Ciclesonide-containing sterile aqueous suspension
View Patent ↗The present invention provides methods of manufacturing a sterile ciclesonide-containing aqueous suspension comprising the step of sterilization by autoclaving a ciclesonide-containing aqueous suspension.
1. A method of manufacturing a sterile ciclesonide-containing aqueous suspension comprising the step of sterilization by autoclaving a ciclesonide-containing aqueous suspension.
2. The method of manufacturing a sterile ciclesonide-containing aqueous suspension according to claim 1 , wherein the concentration of ciclesonide after autoclaving is 95% or more compared to that before autoclaving.
3. The method of manufacturing a sterile ciclesonide-containing aqueous suspension according to claim 1 wherein the ciclesonide-containing aqueous suspension additionally contains hydroxypropylmethylcellulose.
4. The method of manufacturing a sterile ciclesonide-containing aqueous suspension according to claim 3 , wherein the hydroxypropylmethylcellulose is hydroxypropylmethylcellulose 2910.
5. The method of manufacturing a sterile ciclesonide-containing aqueous suspension according to claim 2 , wherein the ciclesonide-containing aqueous suspension additionally contains hydroxypropylmethylcellulose.
6. The method of manufacturing a sterile ciclesonide-containing aqueous suspension according to claim 5 , wherein the hydroxypropylmethylcellulose is hydroxypropylmethylcellulose 2910.
7. The method of manufacturing a sterile ciclesonide-containing aqueous suspension according to claim 1 , wherein the autoclaving is carried out at 115° C. for 30 minutes, at 121° C. for 20 minutes, or at 126° C. for 15 minutes.
8. The method of manufacturing a sterile ciclesonide-containing aqueous suspension according to claim 1 , wherein after the sterilization by autoclaving, the ciclesonide-containing sterile aqueous suspension is packaged in a container-closure system that has a structure avoiding contamination of a microorganism.
9. The method of manufacturing a sterile ciclesonide-containing aqueous suspension according to claim 1 , wherein ciclesonide is dispersed in an aqueous medium optionally including hydroxypropylmethylcellulose and a suspending agent prior to autoclaving the ciclesonide-containing aqueous suspension.
10. The method of manufacturing a sterile ciclesonide-containing aqueous suspension according to claim 9 , wherein the ciclesonide-containing aqueous suspension is autoclaved consecutively in a container that is identical to the container wherein the ciclesonide is dispersed in an aqueous medium.