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Claims for Patent: 5,591,731

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Claims for Patent: 5,591,731

Title: Crystalline amifostine compositions
Abstract:The present invention relates to a sterile, stable vacuum dried crystalline amifostine composition and, optionally, pharmaceutically acceptable excipient(s). Typically, the crystalline compositions of the present invention exhibit enhanced stability at temperatures ranging from about 4.degree. C. to about ambient temperature for a period of at least 2 years relative to existing solid vacuum dried amorphous amifostine preparations. The reconstituted compositions of the present invention are suitable for administration to humans as a radio- or chemoprotecting agent.
Inventor(s): Kennedy; Paul E. (Phoenixville, PA), Rajewski; Roger A. (Lawrence, KS), Baldoni; John M. (Glenmore, PA)
Assignee: U.S. Bioscience, Inc. (West Conshohocken, PA)
Application Number:08/389,386
Patent Claims: 1. A dosage form of crystalline amifostine comprising thermally-stable, sterile, crystalline amifostine trihydrate exhibiting substantially the crystal structure having a space group of P2.sub.1 2.sub.1 2.sub.1 and cell dimensions of about a=8.46 .ANG., b=21.55 .ANG. and c=6.76 .ANG., which is suitable for reconstitution with a pharmaceutically acceptable vehicle into an injectable particulate-free drug product for parenteral administration to a subject.

2. The dosage form of claim 1 wherein said crystalline amifostine trihydrate forms less than about 2% 2-[(3-aminopropyl)amino]ethane thiol when sealed in a nitrogen filled vial and heated to 40.degree. C. for one week.

3. The dosage form of claim 1 wherein said crystalline amifostine trihydrate forms less than about 2% 2-[(3-aminopropyl)amino]ethane thiol when sealed in a nitrogen filled vial and heated to 40.degree. C. for four weeks.

4. The dosage form of claim 1 wherein said crystalline amifostine trihydrate is thermally stable at about 4.degree. C. for at least two years.

5. The dosage form of claim 1 wherein said crystalline amifostine trihydrate is thermally stable at about ambient temperature for at least two years.

6. The dosage form of claim 1 further comprising a pharmaceutically acceptable excipient.

7. The dosage form of claim 6 in which said excipient is selected from the group consisting of sodium chloride glycine, dextrose, sucrose and mannitol.

8. The dosage form of claim 7 in which said excipient is mannitol.

9. The dosage form of claim 1 in which said vehicle is Water for Injection, USP, or normal saline.

10. The dosage form of claim 1 which is a sterile single dose formulation.

11. The dosage form of claim 10 further comprising about 10 to about 10,000 mgs. of said crystalline amifostine trihydrate, and, optionally, about 10 to about 10,000 mgs. of a pharmaceutically acceptable excipient.

12. The dosage form of claim 1 wherein said crystalline amifostine trihydrate is vacuum dried.

13. A sealed container containing a dosage form of crystalline amifostine according to claim 1, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

14. A dosage form of crystalline amifostine comprising thermally-stable, sterile, crystalline amifostine, which is suitable for reconstitution with a pharmaceutically acceptable vehicle into an injectable particulate-free drug product for parenteral administration to a subject.

15. A sealed container containing a dosage form of crystalline amifostine according to claim 14, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

16. The dosage form of claim 14 wherein said crystalline amifostine forms less than about 2% 2-[(3-aminopropyl)amino]ethane thiol when sealed in a nitrogen filled vial and heated to 40.degree. C. for one week.

17. The dosage form of claim 14 wherein said crystalline amifostine forms less than about 2% 2-[(3-aminopropyl)amino]ethane thiol when sealed in a nitrogen filled vial and heated to 40.degree. C. for four weeks.

18. The dosage form of claim 14 wherein said crystalline amifostine is thermally stable at about 4.degree. C. for at least two years.

19. The dosage form of claim 14 wherein said crystalline amifostine is thermally stable at about ambient temperature for at least two years.

20. The dosage form of claim 14 further comprising a pharmaceutically acceptable excipient.

21. The dosage form of claim 21 in which said excipient is selected from the group consisting of sodium chloride, glycine, dextrose, sucrose and mannitol.

22. The dosage form of claim 21 in which said excipient is mannitol.

23. The dosage form of claim 14 in which said vehicle is Water for Injection, USP, or normal saline.

24. The dosage form of claim 14 which is a sterile single dose formulation.

25. The dosage form of claim 24 further comprising about 10 to about 10,000 mgs. of said crystalline amifostine and, optionally, about 10 to about 10,000 mgs. of a pharmaceutically acceptable excipient.

26. The dosage form of claim 14 wherein said crystalline amifostine is vacuum dried.

27. A sealed container a dosage form of crystalline amifostine according to claim 16, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

28. A sealed container containing a dosage form of crystalline amifostine according to claim 17, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

29. A sealed container containing a dosage form of crystalline amifostine according to claim 18, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

30. A sealed container containing a dosage form of crystalline amifostine according to claim 19, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

31. A sealed container containing a dosage form of crystalline amifostine according to claim 20, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

32. A sealed container containing a dosage form of crystalline amifostine according to claim 21, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

33. A sealed container containing a dosage form of crystalline amifostine according to claim 22, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

34. A sealed container containing a dosage form of crystalline amifostine according to claim 23, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

35. A sealed container containing a dosage form of crystalline amifostine according to claim 24, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

36. A sealed container containing a dosage form of crystalline amifostine according to claim 25, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.

37. A sealed container containing a dosage form of crystalline amifostine according to claim 26, said container having sufficient volume to allow for said reconstitution and having a sealing means for maintaining a sterile environment and for allowing entry into the container of the vehicle for reconstitution.
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