CA2410990A1 - Systems and methods for topical treatment with nitric oxide - Google Patents

Systems and methods for topical treatment with nitric oxide Download PDF

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Publication number
CA2410990A1
CA2410990A1 CA002410990A CA2410990A CA2410990A1 CA 2410990 A1 CA2410990 A1 CA 2410990A1 CA 002410990 A CA002410990 A CA 002410990A CA 2410990 A CA2410990 A CA 2410990A CA 2410990 A1 CA2410990 A1 CA 2410990A1
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CA
Canada
Prior art keywords
acid
gel
ointment
salt
composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002410990A
Other languages
French (fr)
Other versions
CA2410990C (en
Inventor
William A. Seitz
Robert E. Garfield
Alexandru T. Balaban
Randall J. Stewart
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Nitric Oxide Solutions
Original Assignee
Nitric Oxide Solutions
William A. Seitz
Robert E. Garfield
Alexandru T. Balaban
Randall J. Stewart
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=22250448&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2410990(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Nitric Oxide Solutions, William A. Seitz, Robert E. Garfield, Alexandru T. Balaban, Randall J. Stewart filed Critical Nitric Oxide Solutions
Publication of CA2410990A1 publication Critical patent/CA2410990A1/en
Application granted granted Critical
Publication of CA2410990C publication Critical patent/CA2410990C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions

Abstract

A simple, biocompatible system and procedure for generating nitric oxide (NO) is described. A mixture of powdered sodium nitrite, ascorbic acid, and maleic acid (or another organic acid of adequate strength) immediately generates nitric oxide (NO) on treatment with water. To slow down the NO generation, one may prepare an ointment from a nonaqueous medium (petrolatum, Vaseline(TM)) and the three powdered ingredients, which on being applied topically on the skin will release NO as water permeates through this medium; alternatively, one may convert the aqueous sodium nitrite solution into a gel with hydroxyethylcellulose (or other gel-forming compound) and combine this gel with another gel obtained from aqueous ascorbic and maleic acids with hydroxyethylcellulose for topical application (on intact skin, burns intra-cavity, burns, intra-cavity, etc.). The two gels may be admixed immediately before use (possibly from a single container with separate chambers and dual nozzle, via pushing or squeezing the two gels through the nozzle), or may be applied in sandwich-like fashion (possibly as a transdermal patch) for further slowing down the delivery of NO.

Claims (35)

1. A method for therapeutically applying NO, the method comprising combining a nitrite salt, a biocompatible reluctant and an acid with a pKa between about 1 and about 4 in a medium and topically applying said combination to a body site.
2. A method for topical delivery of nitric oxide (NO) comprising mixing a powdered nitrite salt with a powdered reluctant and an acid having a pKa between about 1 and about 4 in a diffusion-inhibiting topically applicable medium and topically applying an effective amount of said mixture to a body site.
3. The method of claim 1 or 2 where the reluctant is an ascorbate salt, an erythrobate or .alpha.-tocopherol.
4. The method of claim 1 or 2 where the reluctant is ascorbic acid.
5. The method of claim 1 or 2 where thewhere the acid is an organic acid.
6. The method of claim 1 or 2 where the acid is maleic acid.
7. The method of claim 1 or 2 where the acid is an inorganic acid.
8. The method of claim 1 or 2 where the nitrite salt is an inorganic salt.
9. The method of claim 1 or 2 where the nitrite salt is sodium nitrite.
10. The method of claim 1 or 2 where the medium is an aqueous gel.
11. The method of claim 1 or 2 where the medium comprises hydroxyethyl cellulose or poloxama.
12. The method of claim 1 or 2 where the medium is an organic salve.
13. A topically applicable ointment for controlled NO delivery comprising a nitrite salt, a reluctant and an acid with a pka between about 1 and about 4 in/a medium sufficiently viscous to inhibit diffusion, permit slow NO release and facilitate topical application.
14. The ointment of claim 12 where the reluctant is ascorbic acid, an ascorbate salt, an erythrobate or .alpha.-tocopherol.
15. The ointment of claim 12 where the reluctant is ascorbic acid.
16. The ointment of claim 12 where the acid is an organic acid.
17. The ointment of claim 12 where the acid is maleic acid.
18. The ointment of claim 12 where the acid is an inorganic acid.
19. The ointment of claim 12 where the nitrite salt is an inorganic salt.
20. The ointment of claim 12 where the nitrite salt is sodium nitrite.
21. The ointment of claim 12 where the medium is an aqueous gel.
22. The ointment of claim 12 where the medium is an organic salve.
23. A composition for generating and controlling the release rate of NO for topical applications comprising a first aqueous gel and a second aqueous gel, the first gel comprising a nitrite salt, and the second gel comprising an acid having a pka between about 1 and about 4 and at least one of the first and second gel comprising a reluctant.
24. The composition of claim 22 where the reluctant is ascorbic acid, an ascorbate salt, an erythrobate or .alpha.-tocopherol.
25. The composition of claim 22 where the reductant is ascorbic acid.
26. The composition of claim 22 where thewhere the acid is an organic acid.
27. The composition of claim 22 where the acid is maleic acid.
28. The composition of claim 22 where the acid is an inorganic acid.
29. The composition of claim 22 where the nitrite salt is an inorganic salt.
30. The composition of claim 22 where the nitrite salt is sodium nitrite.
31. A method for delivering the two gels of the composition of claim 22 from a single container with two separate chambers by forcing them through a nozzle with a hole for each chamber.
32. A method for topical application of the gels of the composition of claim 22 in layers, with the nitrite-containing gel layer being in contact with the skin, the second gel layer being separated from the first by an impermeable plastic or metal foil until just before use, when the plastic or foil is removed, and the gel layers are topically applied.
33. A method in which the ointment of claim 12 or the two gels of the composition of claim 22 are applied on the skin through an interposed gas-permeable membrane for lessening any skin irritation.
34. A gel comprising a nitrite salt, an acid with a pKa between 1 and 4, and a reductant, for medical use.
35. A kit containing a first gel comprising a nitrite salt, a second gel comprising an acid with a pKa between 1 and 4, and a reductant in at least one of the first and second gels.
CA2410990A 1998-06-10 2000-05-24 Systems and methods for topical treatment with nitric oxide Expired - Fee Related CA2410990C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/095,174 US6103275A (en) 1998-06-10 1998-06-10 Systems and methods for topical treatment with nitric oxide
PCT/US2000/014239 WO2001089572A1 (en) 1998-06-10 2000-05-24 Systems and methods for topical treatment with nitric oxide

Publications (2)

Publication Number Publication Date
CA2410990A1 true CA2410990A1 (en) 2001-11-29
CA2410990C CA2410990C (en) 2011-08-02

Family

ID=22250448

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2410990A Expired - Fee Related CA2410990C (en) 1998-06-10 2000-05-24 Systems and methods for topical treatment with nitric oxide

Country Status (7)

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US (2) US6103275A (en)
EP (1) EP1283724B1 (en)
AT (1) ATE430584T1 (en)
AU (2) AU5042600A (en)
CA (1) CA2410990C (en)
DE (1) DE60042174D1 (en)
WO (1) WO2001089572A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011085484A1 (en) * 2010-01-13 2011-07-21 Nitric Solutions Inc. Antimicrobial nitric oxide compositions

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US7048951B1 (en) 2006-05-23
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