composition of claim 1 , in a dosage form for transdermal delivery.

7. The method of claim 6 , wherein the topical application of a transdermal patch for the treatment of pain and/or inflammation is selected from the group consisting of 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, once in ten days.

8. The method of claim 6 further providing a constant rate of delivery of the active components of the transdermal patch over a time period.

9. The method of claim 6 further providing a steady absorption rates of the active components of the transdermal patch over a time period.

10. The method of claim 6 further achieving a constant blood serum levels of the active components of the transdermal patch over a time period.

11. The method of claim 6 further achieving a reduced variability in dosage of the active components of the transdermal patches over a time period.

12. The method of claim 6 further providing a plasma concentration of the active components of the transdermal patch in a therapeutic range over a period of time.

13. The method of claim 6 wherein the topical application of a transdermal patch is for the treatment of pain and/or inflammation of indications selected from the group consisting of headaches, migraine, tension headaches, cluster headaches, acute pain, chronic pain, neuropathic pain, nociceptive pain, central pain, inflammatory pain, fibromyalgia, drug-induced neuropathic pain, causalgia, complex regional pain syndrome types I and II, and reflex sympathetic dystrophy (RSDS), pain and wasting associated with AIDS, arthritis and rheumatism, migraines, and muscle spasticity associated with multiple sclerosis and paralysis, Autism Spectrum Disorder (ASD) and Autism Spectrum Disorder (ASD) for Pediatric patients, pain and/or inflammation of patients with liver disease, pain and/or inflammation of patients with kidney disease, pain and/or inflammation for liver cancer patients, treating pain and/or inflammation for kidney cancer patients, pain and/or inflammation for cancer patients; Parkinson's Disease; pain and/or inflammation of patients with Parkinson's Disease, and combinations thereof.

14. A method for the treatment of Parkinson's Disease comprising: selecting a patient in need of treatment of Parkinson's Disease; topically applying a pharmaceutical composition of claim 1 , in a dosage form for transdermal delivery.

15. The method of claim 6 , wherein the topical application of a transdermal patch for the treatment of Parkinson's Disease is selected from the group consisting of 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, once in ten days.

16. The method of claim 6 further providing a constant rate of delivery of the active components of the transdermal patch over a time period.

17. The method of claim 6 further providing a steady absorption rate of the active components of the transdermal patch over a time period.

18. The method of claim 6 further achieving a constant blood serum level of the active components of the transdermal patch over a time period.

19. The method of claim 6 further achieving a reduced variability in dosage of the active components of the transdermal patches over a time period.

20. The method of claim 6 further providing a plasma concentration of the active components of the transdermal patch in a therapeutic range over a period of time.

21. The method of claim 6 wherein the topical application of a transdermal patch is for the treatment of pain and/or inflammation of patients with Parkinson's Disease.

Assignments (4)

Continuity (3)

References Cited (334)