Treatment of lung diseases and pre-lung disease conditions

• US 20060034906A1
• Filed: 05/23/2005
• Published: 02/16/2006
• Est. Priority Date: 05/21/2004
• Status: Abandoned Application

• Current Assignee: Transave Inc. (Insmed Incorporated)
• Original Assignee: Transave Inc. (Insmed Incorporated)
• Inventors: Boni, Lawrence T., Pilkiewicz, Frank G., Perez-Soler, Roman, Perkins, Walter
• Application Number:
  US11/135,625
• Publication Number:
  US 20060034906A1
• Time in Patent Office: Days
• US Class Current: 424/450
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/575 substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• CPC Class Codes: A61K 33/24 Heavy metals; Compounds thereof
• CPC Class Codes: A61K 33/242 Gold; Compounds thereof
• CPC Class Codes: A61K 33/243 Platinum; Compounds thereof
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61K 9/127 Liposomes
• CPC Class Codes: A61K 9/1277 Processes for preparing; Proliposomes
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

In part, the present invention relates to a method of treating lung diseases and pre-lung disease conditions such as precancerous lesions comprising administering to a patient in need a therapeutic agent comprising lipid composition. The present invention also relates to an inhalation device for administering lipid complexes comprising therapeutic agents. The inhalation device may be disposable. In one embodiment, the lung diseases pretreated by the methods of the present invention are those diseases associated with tobacco related products. The present invention also relates to a method of preparing liposomes by an infusion method that yields high entrapment percentages.

Claims

1. A method of treating lung diseases or pre-lung disease conditions in a subject in need thereof comprising administering to the subject a lipid formulation comprising an anticancer agent, wherein

a) the dose amount of anticancer agent is in the range of 1.5 mg/m² to 80 mg/m², and

b) the frequency of treatment cycles is no greater than 3 weeks.

2. The method of claim 1, wherein the anticancer agent is a platinum compound.

3. The method of claim 1, wherein the anticancer agent is cisplatin.

4. The method of claim 1, wherein the lipid formulation comprises a phospholipid.

5. The method of claim 1, wherein the lipid formulation comprises a steroid.

6. The method of claim 1, wherein the lipid formulation comprises a sterol.

7. The method of claim 1, wherein the lipid formulation comprises a phospholipid and a sterol.

8. The method of claim 1, wherein the lipid formulation comprises dipalmitoylphosphatidylcholine (DPPC) and cholesterol.

9. The method of claim 1, wherein the frequency of treatment cycles is no greater than 2 weeks.

10. The method of claim 1, wherein the frequency of treatment cycles is no greater than 1 week.

11. The method of claim 1, wherein the treatment is daily for anywhere from 1 to 7 days.

12. The method of claim 1, wherein the dose amount of the anticancer agent is in the range of 3.0, 6.0, 12.0, 24.0, 30.0, 36.0, 40.0, 48.0, or 60.0 mg/m² to 80 mg/m².

13. The method of claim 1, wherein the lipid formulation is administered by inhalation.

14. The method of claim 1, wherein the lipid formulation is administered intraperitonealy.

15. The method of claim 1, wherein the lipid formulation is administered intravenously.

16. The method claim 1, wherein the anticancer agent is a platinum compound, and the liposome formulation comprises a phospholipid and a sterol.

17. The method of claim 1, wherein the anticancer agent is a platinum compound, and the frequency of treatment cycles is no greater than 2 weeks.

18. The method of claim 1, wherein the anticancer agent is a platinum compound, and the frequency of treatment cycles is no greater than 1 week.

19. The method of claim 1, wherein the anticancer agent is a platinum compound and the dose amount of the platinum compound is in the range of 3.0, 6.0, 12.0, 24.0, 30.0, 36.0, 40.0, 48.0, or 60.0 mg/m² to 80 mg/m².

20. The method of claim 1, wherein the anticancer agent is cisplatin and the lipid formulation comprises a phospholipid and a sterol.

21. The method of claim 1, wherein the anticancer agent is cisplatin and the lipid formulation comprises DPPC and cholesterol.

22. The method of claim 1, wherein the anticancer agent is cisplatin and the frequency of treatment cycles is no greater than 2 weeks.

23. The method of claim 1, wherein the anticancer agent is cisplatin and the frequency of treatment cycles is no greater than 1 week.

24. The method of claim 1, wherein the anticancer agent is cisplatin and the dose amount of the cisplatin is in the range of 3.0, 6.0, 12.0, 24.0, 30.0, 36.0, 40.0, 48.0, or 60.0 mg/m to 80 mg/m².

25. The method of claim 1, wherein the anticancer agent is cisplatin, the lipid formulation comprises DPPC and cholesterol, and the frequency of treatment cycles is no greater than 2 weeks.

26. The method of claim 1, wherein the anticancer agent is cisplatin, the lipid formulation comprises DPPC and sterol, the frequency of treatment cycles is no greater than 2 weeks, and the dose amount of the cisplatin is in the range of 3.0, 6.0, 12.0, 24.0, 30.0, 36.0, 40.0, 48.0, or 60.0 mg/m² to 80 mg/m².

27. The method of claim 1, wherein the anticancer agent is cisplatin, the lipid formulation comprises DPPC and sterol, and the frequency of treatment cycles is no greater than 1 week.

28. The method of claim 1, wherein the anticancer agent is cisplatin, the lipid formulation comprises DPPC and sterol, the frequency of treatment cycles is no greater than 1 week, and the dose amount of the cisplatin is in the range of 3.0, 6.0, 12.0, 24.0, 30.0, 36.0, 40.0, 48.0, or 60 mg/m² to 80 mg/m².

29. The method of claim 1, wherein the anticancer agent is cisplatin, the lipid formulation comprises DPPC and cholesterol, the frequency of treatment cycles is no greater than 2 weeks, and the dose amount of the cisplatin is in the range of 3.0, 6.0, 12.0, 24.0, 30.0, 36.0, 40.0, 48.0, or 60.0 mg/m² to 80 mg/m².

30. The method of claim 1, wherein the anticancer agent is cisplatin, the lipid formulation comprises DPPC and sterol, the frequency of treatment cycles is no greater than 1 week.

31. The method of claim 1, wherein the anticancer agent is cisplatin, the lipid formulation comprises DPPC and cholesterol, the frequency of treatment cycles is no greater than 1 week, and the dose amount of the cisplatin is in the range of 3.0, 6.0, 12.0, 24.0, 30.0, 36.0, 40.0, 48.0, or 60.0 mg/m² to 80 mg/m².

32. A system for treating lung diseases or pre-lung disease conditions in a subject in need thereof comprising:

a) a lipid formulation comprising an anticancer agent, wherein the dose amount of anticancer agent is in the range of 1.5 mg/m² to 80 mg/m², and the frequency of treatment cycles is no greater than 3 weeks; and

b) an inhalation device.

33. The system of claim 32, wherein the inhalation device is disposable.