CA2446917A1 - Delivery of antipsychotics through an inhalation route - Google Patents

Delivery of antipsychotics through an inhalation route Download PDF

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Publication number
CA2446917A1
CA2446917A1 CA002446917A CA2446917A CA2446917A1 CA 2446917 A1 CA2446917 A1 CA 2446917A1 CA 002446917 A CA002446917 A CA 002446917A CA 2446917 A CA2446917 A CA 2446917A CA 2446917 A1 CA2446917 A1 CA 2446917A1
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CA
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Prior art keywords
compound
aerosol
promazine
loxapine
trifluoperazine
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Granted
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CA002446917A
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French (fr)
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CA2446917C (en
Inventor
Joshua D. Rabinowitz
Alejandro C. Zaffaroni
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Alexza Pharmaceuticals Inc
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Individual
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Publication of CA2446917C publication Critical patent/CA2446917C/en
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32Alcohol-abuse
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24HEATING; RANGES; VENTILATING
    • F24VCOLLECTION, PRODUCTION OR USE OF HEAT NOT OTHERWISE PROVIDED FOR
    • F24V30/00Apparatus or devices using heat produced by exothermal chemical reactions other than combustion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/04Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
    • A61M11/041Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters
    • A61M11/042Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters electrical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/82Internal energy supply devices
    • A61M2205/8206Internal energy supply devices battery-operated

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 composition aspect of the present invention, the aerosol comprises particles comprising at least 5 percent by weight of an antipsychotic. In a method aspect of the present invention, an antipsychotic is delivered to a mammal through an inhalation route. The method comprises: a) Heating a composition, wherein the compositi on comprises at least 5 percent by weight of an antipsychotic, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles, which is inhaled by the mammal. In a kit aspect of the present invention, a kit for delivering an antipsychotic through an inhalati on route to a mammal is provided which comprises: a) a composition comprising a t least 5 percent by weight of an antipsychotic; and, b) a device that forms a n antipsychotic containing aerosol from the composition, for inhalation by the mammal.

Claims (10)

1. A composition for delivery of an antipsychotic compound comprising a condensation aerosol a) formed by volatilizing an antipsychotic compound under conditions effective to produce a heated vapor of the compound, and condensing the heated vapor of the compound to form condensation aerosol particles, and b) wherein said condensation aerosol particles are charaterized by less than 5% compound degradation products, and c) the aerosol has an MMAD less than 3 microns.
2. A composition for delivery of an antipsychotic compound comprising a condensation aerosol a) formed by volatilizing an antipsychotic compound selected from the group consisting of olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol, prochlorperazine and fluphenazine under conditions effective to produce a heated vapor of the compound substantially lacking in pyrolysis products, and condensing the heated vapor of the compound to form condensation aerosol particles, and b) wherein said condensation aerosol particles are characterized by less than 5% compound degradation products, c) the aerosol has an MMAD less than 3 microns.
3. The composition according to claim 2, wherein the condensation aerosol particles are characterized by less than 2.5 percent by weight of olanzapine, trifluoperazine, haloperidol, loxapine, clozapine, quetiapine, promazine, or chlorpromazine-degradation products.
4. ~The composition according to claim 2 or 3, wherein the condensation aerosol particles comprise at least 90 percent by weight of olanzapine, trifluoperazine, haloperidol, loxapine, clozapine, quetiapine, promazine, chlorpromazine, prochlorperazine, or fluphenazine.
5. ~The aerosol according to claim 4, wherein the condensation aerosol particles comprise at least 97 percent by weight of olanzapine, trifluoperazine, haloperidol, loxapine, clozapine, quetiapine, promazine, chlorpromazine, or prochlorperazine.
6. ~A method of producing the antipsychotic compound olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol or fluphenazine in an aerosol form comprising a) volatilizing an antipsychotic compound selected from the group consisting of olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine promazine, thiothixene, chlorpromazine, droperidol and fluphenazine, under conditions effective to produce a heated vapor of the compound substantially lacking in pyrolysis products, and b) during said volatilizing, passing air through the heated vapor to produce aerosol particles of the compound comprising less than 5% compound degradation products, and c) an aerosol having an MMAD less than 3 µm.
7. The method according to claim 6, wherein the aerosol particles are formed at a rate of greater than 0.5 mg/sec.
8. The method according to claim 6 or 7, wherein said volatilizing includes heating a coating, which includes the compound and is formed on a solid support having the surface texture of a metal foil, to a temperature sufficient to volatilize the compound from the coating.
9. The method according to claim 6, 7 or 8, wherein the aerosol particles comprise at least 97 percent by weight of olanzapine, trifluoperazine, haloperidol, loxapine, clozapine, quetiapine, promazine, chlorpromazine, or prochlorperazine.
10. A kit for delivering an olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol or fluphenazine aerosol, wherein the kit comprises:

a) a composition comprising olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol or fluphenazine; and, b) a device that forms a olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol or fluphenazine aerosol from the composition, and wherein the device comprises:

a) an element for heating the olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol or fluphenazine composition to form a vapor;

b) an element allowing the vapor to cool to form an aerosol; and, c) an element permitting inhalation of the aerosol.
CA002446917A 2001-05-24 2002-05-20 Delivery of antipsychotics through an inhalation route Expired - Lifetime CA2446917C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US29420301P 2001-05-24 2001-05-24
US60/294,203 2001-05-24
US31747901P 2001-09-05 2001-09-05
US60/317,479 2001-09-05
PCT/US2002/016118 WO2002094236A1 (en) 2001-05-24 2002-05-20 Delivery of antipsychotics through an inhalation route

Publications (2)

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CA2446917A1 true CA2446917A1 (en) 2002-11-28
CA2446917C CA2446917C (en) 2009-12-22

Family

ID=30772632

Family Applications (7)

Application Number Title Priority Date Filing Date
CA002446904A Abandoned CA2446904A1 (en) 2001-05-24 2002-05-13 Delivery of drug esters through an inhalation route
CA002446990A Expired - Fee Related CA2446990C (en) 2001-05-24 2002-05-17 Delivery of sedative-hypnotics through an inhalation route
CA002446917A Expired - Lifetime CA2446917C (en) 2001-05-24 2002-05-20 Delivery of antipsychotics through an inhalation route
CA002447521A Expired - Fee Related CA2447521C (en) 2001-05-24 2002-05-21 Delivery of antihistamines through an inhalation route
CA002446916A Expired - Fee Related CA2446916C (en) 2001-05-24 2002-05-21 Delivery of opioids through an inhalation route
CA002447166A Expired - Fee Related CA2447166C (en) 2001-05-24 2002-05-22 Delivery of erectile dysfunction drugs through an inhalation route
CA2447099A Expired - Fee Related CA2447099C (en) 2001-05-24 2002-05-23 Delivery of compounds for the treatment of migraine through an inhalation route

Family Applications Before (2)

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CA002446904A Abandoned CA2446904A1 (en) 2001-05-24 2002-05-13 Delivery of drug esters through an inhalation route
CA002446990A Expired - Fee Related CA2446990C (en) 2001-05-24 2002-05-17 Delivery of sedative-hypnotics through an inhalation route

Family Applications After (4)

Application Number Title Priority Date Filing Date
CA002447521A Expired - Fee Related CA2447521C (en) 2001-05-24 2002-05-21 Delivery of antihistamines through an inhalation route
CA002446916A Expired - Fee Related CA2446916C (en) 2001-05-24 2002-05-21 Delivery of opioids through an inhalation route
CA002447166A Expired - Fee Related CA2447166C (en) 2001-05-24 2002-05-22 Delivery of erectile dysfunction drugs through an inhalation route
CA2447099A Expired - Fee Related CA2447099C (en) 2001-05-24 2002-05-23 Delivery of compounds for the treatment of migraine through an inhalation route

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US (75) US6737042B2 (en)
EP (14) EP1392262A1 (en)
JP (7) JP2005503425A (en)
AT (11) ATE462420T1 (en)
AU (3) AU2002314784A1 (en)
BE (1) BE2013C054I2 (en)
CA (7) CA2446904A1 (en)
DE (4) DE60235851D1 (en)
DK (1) DK1389098T3 (en)
ES (5) ES2312571T3 (en)
FR (1) FR13C0051I1 (en)
MX (2) MXPA03010703A (en)
NZ (6) NZ529422A (en)
PL (3) PL363996A1 (en)
PT (2) PT1389098E (en)
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US20030017119A1 (en) 2003-01-23
ATE418971T1 (en) 2009-01-15
US20030005924A1 (en) 2003-01-09
US7465436B2 (en) 2008-12-16
US20040191179A1 (en) 2004-09-30
US6776978B2 (en) 2004-08-17
US20040184997A1 (en) 2004-09-23
US20030017116A1 (en) 2003-01-23
ATE404184T1 (en) 2008-08-15
US6780399B2 (en) 2004-08-24
US7014841B2 (en) 2006-03-21
US6740307B2 (en) 2004-05-25
US6855310B2 (en) 2005-02-15
DE60220909D1 (en) 2007-08-09
US7029658B2 (en) 2006-04-18
PT1389098E (en) 2008-11-14
NZ529416A (en) 2006-11-30
NZ529421A (en) 2006-11-30
EP1389097B1 (en) 2008-08-13
ATE425746T1 (en) 2009-04-15
US7465435B2 (en) 2008-12-16
MXPA03010702A (en) 2004-03-02
US7018620B2 (en) 2006-03-28
JP2004535403A (en) 2004-11-25
US6737042B2 (en) 2004-05-18
US7465437B2 (en) 2008-12-16
US7988952B2 (en) 2011-08-02
US20090246147A1 (en) 2009-10-01

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