Delivery of antipsychotics through an inhalation route

• US 7,601,337 B2
• Filed: 07/18/2006
• Issued: 10/13/2009
• Est. Priority Date: 05/24/2001
• Status: Expired due to Term

• Current Assignee: Alexza Pharmaceuticals Inc. (Grupo Ferrer Internacional SA)
• Original Assignee: Alexza Pharmaceuticals Inc. (Grupo Ferrer Internacional SA)
• Inventors: Zaffaroni, Alejandro C, Rabinowitz, Joshua D
• Primary Examiner(s): Haghighatian; Mina
• Application Number:
  US11/488,932
• Publication Number:
  US 20060280692A1
• Time in Patent Office: 1,183 Days
• Field of Search: 424/45, 424/46, 424/434, 424/489, 424/499, 514/958, 128/200.14, 128/200.24, 128/203.15
• US Class Current: 424/45
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/27 of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
• CPC Class Codes: A61K 31/404 Indoles, e.g. pindolol
• CPC Class Codes: A61K 31/405 Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
• CPC Class Codes: A61K 31/407 condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
• CPC Class Codes: A61K 31/4196 1,2,4-Triazoles
• CPC Class Codes: A61K 31/421 1,3-Oxazoles, e.g. pemoline, trimethadione
• CPC Class Codes: A61K 31/422 not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 31/423 condensed with carbocyclic rings
• CPC Class Codes: A61K 31/437 the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
• CPC Class Codes: A61K 31/473 ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/49 Cinchonan derivatives, e.g. quinine
• CPC Class Codes: A61K 31/495 : having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazinesA61K31/48 takes precedence ; with three nitrogen atoms A61K31/53
• CPC Class Codes: A61K 31/496 : Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 31/4985 : Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
• CPC Class Codes: A61K 31/501 : not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 31/519 : ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/53 : having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine melarsoprol A61K31/555 ; with four nitrogen atoms A61K31/495
• CPC Class Codes: A61K 31/551 : having two nitrogen atoms, e.g. dilazep
• CPC Class Codes: A61K 31/5517 : condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
• CPC Class Codes: A61K 47/54 : the modifying agent being an organic compound
• CPC Class Codes: A61K 9/007 : Pulmonary tract; Aromatherapy
• CPC Class Codes: A61K 9/0073 : Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61K 9/12 : Aerosols; Foams A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015
• CPC Class Codes: A61M 11/042 : electrical
• CPC Class Codes: A61M 15/06 : Inhaling appliances shaped like cigars, cigarettes or pipes
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61P 15/10 : for impotence
• CPC Class Codes: A61P 21/02 : Muscle relaxants, e.g. for tetanus or cramps
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/06 : Antimigraine agents
• CPC Class Codes: A61P 25/08 : Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/16 : Anti-Parkinson drugs
• CPC Class Codes: A61P 25/18 : Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/20 : Hypnotics; Sedatives
• CPC Class Codes: A61P 25/22 : Anxiolytics
• CPC Class Codes: A61P 25/24 : Antidepressants
• CPC Class Codes: A61P 25/32 : Alcohol-abuse
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: F24V 30/00 : Apparatus or devices using heat produced by exothermal chemical reactions other than combustion

Abstract

The present invention relates to the delivery of antipsychotics through an inhalation route. Specifically, it relates to aerosols containing antipsychotics that are used in inhalation therapy. In a method aspect of the present invention, an antipsychotic is delivered to a patient through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises an antipsychotic, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% antipsychotic drug degradation products. In a kit aspect of the present invention, a kit for delivering an antipsychotic through an inhalation route is provided which comprises: a) a thin coating of an antipsychotic composition and b) a device for dispensing said thin coating as a condensation aerosol.

Claims

1. A condensation aerosol for delivery of olanzapine formed by heating a composition containing olanzapine coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of olanzapine and less than 5 percent by weight of olanzapine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

2. The condensation aerosol according to claim 1, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

3. The condensation aerosol according to claim 1 or claim 2, wherein the geometric standard deviation around the MMAD is less than 3.0.

85. The condensation aerosol according to claim 2, wherein the condensing comprises allowing the vapor to cool.

4. A condensation aerosol for delivery of trifluoperazine formed by heating a composition containing trifluoperazine coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of trifluoperazine and less than 5 percent by weight of trifluoperazine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

5. The condensation aerosol according to claim 4, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

6. The condensation aerosol according to claim 4 or claim 5, wherein the geometric standard deviation around the MMAD is less than 3.0.

86. The condensation aerosol according to claim 5, wherein the condensing comprises allowing the vapor to cool.

7. A condensation aerosol for delivery of haloperidol formed by heating a composition containing haloperidol coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of haloperidol and less than 5 percent by weight of haloperidol degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

8. The condensation aerosol according to claim 7, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

9. The condensation aerosol according to claim 7 or claim 8, wherein the geometric standard deviation around the MMAD is less than 3.0.

87. The condensation aerosol according to claim 8, wherein the condensing comprises allowing the vapor to cool.

10. A condensation aerosol for delivery of loxapine formed by heating a composition containing loxapine coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of loxapine and less than 5 percent by weight of loxapine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

11. The condensation aerosol according to claim 10, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

12. The condensation aerosol according to claim 10 or claim 11, wherein the geometric standard deviation around the MMAD is less than 3.0.

88. The condensation aerosol according to claim 11, wherein the condensing comprises allowing the vapor to cool.

110. The method according to claim 88, wherein the condensing comprises allowing the vapor to cool.

13. A condensation aerosol for delivery of risperidone formed by heating a composition containing risperidone coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of risperidone and less than 5 percent by weight of risperidone degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

14. The condensation aerosol according to claim 13, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

15. The condensation aerosol according to claim 13 or claim 14, wherein the geometric standard deviation around the MMAD is less than 3.0.

89. The condensation aerosol according to claim 14, wherein the condensing comprises allowing the vapor to cool.

16. A condensation aerosol for delivery of clozapine formed by heating a composition containing clozapine coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of clozapine and less than 5 percent by weight of clozapine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

17. The condensation aerosol according to claim 16, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

18. The condensation aerosol according to claim 16 or claim 17, wherein the geometric standard deviation around the MMAD is less than 3.0.

90. The condensation aerosol according to claim 17, wherein the condensing comprises allowing the vapor to cool.

19. A condensation aerosol for delivery of quetiapine formed by heating a composition containing quetiapine coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of quetiapine and less than 5 percent by weight of quetiapine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

20. The condensation aerosol according to claim 19, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

21. The condensation aerosol according to claim 19 or claim 20, wherein the geometric standard deviation around the MMAD is less than 3.0.

91. The condensation aerosol according to claim 20, wherein the condensing comprises allowing the vapor to cool.

22. A condensation aerosol for delivery of promazine formed by heating a composition containing promazine coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of promazine and less than 5 percent by weight of promazine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

23. The condensation aerosol according to claim 22, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

24. The condensation aerosol according to claim 22 or claim 23, wherein the geometric standard deviation around the MMAD is less than 3.0.

92. The condensation aerosol according to claim 23, wherein the condensing comprises allowing the vapor to cool.

25. A condensation aerosol for delivery of thiothixene formed by heating a composition containing thiothixene coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of thiothixene and less than 5 percent by weight of thiothixene degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

26. The condensation aerosol according to claim 25, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

27. The condensation aerosol according to claim 25 or claim 26, wherein the geometric standard deviation around the MMAD is less than 3.0.

93. The condensation aerosol according to claim 26, wherein the condensing comprises allowing the vapor to cool.

28. A condensation aerosol for delivery of chlorpromazine formed by heating a composition containing chlorpromazine coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of chlorpromazine and less than 5 percent by weight of chlorpromazine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

29. The condensation aerosol according to claim 28, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

30. The condensation aerosol according to claim 28 or claim 29, wherein the geometric standard deviation around the MMAD is less than 3.0.

94. The condensation aerosol according to claim 29, wherein the condensing comprises allowing the vapor to cool.

31. A condensation aerosol for delivery of droperidol formed by heating a composition containing droperidol coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of droperidol and less than 5 percent by weight of droperidol degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

32. The condensation aerosol according to claim 31, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

33. The condensation aerosol according to claim 31 or claim 32, wherein the geometric standard deviation around the MMAD is less than 3.0.

95. The condensation aerosol according to claim 32, wherein the condensing comprises allowing the vapor to cool.

34. A method of forming an olanzapine containing aerosol comprising:

(a) heating a composition containing olanzapine coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of olanzapine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

35. The method according to claim 34, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

36. The method according to claim 35, wherein the coated composition comprises at least 10 percent by weight of olanzapine.

98. The method according to claim 35, wherein the condensing comprises allowing the vapor to cool.

37. A method of forming a trifluoperazine containing aerosol comprising:

(a) heating a composition containing trifluoperazine coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of trifluoperazine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

38. The method according to claim 37, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

39. The method according to claim 38, wherein the coated composition comprises at least 10 percent by weight of trifluoperazine.

99. The method according to claim 38, wherein the condensing comprises allowing the vapor to cool.

40. A method of forming a haloperidol containing aerosol comprising:

(a) heating a composition containing haloperidol coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of haloperidol degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

41. The method according to claim 40, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

42. The method according to claim 41, wherein the coated composition comprises at least 10 percent by weight of haloperidol.

100. The method according to claim 41, wherein the condensing comprises allowing the vapor to cool.

43. A method of forming a loxapine containing aerosol comprising:

(a) heating a composition containing loxapine coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of loxapine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

44. The method according to claim 43, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

45. The method according to claim 44, wherein the coated composition comprises at least 10 percent by weight of loxapine.

101. The method according to claim 44, wherein the condensing comprises allowing the vapor to cool.

46. A method of forming a risperidone containing aerosol comprising:

(a) heating a composition containing resperidone coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of risperidone degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

47. The method according to claim 46, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

48. The method according to claim 47, wherein the coated composition comprises at least 10 percent by weight of risperidone.

102. The method according to claim 47, wherein the condensing comprises allowing the vapor to cool.

49. A method of forming a clozapine containing aerosol comprising:

(a) heating a composition containing clozapine coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of clozapine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

50. The method according to claim 49, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

51. The method according to claim 50, wherein the coated composition comprises at least 10 percent by weight of clozapine.

103. The method according to claim 50, wherein the condensing comprises allowing the vapor to cool.

52. A method of forming a quetiapine containing aerosol comprising:

(a) heating a compostion containing quetiapine coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of quetiapine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

53. The method according to claim 52, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

54. The method according to claim 53, wherein the coated composition comprises at least 10 percent by weight of quetiapine.

104. The method according to claim 53, wherein the condensing comprises allowing the vapor to cool.

55. A method of forming a promazine containing aerosol comprising:

(a) heating a composition containing promazine coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of promazine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

56. The method according to claim 55, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

57. The method according to claim 56, wherein the coated composition comprises at least 10 percent by weight of promazine.

105. The method according to claim 56, wherein the condensing comprises allowing the vapor to cool.

58. A method of forming a thiothixene containing aerosol comprising:

(a) heating a composition containing thiothixene coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of thiothixene degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

59. The method according to claim 58, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

60. The method according to claim 59, wherein the coated composition comprises at least 10 percent by weight of thiothixene.

106. The method according to claim 59, wherein the condensing comprises allowing the vapor to cool.

61. A method of forming a chlorpromazine containing aerosol comprising:

(a) heating a composition containing chlorpromazine coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of chlorpromazine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

62. The method according to claim 61, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

63. The method according to claim 62, wherein the coated composition comprises at least 10 percent by weight of chlorpromazine.

107. The method according to claim 62, wherein the condensing comprises allowing the vapor to cool.

64. A method of forming a droperidol containing aerosol comprising:

(a) heating a composition containing droperidol coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of droperidol degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

65. The method according to claim 64, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

66. The method according to claim 65, wherein the coated composition comprises at least 10 percent by weight of droperidol.

108. The method according to claim 65, wherein the condensing comprises allowing the vapor to cool.

67. A method of forming a prochlorperazine containing aerosol comprising:

(a) heating a composition containing prochlorperazine coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of prochlorperazine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

68. The method according to claim 67, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

69. The method according to claim 68, wherein the coated composition comprises at least 10 percent by weight of prochlorperazine.

109. The method according to claim 68, wherein the condensing comprises allowing the vapor to cool.

70. A method of forming a fluphenazine containing aerosol comprising:

(a) heating a composition containing fluphenazine coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the particles comprise less than 5 percent by weight of fluphenazine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

71. The method according to claim 70, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

72. The method according to claim 71, wherein the coated composition comprises at least 10 percent by weight of fluphenazine.

73. A condensation aerosol for delivery of prochlorperazine formed by heating a composition containing prochlorperazine coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of prochlorperazine and less than 5 percent by weight of prochlorperazine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

74. The condensation aerosol according to claim 73, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

75. The condensation aerosol according to claim 73 or claim 74, wherein the geometric standard deviation around the MMAD is less than 3.0.

96. The condensation aerosol according to claim 74, wherein the condensing comprises allowing the vapor to cool.

76. A condensation aerosol for delivery of fluphenazine formed by heating a composition containing fluphenazine coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of fluphenazine and less than 5 percent by weight of fluphenazine degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

77. The condensation aerosol according to claim 76, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

78. The condensation aerosol according to claim 76 or claim 77, wherein the geometric standard deviation around the MMAD is less than 3.0.

97. The condensation aerosol according to claim 77, wherein the condensing comprises allowing the vapor to cool.

79. A method of forming a drug containing aerosol comprising:

(a) heating a composition containing the drug and a pharmaceutically acceptable excipient coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the drug is selected from the group consisting of olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol, prochlorperazine, and fluphenazine, and

wherein the particles comprise at least 10 percent by weight of the drug and less than 5 percent by weight of the drug degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

80. The method according to claim 79, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

81. The method according to claim 80, wherein the coated composition comprises at least 10 percent by weight of the drug.

111. The method according to claim 80, wherein the condensing comprises allowing the vapor to cool.

82. A method of forming a drug containing aerosol comprising:

(a) heating a composition containing a salt form of the drug coated on a solid support to form a vapor; and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the drug is selected from the group consisting of olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol, prochlorperazine, and fluphenazine, and

wherein the particles comprise at least 10 percent by weight of the drug and less than 5 percent by weight of the drug degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

83. The method according to claim 82, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

84. The method according to claim 83, wherein the coated composition comprises at least 10 percent by weight of the salt form of the drug.

112. The method according to claim 83, wherein the condensing comprises allowing the vapor to cool.

113. A method of forming a drug containing aerosol comprising:

(a) heating a composition containing the drug coated on a solid support to form a vapor, and

(b) condensing the vapor to form a condensation aerosol comprising particles,

wherein the drug is selected from the group consisting of olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol, prochlorperazine, and fluphenazine,

wherein the condensation aerosol is formed at a rate greater than 0.5 mg/second, and

wherein the particles comprise at least 10 percent by weight of the drug and less than 5 percent by weight of the drug degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

114. The method according to claim 113, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

115. The method according to claim 114, wherein the condensation aerosol is formed at a rate greater than 0.75 mg/second.

116. The method according to claim 115, wherein the condensation aerosol is formed at a rate greater than 1 mg/second.

117. The method according to claim 116, wherein the condensation aerosol is formed at a rate greater than 2 mg/second.

118. The method according to claim 113, wherein the condensing comprises allowing the vapor to cool.