CA2218116A1 - Pulmonary delivery of aerosolized medicaments - Google Patents

Pulmonary delivery of aerosolized medicaments

Info

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
Application number
CA002218116A
Other languages
French (fr)
Other versions
CA2218116C (en
Inventor
Robert M. Platz
John S. Patton
Linda Foster
Mohammed Eljamal
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novartis AG
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=23679173&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2218116(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2218116A1 publication Critical patent/CA2218116A1/en
Application granted granted Critical
Publication of CA2218116C publication Critical patent/CA2218116C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

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    • 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
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A61M15/0046—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier
    • A61M15/0051—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier the dosages being arranged on a tape, e.g. strips
    • 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
    • A61M15/00—Inhalators
    • A61M15/0086—Inhalation chambers
    • 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
    • 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.
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.
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%.
CA002218116A 1995-04-14 1996-04-12 Pulmonary delivery of aerosolized medicaments Expired - Fee Related CA2218116C (en)

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

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CA2218116A1 true CA2218116A1 (en) 1996-10-17
CA2218116C CA2218116C (en) 2009-12-08

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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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