CA2218116A1 - Pulmonary delivery of aerosolized medicaments - Google Patents
Pulmonary delivery of aerosolized medicamentsInfo
- Publication number
- CA2218116A1 CA2218116A1 CA002218116A CA2218116A CA2218116A1 CA 2218116 A1 CA2218116 A1 CA 2218116A1 CA 002218116 A CA002218116 A CA 002218116A CA 2218116 A CA2218116 A CA 2218116A CA 2218116 A1 CA2218116 A1 CA 2218116A1
- Authority
- CA
- Canada
- Prior art keywords
- composition
- pharmaceutical
- dry powder
- effective amount
- pharmaceutically acceptable
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
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- A61M—DEVICES 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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0233—Conductive materials, e.g. antistatic coatings for spark prevention
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/07—General characteristics of the apparatus having air pumping means
- A61M2205/071—General characteristics of the apparatus having air pumping means hand operated
- A61M2205/073—Syringe, piston type
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2799/00—Uses of viruses
- C12N2799/02—Uses of viruses as vector
- C12N2799/021—Uses of viruses as vector for the expression of a heterologous nucleic acid
- C12N2799/022—Uses of viruses as vector for the expression of a heterologous nucleic acid where the vector is derived from an adenovirus
Abstract
According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry power pharmaceutical-based composition is one having a moisture content of less than about 10 % by weight (%w) water, usually below about 5 %w and preferably less than about 3 %w; a particle size of about 1.0-5.0 µm mass median diameter (MMD), usually 1.0-4.0 µm MMD, and preferably 1.0-3.0 µm MMD; a delivered dose of about >30 %, usually >40 %, preferably >50 %, and most preferred >60 %; and an aerosol particle size distribution of about 1.0-5.0 µm mass median aerodynamic diameter (MMAD), usually 1.5-4.5 µm MMAD, and preferably 1.5-4.0 µm MMAD. Such composistions are of pharmaceutical grade purity.
Claims (19)
1. A dispersible pharmaceutical-based dry powder composition for pulmonary delivery, said composition.
comprising a therapeutically effective amount of a pharmaceutical in combination with a pharmaceutically acceptable carrier, wherein the composition comprises particles and wherein 95% of the mass of the composition comprises particles having a particle size below 10 µm.
comprising a therapeutically effective amount of a pharmaceutical in combination with a pharmaceutically acceptable carrier, wherein the composition comprises particles and wherein 95% of the mass of the composition comprises particles having a particle size below 10 µm.
2. A dispersible pharmaceutical-based dry powder composition for pulmonary delivery, said composition comprising a therapeutically effective amount of a macromolecule selected from the group consisting of interleukin 1 receptor, heparin, low molecular weight heparin, and calcitonin, in combination with pharmaceutically acceptable carrier.
3. The composition of claim 1 or 2, wherein the composition is substantially free from penetration enhancers.
4. The composition of claim 2 or 3, wherein the carrier comprises HSA.
5. The composition of claim 3 or 4, wherein the carrier further comprises a carbohydrate bulking agent.
6. The composition of claim 1 or 2, wherein about 95% of the mass of the dry powder composition has a particle size of less than 10 µm.
7. The composition of claim 1 or 6, wherein about 80% of the mass of the dry powder composition has a particle size of less than 5 µm.
8. The composition of claim 1, wherein the pharmaceutical comprises a macromolecule selected from the group consisting of insulin, interleukin 1 receptor, parathyroid hormone alpha-1 antitrypsin, calcitonin, low molecular weight heparin, and nucleic acids.
9. A unit dosage form for pulmonary delivery of a pharmaceutical, which dosage form comprises a unit dosage receptacle containing a dispersible pharmaceutical-based dry powder composition, which composition comprises a therapeutically effective amount of the pharmaceutical in combination with a pharmaceutically acceptable carrier according to any of claims 1-8.
10. A method of treating a disease state responsive to treatment by a pharmaceutical, which method comprises pulmonarily administering to a subject in need thereof a physiologically effective amount of a dispersible pharmaceutical-based dry powder composition according to any of claims 1-8.
11. A method for aerosolizing a pharmaceutical-based dry powder composition that comprises a therapeutically effective amount of the pharmaceutical in combination with a pharmaceutically acceptable carrier, which method comprises:
dispersing an amount of a dry powder composition according to any of claims 1-8 in a gas stream to form an aerosol and capturing the aerosol in a chamber suitable for subsequent inhalation by a patient.
dispersing an amount of a dry powder composition according to any of claims 1-8 in a gas stream to form an aerosol and capturing the aerosol in a chamber suitable for subsequent inhalation by a patient.
12. A method for preparing a spray-dried, pharmaceutical-based dry powder that comprises a therapeutically effective amount of a pharmaceutical and a pharmaceutically acceptable carrier, which method comprises spray drying an aqueous mixture of the pharmaceutical and the carrier under conditions to provide a respirable dry powder comprising particles wherein 95% of the mass of the composition comprises particles having a particle size below 10 µm.
13. A method for preparing a spray-dried pharmaceutical-based dry powder composition that comprises a therapeutically effective amount of a pharmaceutical and a pharmaceutically acceptable carrier, which method comprises spray drying an aqueous mixture of a pharmaceutical selected from the group consisting of parathyroid hormone, interleukin 1 receptor, heparin, low molecular weight heparin, and calcitonin.
14. The method of claim 12 or 13, wherein the carrier comprises HSA.
15. The method of claim 14, wherein the carrier further comprises a carbohydrate bulking agent.
16. The method of claim 15, wherein the bulking agent is mannitol.
17. The method of claim 12, wherein 80% of the mass of the spray-dry composition has a particle size less than 5 µm.
18. A spray-dried, macromolecule-based dry powder composition for pulmonary delivery, said composition comprising a therapeutically effective amount of the macromolecule in combination with a pharmaceutically acceptable carrier produced by the method of claims 12-17.
19. Compositions as in claims 1-8, having a moisture content below 10%.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/423,515 | 1995-04-14 | ||
US08/423,515 US6582728B1 (en) | 1992-07-08 | 1995-04-14 | Spray drying of macromolecules to produce inhaleable dry powders |
PCT/US1996/005070 WO1996032149A1 (en) | 1995-04-14 | 1996-04-12 | Pulmonary delivery of aerosolized medicaments |
Publications (2)
Publication Number | Publication Date |
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CA2218116A1 true CA2218116A1 (en) | 1996-10-17 |
CA2218116C CA2218116C (en) | 2009-12-08 |
Family
ID=23679173
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002218116A Expired - Fee Related CA2218116C (en) | 1995-04-14 | 1996-04-12 | Pulmonary delivery of aerosolized medicaments |
Country Status (11)
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US (10) | US6582728B1 (en) |
EP (2) | EP1428524A1 (en) |
JP (2) | JPH11503731A (en) |
KR (1) | KR100466486B1 (en) |
AT (1) | ATE261742T1 (en) |
AU (1) | AU702150B2 (en) |
CA (1) | CA2218116C (en) |
DE (1) | DE69631881T2 (en) |
ES (1) | ES2215191T3 (en) |
MX (1) | MX9707855A (en) |
WO (1) | WO1996032149A1 (en) |
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GB9515182D0 (en) | 1995-07-24 | 1995-09-20 | Co Ordinated Drug Dev | Improvements in and relating to powders for use in dry powder inhalers |
DE19539574A1 (en) | 1995-10-25 | 1997-04-30 | Boehringer Mannheim Gmbh | Preparations and processes for stabilizing biological materials by means of drying processes without freezing |
TW403653B (en) | 1995-12-25 | 2000-09-01 | Otsuka Pharma Co Ltd | Dry compositions |
US5611344A (en) * | 1996-03-05 | 1997-03-18 | Acusphere, Inc. | Microencapsulated fluorinated gases for use as imaging agents |
US5855913A (en) * | 1997-01-16 | 1999-01-05 | Massachusetts Instite Of Technology | Particles incorporating surfactants for pulmonary drug delivery |
US5874064A (en) * | 1996-05-24 | 1999-02-23 | Massachusetts Institute Of Technology | Aerodynamically light particles for pulmonary drug delivery |
US5985309A (en) * | 1996-05-24 | 1999-11-16 | Massachusetts Institute Of Technology | Preparation of particles for inhalation |
US6254854B1 (en) * | 1996-05-24 | 2001-07-03 | The Penn Research Foundation | Porous particles for deep lung delivery |
USRE37053E1 (en) * | 1996-05-24 | 2001-02-13 | Massachusetts Institute Of Technology | Particles incorporating surfactants for pulmonary drug delivery |
US20030035778A1 (en) * | 1997-07-14 | 2003-02-20 | Robert Platz | Methods and compositions for the dry powder formulation of interferon |
EP0913177A1 (en) | 1997-11-03 | 1999-05-06 | Roche Diagnostics GmbH | Process for producing dry, amorphous products comprising biological active materials by means of convection drying technique, especially spray drying |
EP0913178A1 (en) | 1997-11-03 | 1999-05-06 | Boehringer Mannheim Gmbh | Process for the manufacture of dry, amorphous products comprising biologically active material by means of convection drying and products obtainable by the process |
GB9827145D0 (en) | 1998-12-09 | 1999-02-03 | Co Ordinated Drug Dev | Improvements in or relating to powders |
ATE313318T1 (en) * | 1999-10-29 | 2006-01-15 | Nektar Therapeutics | DRY POWDER COMPOSITIONS WITH IMPROVED DISPERSITY |
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-
1995
- 1995-04-14 US US08/423,515 patent/US6582728B1/en not_active Expired - Lifetime
-
1996
- 1996-04-12 MX MX9707855A patent/MX9707855A/en not_active IP Right Cessation
- 1996-04-12 KR KR1019970707278A patent/KR100466486B1/en not_active IP Right Cessation
- 1996-04-12 EP EP04075809A patent/EP1428524A1/en not_active Ceased
- 1996-04-12 AT AT96911738T patent/ATE261742T1/en not_active IP Right Cessation
- 1996-04-12 JP JP8531213A patent/JPH11503731A/en not_active Withdrawn
- 1996-04-12 CA CA002218116A patent/CA2218116C/en not_active Expired - Fee Related
- 1996-04-12 EP EP96911738A patent/EP0825885B1/en not_active Revoked
- 1996-04-12 DE DE69631881T patent/DE69631881T2/en not_active Revoked
- 1996-04-12 AU AU54827/96A patent/AU702150B2/en not_active Ceased
- 1996-04-12 WO PCT/US1996/005070 patent/WO1996032149A1/en active IP Right Grant
- 1996-04-12 ES ES96911738T patent/ES2215191T3/en not_active Expired - Lifetime
-
1999
- 1999-11-22 US US09/447,753 patent/US6372258B1/en not_active Expired - Fee Related
-
2002
- 2002-02-01 US US10/066,106 patent/US20020127188A1/en not_active Abandoned
- 2002-02-08 US US10/072,430 patent/US6797258B2/en not_active Expired - Fee Related
- 2002-09-13 US US10/242,714 patent/US7097827B2/en not_active Expired - Lifetime
- 2002-12-06 US US10/313,961 patent/US20030198601A1/en not_active Abandoned
-
2003
- 2003-01-31 US US10/355,578 patent/US6921527B2/en not_active Expired - Fee Related
- 2003-03-14 US US10/388,814 patent/US20030185765A1/en not_active Abandoned
-
2006
- 2006-06-27 US US11/426,927 patent/US20070042048A1/en not_active Abandoned
-
2007
- 2007-01-26 US US11/627,884 patent/US20070122418A1/en not_active Abandoned
-
2008
- 2008-01-28 JP JP2008016775A patent/JP2008163033A/en not_active Withdrawn
Also Published As
Publication number | Publication date |
---|---|
US6372258B1 (en) | 2002-04-16 |
EP0825885A4 (en) | 1998-08-26 |
EP0825885A1 (en) | 1998-03-04 |
WO1996032149A1 (en) | 1996-10-17 |
KR100466486B1 (en) | 2005-06-16 |
US6797258B2 (en) | 2004-09-28 |
US7097827B2 (en) | 2006-08-29 |
MX9707855A (en) | 1998-02-28 |
US6921527B2 (en) | 2005-07-26 |
US6582728B1 (en) | 2003-06-24 |
US20030068279A1 (en) | 2003-04-10 |
US20030129141A1 (en) | 2003-07-10 |
EP0825885B1 (en) | 2004-03-17 |
DE69631881D1 (en) | 2004-04-22 |
KR19980703878A (en) | 1998-12-05 |
US20020127188A1 (en) | 2002-09-12 |
AU5482796A (en) | 1996-10-30 |
JPH11503731A (en) | 1999-03-30 |
ATE261742T1 (en) | 2004-04-15 |
DE69631881T2 (en) | 2004-08-19 |
US20020117170A1 (en) | 2002-08-29 |
US20030185765A1 (en) | 2003-10-02 |
EP1428524A1 (en) | 2004-06-16 |
ES2215191T3 (en) | 2004-10-01 |
US20070042048A1 (en) | 2007-02-22 |
CA2218116C (en) | 2009-12-08 |
AU702150B2 (en) | 1999-02-18 |
US20070122418A1 (en) | 2007-05-31 |
JP2008163033A (en) | 2008-07-17 |
US20030198601A1 (en) | 2003-10-23 |
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