US 11,052,042 B2
Aqueous suspensions of ciclesonide for nebulisation
Antje Brueck-Scheffler, Constance (DE)
Assigned to Covis Pharma GMBH, Zug (CH)
Filed by Covis Pharma B.V., Baarn (NL)
Filed on Sep. 25, 2015, as Appl. No. 14/865,637.
Application 14/865,637 is a division of application No. 10/582,499, abandoned, previously published as PCT/EP2004/053495, filed on Dec. 15, 2004.
Claims priority of application No. 03028848 (EP), filed on Dec. 16, 2003.
Prior Publication US 2016/0015634 A1, Jan. 21, 2016
Int. Cl. A61K 31/58 (2006.01); A61K 9/50 (2006.01); A61K 9/00 (2006.01); C07J 71/00 (2006.01); A61K 47/10 (2017.01); A61K 47/26 (2006.01); A61K 47/44 (2017.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01)
CPC A61K 9/0078 (2013.01) [A61K 31/58 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/26 (2013.01); A61K 47/44 (2013.01); C07J 71/00 (2013.01); C07J 71/0005 (2013.01)] 14 Claims
 
1. A sterile aqueous suspension of ciclesonide suitable for nebulization comprising
ciclesonide having a mean particle size of about 0.1 to 8 μm,
water,
an effective amount of at least one non-ionic isotonization agent for adjusting the osmolality of the suspension to about 225-430 mosmol/kg, wherein the non-ionic isotonizing agent is selected from the group consisting of mannitol, glycerol, glucose, and mixtures thereof,
an effective amount of suspending agent for homogenously suspending the ciclesonide in the sterile aqueous suspension, wherein the suspending agent comprises polysorbate, and
at least one non-ionic pharmaceutically acceptable excipient, wherein the at least one non-ionic pharmaceutically acceptable excipient comprises citric acid in an amount to adjust the pH-value of the sterile aqueous suspension to pH of 4 to 7,
wherein the sterile aqueous suspension does not comprise sodium chloride and hydroxypropylmethylcellulose, and
wherein the aqueous suspension is sterilized using moist heat.