Claims for Patent: 5,306,509

Summary for Patent: 5,306,509

Title:	Prevention and treatment of oral lesions
Abstract:	The present invention involves a preparation adapted for prophylaxis and treatment of oral lesions, The preparation comprises water, 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 hydrogen peroxide is about 0.4% and the sodium bicarbonate is about 0.2%. Additionally, a method for prophylaxis and treatment of oral lesions is included in the present invention. This method involves the step of initially providing a preparation preferably 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, enhances healing of oral lesions and impedes or prevents the development of oral lesions such as, for example, those frequently incident to cancer chemotherapy. SOL also appears to be dental plaque retardant. The clinical crowns of the patients teeth appear to be free of debris during the periods of significant myelosuppression when dental flossing and toothbrushing should not and were not performed.
Inventor(s):	Turner; Robert E. (Coraopolis, PA)
Assignee:
Application Number:	07/423,500
Patent Claims:	1. A method for prophylaxis and treatment of oral lesions incident to use of a chemotherapeutic agent, the method comprising the steps of: identifying a patient with a susceptibility to or already having oral lesions incident use of a chemotherapeutic agent; and orally rinsing said patient multiple times per day for a period of time at least as long as the chemotherapeutic agent is administered, and until the patient is hematologically competent, with a premixed aqueous solution consisting essentially of between about 0.1% and about 0.8% hydrogen peroxide, and between about 0.1% and about 0.4% sodium bicarbonate, wherein the premixed aqueous solution is therapeutically effective for at least 6 days after mixture stored in a light impeding container. 2. A method for preventing oral lesions incident use of a chemotherapeutic agent, the method comprising the steps of: identifying a patient with a susceptibility to oral lesions incident use of a chemotherapeutic agent; and orally rinsing said patient multiple times per day for a period of time at least as long as the chemotherapeutic agent is administered, and until the patient is hematologically competent, with a premixed aqueous solution comprising between about 0.1% and about 0.8% hydrogen peroxide, and between about 0.1% and about 0.4% sodium bicarbonate, wherein the premixed aqueous solution is therapeutically effective for at least 6 days stored in a light impeding container. 3. A method for treating oral lesions incident use of a chemotherapeutic agent, the method comprising the steps of: identifying a patient with a susceptibility to, or with oral lesions incident to use of, a chemotherapeutic agent; and orally rinsing said patient multiple times per day for a period of time at least as long as chemotherapy is conducted, and until the patient is hematologically competent, with a premixed aqueous solution consisting essentially of between about 0.1% and about 0.8% hydrogen peroxide, and between about 0.1% and about 0.4% sodium bicarbonate, wherein the premixed aqueous solution is therapeutically effective for at least 6 days after mixture stored in a light impeding container. 4. The method of claim 1, 2 or 3 wherein the aqueous solution comprises between about 20% and about 50% isotonic saline solution. 5. The method of claim 1, 2 or 3 wherein the aqueous solution comprises about 0.4% hydrogen peroxide. 6. The method of claim 1, 2 or 3 wherein the aqueous solution, comprises ethyl alcohol. 7. The method of claim 1, 2 or 3 wherein the aqueous solution comprises about 0.2% sodium bicarbonate. 8. The method of claim 1, 2 or 3 wherein the aqueous solution comprises between about 0.5% and about 2.0% ethyl alcohol. 9. The method of claim 1, 2 or 3 wherein the aqueous solution consists essentially of about 0.4% hydrogen peroxide and about 0.2% sodium bicarbonate. 10. The method of claim 1, 2 or 3, wherein the chemotherapeutic agent is an orally toxic chemotherapeutic agent Ara-C, 5-fluorouracil, daunomycin, methotrexate, m-AMSA, cis-platinum, bleomycin or cytosine arabinoside. 11. The method of claim 1, 2 or 3 wherein the premixed aqueous solution is stored in an amber-colored light impeding container. 12. A premixed aqueous 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, said premixed aqueous formulation being therapeutically effective for treating oral lesions for at least 6 days stored in a light impeding container. 13. The premixed aqueous formulation of claim 12 wherein the formulation has a pH of between 8.2-8.4 and is stored in an amber-colored light impeding container.

Details for Patent 5,306,509

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		2011-04-26