Claims for Patent: 6,979,437

Summary for Patent: 6,979,437

Title:	Pulmonary delivery in treating disorders of the central nervous system
Abstract:	A method for treating a disorder of the central nervous system includes administering to the respiratory tract of a patient a drug which is delivered to the pulmonary system, for instance to the alveoli or the deep lung. The drug is administered at a dose which is at least about two-fold less than the dose required by oral administration. Particles that include the drug can be employed. Preferred particles have a tap density of less than about 0.4 g/cm.sup.3. In addition to the medicament, the particles can include other materials such as, for example, phospholipids, amino acids, combinations thereof and others.
Inventor(s):	Bartus; Raymond T. (Sudbury, MA), Emerich; Dwaine F. (Cranston, RI)
Assignee:	Advanced Inhalation Research, Inc. (Cambridge, MA)
Application Number:	10/441,968
Patent Claims:	1. A method for treating a disorder of the central nervous system comprising administering to the respiratory tract of a patient in need of treatment a drug for treating said disorder, wherein the drug is administered in a dose that is at least about two times less than that required by oral administration and wherein delivery is to the pulmonary system and wherein the drug is present in dry powder particles having a tap density of less than 0.4 g/cm.sup.3. 2. The method of claim 1 wherein the dose is between about two times and about five times less than that required by oral administration. 3. The method of claim 1 wherein the dose is between about two times and about ten times less than that required by oral administration. 4. The method of claim 1 wherein delivery is to the alveoli region of the pulmonary system. 5. The method of claim 1 wherein administering is for rescue therapy. 6. The method of claim 1 wherein administering is during ongoing treatment. 7. The method of claim 1 wherein the patient in need of treatment is suffering from diseases selected from the group consisting of anxiety, psychosis, depression, bipolar disorder, obsessive compulsive disorder, convulsions, seizures, epilepsy, Alzheimer's, attention deficit hyperactivity disorder and migraines. 8. The method of claim 1 wherein the drug is present in the dry powder particles in an amount of at least 20 weight percent. 9. The method of claim 1 wherein the drug is present in the dry powder particles in an amount of at least 40 weight percent. 10. The method of claim 1 wherein the drug is present in the dry powder particles in an amount of at least 50 weight percent. 11. The method of claim 1 wherein the particles have a mass median aerodynamic diameter of less than about 5 microns. 12. The method of claim 1 wherein the particles have a mass median geometric diameter greater than about 5 microns. 13. The method of claim 1 wherein the particles have a mass median aerodynamic diameter of less than about 3 microns. 14. The method of claim 1 wherein the particles include a phospholipid. 15. The method of claim 1 wherein the particles include an amino acid. 16. The method of claim 15 wherein the amino acid is leucine. 17. The method of claim 1 wherein the particles are administered via a dry powder inhaler. 18. A method for treating a disorder of the central nervous system comprising administering to the respiratory tract of a patient in need of treatment a drug for treating said disorder, wherein the drug is administered in a dose that is at least about two times less than that required by administration routes other than intravenous and wherein delivery is to the pulmonary system and wherein the drug is present in dry powder particles having a tap density of less than 0.4 g/cm.sup.3. 19. A method for delivering ketoprofen to the central nervous system comprising administering to the respiratory tract of a patient in need of treatment or rescue therapy with ketoprofen, wherein ketoprofen is administered in a dose that is at least about two times less than that required by oral administration and wherein delivery is to the pulmonary system and wherein the drug is present in dry powder particles having a tap density of less than 0.4 g/cm.sup.3. 20. A method for delivering a benzodiazepine drug to the central nervous system comprising administering to the respiratory tract of a patient in need of rescue therapy with a benzodiazepine drug, wherein the benzodiazepine drug is administered in a dose that is at least about two times less than that required by oral administration and wherein delivery is to the pulmonary system and wherein the drug is present in dry powder particles having a tap density of less than 0.4 g/cm.sup.3. 21. A method of providing rescue therapy to the central nervous system comprising: administering to the respiratory tract of a patient in need of rescue therapy particles comprising an effective amount of a benzodiazepine drug wherein the drug is present in dry powder particles having a tap density of less than 0.4 g/cm.sup.3. 22. The method of claim 21 wherein the rescue therapy is for a panic attack. 23. The method of claim 21 wherein the benzodiazepine drug is present in the particles in an amount ranging from about 1 to about 90 weight percent. 24. The method of claim 21 wherein the particles have a volume median geometric diameter of between about 5 micrometers and about 30 micrometers. 25. The method of claim 21 wherein the particles have an aerodynamic diameter of between about 1 and about 5 microns. 26. The method of claim 25 wherein the particles have an aerodynamic diameter of between about 1 and about 3 microns. 27. The method of claim 25 wherein the particles have an aerodynamic diameter of between about 3 and about 5 microns. 28. The method of claim 21 wherein delivery to the pulmonary system includes delivery to the alveoli. 29. The method of claim 21 wherein the particles include a phospholipid. 30. The method of claim 29 wherein the phospholipid has a matrix transition temperature which is no higher than the patient's physiological temperature. 31. The method of claim 29 wherein the phospholipid is present in the particles in an amount ranging from about 10 to about 99 weight percent. 32. The method of claim 21 wherein the particles include a hydrophobic amino acid. 33. The method of claim 32 wherein the hydrophobic amino acid is present in the particles in an amount of a least 10% by weight. 34. The method of claim 21 wherein the particles further include calcium chloride. 35. The method of claim 21 wherein delivery to the pulmonary system is by means of a dry powder inhaler. 36. The method of claim 21 wherein delivery to the pulmonary system is by means of a metered dose inhaler.