Thin-film drug delivery article and method of use
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-009/12
A61K-009/14
A61M-015/00
출원번호
UP-0633877
(2003-08-04)
등록번호
US-7585493
(2009-09-22)
발명자
/ 주소
Hale, Ron L.
Lu, Amy
Myers, Daniel J.
Rabinowitz, Joshua D.
Wensley, Martin J.
출원인 / 주소
Alexza Pharmaceuticals, Inc.
대리인 / 주소
Swanson & Bratschun, L.L.C.
인용정보
피인용 횟수 :
36인용 특허 :
373
초록▼
An article for use in an aerosol device, for producing an aerosol of a drug composition is disclosed. The article includes a heat-conductive substrate having a surface with a selected surface area, and a drug composition film on the substrate surface having a selected film thickness of between 0.05
An article for use in an aerosol device, for producing an aerosol of a drug composition is disclosed. The article includes a heat-conductive substrate having a surface with a selected surface area, and a drug composition film on the substrate surface having a selected film thickness of between 0.05 and 20 μm. The film thickness is such that an aerosol formed by vaporizing the drug composition by heating the substrate and condensing the vaporized compound contains 10% or less drug-degradation product and at least 50% of the total amount of drug composition contained in the film. The selected substrate surface area is such as to yield an effective human therapeutic dose of the drug aerosol. Also disclosed are methods of making and using the article.
대표청구항▼
It is claimed: 1. An article for use in an aerosol device, for producing an aerosol, comprising a heat conductive substrate having a surface with a surface area, and a film comprising a drug composition on the surface, the film having a film thickness, wherein the drug composition and film thicknes
It is claimed: 1. An article for use in an aerosol device, for producing an aerosol, comprising a heat conductive substrate having a surface with a surface area, and a film comprising a drug composition on the surface, the film having a film thickness, wherein the drug composition and film thickness are selected from the group consisting of the following combinations: alprazolam, film thickness between 0.1 and 10 μm; amoxapine, thickness between 2 and 20 μm; apomorphine HCl, film thickness between 0.1 and 5 μm; atropine, film thickness between 0.1 and 10 μm; budesonide, film thickness between 0.05 and 20 μm; bumetanide film thickness between 0.1 and 5 μm; buprenorphine, film thickness between 0.05 and 10 μm; butorphanol, film thickness between 0.1 and 10 μm; celecoxib, film thickness between 2 and 20 μm; chlorpheniramine, film thickness between 0.05 and 20 μm; ciclesonide, film thickness between 0.05 and 5 μm; clomipramine, film thickness between 1 and 8 μm; diazepam, film thickness between 0.05 and 20 μm; diphenhydramine, film thickness between 0.05 and 20 μm; donepezil, film thickness between 1 and 10 μm; eletriptan, film thickness between 0.2 and 20 μm; fentanyl, film thickness between 0.05 and 5 μm; granisetron, film thickness between 0.05 and 20 μm; hydromorphone, film thickness between 0.05 and 10 μm; lorazepam, film thickness between 0.05 and 20 μm; loxapine, film thickness between 1 and 20 μm; midazolam, film thickness between 0.05 and 20 μm; morphine, film thickness between 0.2 and 10 μm; nalbuphine, film thickness between 0.2 and 5 μm; naratriptan, film thickness between 0.2 and 5 μm; olanzapine, film thickness between 1 and 20 μm; parecoxib, film thickness between 0.5 and 2 μm; paroxetine, film thickness between 1 and 20 μm; prochlorperazine, film thickness between 0.1 and 20 μm; quetiapine, film thickness between 1 and 20 μm; ropinirole, film thickness between 0.05 and 20 μm; sertraline, film thickness between 1 and 20 μm; sibutramine, film thickness between 0.5 and 2 μm; sildenafil, film thickness between 0.2 and 3 μm; sumatriptan, film thickness between 0.2 and 6 μm; tadalafil, film thickness between 0.2 and 5 μm; valdecoxib, film thickness between 0.5 and 10 μm; and vardenafil, film thickness between 0.1 and 2 μm; venlafaxine, film thickness between 2 and 20 μm; zaleplon, film thickness between 0.05 and 20 μm; and zolpidem, film thickness between 0.1 and 10 μm; wherein an aerosol formed by vaporizing the drug composition by heating the substrate and condensing the vaporized drug composition contains 10% by weight or less drug degradation products and at least 50% of the total amount of drug composition in the film, and wherein the substrate surface area is such as to yield an effective human therapeutic dose of the drug aerosol. 2. The article of claim 1, wherein said substrate surface area is between about 0.05-100 cm2. 3. The article of claim 1, wherein said substrate surface is impermeable. 4. The article of claim 1, wherein said substrate comprises a material selected from the group consisting of metals, polymers, ceramics, and glass. 5. The article of claim 4, wherein said material is a metal selected from the group consisting of stainless steel and aluminum. 6. The article of claim 1, wherein said substrate has a contiguous surface area of greater than 1 mm2 and a material density of greater than 0.5 g/cc. 7. The article of claim 1, wherein said aerosol has 5% by weight or less drug degradation products. 8. A method of forming an effective human therapeutic inhalation dose of a drug composition aerosol having 10% or less drug degradation products and an aerosol particle mass median aerodynamic diameter (MMAD) between 0.01 and 3 μm, comprising (a) providing a heat conductive substrate having a surface with a surface area, and a film comprising a drug composition on the surface, the film having a film thickness, wherein the drug composition and film thickness are selected from the group consisting of the following combinations: alprazolam, film thickness between 0.1 and 10 μm; amoxapine, thickness between 2 and 20 μm; apomorphine HCl, film thickness between 0.1 and 5 μm; atropine, film thickness between 0.1 and 10 μm; budesonide, film thickness between 0.05 and 20 μm; bumetanide film thickness between 0.1 and 5 μm; buprenorphine, film thickness between 0.05 and 10 μm; butorphanol, film thickness between 0.1 and 10 μm; celecoxib, film thickness between 2 and 20 μm; chlorpheniramine, film thickness between 0.05 and 20 μm; ciclesonide, film thickness between 0.05 and 5 μm; clomipramine, film thickness between 1 and 8 μm; diazepam, film thickness between 0.05 and 20 μm; diphenhydramine, film thickness between 0.05 and 20 μm; donepezil, film thickness between 1 and 10 μm; eletriptan, film thickness between 0.2 and 20 μm; fentanyl, film thickness between 0.05 and 5 μm; granisetron, film thickness between 0.05 and 20 μm; hydromorphone, film thickness between 0.05 and 10 μm; lorazepam, film thickness between 0.05 and 20 μm; loxapine, film thickness between 1 and 20 μm; midazolam, film thickness between 0.05 and 20 μm; morphine, film thickness between 0.2 and 10 μm; nalbuphine, film thickness between 0.2 and 5 μm; naratriptan, film thickness between 0.2 and 5 μm; olanzapine, film thickness between 1 and 20 μm; parecoxib, film thickness between 0.5 and 2 μm; paroxetine, film thickness between 1 and 20 μm; prochlorperazine, film thickness between 0.1 and 20 μm; quetiapine, film thickness between 1 and 20 μm; ropinirole, film thickness between 0.05 and 20 μm; sertraline, film thickness between 1 and 20 μm; sibutramine, film thickness between 0.5 and 2 μm; sildenafil, film thickness between 0.2 and 3 μm; sumatriptan, film thickness between 0.2 and 6 μm; tadalafil, film thickness between 0.2 and 5 μm; valdecoxib, film thickness between 0.5 and 10 μm; and vardenafil, film thickness between 0.1 and 2 μm; venlafaxine, film thickness between 2 and 20 μm; zaleplon, film thickness between 0.05 and 20 μm; and zolpidem, film thickness between 0.1 and 10 μm; (b) heating the substrate to a temperature between 300° C. and 500° C., thereby vaporizing a at least a portion of the drug composition film, and (c) flowing a gas during said heating across the substrate at a gas flow rate effective to produce a desired size of aerosol particles by condensation. 9. The method according to claim 8, wherein said heating vaporizes the drug composition film on the substrate within a time period of 2 seconds. 10. The method according to claim 9, wherein said heating vaporizes the drug composition film on the substrate within a time period of 0.5 seconds. 11. The method of claim 8, wherein said flowing is at a gas flow rate of between 4 and 50 L/minute. 12. The method of claim 8, wherein the aerosol contains 5% by weight or less drug degradation products.
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이 특허에 인용된 특허 (373)
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Burnett George H. (Richmond VA) Claflin Warren E. (Bon Air VA) Lanzillotti Harry V. (Midlothian VA) Lilly ; Jr. A. Clifton (Richmond VA) Nienow John F. (Midlothian VA) Osdene Thomas S. (Richmond VA) , Smoking article.
Serrano Mark A. (Greenwich CT) Houghton Kenneth S. (Midlothian VA) Lanzillotti Harry V. (Midlothian VA) Sanders Edward B. (Richmond VA) Lilly ; Jr. A. Clifton (Chesterfield VA) Hayward Charles R. (Mi, Smoking article.
Clearman Jack F. (Blakely GA) Casey William J. (Clemmons NC) Furin Olivia P. (Clemmons NC) Stewart Grant M. (Winston-Salem NC), Smoking article with an enclosed heat conductive capsule containing an aerosol forming substance.
Banerjee Chandra K. (Pfafftown NC) Ridings Henry T. (Lewisville NC) Sensabaugh ; Jr. Andrew J. (Winston-Salem NC) Shannon Michael D. (Winston-Salem NC), Smoking article with conductive aerosol chamber.
Clearman Jack F. (Blakely GA) Resce James L. (Yadkinville NC) Farrier Ernest G. (Winston-Salem NC) Norman Alan B. (Clemmons NC) Furin Olivia P. (Clemmons NC) Squires William C. (Winston-Salem NC), Smoking article with improved fuel element.
Farrier Ernest G. (Winston-Salem) Harris James L. (Westfield) Norman Alan B. (Clemmons) Resce James L. (Yadkinville) Sensabaugh ; Jr. Andrew J. (Winston-Salem) Shannon Michael D. (Winston-Salem), Smoking article with improved fuel element.
Brooks Johnny L. (Winston-Salem NC) Roberts Donald L. (Winston-Salem NC) Simmons Jerry S. (Rural Hall NC), Smoking articles utilizing electrical energy.
O'Malley Stephanie ; Meandzija Boris ; Krishnan-Sarin Suchitra ; O'Connor Patrick G., Smoking cessation treatments using naltrexone and related compounds.
Ehretsmann Jacques (Conches CHX) Cowling Robert D. (Geneva CHX) Schweizer Alfred D. (Geneva CHX) Caldwell William M. (Newtownards GB5) Boyd Dennis F. (Belfast GB5) Boyd Robert J. (Craigavad GB5), Smoking materials.
Sutton Andrew D.,GBX ; Johnson Richard A.,GBX ; Senior Peter J.,GBX ; Heath David,GBX, Spray-dried microparticles and their use as therapeutic vehicles.
Lloyd Lester J. (Orinda CA) Lloyd Peter M. (Oakland CA) Rubsamen Reid M. (Berkeley CA) Schuster Jeffrey A. (Berkeley CA), Systems for the intrapulmonary delivery of aerosolized aqueous formulations.
Lloyd Lester John (Orinda CA) Lloyd Peter M. (Oakland CA) Rubsamen Reid M. (Berkeley CA) Schuster Jeffrey Arthur (Berkeley CA), Systems for the intrapulmonary delivery of aerosolized aqueous formulations.
Hale Ron L. (Woodside CA) Lu Amy T. (Los Altos CA) Solas Dennis W. (San Francisco CA) Cormier Michel J. N. (Mountain View CA), Testosterone prodrugs for improved drug delivery.
Banerjee Chandra K. (Pfafftown NC) Chiou Joseph J. (Clemmons NC) Farrier Ernest G. (Winston-Salem NC) Gentry Thomas L. (Winston-Salem NC) Lehman Richard L. (Belle Mead NJ) Ridings Henry T. (Lewisvill, Tobacco smoking article with electrochemical heat source.
Emiliangelo Ratti IT; David Gordon Trist IT; Giovanni Gaviraghi IT; Francesco Crespi IT; Angelo Mario Reggiani IT, Use of cck-b receptor antagonists for the treatment of sleep disorders.
Schultz Robert K. (Shoreview MN) Quessy Stephen N. (St. Paul MN), Use of soluble fluorosurfactants for the preparation of metered-dose aerosol formulations.
Mazloomdoost Manoochehr (Lexington KY) Foon Wilfred L. (Pittsburgh PA), Vaporizer for inhalation anesthetics during high-frequency jet ventilation and associated method.
Hale, Ron L.; Hodges, Craig C.; Lloyd, Peter M.; Lu, Amy T.; Myers, Daniel J.; Rabinowitz, Joshua D.; Wensley, Martin J.; McKinney, Jeffrey A.; Zaffaroni, Alejandro C., Drug condensation aerosols and kits.
Hale, Ron L.; Hodges, Craig C.; Lloyd, Peter M.; Lu, Amy T.; Myers, Daniel J.; Rabinowitz, Joshua D.; Wensley, Martin J.; McKinney, Jeffrey A.; Zaffaroni, Alejandro C., Drug condensation aerosols and kits.
Hale, Ron L.; Hodges, Craig C.; Lloyd, Peter M.; Lu, Amy T.; Myers, Daniel J.; Rabinowitz, Joshua D.; Wensley, Martin J.; McKinney, Jeffrey A.; Zaffaroni, Alejandro C., Drug condensation aerosols and kits.
Hale, Ron L.; Hodges, Craig C.; Lloyd, Peter M.; Mufson, Daniel; Rogers, Daniel D.; Song, Soonho; Wensley, Martin J.; Myers, Daniel J.; McKinney, Jeffrey A.; Quintana, Reynaldo J.; Rabinowitz, Joshua D., Method of forming an aerosol for inhalation delivery.
Hale, Ron L.; Hodges, Craig C.; Lloyd, Peter M.; Mufson, Daniel; Rogers, Daniel D.; Song, Soonho; Wensley, Martin J.; Myers, Daniel J.; McKinney, Jeffrey A.; Quintana, Reynaldo J.; Rabinowitz, Joshua D., Method of forming an aerosol for inhalation delivery.
Hale, Ron L.; Lloyd, Peter M.; Lu, Amy T.; Rabinowitz, Joshua D.; Wensley, Martin J., Respiratory drug condensation aerosols and methods of making and using them.
Damani, Ramesh; Hale, Ron L.; Myers, Daniel J.; Quintana, Reynaldo J.; Solas, Dennis W.; Song, Soonho; Soni, Pravin; Tom, Curtis; Sharma, Krishnamohan, Self-contained heating unit and drug-supply unit employing same.
Damani, Ramesh; Hale, Ron L.; Myers, Daniel J.; Quintana, Reynaldo J.; Solas, Dennis W.; Song, Soonho; Soni, Pravin; Tom, Curtis; Sharma, Krishnamohan, Self-contained heating unit and drug-supply unit employing same.
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