Pharmaceutical Aerosol Product for Administration by Oral or Nasal Inhalation

Abstract

This invention relates to a pharmaceutical aerosol product suitable for administration by oral or nasal inhalation and its use in the treatment of respiratory diseases, in particular in the treatment of children. The aerosol composition comprises ciclesonide, ethanol and either 1, 1, 1, 2-tetrafluoroethane, or 1, 1, 1, 2, 3, 3, 3-heptafluoropropane.

Claims

1. A method for preparing a pharmaceutical composition, the method comprising: (a) ciclesonide, (b) a propellant selected from 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and a mixture thereof, and (c) ethanol in an amount effective to solubilize the ciclesonide and (d) optionally a surfactant, wherein the concentration of ciclesonide in the composition is from 0.1 to 0.8 mg per ml.

2-17. (canceled)

Description

EXAMPLES

[0123] Ciclesonide can be provided as a pharmaceutical product comprising an aerosol vial equipped with a dispensing valve. Further, ciclesonide can be provided as a pharmaceutical product comprising an actuator and an aerosol vial equipped with a dispensing metering valve. The following compositions further illustrate the present invention in terms of exemplary formulations and ingredients. However, it will be understood that the invention is not limited to these specific embodiments.

Composition 1

[0124]

TABLE-US-00001 Ingredient mg per ml % w/w Ciclesonide 0.50 0.04 Ethanol 94.84 8.00 1,1,1,2-Tetrafluoroethane 1090.66 91.96 (Propellant 134a) Total 1186.00 100

Composition 2

[0125]

TABLE-US-00002 Ingredient mg per ml % w/w Ciclesonide 0.25 0.02 Ethanol 94.88 8.00 1,1,1,2-Tetrafluoroethane 1090.87 91.98 (Propellant 134a) Total 1186.00 100

Composition 3

[0126]

TABLE-US-00003 Ingredient mg per ml % w/w Ciclesonide 0.75 0.06 Ethanol 94.80 8.00 1,1,1,2-Tetrafluoroethane 1090.45 91.94 (Propellant 134a) Total 1186.00 100

Composition 4

[0127]

TABLE-US-00004 Ingredient mg per ml % w/w Ciclesonide 0.50 0.04 Ethanol 47.42 3.93 1,1,1,2-Tetrafluoroethane 1159.08 96.03 (Propellant 134a) Total 1207.00 100

Composition 5

[0128]

TABLE-US-00005 Ingredient mg per ml % w/w Ciclesonide 0.50 0.04 Ethanol 71.13 5.93 1,1,1,2-Tetrafluoroethane 1127.37 94.03 (Propellant 134a) Total 1199.00 100

Composition 6

[0129]

TABLE-US-00006 Ingredient mg per ml % w/w Ciclesonide 0.50 0.04 Ethanol 118.55 10.03 1,1,1,2-Tetrafluoroethane 1062.95 89.93 (Propellant 134a) Total 1182.00 100

Composition 7

[0130]

TABLE-US-00007 Ingredient mg per ml % w/w Ciclesonide 0.50 0.04 Ethanol 55.32 4.00 1,1,1,2,3,3,3 1327.18 95.96 heptafluoropropane (Propellant 227) Total 1383.00 100

Composition 8

[0131]

TABLE-US-00008 Ingredient mg per ml % w/w Ciclesonide 0.50 0.04 Ethanol 106.08 8.00 1,1,1,2,3,3,3 1219.42 91.96 heptafluoropropane (Propellant 227) Total 1326.00 100

Composition 9

[0132]

TABLE-US-00009 Ingredient mg per ml % w/w Ciclesonide 0.50 0.04 Ethanol 130.90 10.00 1,1,1,2,3,3,3 1177.60 89.96 heptafluoropropane (Propellant 227) Total 1309.00 100

Composition 10

[0133]

TABLE-US-00010 Ingredient mg per ml % w/w Ciclesonide 0.50 0.04 Ethanol 101.92 8.00 1,1,1,2-Tetrafluoroethane 585.79 45.98 (Propellant 134a) 1,1,1,2,3,3,3 585.79 45.98 heptafluoropropane (Propellant 227) Total 1274.00 100