DELIVERY OF OPIOIDS THROUGH AN INHALATION ROUTE
First Claim
1. A composition for delivery of naltrexone consisting of a condensation aerosol a. formed by volatilizing a thin layer of naltrexone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of naltrexone and condensing the heated vapor of naltrexone to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% naltrexone degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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Abstract
The present invention relates to the delivery of opioids through an inhalation route. Specifically, it relates to aerosols containing opioids that are used in inhalation therapy. In a method aspect of the present invention, an opioid is delivered to a patient through an inhalation route. The method comprises: a) heating a thin layer of an opioid, on a solid support, to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% opioid degradation products. In a kit aspect of the present invention, a kit for delivering an opioid through an inhalation route is provided which comprises: a) a thin layer of an opioid and b) a device for dispensing said thin layer as a condensation aerosol.
145 Citations
66 Claims
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1. A composition for delivery of naltrexone consisting of a condensation aerosol
a. formed by volatilizing a thin layer of naltrexone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of naltrexone and condensing the heated vapor of naltrexone to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% naltrexone degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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4. A composition for delivery of buprenorphine consisting of a condensation aerosol
a. formed by volatilizing a thin layer of buprenorphine on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of buprenorphine and condensing the heated vapor of buprenorphine to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% buprenorphine degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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7. A composition for delivery of naloxone consisting of a condensation aerosol
a. formed by volatilizing a thin layer of naloxone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of naloxone and condensing the heated vapor of naloxone to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% naloxone degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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10. A composition for delivery of butorphanol consisting of a condensation aerosol
a. formed by volatilizing a thin layer of butorphanol on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of butorphanol and condensing the heated vapor of butorphanol to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% butorphanol degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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13. A composition for delivery of hydromorphone consisting of a condensation aerosol
a. formed by volatilizing a thin layer of hydromorphone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of hydromorphone and condensing the heated vapor of hydromorphone to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% hydromorphone degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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16. A composition for delivery of oxycodone consisting of a condensation aerosol
a. formed by volatilizing a thin layer of oxycodone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of oxycodone and condensing the heated vapor of oxycodone to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% oxycodone degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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19. A composition for delivery of methadone consisting of a condensation aerosol
a. formed by volatilizing a thin layer of methadone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of methadone and condensing the heated vapor of methadone to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% methadone degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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22. A composition for delivery of remifentanil consisting of a condensation aerosol
a. formed by volatilizing a thin layer of remifentanil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of remifentanil and condensing the heated vapor of remifentanil to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% remifentanil degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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25. A composition for delivery of sufentanil consisting of a condensation aerosol
a. formed by volatilizing a thin layer of sufentanil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of sufentanil and condensing the heated vapor of sufentanil to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% sufentanil degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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28. A composition for delivery of nalbuphine consisting of a condensation aerosol
a. formed by volatilizing a thin layer of nalbuphine on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of nalbuphine and condensing the heated vapor of nalbuphine to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% flurbiprofen degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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31. A composition for delivery of fentanyl consisting of a condensation aerosol
a. formed by volatilizing a thin layer of fentanyl on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of fentanyl and condensing the heated vapor of fentanyl to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% fentanyl degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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34. A method of producing naltrexone in an aerosol form comprising:
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a. heating a thin layer of naltrexone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the naltrexone to form a heated vapor of the naltrexone, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the naltrexone comprising less than 5% naltrexone degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (35, 36)
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37. A method of producing buprenorphine in an aerosol form comprising:
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a. heating a thin layer of buprenorphine on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the buprenorphine to form a heated vapor of the buprenorphine, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the buprenorphine comprising less than 5% buprenorphine degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (38, 39)
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40. A method of producing naloxone in an aerosol form comprising:
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a. heating a thin layer of naloxone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the naloxone to form a heated vapor of the naloxone, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the naloxone comprising less than 5% naloxone degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (41, 42)
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43. A method of producing butorphanol in an aerosol form comprising:
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a. heating a thin layer of butorphanol on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the butorphanol to form a heated vapor of the butorphanol, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the butorphanol comprising less than 5% butorphanol degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (44, 45)
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46. A method of producing hydromorphone in an aerosol form comprising:
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a. heating a thin layer of hydromorphone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the hydromorphone to form a heated vapor of the hydromorphone, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the hydromorphone comprising less than 5% hydromorphone degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (47, 48)
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49. A method of producing oxycodone in an aerosol form comprising:
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a. heating a thin layer of oxycodone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the oxycodone to form a heated vapor of the oxycodone, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the oxycodone comprising less than 5% oxycodone degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (50, 51)
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52. A method of producing methadone in an aerosol form comprising:
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a. heating a thin layer of methadone on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the methadone to form a heated vapor of the methadone, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the methadone comprising less than 5% methadone degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (53, 54)
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55. A method of producing remifentanil in an aerosol form comprising:
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a. heating a thin layer of remifentanil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the remifentanil to form a heated vapor of the remifentanil, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the remifentanil comprising less than 5% remifentanil degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (56, 57)
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58. A method of producing sufentanil in an aerosol form comprising:
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a. heating a thin layer of sufentanil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the sufentanil to form a heated vapor of the sufentanil, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the sufentanil comprising less than 5% sufentanil degradation products, and an aerosol having an MMAD of less than 3 microns.
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59. The method according to claim 59, wherein the aerosol particles are formed at a rate of greater than 109 particles per second.
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60. The method according to claim 60, wherein the aerosol particles are formed at a rate of greater than 1010 particles per second.
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61. A method of producing fentanyl in an aerosol form comprising:
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a. heating a thin layer of fentanyl on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the fentanyl to form a heated vapor of the fentanyl, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the fentanyl comprising less than 5% fentanyl degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (62, 63)
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64. A method of producing morphine in an aerosol form comprising:
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a. heating a thin layer of morphine on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the morphine to form a heated vapor of the morphine, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the morphine comprising less than 5% morphine degradation products, and an aerosol having an MMAD of less than 3 microns.
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- 65. The method according to claim 65, wherein the aerosol particles are formed at a rate of greater than 109 particles per second.
Specification