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Claims for Patent: 4,999,375

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Claims for Patent: 4,999,375

Title: Psoralen reagent compositions for extracorporeal treatment of blood
Abstract:Psoralen compositions for extracorporeal administration to blood prior to reinfusion into a subject comprising a sterile aqueous solution of about 0.005 to about 1 mg/ml of a psoralen ethyl alcohol, propylene glycol and water and having a pH from about 2.0 to about 6.0 are disclosed. These compositions are useful for the therapy of a subject being treated by ultraviolet-A photophoresis.
Inventor(s): Bachynsky; Maria O. (Nutley, NJ), Infeld; Martin H. (Upper Montclair, NJ), Margolis; Richard J. (Wayne, NJ), Perla; Dennis A. (Wayne, NJ)
Assignee: Hoffmann-La Roche Inc. (Nutley, NJ)
Application Number:07/336,179
Patent Claims: 1. A reagent composition for extracorporeal administration to blood prior to reinfusion into a subject, said composition comprising a sterile aqueous solution of about 0.005 mg/ml to about 1 mg/ml of a psoralen, ethyl alcohol, propylene glycol and water, said composition having a pH from about 2.0 to about 5.5.

2. The composition of claim 1 wherein the psoralen is 8-methoxypsoralen (8-MOP).

3. The composition of claim 2 containing from about 0.005-0.05 mg/ml 8-MOP, from about 0.1-15% ethyl alcohol, and about 25-400 mg/ml propylene glycol.

4. The composition of claim 3 containing approximately 0.02 mg/ml 8-MOP, approximately 5% ethyl alcohol, and approximately 50 mg/ml propylene glycol.

5. A reagent composition for extracorporeal administration to blood prior to reinfusion into a subject, said composition comprising a sterile aqueous solution of about 0.005 mg/ml to about 1 mg/ml of a psoralen, ethyl alcohol, propylene glycol, water, and a buffer, said composition having a pH from about 2.0 to about 5.5.

6. The composition of claim 5 wherein the psoralen is 8-MOP.

7. The composition of claim 5 wherein the pH is 3.5 to 4.5.

8. The composition of claim 7 wherein the buffer is selected from the group consisting of acetic acid/acetate, lactic acid/lactate, benzoic acid/benzoate, phosphoric acid/phosphate, maleic acid/malate, or citric acid/citrate.

9. The composition of claim 8 wherein the buffer is acetic acid/sodium acetate.

10. The composition of claim 9 containing from about 0.005-0.05 mg/ml 8-MOP, about 0.1 to 15% alcohol, about 25-400 mg/ml propylene glycol, about 0.01 to 0.25% acetic acid, sodium acetate to pH, and water to volume.

11. The composition of claim 10 containing approximately 0.02 mg/ml 8-MOP, approximately 5% alcohol, approximately 0.12% acetic acid, and approximately 50 mg/ml propylene glycol.

12. The composition of claim 5 wherein the buffer is an inorganic base and an acid selected from the group consisting of lactic, acetic, phosphoric, benzoic, maleic, or citric acid.

13. The composition of claim 12 wherein the inorganic base is sodium hydroxide.

14. The composition of claim 13 wherein the acid is acetic acid.

15. The composition of claim 14 containing from about 0.005-0.05 mg/ml 8-MOP, 0.1 to 15% alcohol, 25-400 mg/ml propylene glycol, 0.01 to 0.25% acetic acid, sodium hydroxide to pH and water to volume.

16. The composition of claim 15 containing approximately 0.02 mg/ml 8-MOP, approximately 5% alcohol, approximately 50 mg/ml propylene glycol, and approximately 0.12% acetic acid.

17. A psoralen composition comprising a lyophilized solution of a psoralen, a bulking agent, a buffer and water, said composition having a pH from about 2.0 to about 5.5 prior to addition to the patient's blood.

18. The composition of claim 17 wherein the psoralen is 8-MOP.

19. The composition of claim 18 wherein the bulking agent is selected from the group consisting of sodium chloride, dextrose, or mannitol.

20. The composition of claim 19 wherein the bulking agent is mannitol and the buffer system is acetic acid/sodium hydroxide.

21. The composition of claim 20 comprising 0.20 mg 8-MOP, 50.00 mg mannitol, 0.012 ml acetic acid, 10% sodium hydroxide to pH and water.

22. The composition of claim 21 which, after lyophilization comprises about 0.20 mg 8-MOP, about 50.00 mg mannitol, a trace of acetic acid, and a trace of sodium hydroxide.

23. A blood composition adapted to be reinfused into a patient undergoing ultraviolet-A photopheresis therapy comprising blood withdrawn from said patient and a sterile aqueous solution of about 0.005 mg/ml to about 1 mg/ml of a psoralen, ethyl alcohol, propylene glycol and water, said solution having a pH from about 2.0 to about 5.5 prior to addition to the patient's blood.

24. A psoralen reagent composition for extra corporeal administration to blood prior to reinfusion into a subject, said composition being stored in a container especially suited to prevent the psoralen from being adsorbed onto or adsorbed into the container and to prevent leaching of the components of the container into the reagent composition, said reagent composition comprising a sterile aqueous solution of about 0.005 mg/ml to about 1 mg/ml of a psoralen, ethyl alcohol, propylene glycol and water and having a pH from about 2.0 to about 5.5.

25. The composition of claim 24 wherein the psoralen is 8-MOP.

26. The composition of claim 24 where the container is suited to hold a unit dose of the psoralen reagent composition.

27. The composition of claim 26 stored in a syringe, ampul or vial.

28. The composition of claim 24 where the container is especially suited to prevent ultraviolet light from reaching the psoralen reagent composition.

29. The composition of claim 28 stored in an amber glass vial stoppered with a fluoro-resin laminated (teflonized) rubber stopper.

30. The composition of claim 29 wherein the concentration of a psoralen is approximately 20 mg/ml in a total volume of about 10 ml of solution.

31. The composition of claim 30 wherein the psoralen is 8-MOP.
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