Dusa Pharmaceuticals, Inc.

Allyn Golub

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.

Sterilized 5-aminolevulinic acid

A method and apparatus for storing, mixing and applying ALA as a treatment for lesions. The apparatus comprises a deformable container enclosing a hermetically sealed compartment of essentially anhydrous ALA which is shielded from exposure to air and moisture, and a liquid diluent. The liquid diluent may be in a second compartment. The deformable container is squeezed to crush the compartments and mix the essentially anhydrous ALA with the liquid diluent. The ALA may be delivered from the deformable container through a point applicator for controlling and precisely directing the application during treatment.

Method and apparatus for applying 5-aminolevulinic acid

Colored 5-aminolevulinic acid crystals useful for photodynamic therapy are 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.

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Miramar, FL, United States of America

Allyn Golub