Ciclesonide-containing sterile aqueous suspension

• US 8,268,240 B2
• Filed: 08/19/2009
• Issued: 09/18/2012
• Est. Priority Date: 07/02/2002
• Status: Active Grant

• Current Assignee: Covis Pharma GmbH (Apollo Global Management, Inc.)
• Original Assignee: Nycomed GmbH (Takeda Pharmaceutical Company Limited)
• Inventors: Nishibe, Yoshihisa, Nagano, Atsuhiro, Takanashi, Kazuya, Uejima, Yasuhide
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Palenik, Jeffrey T
• Application Number:
  US12/461,647
• Publication Number:
  US 20100034696A1
• Time in Patent Office: 1,126 Days
• Field of Search: None
• US Class Current: 422/26
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system

Abstract

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.

Claims

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.