Engineered particles and methods of use
Engineered particles are provided may be used for the delivery of a bioactive agent to the respiratory tract of a patient. The particles may be used in the form of dry powders or in the form of stabilized dispersions comprising a nonaqueous continuous phase. In particularly preferred embodiments the particles may be used in conjunction with an inhalation device such as a dry powder inhaler, metered dose inhaler or a nebulizer.
1 . (canceled)
2 . A composition comprising microspheres, wherein said microspheres have a wall thickness of 100 to 500 nm, and a bulk density of no more than 0.1 g/cm 3 .
3 . The composition according to claim 2 , wherein the mean geometric particle size of said microspheres is less than 20 μm.
4 . A composition comprising microspheres, wherein said microspheres have a wall thickness of 43.5 to 261 nm.
5 . The composition according to claim 2 wherein the walls of said microspheres comprise albumin.
6 . The composition according to claim 2 obtainable by spray-drying a wall-forming material in combination with a blowing agent.
7 . The composition according to claim 2 wherein said microspheres comprise a bioactive agent.
8 . The composition according to claim 7 , wherein said microspheres comprise a protein or peptide.
9 . The composition according to claim 7 , wherein said microspheres comprise an active agent selected from the group consisting of insulin, growth hormone and interferon.
10 . An inhaler comprising an inhalable formulation of microspheres wherein said microspheres have a wall thickness of 100 to 500 nm, and a bulk density of no more than 0.1 g/cm 3 and wherein said microspheres comprise a bioactive agent.
11 . The inhaler according to claim 10 , wherein the formulation comprises the microspheres as the sole or the predominant component thereof.
12 . A method for pulmonary administration of a bioactive agent wherein said method comprises the administration to the lungs of a composition which comprises microspheres having a wall thickness of 100 to 500 nm and a bulk density of no more than 0.1 g/cm 3 , wherein said microspheres further comprise a bioactive agent.
13 . (previously presented) The method according to claim 12 , wherein the mean geometric diameter of said microspheres is less than 20 μm.
14 . A method for pulmonary administration of a bioactive agent wherein said method comprises the administration to the lungs of a composition which comprises microspheres having a wall thickness of 43.5 to 261 nm and a bulk density of no more than 0.1 g/cm 3 , wherein said microspheres further comprise a bioactive agent.
15 . The method according to claim 12 , wherein the walls of said microspheres comprise albumin.
16 . The method according to claim 12 , wherein said microspheres are obtainable by spray-drying a wall-forming material, in combination with a blowing agent.
17 . The method according to claim 12 , wherein said microspheres comprise a protein or peptide.
18 . The method according to claim 12 , wherein said microspheres contain a bioactive agent selected from the group consisting of insulin, growth hormone and interferon.
19 . A method for diagnosis wherein said method comprises administering to a patient in need of such diagnosis, a composition which comprises microspheres having a wall thickness of 100 to 500 nm and a bulk density of no more than 0.1 g/cm 3 .
20 . The method according to claim 19 , wherein the mean geometric diameter of said microspheres is less than 20 μm.
21 . A method for diagnosis wherein said method comprises administering to a patient in need of such diagnosis, a composition which comprises microspheres having a wall thickness of 43.5 to 261 nm and a bulk density of no more than 0.1 g/cm 3 .
22 . The method according to claim 19 , wherein the walls of said microspheres comprise albumin.
23 . The method according to claim 19 , wherein said microspheres are obtainable by spray-drying a wall-forming material, in combination with a blowing agent.
24 . A method for preparing microparticles, wherein said method comprises spray-drying wall-forming materials and wherein said method further comprises inclusion of a blowing agent in the feedstock for spray-drying.
25 . The method according to claim 24 , wherein said blowing agent is selected from the group consisting of ammonium acetate, ammonium carbonate, and acids.
26 . The method according to claim 24 , wherein said wall-forming material is albumin.
27 . A composition comprising microspheres, wherein said microspheres have a wall thickness of 100 to 500 nm, and a bulk density of no more than 0.3 g/cm 3 .
28 . The composition according to claim 2 wherein the bulk density is no more than 0.05 g/cm 3 .