Treatment using D-threo methylphenidate

• US 20060127421A1
• Filed: 12/08/2005
• Published: 06/15/2006
• Est. Priority Date: 12/09/2004
• Status: Abandoned Application

• Current Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Original Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Inventors: Khetani, Vikram
• Application Number:
  US11/298,093
• Publication Number:
  US 20060127421A1
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• 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: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/14 for treating abnormal movements, e.g. chorea, dyskinesia
• 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 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Methods for treating a disease responsive to the administration of methylphenidate and/or one or more isomers thereof, said method comprising identifying a patient suffering from a disease or disorder having a family history or diagnosis of tics or Tourette'"'"'s Syndrome and administering to said patient a therapeutically effective amount of D-threo methylphenidate substantially free of the l-threo isomer and of erythro methylphenidates.

Claims

1. A method for treating a disease or disorder responsive to the administration of D-threo methylphenidate or a salt thereof, said method comprising the steps of:

identifying a patient suffering from said disease or disorder and suffering from Tourette'"'"'s Syndrome or tics or having a family history of Tourette'"'"'s Syndrome or tics; and

administering to said patient a dosage form comprising a therapeutically effective amount of D-threo-methylphenidate or a salt thereof, said D-threo methlyphenidate substantially free of both the l-threo isomer and salts thereof and the erythro methylphenidates and salts thereof.

2. The method of claim 1 wherein said therapeutically effective amount is a bolus dose.

3. The method of claim 1 wherein said dosage form is suitable for oral administration.

4. The method of claim 1 wherein said administration is subcutaneous, intravenous, intramuscular, or interperitoneal.

5. The method of claim 1 wherein said administration is via a pharmaceutical carrier selected from the group consisting of a sterile liquid or mixture of liquids, an alcohol, glycols, glycerol ketals, and ethers.

6. The method of claim 5 wherein said sterile liquid or mixture of liquids is water, saline, aqueous dextrose, or related sugar solutions.

7. The method of claim 5 wherein said alcohol is ethanol.

8. The method of claim 5 wherein said glycols are propylene glycol or polyethylene glycol.

9. The method of claim 5 wherein said glycerol ketal is 2,2-dimethyl-1,3-dioxolane-4-methanol.

10. The method of claim 5 wherein said ether is poly(ethyleneglycol)400, oils, fatty acids, fatty acid esters, or glycerides.

11. The method of claim 10 further comprising at least one pharmaceutically acceptable surfactant, a suspending agent, an emulsifying agent, or other pharmaceutically acceptable adjuvants.

12. The method of claim 11 wherein said surfactant is a soap, detergent, or mixture of detergents.

14. The method of claim 10 wherein said oils are selected from the group consisting of petroleum, animal, vegetable, or synthetic oils.

16. The method of claim 10 wherein said fatty acids are selected from the group consisting of oleic acid, stearic acid, and isostearic acid.

17. The method of claim 10 wherein said fatty acid esters are selected from the group consisting of ethyl oleate and isopropyl myristate.

18. The method of claim 12 wherein said soap is alkaline metal, ammonium and triethanolamine salts of fatty acids.

19. The method of claim 12 wherein said detergent is selected from the group consisting of cationic detergents, anionic detergents, nonionic detergents, and amphoteric detergents.

20. The method of claim 19 wherein said detergent is dimethyl dialkyl ammonium halides, alkyl pyridinium halides, alkyl, aryl and olefin sulfonates, monoglyceride sulfates, sulfasucciantes, fatty amine oxides, fatty acid alkanolamides, polyoxyethylenepropylene copolymers, alkyl-aminopropoionates, or 2-alkylimidazoline quaternary ammonium salts.

21. The method of claim 1 wherein said therapeutically effective amount is 0.01% by weight of D-threo methylphenidate or salt thereof.

22. The method of claim 1 further comprising administering a viscosity increasing substance selected from the group consisting of sodium carboxymethylcellulose, sorbitol, dextran, and stabilizers.

23. The method of claim 11 wherein said surfactant is about 5% to about 15% by weight of the dosage form.

24. The method of claim 11 wherein said surfactant is selected from the group consisting of polyethene sorbitan fatty acid esters.

25. The method of claim 24 wherein the surfactant is sorbitan monooleate.

26. The method of claim 1 wherein said disorder is attention deficit-hyperactivity disorder, symptoms associated with menopause, or one or more of a decrease in cognitive function, fatigue, and neurobehavioral slowing that is unrelated to the administration of analgesics, but may be related to an underlying cancer, the treatment of the cancer, or both.

27. The method of claim 1 wherein said disorder is fatigue, neurobehavioral slowing and cognitive side effects arising from cancer, or from a treatment therefor, such as chemotherapy, radiation therapy, administration of medication to control pain, or neurobehavioral slowing arising from the administration of a treatment for an oncological condition.

28. The method of claim 1 wherein said administration is by pulsatile dosage forms.

29. The method of claim 1 wherein said dosage forms give two doses of drug.

13. The method of 11 wherein said suspending agent is pectin, carbomers, methylcellulose, hydroxypropylmethylcellulose, or carboxymethylcellulose.

15. The dosage method of 14 wherein said oils are peanut oil, soybean oil, sesame oil, cottonseed oil, corn oil, olive oil, petrolatum, or mineral oil.