Claims for Patent: 5,856,364

Summary for Patent: 5,856,364

Title:	Therapeutic antiviral-wound healing compositions and methods for preparing and using same
Abstract:	This invention pertains to therapeutic wound healing compositions for protecting and resuscitating mammalian cells (Embodiment One (I)). This invention also pertains to therapeutic antiviral-wound healing compositions for reducing viral titers and increasing the proliferation and resuscitation rate of mammalian cells (Embodiment Two (II)). In a first aspect of Embodiment One (I.A), the therapeutic wound healing composition comprises (a) pyruvate, (b) an antioxidant, and (c) a mixture of saturated and unsaturated fatty acids. In a second aspect of Embodiment One (I.B), the therapeutic wound healing composition comprises (a) pyruvate, (b) lactate, and (c) a mixture of saturated and unsaturated fatty acids. In a third aspect of Embodiment One (I.C), the therapeutic wound healing composition comprises (a) an antioxidant and (b) a mixture of saturated and unsaturated fatty acids. In a fourth aspect of Embodiment One (I.D), the therapeutic wound healing composition comprises (a) lactate, (b) an antioxidant, and (c) a mixture of saturated and unsaturated fatty acids. In Embodiment Two (II), the therapeutic wound healing compositions of Embodiment One (I.A-D) are combined with a therapeutically effective amount of an antiviral agent (V) to form antiviral-wound healing compositions (II.A-D+V). This invention also pertains to methods for preparing and using the antiviral-wound healing compositions and the topical and ingestible pharmaceutical products in which the therapeutic compositions may be used.
Inventor(s):	Martin; Alain (Ringoes, NJ)
Assignee:	Warner Lambert Company (Morris Plains, NJ)
Application Number:	08/410,079
Patent Claims:	1. A therapeutic antiviral-wound healing composition which comprises a therapeutically effective amount of an antiviral agent and a wound healing composition, wherein the wound healing composition comprises: (a) pyruvate selected from the group consisting of pyruvic acid, pharmaceutically acceptable salts of pyruvic acid, and mixtures thereof; (b) an antioxidant; and (c) a mixture of saturated and unsaturated fatty wherein said fatty acids are those fatty acids required for the resuscitation of injured mammalian cells; wherein components a, b, and c are present in amounts sufficient to synergistically enhance wound healing. 2. The composition according to claim 1, wherein the antiviral agent is selected from the group consisting of acyclovir, foscarnet sodium, ribavirin, vidarabine, ganeiclovir sodium, zidovudine, phenol, amantadine hydrochloride, and interferon alfa-n3. 3. The composition according to claim 2, wherein the antiviral agent is acyclovir. 4. The composition according to claim 1, wherein the pyruvate is selected from the group consisting of pyruvic acid, lithium pyruvate, sodium pyruvate, potassium pyruvate, magnesium pyruvate, calcium pyruvate, zinc pyruvate, manganese pyruvate, methyl pyruvate, .alpha.-ketoglutaric acid, pharmaceutically acceptable salts of pyruvic acid, prodrugs of pyruvic acid, and mixtures thereof. 5. The composition according to claim 4, wherein the pyruvate is sodium pyruvate. 6. The composition according to claim 1, wherein said antioxidant is Vitamin E acetate. 7. The composition according to claim 1, wherein the antiviral agent is present in the therapeutic wound healing composition in an amount from about 0.1% to about 20%, by weight of the therapeutic wound healing composition. 8. The composition according to claim 1, wherein pyruvate is present in the therapeutic wound healing composition in an amount from about 10% to about 50%, by weight of the therapeutic wound healing composition. 9. The composition according to claim 1, wherein the antioxidant is present in the therapeutic wound healing composition in an amount from about 0.1% to about 40%, by weight of the therapeutic wound healing composition. 10. A method for treating an infected wound in a mammal with an antiviral-wound healing composition which comprises administering to a mammal in need thereof: a therapeutic antiviral-wound healing composition which comprises: (1) a therapeutically effective amount of an antiviral agent; and (2) a wound healing composition which comprises: (a) pyruvate selected from the group consisting of pyruvic acid, pharmaceutically acceptable salts of pyruvic acid, and mixtures thereof; (b) an antioxidant; and, (c) a mixture of saturated and unsaturated fatty acids wherein said fatty acids are those fatty acids required for the resuscitation of injured mammalian cells; wherein components a, b, and c are present in synergistic amounts sufficient to synergistically enhance wound healing. 11. An augmented antiviral-wound healing composition having an enhanced ability to prevent and reduce injury to mammalian cells which comprises: (A) a therapeutic antiviral-wound healing composition which comprises: (1) a therapeutically effective amount of an antiviral agent; and (2) a wound healing composition which comprises: a) pyruvate selected from the group consisting of pyruvic acid, pharmaceutically acceptable salts of pyruvic acid, and mixtures thereof; (b) an antioxidant; and, (c) a mixture of saturated and unsaturated fatty acids wherein said fatty acids are those fatty acids required for the repair of cellular membranes and resuscitation of mammalian cells: wherein components a, b, and c are present in amounts sufficient to synergistically enhance wound healing; and, (B) a medicament useful for treating wounds. 12. The augmented antiviral-wound healing composition according to claim 11, wherein the medicament useful for treating wounds is selected from the group consisting of immunostimulating agents, other antiviral agents, antikeratolytic agents, anti-inflammatory agents, antifungal agents, acne treating agents, sunscreen, agents, dermatological agents, antihistamine agents, antibacterial agents, bioadhesive agents, respiratory bursting inhibitors, inhibitors of prostaglandin synthesis, antimicrobial agents, antiseptic agents, anesthetic agents, cell nutrient media, burn relief medications, sun burn medications, insect bite and sting medications, wound cleansers, wound dressings, scar reducing agents, and mixtures thereof. 13. A method for treating an infected wound in a mammal with an augmented antiviral-wound healing composition which comprises administering to a mammal in need thereof: (A) a therapeutic augmented antiviral-wound healing composition which comprises: (1) a therapeutically effective amount of an antiviral agent; (2) a wound healing composition which comprises: (a) pyruvate selected from the group consisting of pyruvic acid, pharmaceutically acceptable salts of pyruvic acid, and mixtures thereof; (b) an antioxidant; and, (c) a mixture of saturated and unsaturated fatty acids wherein said fatty acids are those fatty acids required for the repair of cellular membranes and resuscitation of injured mammalian cells; wherein components a, b, and c present in amount sufficient to synergistically enhance wound healing; and (3) a medicament useful for treating wounds. 14. An antiviral-wound healing pharmaceutical composition which comprises: (A) a therapeutic antiviral-wound healing composition which comprises: (1) a therapeutically effective amount of an antiviral agent; and (2) a wound healing composition which comprises: (a) pyruvate selected from the group consisting of pyruvic acid, pharmaceutically acceptable salts of pyruvic acid, and mixtures thereof; (b) an antioxidant; and, (c) a mixture of saturated and unsaturated fatty acids wherein the fatty acids are those fatty acids required for the repair of cellular membranes and resuscitation of mammalian cells; wherein components a, b, and c are present in amounts sufficient to synergistically enhance wound healing; and, (B) a pharmaceutically acceptable carrier selected from the group consisting of pharmaceutical appliances, bioadhesives, and occlusive vehicles. 15. The composition according to claim 1, wherein the antioxidant is selected from the group consisting of all forms of Vitamin A; all forms of carotene; all forms of Vitamin C; all forms of Vitamin E; Vitamin E esters which readily undergo hydrolysis to Vitamin E; prodrugs of Vitamin A, carotene, Vitamin C, and Vitamin E; pharmaceutically acceptable salts of Vitamin A. carotene, Vitamin C, and Vitamin E; and mixtures thereof. 16. The composition according to claim 1 wherein the mixture of saturated and unsaturated fatty acids is selected from the group consisting of animal and vegetable fats and waxes. 17. The composition according to claim 16, wherein the mixture of saturated and unsaturated fatty acids is selected from the group consisting of human fat, chicken fat, cow fat, sheep fat, horse fat, pig fat, and whale fat. 18. he composition according to claim 17, wherein the mixture of saturated and unsaturated fatty acids comprises lauric acid, myristic acid, myristoleic acid, pentadecanoic acid, palmitic acid, palmitoleic acid, margaric acid, margaroleic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidic acid, and gadoleic acid. 19. The composition according to claim 1, wherein the mixture of saturated and unsaturated fatty acids is present in the therapeutic wound healing composition in an amount from about 10% to about 50%, by weight of the therapeutic wound healing composition.

Details for Patent 5,856,364

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hemispherx Biopharma, Inc.	ALFERON N INJECTION	interferon alfa-n3 (human leukocyte derived)	Injection	103158	10/10/1989		2016-01-05
Hoffmann-la Roche Inc.	PEGASYS COPEGUS COMBINATION PACK	peginterferon alfa-2a and ribavirin		125083	06/04/2004		2016-01-05
Schering Corporation A Subsidiary Of Merck & Co., Inc.	PEGINTRON/ REBETOL COMBO PACK	peginterferon alfa-2b and ribavirin		125196	06/13/2008		2016-01-05