Details for Patent: 6,716,415
✉ Email this page to a colleague
Title: | Delivery of sedative-hypnotics through an inhalation route |
Abstract: | The present invention relates to the delivery of sedative-hypnotics through an inhalation route. Specifically, it relates to aerosols containing sedative-hypnotics 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 a sedative-hypnotic. In a method aspect of the present invention, a sedative-hypnotic 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 a sedative-hypnotic, 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 a sedative-hypnotic through an inhalation route to a mammal is provided which comprises: a) a composition comprising at least 5 percent by weight of a sedative-hypnotic; and, b) a device that forms a sedative-hypnotic containing 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 17, 2002 |
Application Number: | 10/150,857 |
Claims: | 1. A composition for delivery of a sedative-hypnotic compound comprising a condensation aerosol (a) formed by volatilizing a sedative-hypnotic compound selected from the group consisting of zaleplon, zolpidem and zopiclone 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 characterized by less than 5% compound degradation products, and (c) aerosol MMAD is less than 3 .mu.m. 2. The composition according to claim 1, wherein the condensation aerosol particles are characterized by less than 2.5 percent by weight of zaleplon, zolpidem or zopiclone degradation products. 3. The composition according to claim 1, wherein the condensation aerosol particles comprise at least 95 percent by weight of zaleplon, zolpidem or zopiclon. 4. The composition according to claim 3, wherein the condensation aerosol particles comprise at least 97 percent by weight of zaleplon, zolpidem or zopiclone. 5. A method of producing a sedative-hypnotic compound zaleplon, zolpidem or zopiclone in an aerosol form comprising a) volatilizing a sedative-hypnotic compound selected from the group consisting of zaleplon, zolpidem and zopiclone 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. 6. The method according to claim 5, wherein said aerosol particles are formed at a rate of greater than 0.5 mg/sec. 7. The method of claim 5, wherein said volatilizing includes heating a coating which includes the compound and 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. 8. The method according to claim 5, wherein the aerosol particles comprise less than 2.5 percent by weight of zaleplon, zolpidem or zopiclone degradation products. 9. The method according to claim 7, the coating on said solid support surface has a thickness between 1.5 and 4.4 microns. 10. The method according to claim 9, wherein the aerosol particles comprise at least 97 percent by weight of zaleplone, zolpidem or zopiclone. |