CA2304973A1 - Stabilized preparations for use in nebulizers - Google Patents

Stabilized preparations for use in nebulizers Download PDF

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Publication number
CA2304973A1
CA2304973A1 CA002304973A CA2304973A CA2304973A1 CA 2304973 A1 CA2304973 A1 CA 2304973A1 CA 002304973 A CA002304973 A CA 002304973A CA 2304973 A CA2304973 A CA 2304973A CA 2304973 A1 CA2304973 A1 CA 2304973A1
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Prior art keywords
dispersion
perforated microstructures
group
combinations
surfactant
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CA002304973A
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French (fr)
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CA2304973C (en
Inventor
Ernest G. Schutt
Thomas E. Tarara
Luis A. Dellamary
Alexey Kabalnov
Jeffry G. Weers
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Novartis AG
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Individual
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Priority claimed from PCT/US1998/020603 external-priority patent/WO1999016420A1/en
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    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
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Abstract

Stabilized dispersions are provided for the delivery of a bioactive agent to the respiratory tract of a patient. The dispersions preferably comprise a stabilized colloidal system which may comprise a fluorochemical component. In particularly preferred embodiments, the stabilized dispersions comprises perforated microstructures dispersed in a fluorochemical suspension medium. As density variations between the suspended particles and suspension medium are minimized and attractive forces between microstructures are attenuated, the disclosed dispersions are particularly resistant to degradation, such as by settling or flocculation. In particularly preferred embodiments, the stabilized dispersions may be administered to the lung of a patient using a nebulizer.

Claims (50)

WHAT IS CLAIMED:
1. Use of a liquid fluorochemical in the manufacture of a medicament for the pulmonary delivery of a bioactive agent whereby the medicament comprises a stabilized dispersion having a fluorochemical continuous phase which is nebulized using a nebulizer to form an aerosolized medicament comprising said bioactive agent wherein said aerosolized medicament is in a form for administration to at least a portion of the pulmonary air passages of a patient in need thereof.
2. The use of claim 1 wherein said stabilized dispersion comprises a reverse emulsion, microemulsion or a particulate dispersion.
3. The use of claim 1 wherein said stabilized dispersion comprises a plurality of particulates suspended in said fluorochemical continuous phase wherein said particulates are selected from the group consisting of microrized particles, nanocrystals, spray dried microspheres, perforated microstructures and combinations thereof.
4. The use of claim 1 wherein said stabilized dispersion comprises a plurality of perforated microstructures suspended in said fluorochemical continuous phase
5. The use of claim 4 wherein said perforated microstructures comprise a surfactant.
6. The use of claim 5 wherein said surfactant is selected from the group consisting of phospholipids, nonionic detergents, nonionic block copolymers, ionic surfactants, biocompatible fluorinated surfactants and combinations thereof.
7. The use of claims 5 or 6 wherein said surfactant is a phospholipid.
8. The use of claim 7 wherein said phospholipid is selected from the group consisting of dilauroylphosphatidylcholine, dioleylphosphatidylcholine, dipalmitoylphosphatidylcholine, disteroylphosphatidylcholine, behenoylphosphatidyl-choline, arachidoylphosphatidylcholine and combinations thereof.
9. The use of claims 4 to 8 wherein the mean aerodynamic diameter of the perforated microstructures is between 0.5 and 6 µm.
10. The use of any of claims 1 to 9 wherein said bioactive agent is selected from the group consisting of antiallergics, bronchodilators, pulmonary lung surfactants, analgesics, antibiotics, leukotriene inhibitors or antagorists, antihistamines, antiinflammatories, antineoplastics, anticholinergics, anesthetics, anti-tuberculars, imaging agents, cardiovascular agents, enzymes, steroids, genetic materiel, viral vectors, antisense agents, proteins, peptides and combinations thereof.
11. The use of any of claims 1 to 10 wherein said bioactive agent is delivered to the systemic circulation of said patient.
12. A method for forming a stabilized respiratory dispersion comprising the steps of:

combining a plurality of perforated microstructures comprising at least one bioactive agent with a predetermined volume of a nonaqueous suspension medium to provide a respiratory blend wherein said suspension medium permeates said perforated microstructures; and mixing said respiratory blend to provide a substantially homogeneous respiratory dispersion.
13. The method of claim 12 wherein said perforated microstructures comprise a surfactant.
14. The method of claim 13 wherein said surfactant is selected from the group consisting of phospholipids, nonionic detergents, nonionic block copolymers, ionic surfactants, biocompatible fluorinated surfactants and combinations thereof.
15. The method of claim 13 or 14 wherein said surfactant is a phospholipid.
16. The method of claim 15 wherein said phospholipid is selected from the group consisting of dilauroylphosphatidylcholine, dioleylphosphatidylcholine, dipalmitoylphosphatidylcholine, disteroylphosphatidylcholine behenoylphosphatidylcholine, arachidoylphosphatidylcholine and combinations thereof.
17. The method of any of claims 12 to 16 wherein said suspension medium and said perforated microstructures have a refractive index differential of less than about 0.5.
18. The method of any of claims 12 to 17 wherein said perforated microstructures comprise hollow porous microspheres.
19. The method of any of claims 12 to 18 wherein the mean aerodynamic diameter of said perforated microstructures is between 0.5 and 5µm.
20. The method of any of claims 12 to 19 wherein said bioactive agent is selected from the group consisting of antiallergics, bronchodilators, pulmonary lung surfactants, analgesics, antibiotics, leukotriene inhibitors or antagonists, antihistamines, antiinflammatories, antineoplastics, anticholinergics, anesthetics, anti-tuberculars, imaging agents, cardiovascular agents, enzymes, steroids, genetic material, viral vectors, antisense agents, proteins, peptides and combinations thereof.
21. A method for stabilizing a respiratory dispersion by reducing attractive van der Waals forces comprising the steps of:
providing a plurality of perforated microstructures;
combining the perforated microstructures with a suspension medium comprising at least one fluorochemical wherein the suspension medium and the perforated microstructures are selected to provide a refractive index differential value of less than about 0.5.
22. The method of claim 21 wherein said perforated microstructures comprise a surfactant.
23. The method of claim 22 wherein said surfactant is selected from the group consisting of phospholipids, nonionic detergents, nonionic block copolymers, ionic surfactants, biocompatible fluorinated surfactants and combinations thereof.
24. The method of claim 22 or 23 wherein said surfactant is a phospholipid.
25. The method of claim 24 wherein said phospholipid is selected from the group consisting of dilauroylphosphatidylcholine, dioleylphosphatidylcholine.
dipalmitoylphosphatidylcholine, disteroylphosphatidylcholine behenoylphosphatidylcholine, arachidoylphosphatidylcholine and combinations thereof.
26. The method of any of claims 21 to 25 wherein said perforated microstructures comprise hollow porous microspheres.
27. The method of any of claims 21 to 26 wherein said bioactive agent is selected from the group consisting of antiallergics, bronchodilators, pulmonary lung surfactants, analgesics, antibiotics, leukotriene inhibitors or antagonists, antihistamines, antiinflammatories, antineoplastics, anticholinergics, anesthetics, anti-tuberculars, imaging agents, cardiovascular agents, enzymes, steroids, genetic materiel, viral vectors, antisense agents, proteins, peptides and combinations thereof.
28. A stable respiratory dispersion for use in a nebulizer comprising a suspension medium having dispersed therein a plurality of perforated microstructures comprising at least one bioactive agent wherein said suspension medium substantially permeates said perforated microstructures.
29. The dispersion of claim 28 wherein said perforated microstructures comprise a surfactant.
30. The dispersion of claim 29 wherein said surfactant is selected from the group consisting of phospholipids, nonionic detergents, nonionic block copolymers, ionic surfactants, biocompatible fluorinated surfactants and combinations thereof.
31. The dispersion of claim 29 or 30 wherein said surfactant is a phospholipid.
32. The dispersion of claim 31 wherein said phospholipid is selected from the group consisting of dilauroylphosphatidylcholine, dioleylphosphatidylcholine, dipalmitoylphosphatidylcholine, disteroylphosphatidylcholine behenoylphosphatidylcholine, arachidoylphosphatidylcholine and combinations thereof.
33. The dispersion of any of claims 28 to 32 wherein said suspension medium and said perforated microstructures have a refractive index differential of less than about 0.4.
34. The dispersion of any of claims 28 to 33 wherein said perforated microstructure comprise hollow porous microspheres.
35. The dispersion of any of claims 28 to 34 wherein the mean aerodynamic diameter of said perforated microstructures is between 0.5 and 5µm.
36. The method of any of claims 28 to 35 wherein said bioactive agent is selected from the group consisting of antiallergics, bronchodilators, pulmonary lung surfactants, analgesics, antibiotics, leukotriene inhibitors or antagonists, antihistamines, antiinflammatories, antineoplastics, anticholinergics, anesthetics, anti-tuberculars, imaging agents, cardiovascular agents, enzymes, steroids, genetic material, viral vectors, antisense agents, proteins, peptides and combinations thereof.
37. An inhalation system for the pulmonary administration of a bioactive agent to a patient comprising:
a fluid reservoir;
a stable respiratory dispersion in said fluid reservoir wherein said stabilized dispersion comprises a fluorochemical continuous phase end at least one bioactive agent, and a nebulizer operably associated with said fluid reservoir wherein the nebulizer is capable of aerosolizing and discharging the stable respiratory dispersion.
38. The system of claim 37 wherein said stabilized dispersion comprises a reverse emulsion, microemulsion or a particulate dispersion.
39. The system of claim 37 wherein said stabilized dispersion comprises a plurality of particulates suspended in said fluorochemical continuous phase wherein said particulates are selected from the group consisting of micronized particles, nanocrystals, spray dried microspheres, perforated microstructures and combinations thereof.
40. The system of claim 37 wherein said stabilized dispersion comprises a plurality of perforated microstructures suspended in said fluorochemical continuous phase
41. The system of claim 40 wherein said perforated microstructures comprise a surfactant.
42. The system of claim 41 wherein said surfactant is selected from the group consisting of phospholipids, nonionic detergents, nonionic block copolymers, ionic surfactants, biocompatible fluorinated surfactants and combinations thereof.
43. The system of claims 41 or 42 wherein said surfactant is a phospholipid.
44. The system of claim 43 wherein said phospholipid is selected from the group consisting of dilauroylphasphatidylcholine, dioleylphosphatidylcholine, dipalmitoylphosphatidylcholine, disteroylphosphatidylcholine, behenoylphosphatidyl-choline, arachidoylphosphatidylcholine and combinations thereof.
45. The system of any of claims 40 to 44 wherein the mean aerodynamic diameter of the perforated microstructures is between 0.5 and 5 µm.
48. The system of any of claims 37 to 45 wherein said bioactive agent is selected from the group consisting of antiallergics, bronchodilators, pulmonary lung surfactants, analgesics, antibiotics, leukotriene inhibitors or antagonists, antihistamines, antiinflammatories, antineoplastics, anticholinergics, anesthetics, anti-tuberculars, imaging agents, cardiovascular agents, enzymes, steroids, genetic material, viral vectors, antisense agents, proteins, peptides and combinations thereof.
47. The system of any of claims 37 to 46 wherein said bioactive agent comprises a compound selected from the group consisting of proteins, peptides and genetic material.
48. The system of any of claims 37 to 47 wherein said fluid reservoir is a multi-dose reservoir or a single dose reservoir.
49. The system of any of claims 37 to 48 wherein said nebulizer is a jet nebulizer, an ultrasonic nebulizer or a single-bolus nebulizer.
50. A method for the pulmonary delivery of one or more bioactive agents comprising the steps of:
providing a stabilized respiratory dispersion comprising one or more bioactive agents wherein the respiratory dispersion comprises a fluorochemical continuous phase;
nebulizing said respiratory dispersion with a nebulizer to provide an aerosolized medicament; and administering a therapeutically effective amount of said aerosolized medicament to at least a portion of the pulmonary passages of a patient in need thereof.
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