Claims for Patent: 6,335,465

Summary for Patent: 6,335,465

Title:	Sterilized 5-aminolevulinic acid
Abstract:	Colored 5-aminolevulinic acid crystals useful for photodynamic therapy Eire disclosed. Preferably the colored 5-aminolevulinic acid crystals have the color imparted by irradiation of the crystals, such as gamma radiation. The colored ALA crystals are preferably pharmaceutically pure and sterile and can be contained in a sealed sterile container. Also disclosed is sterile aqueous ALA solution which includes the colored ALA crystals contained in water. Also disclosed is a method for preparing colored ALA crystals which includes exposing non-irradiated ALA crystals to a radiation source at a dose sufficient impart a color which is different than any color present in the non-irradiated crystals. Preferably the irradiation is sufficient to sterilize the ALA crystals. The sterile colored ALA crystals can be used in a kit for internal or external treatment and/or detection of a condition in a mammal, which includes the sterile, colored ALA crystals and sterile diluent, and in the case of internal treatment and/or detection optionally a catheter for administration of the ALA.
Inventor(s):	Golub; Allyn (Miramar, FL)
Assignee:	Dusa Pharmaceuticals, Inc. (Ontario, CA)
Application Number:	09/486,604
Patent Claims:	1. Colored 5-aminolevulinic acid crystals, wherein said color is imparted by irradiation of the crystals. 2. The yellow ALA crystals according to claim 1, wherein said crystals are pharmaceutically pure and sterile. 3. The yellow ALA crystals according to claim 1, wherein said irradiation is ganmna irradiation. 4. The yellow ALA crystals according to claim 3, wherein said gamma irradiation is sufficient to sterilize said crystals. 5. The yellow ALA crystals according to claim 4, wherein said gamma irradiation provides a dose of at least 5 kilograys. 6. The yellow ALA crystals according to claim 4, wherein said gamma irradiation provides a dose of at least 25 kilograys. 7. The yellow ALA crystals according to claim 1, wherein said ALA contains less than 2.0 wt % impurities. 8. The yellow ALA crystals according to claim 1, wherein said ALA contains less than 1.0 wt % impurities. 9. The yellow ALA crystals according to claim 1. wherein said ALA contains less than 0.5 wt % impurities. 10. The yellow ALA crystals according to claim 1, wherein said crystals dissolved in an aqueous solution have substantially the same spectroscopic, chromatographic, solution pH and solubility profile as nonirrmdiated 5-aminolevulinic acid. 11. A sterile ALA solution comprising the colored ALA crystals according to claim 2, contained in a diluent. 12. A sterile package comprising colored ALA crystals according to claim 2 in a scaled sterile container. 13. A sterile package according to claim 12, wherein the container is sterilized by irradiation. 14. A method for preparing colored ALA crystals according to claim 1, comprising exposing non-irradiated ALA crystals to a radiation source at a dose sufficient to inpart a color which is different than any color present in the non-irradiated crystals. 15. A method for preparing colored ALA crystals according to claim 14 further comprising: placing non-irradiated ALA crystals into a container; scaling said container; and exposing the non-irradiated ALA crystals and the container to a radiation source at a dose sufficient to impart a color which is different than any color present in the non-irradiated crystals and is sufficient to sterilize said crystals and container. 16. A kit for internal treatment and/or detection of a condition in a mammal, comprising the sterile colored ALA crystals according to claim 2 and sterile diluent. 17. A kit according to claim 16, further comprsing a catheter. 18. A kit according to claim 16, wherein the colored ALA crystals are packaged in a sterile container. 19. A method of admrinisterig 5-aminolevulinic acid in a stable form for internal and/or external mammal administration which comprises the administration of a solution of ALA derived from the colored ALA according to claim 1. 20. Yellow 5-aminolevuinic acid crystals comprising an F-center point defect in the crystal lattice, wherein said F-center point defect imparts said yellow color to the crystals. 21. A method for targeting hyperproliferative cells or tissues comprising: administering a solution of ALA derived from the colored ALA according to claim 1 to the hyperproliferative cells or tissues of a subject in need thereof; and irradiating the target cells or tissues with light for a time sufficient to damage or destroy the hyperproliferative cells or tissues. 22. A method for targeting malignant hyperproliferative cells or tissues comprising: administering a solution of ALA derived from the colored ALA according to claim 1 to the malignant hyperproliferative cells or tissues of a subject; and irradiating the target cells or tissues with light for a time sufficient to damage or destroy the malignant hyperproliferative cells or tissues. 23. A method for targeting cells or tissues infected with an infective agent comprising: administering a solution of ALA derived from the colored ALA according to claim 1 to the cells or tissues infected with an infective agent of a subject; and irradiating the target cells or tissues with light for a time sufficient to damage or destroy the cells or tissues infected with an infective agent wherein the infective agent is of a viral, bacteria, parasite, or fungal origin. 24. A method for targeting cells or tissues of viral, bacteria, parasite or fungal origin comprising: administering a solution of ALA derived from the colored ALA according to claim 1 to the cells or tissues of viral, bacteria, parasite or fungal origin; and irradiating the target cells with light for a time sufficient to damage or destroy the cells or tissues of viral, bacteria, parasite or fungal origin. 25. A method for treating actinic keratoses comprising: administering a solution of ALA derived from the colored ALA according to claim 1 to an afflicted region of a subject in need thereof; and irradiating the afflicted region with light for a time sufficient to treat the actinic keratoses. 26. A method for hair removal comprising: administering a solution of ALA derived from the colored ALA according to claim 1 to a region of a subject in need of hair removal; and irradiating the region with light for a time sufficient to remove hair. 27. A method for treating acne comprising: administering a solution of ALA derived from the colored ALA according to claim 1 to an acne containing region of a subject; and irradiating the region with light for a time sufficient to treat acne. 28. A method for treatment of endometrial ablation comprising: administering a solution of ALA derived from the colored ALA according to claim 1 to a region of a subject in need thereof; and irradiating the region with light for a time sufficient to treat endometrial ablation. 29. A sterile package comprising colored ALA crystals according to claim 2 in a sealed sterile container, wherein the container is darkened by the irradiation. 30. A kit according to claim 16, further comprising a endoscope. 31. A method of administering 5-aminolevulinic in a stable form for external mammal administration which comprises applying a solution of ALA derived from the colored ALA according to claim 1 with an applicator to a subject in need thereof. 32. A method for treating bladder cancer comprising: administering a solution of ALA derived from the colored ALA according to claim 1 to a bladder containing malignant cells; and irradiating the bladder with light for a time sufficient to damage or destroy the malignant cells.

Details for Patent 6,335,465

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		2017-09-02