Claims for Patent: 5,296,216

Summary for Patent: 5,296,216

Title:	Prevention and treatment of oral lesions
Abstract:	The present invention involves a preparation adapted for prophylaxis and treatment of oral lesions. The preparation is suitable for use as an oral lavage, and comprises water, hydrogen peroxide in a premixed aqueous form in the preparation mixture, with between about 0.1% and about 0.4% sodium bicarbonate. To produce such a preparation adapted for the prophylaxis and treatment of oral lesions most preferably involves dissolving hydrogen peroxide and sodium bicarbonate in an aqueous solution to produce a premixed preparation having between about 0.1% and about 0.8% hydrogen peroxide and between about 0.1% and about 0.4% sodium bicarbonate. In more preferable embodiments of the present invention, the oral lavage (formulation) includes hydrogen peroxide at a concentration of about 0.4% and sodium bicarbonate at a concentration of about 0.2%. Additionally, a method for prophylaxis and treatment of oral lesions incident the use of chemotherapeutic agents is included in the present invention. This method involves the step of initially providing a premixed preparation comprising water, between about 0.1% and about 0.8% hydrogen peroxide and between about 0.1% and about 0.4% sodium bicarbonate. Oral rinsing with said preparation, particularly multiple daily oral rinsing, is shown to enhance healing of oral lesions and impedes or prevents the development of oral lesions.
Inventor(s):	Turner; Robert E. (Coraopolis, PA)
Assignee:
Application Number:	07/766,365
Patent Claims:	1. A premixed hydrogen peroxide and sodium bicarbonate pharmaceutical formulation for the treatment of oral lesions consisting essentially of between about 0.1% and about 0.8% hydrogen peroxide and between about 0.1% and about 0.4% sodium bicarbonate, together in sterile saline or sterile water. 2. An oral lavage preparation for prophylaxis and treatment of oral lesions, the preparation consisting essentially of a premixed formulation of water, about 0.4% hydrogen peroxide, about 0.2% sodium bicarbonate and about 30% isotonic saline. 3. The oral lavage of claim 2 wherein the oral lesions are incident therapy of a patient with a chemotherapeutic agent. 4. The oral lavage of claim 2 wherein the oral lesions are stomatitis lesions. 5. The oral lavage of claim 2 wherein the oral lavage is stored in a light impeding container. 6. The pharmaceutical formulation of claim 1 wherein the hydrogen peroxide is in premixed aqueous form in contact with sodium bicarbonate. 7. A method for prophylaxis and treatment of oral lesions in a patient, the method comprising the steps of: identifying a susceptibility to a presence of oral lesions in a patient; preparing a premixed formulation consisting essentially of about between about 0.1% and about 0.8% hydrogen peroxide, about between about 0.1% and about 0.4% sodium bicarbonate and about 30% isotonic saline; storing said premixed formulation in a light-impeding container; and orally rinsing the identified patient multiple times per day for a period of time at least as long as the lesion is present with the premixed formulation. 8. The method of claim 7 wherein the oral lesions are induced by a chemotherapeutic agent. 9. A method for producing an oral lavage for use in the prevention of chemotherapeutic agent-induced oral lesions comprising: preparing a premixed aqueous solution consisting essentially of about 0.4% hydrogen peroxide, about 0.2% sodium bicarbonate and about 30% isotonic saline; and storing the premixed aqueous solution in a light impeding container. 10. A method for producing an oral lavage for use in the prophylaxis and treatment of chemotherapeutic agent-induced oral lesions, the method comprising: dissolving hydrogen peroxide and sodium bicarbonate in an aqueous solution to produce a preparation consisting of between about 0.1% and about 0.8% hydrogen peroxide and between about 0.1% and about 0.4% sodium bicarbonate; and storing the preparation in a light impeding container until use. 11. A method for treatment of chemotherapeutic agent-induced oral lesions, the method comprising: identifying a patient having chemotherapeutic agent-induced oral lesions; orally treating the patient with a premixed oral lavage consisting essentially of water, between about 0.1% and about 0.8% hydrogen peroxide and between about 0.1% and about 0.4% sodium bicarbonate; and repeating the treatment of the patient until the chemotherapy-induced lesions are reduced in size. 12. An oral lavage for prophylaxis of chemotherapeutic agent-induced oral lesions, the oral lavage consisting essentially of water, between about 0.1% and about 0.8% hydrogen peroxide and between about 0.1% and about 0.4% sodium bicarbonate. 13. The oral lavage of claim 12 defined further as comprising between about 20% and about 50% isotonic saline solution. 14. The oral lavage of claim 12 defined further as comprising about 0.4% hydrogen peroxide. 15. The oral lavage of claim 12 defined further a comprising ethyl alcohol. 16. The oral lavage of claim 12 defined further as comprising about 0.2% sodium bicarbonate. 17. The method of claim 7 or claim 11 wherein the oral lavage is defined further as including about 0.4% hydrogen peroxide, about 0.2% sodium bicarbonate and about 30% isotonic saline. 18. The method of claim 7 or claim 11 wherein the oral lavage is defined further as comprising between about 20% and about 50% isotonic saline solution. 19. The method of claim 7 or claim 11 wherein the oral lavage is defined further as comprising about 0.4% hydrogen peroxide. 20. The method of claim 9 or claim 10 wherein the oral lavage is defined further as comprising about 0.2% sodium bicarbonate. 21. The method of claim 9 or claim 10 wherein the chemotherapeutic agent-induced oral lesion is induced by the chemotherapeutic agent methotrexate, 5-fluorouracil, Ara-C, cis-platinum, m-AMSA, daunorubicin, bleomycin, cytosine arabinoside or a mixture thereof.

Details for Patent 5,296,216

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2011-03-22