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Details for Patent: 6,776,978

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Details for Patent: 6,776,978

Title: Delivery of opioids through an inhalation route
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 composition aspect of the present invention, the aerosol comprises particles comprising at least 5 percent by weight of an opioid. In a method aspect of the present invention, an opioid is delivered to a mammal through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises at least 5 percent by weight of an opioid, 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 opioid through an inhalation route to a mammal is provided which comprises: a) a composition comprising at least 5 percent by weight of an opioid; and, b) a device that forms an opioid aerosol from the composition, for inhalation by the mammal.
Inventor(s): Rabinowitz; Joshua D. (Mountain View, CA), Zaffaroni; Alejandro C. (Atherton, CA)
Assignee: Alexza Molecular Delivery Corporation (Palo Alto, CA)
Filing Date:May 21, 2002
Application Number:10/153,839
Claims:1. A composition for delivery of a therapeutic compound comprising a condensation aerosol a) formed by volatilizing a therapeutic compound selected from the group consisting of naltrexone, buprenorphine, nalbuphine, naloxone, butorphanol, hydromorphone, oxycodone, methadone, remifentanil, or sufentanil under conditions effective to produce a heated vapor of the compound and condensing the heated vapor of the compounds to form condensation aerosol particles, and b) wherein said condensation aerosol particles are characterized by less than 5% compound degradation products and c) aerosol MMAD less than 3 .mu.m.

2. The composition according to claim 1, wherein said therapeutic compound is in free base form.

3. The composition according to claim 1, wherein the condensation aerosol particles are by less than 2.5 percent by weight of naltrexone, buprenorphine, nalbuphine, naloxone, butorphanol, hydromorphone, oxycodone, methadone, remifentanil, or sufentanil degradation products.

4. The composition according to claim 1, wherein the condensation aerosol particles comprise at least 90 percent by weight of naltrexone, buprenorphine, nalbuphine, naloxone, butorphanol, hydromorphone, oxycodone, methadone, remifentanil, or sufentanil.

5. The composition according to claim 4, wherein the aerosol has a mass median aerodynamic diameter less than 2 microns.

6. The composition according to claim 5, wherein the condensation aerosol particles comprise at least 95 percent by weight of naltrexone, buprenorphine, nalbuphine, naloxone, butorphanol, hydromorphone, oxycodone, methadone, remifentanil, or sufentanil.

7. A method of producing the therapeutic compound naltrexone, buprenorphine, nalbuphine, naloxone, butorphanol, hydromorphone, oxycodone, methadone, remifentanil, or sufentanil in an aerosol form comprising: a) volatilizing a therapeutic compound selected from the group consisting of naltrexone, buprenorphine, nalbuphine, naloxone, butorphanol, hydromorphone, oxycodone, methadone, remifentanil, or sufentanil, under conditions effective to produce a heated vapor of the compound-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) aerosol MMAD is less than 3 .mu.m.

8. The method according to claim 7, wherein the aerosol particles are formed at a rate of greater than 1 mg/sec.

9. The method according to claim 7, wherein the aerosol has a mass median aerodynamic diameter of less than 2 microns.

10. The method according to claim 7, wherein said volatilizing includes heating a coating which includes the therapeutic compound, which 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.

11. The method according to claim 10, wherein said solid support comprises aluminum or stainless steel.

12. The method according to claim 11, wherein said solid support has a thickness of 0.25 mm or less.

13. The method according to claim 12, wherein the aerosol particles comprise at least 95 percent by weight of naltrexone, buprenorphine, nalbuphine, naloxone, butorphanol, hydromorphone, oxycodone, methadone, remifentanil, or sufentanil.

14. The composition according to claim 1, wherein said therapeutic compound is hydromorphone.

15. The composition according to claim 1, wherein said therapeutic compound is remifentanyl or sufentanyl.

16. The composition according to claim 1, wherein said therapeutic compound is buprenorphine, nalbuphine, or butorphanol.

17. The composition according to claim 1, wherein said therapeutic compound is methadone.

18. The composition according to claim 1, wherein said therapeutic compound is naltrexone or naloxone.

19. A composition for delivery of fentanyl comprising a condensation aerosol a) formed by volatilizing fentanyl under conditions effective to produce a heated vapor of fentanyl, and condensing the heated vapor of fentanyl to form condensation aerosol particles, and b) wherein said condensation aerosol particles are characterized by less than 2.5% compound degradation products, and c) aerosol MMAD is less than 3 .mu.m.

20. The composition according to claim 19, wherein said fentanyl is in a freebase form.

21. The composition according to claim 19, wherein the condensation aerosol particles comprise less than 1 percent by weight of fentanyl degradation products.

22. The composition according to claim 19, wherein the condensation aerosol particles comprise at least 90 percent by weight of fentanyl.

23. The composition according to claim 19, wherein the condensation aerosol particles comprise at least 95 percent by weight of fentanyl.

24. A method of producing the therapeutic compound morphine or fentanyl in an aerosol form comprising a) volatilizing a therapeutic compound selected from the group consisting of morphine or fentanyl under conditions effective to produce a heated vapor of the compound and b) during said volatilizing, passing air through the heated vapor to produce aerosol particles of the compound comprising less than 2.5% compound degradation products and c) aerosol MMAD is less than 3 .mu.m.

25. The method according to claim 24, wherein the aerosol particles are formed at a rate greater than 1 mg/sec.

26. The method according to claim 24, wherein said volatilizing includes heating a coating which includes the therapeutic compound, which 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.

27. The method according to claim 26, wherein said solid support comprises aluminum or stainless steel.

28. The method according to claim 27, wherein said solid support has a thickness of 0.25 mm or less.
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