Nanoparticle dispersion containing lactam compound

• US 20090004277A1
• Filed: 05/16/2005
• Published: 01/01/2009
• Est. Priority Date: 05/18/2004
• Status: Abandoned Application

• Current Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Original Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Inventors: Franchini, Miriam K., Liversidge, Elaine, Haby, Thomas A.
• Application Number:
  US11/129,807
• Publication Number:
  US 20090004277A1
• Time in Patent Office: Days
• US Class Current: 424/489
• CPC Class Codes: A61K 31/427 not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/145 with organic compounds
• CPC Class Codes: A61K 9/146 with organic macromolecular compounds
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 7/06 Antianaemics
• CPC Class Codes: A61P 9/06 : Antiarrhythmics
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Disclosed is a nanoparticle dispersion comprising nanoparticles dispersed in an aqueous medium in the presence of at least one stabilizer. The nanoparticles comprise at least lactam compound of formula I:

wherein R¹, R², R³, R⁴, R⁵, R⁶, R⁷, and Q are defined herein. A method is provided of the parenteral administration of the nanoparticle dispersion as a treatment for cancer or another proliferative disease. Also, a solid nanoparticulate composition comprising the nanoparticles of the lactam compound, and a method of administration are disclosed.

Claims

1. A nanoparticle dispersion comprising:

i) nanoparticles having an average particle diameter of less than about 1 micron and which comprise at least one lactam compound having the formula;

3. The nanoparticle dispersion according to claim 1 comprising up to about 40 weight % of said nanoparticles, based on weight of said nanoparticle dispersion.

4. The nanoparticle dispersion according to claim 1 comprising from about 0.1 to about 10 weight % of said at least one stabilizer, based on weight of said nanoparticle dispersion.

5. The nanoparticle dispersion according to claim 1 wherein said liquid medium is an aqueous medium.

6. The nanoparticle dispersion according to claim 5 wherein said at least one stabilizer is selected from the group consisting of sodium deoxycholate, polyvinylpyrrolidone, albumin, polyethylene glycol-phospholipids, lecithin, and block copolymers of ethylene oxide and propylene oxide.

7. The nanoparticle dispersion according to claim 5 wherein said aqueous medium has a pH in a range of from about 4 to about 9.

8. The nanoparticle dispersion according to claim 5 comprising, based on weight of said nanoparticle dispersion:

i) from about 0.1 to about 40 weight % of said nanoparticles comprising said lactam compound of formula I having formula;

9. A process for making a solid nanoparticulate composition comprising:

nanoparticles comprising at least one lactam compound

10. A solid nanoparticulate composition prepared according to claim 9.

12. A method for treating cancer or other proliferative diseases in a mammal, comprising:

administering an effective amount of a pharmaceutical composition to said mammal, wherein said pharmaceutical composition comprises a nanoparticle dispersion according to claim 1.

13. The method according to claim 12 wherein said pharmaceutical composition is administered intravenously.

14. The method according to claim 12 wherein said cancer is breast cancer, prostate cancer, or lung cancer.

15. The method according to claim 12 wherein said lactam compound of formula I is:

19. A solid nanoparticulate composition comprising the lactam compound having the formula,

2. (canceled)

11. (canceled)

16-18. -18. (canceled)