Perfluorocarbon gel formulations

• US 8,343,515 B2
• Filed: 11/17/2009
• Issued: 01/01/2013
• Est. Priority Date: 11/25/2008
• Status: Expired due to Fees

• Current Assignee: Tenax Therapeutics, Inc.
• Original Assignee: Oxygen Biotherapeutics, Inc.
• Inventors: Huvard, Gary, Kiral, Richard, Quitaro, Maxine, Thompson, Deborah P., Grossman, Aharon, Clauson, Gary, Sandhu, Gurbhagat
• Primary Examiner(s): Padmanabhan, Sreeni
• Assistant Examiner(s): Soroush, Layla
• Application Number:
  US12/590,996
• Publication Number:
  US 20100144861A1
• Time in Patent Office: 1,141 Days
• Field of Search: 424/400
• US Class Current: 424/400
• CPC Class Codes: A61K 31/025 carbocyclic
• CPC Class Codes: A61K 31/355 Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 8/042 Gels
• CPC Class Codes: A61K 8/315 Halogenated hydrocarbons
• CPC Class Codes: A61K 8/70 containing perfluoro groups, e.g. perfluoroethers
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: A61Q 19/08 Anti-ageing preparations

Abstract

A perfluorocarbon gel composition is disclosed with numerous uses including topical medical and cosmetic uses.

Claims

1. A perfluorocarbon gel composition comprising 84-90 wt % perfluorocarbon and 8-11 wt % water and 2-4 wt % surfactants relative to the total weight of the gel, wherein the perfluorocarbon is perfluoro(tert-butylcyclohexane).

2. The perfluorocarbon gel composition of claim 1, wherein the surfactants include polyoxyethylene-polyoxypropylene block copolymers.

3. The perfluorocarbon gel composition of claim 2, wherein the polyoxyethylene-polyoxypropylene block copolymers include Poloxamer 105 and/or Poloxamer 188.

4. The perfluorocarbon gel composition of claim 1, wherein the composition further comprises 0.01-6 wt % Vitamin E.

5. The perfluorocarbon gel composition of claim 4, wherein the composition comprises 0.03 wt % Vitamin E.

6. The perfluorocarbon gel composition of claim 1, wherein the composition further comprises 0.02-3.20 wt % preservatives.

7. The perfluorocarbon gel composition of claim 1, wherein the composition comprises 90 wt % perfluorocarbon, 8 wt % water, and 2 wt % surfactants.

8. The perfluorocarbon gel composition of claim 1, wherein the composition comprises 86.86 wt % perfluorocarbon, 10.42 wt % water, 2.69 wt % surfactants and 0.03 wt % Vitamin E.

9. The perfluorocarbon gel composition of claim 8, wherein the composition comprises 86.86 wt % perfluoro(tert-butylcyclohexane), 10.42 wt % water, 2.43 wt % Poloxamer 105, 0.26 Wt % Poloxamer 188 and 0.03 wt % Vitamin E.

10. The perfluorocarbon gel composition of claim 1, characterized by that it continuously delivers oxygen to a tissue at a rate of 0.2 cc/hour −

20.0 cc/hour for up to 24 hours.

11. The perfluorocarbon gel composition of claim 10, wherein the composition continuously delivers oxygen to the tissue at a rate of 2.0 cc/hour for 24 hours.

12. The perfluorocarbon gel composition of claim 1, further comprising urea hydrogen peroxide.

13. A process of manufacturing the perfluorocarbon gel composition of claim 1 comprising the steps:

a) mixing water and surfactants—

as an aqueous phase in a vessel;

b) homogenizing the mixture;

c) adding perfluorocarbon to the mixture over time during high speed homogenization; and

d) obtaining the gel.

14. The process of claim 13, wherein in step a) the aqueous phase include distilled water, as said water, surfactants, and further optionally, preservatives.

15. The process of claim 13, wherein in step a) the vessel is a glass, polyethylene, PET, or stainless steel vessel.

16. The process of claim 13, wherein in step b) the homogenizer is a rotor stator homogenizer.

17. The process of claim 13, wherein in step b) the mixture is homogenized for 4-6 minutes.

18. The process of claim 17, wherein step b) the mixture is homogenized for 5 minutes.

19. The process of claim 13, wherein in step b) the mixture is homogenized at 10,000-35,000 RPM.

20. The process of claim 13, wherein in step c) the perfluorocarbon is added in aliquots or continuously over 10-30 minutes.

21. The perfluorocarbon gel composition of claim 1, comprising 84-90 wt % perfluorocarbon, 9-11 wt % water, and 2-4 wt % surfactants, and 0.02-3.20 wt % preservatives relative to the total weight of the gel.

22. The perfluorocarbon gel composition of claim 21, wherein the surfactants are polyoxyethylene-polyoxypropylene block copolymers.

23. The perfluorocarbon gel composition of claim 22, wherein the polyoxyethylene-polyoxypropylene block copolymers include Poloxamer 105.