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US Patent 4996193 - Combined topical and systemic method of administration of cyclosporine

US Patent Issued on February 26, 1991
Estimated Patent Expiration Date: Icon_subject March 3, 2009Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
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Abstract

The present invention provides formulations for the topical application of cyclosporin to skin tissue for treatment of autoimmune, T-cell mediated immune disease, and inflammatory conditions, and for producing prolonged skin allograft survival and wound healing. In addition, methods for the use of said formulations--in tandem with systemic applications of cyclosporin or without same--are suggested. The present invention also suggests alternative formulations and delivery systems for the efficacious treatment of the aforementioned conditions, and further suggests a model with which formulations may be tested.

Other References

  • C. W. Hewitt et al., "Cyclosporine and Skin Allografts for the Treatment of Thermal Injury: I. Extensive Graft Survival with Low-Level Long-Term Administration and Prolongation in a Rat Burn Model", Transplantation 45: 13 (1988)
  • A. D. Hess et al., "Mechanisms of Action of Cyclosporine: Effect on Cells of the Immune System and on Subcellular Events in T Cell Activation", Transpl. Proc. 20: 29 (1988)
  • C. N. Ellis et al., "Cyclosporine Improves Psoriasis in a Double-Blind Study", JAMA 256: 3110 (1986)
  • L. H. Toledo-Pereyra et al., "Prolongation of Kidney Transplant Survival by Cyclosporine A Graft Pretreatment", Transplantation 33: 330 (1982)
  • R. D. Aldridge et al., "Inhibition of Contact Sensitivity Reactions to DNFB by Topical Cyclosporin Application in the Guinea-Pig", Clin. Exp. Immunol. 59: 23 (1985)
  • C. S. Lai et al., "Long-Term Survival of Skin Allografts in Rats Treated with Topical Cyclosporine", 44: 83 (1987)
  • X. F. Zhao et al., "The Prolongation of Skin Allograft Survival by Topical Use of Cyclosporine A", Transpl. Proc. 20: 670 (1988)
  • E. Towpik et al., "Cyclosporine and Experimental Skin Allografts", Transpl. 40: 714 (1985)
  • Biren et al., "Prolonged Viability of Human Skin Xenografts in Rats by Cyclosporine", J. Invest. Dermatol. 86: 611 (1986)
  • M. Ried et al., "Cyclosporine Levels in Human Tissues of Patients Treated for One Week to One Year", Transpl. Proc. 15: 2434 (1983)
  • J. Thivolet et al., "Effects of Cyclosporin on Bullous Pemphigoid and Pemphigus", Lancet 1: 334 (1985)
  • J. I. Harper et al., "Cyclosporine for Psoriasis", Lancet 2: 981 (1984)
  • A. W. Thompson et al., "Topical Cyclosporin and Immunologically Mediated Skin Disorders", Lancet 1: 1212 (1987)
  • M. W. Mosteller et al., "Penetration of Topical Cyclosporine into the Rabbit Cornea, Aqueous Humor, and Serum", Arch Opthalmol 103: 101 (1985)
  • S. Levinger et al., "Effects of Systemic Administration of Chlorambucil and Topical Application of Cyclosporin A on Corneal Graft Survival in Rabbits", Isr. J. Med. Sci. 21: 670 (1985)
  • G. F. Babcock et al., "Prolongation of Skin and Graft Survival with Topical Immunosuppression", Seventh International Congress on Burn Injuries, Melbourne, Australia (Feb. 1986)
  • S. Shuster, "Cyclosporine in Dermatology", Transpl. Proc. 20: 19 (1988)
  • K. S. Black et al, "Transdermal Application of Cyclosporine Prolongs Skin Allograft Survival", Transpl. Proc. 20: 660 (1988)
  • C. A. Biren et al., "Dermatologic Applications of Cyclosporine", Arch Dermatol. 122: 1028 (1986)
  • R. D. Aldridge et al., "Cyclosporine and Skin Disease", Lancet 1: 160 (1985)
  • W. Muller et al., "Cyclosporin A for Psoriasis", NEJM 301: 555 (1979

Inventors

Assignee

Application

No. 318676 filed on 03/03/1989

US Classes:

514/11, Monocyclic514/885, IMMUNE RESPONSE AFFECTING DRUG514/886, INFLAMMATION, SKIN514/887Topical Treatment

Field of Search

514/11, Monocyclic514/825, ARTHRITIS514/885, IMMUNE RESPONSE AFFECTING DRUG514/886, INFLAMMATION, SKIN514/887Topical Treatment

Examiners

Primary: Cashion, Merrell C. Jr.
Assistant: Kishore, G. S.

Attorney, Agent or Firm

US Patent References

3288824, 4108985, Dihydrocyclosporin C
Issued on: 08/22/1978
Inventor: Ruegger ,   et al.
4117118, Organic compounds
Issued on: 09/26/1978
Inventor: Harri ,   et al.
4210581, Organic compounds
Issued on: 07/01/1980
Inventor: Ruegger ,   et al.
4220641, Organic compounds
Issued on: 09/02/1980
Inventor: Traber ,   et al.
4288431, Cyclosporin derivatives, their production and pharmaceutical compositions containing them
Issued on: 09/08/1981
Inventor: Traber ,   et al.
4289851, Process for producing cyclosporin derivatives
Issued on: 09/15/1981
Inventor: Traber ,   et al.
4384996, Novel cyclosporins
Issued on: 05/24/1983
Inventor: Bollinger ,   et al.
4388307, Galenical compositions
Issued on: 06/14/1983
Inventor: Cavanak
4396542, Method for the total synthesis of cyclosporins, novel cyclosporins and novel intermediates and methods for their production
Issued on: 08/02/1983
Inventor: Wenger
4553974, Treatment of collagenous tissue with glutaraldehyde and aminodiphosphonate calcification inhibitor
Issued on: 11/19/1985
Inventor: Dewanjee
4554351, Method for the total synthesis of cyclosporins, novel cyclosporins and novel intermediates and methods for their production
Issued on: 11/19/1985
Inventor: Wenger
4639434, Novel cyclosporins
Issued on: 01/27/1987
Inventor: Wenger ,   et al.
4649047, Ophthalmic treatment by topical administration of cyclosporin
Issued on: 03/10/1987
Inventor: Kaswan
4677968, Methods of testing the reaction of various substances on living human skin
Issued on: 07/07/1987
Inventor: Krueger
4681754, Counteracting cyclosporin organ toxicity
Issued on: 07/21/1987
Inventor: Siegl
4703033, Novel cyclosporins
Issued on: 10/27/1987
Inventor: Seebach
4764503, Novel cyclosporins
Issued on: 08/16/1988
Inventor: Wenger
4771122, Novel cyclosporins
Issued on: 09/13/1988
Inventor: Seebach
4839342, Method of increasing tear production by topical administration of cyclosporin
Issued on: 06/13/1989
Inventor: Kaswan
4857662N-phenylbenzamide derivatives
Issued on: 08/15/1989
Inventor: Satzinger ,   et al.

Foreign Patent References

  • 2019512 JP. 01/22/1987
  • 2019513 JP. 01/22/1987
  • 2207678 GB 02/22/1989

International Class

A61K 037/02

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