CA2468958A1 - Pulmonary delivery of aminoglycosides - Google Patents

Pulmonary delivery of aminoglycosides Download PDF

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Publication number
CA2468958A1
CA2468958A1 CA002468958A CA2468958A CA2468958A1 CA 2468958 A1 CA2468958 A1 CA 2468958A1 CA 002468958 A CA002468958 A CA 002468958A CA 2468958 A CA2468958 A CA 2468958A CA 2468958 A1 CA2468958 A1 CA 2468958A1
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CA
Canada
Prior art keywords
composition according
aminoglycoside
composition
dry powder
less
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
CA002468958A
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French (fr)
Other versions
CA2468958C (en
Inventor
Thomas E. Tarara
Jeffry G. Weers
Geraldine Venthoye
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BGP Products Operations GmbH
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Individual
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Publication of CA2468958A1 publication Critical patent/CA2468958A1/en
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Publication of CA2468958C publication Critical patent/CA2468958C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics

Abstract

The present invention is directed to the administration of aminoglycosides. In particular, the present invention is directed to compositions and methods fo r the pulmonary administration of aminoglycosides. According to a preferred embodiment, compositions and methods are provided for the localized treatmen t of respiratory infections.

Claims (35)

1. A dispersible dry powder composition for localized delivery to the lung for the treatment of respiratory infections comprising a pharmacologically effective amount of an aminoglycoside, said composition being effective to provide a therapeutically effective therapy via administration of less than 6 unit doses administered by a dry powder inhalation device.
2. A composition according to claim 1 further comprising a pharmaceutically acceptable excipient.
3. A composition according to claim 2 wherein the pharmaceutically acceptable excipient comprises a dispersing agent selected from the group consisting of hydrophobic amino acids and water soluble polypeptides.
4. A composition according to claim 3 wherein the dispersing agent is a hydrophobic amino acid selected from the group consisting of alanine, isoleucine, leucine, methionine, phenylalanine, proline, tryptophan, and valine.
5. A composition according to claim 4 wherein the dispersing agent is leucine.
6. A composition according to claim 1 wherein the aminoglycoside is present in an amount of at least 50% by weight.
7. A composition according to claim 6 wherein the aminoglycoside is present in an amount of at least 60% by weight.
8. A composition according to claim 1 wherein the aminoglycoside is selected from the group consisting of gentamicin, netilmicin, paramecin, tobramycin, amikacin, kanamycin, neomycin, azithromycin, and streptomycin.
9. A composition according to claim 1 having a residual moisture content of less than 15 % by weight.
10. A composition according to claim 1 wherein the residual moisture content is less than 8 % by weight.
11. A composition according to claim 1 wherein said composition comprises particles having a geometric diameter from 0.5 - 5 microns.
12. A composition according to claim 1 wherein said composition comprises particles having a mass median aerodynamic diameter less than 5 microns.
13. A composition according to claim 12 wherein said mass median aerodynamic diameter is less than 4.0 microns.
14. A composition according to claim 1 wherein the emitted dose is at least 70%.
15. A composition according to claim 12 comprising at least 75% w/w tobramycin.
16. A composition according to claim 15 comprising at least 85% w/w tobramycin.
17. A composition according to claim 15 further comprising up to 20% w/w of a phospholipid.
18. A composition according to claim 17 comprising a bulk density of greater than 0.10 g/cm3.
19. A composition according to claim 18 comprising a geometric diameter of less than 5 microns.
20. A composition according to claim 19 comprising a hollow and porous morphology.
21. A composition according to claim 15 comprising a tobramycin potency of greater than 60%.
22. A spray dried composition according to any of claims 1 - 21.
23. A method for administering an aminoglycoside to the lungs of a human patient, said method comprising administering by inhalation the dry powder composition of claim 1 in aerosolized form.
24. A method for administering an aminoglycoside to the lungs of a human patient, said method comprising administering by inhalation the dry powder composition of claim 5 in aerosolized form.
25. The composition of claim 15, wherein said dry powder composition is administered by means of a dry powder inhaler.
26. A method for administering an aminoglycoside comprising:
a) providing a dry powder composition comprising an aminoglycoside;
b) dispersing said composition into a gas stream to form a dry powder aerosol;
and c) delivering said aerosolized powder pulmonarily to a patient at an emitted dose of at least 50%.
27. A method according to claim 26 wherein said composition comprises at least 50%
by weight of an aminoglycoside.
28. A method according to claim 26 wherein the aminoglycoside is present in an amount of at least 60 weight %.
29. A method according to claim 26 wherein said dry powder composition is provided in a plurality of unit doses.
30. A method according to claim 29 wherein less than 6 unit doses are provided and are effective to provide a therapeutically effective amount of aminoglycoside throughout a 24 hour period.
31. A method according to claim 30 wherein less than 4 unit doses are provided.
32. A method according to claim 31 wherein the aminoglycoside is selected from the group consisting of gentamicin, netilmicin, paramecin, tobramycin, amikacin, kanamycin, neomycin, azithromycin and streptomycin.
33. A method according to claim 26 wherein the emitted dose is at least 70%.
34. A method for reducing side effects associated with aminoglycoside therapy comprising administering a therapeutically effective amount of an aminoglycoside pulmonarily to achieve localized concentration of aminoglycoside in the lungs.
35. A method according to claim 34 wherein an aminoglycoside and an antibiotic of a different class are administered pulmonarily in rotation.
CA2468958A 2001-12-19 2002-12-19 Pulmonary delivery of aminoglycosides Expired - Lifetime CA2468958C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US34282701P 2001-12-19 2001-12-19
US60/342,827 2001-12-19
PCT/US2002/041733 WO2003053411A1 (en) 2001-12-19 2002-12-19 Pulmonary delivery of aminoglycosides

Publications (2)

Publication Number Publication Date
CA2468958A1 true CA2468958A1 (en) 2003-07-03
CA2468958C CA2468958C (en) 2012-07-03

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2468958A Expired - Lifetime CA2468958C (en) 2001-12-19 2002-12-19 Pulmonary delivery of aminoglycosides

Country Status (14)

Country Link
US (3) US7368102B2 (en)
EP (1) EP1458360B1 (en)
JP (2) JP2005514393A (en)
KR (1) KR100958235B1 (en)
AT (1) ATE508735T1 (en)
CA (1) CA2468958C (en)
CY (1) CY1112560T1 (en)
DK (1) DK1458360T3 (en)
ES (1) ES2364636T3 (en)
MX (1) MXPA04005865A (en)
PT (1) PT1458360E (en)
SI (1) SI1458360T1 (en)
TW (1) TWI324518B (en)
WO (1) WO2003053411A1 (en)

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