Granted Patent B2

US 8,481,516 · App. 12/448,351 · Granted Jul 9, 2013

Abstract

Claims (8)

1. A sterile aqueous suspension comprising water, ciclesonide, a polyion, a microgel and a water-soluble ionic polymer, wherein the microgel is obtained by microgelation of at least one water soluble polymer selected from the group consisting of gellan gum, carrageenan, agar, pectin, xanthan gum, gelatin, polyvinyl alcohol, sodium polyacrylate and alkyl polyacrylate esters by cross-linking via an electrostatic (ionic) bond or a coordination bond.

2. The sterile aqueous suspension according to claim 1 , wherein the water-soluble ionic polymer is at least one selected from the group consisting of carmellose sodium, sodium hyarulonate and polylysine.

3. The sterile aqueous suspension according to claim 1 , wherein ciclesonide is the compound [11β,16α(R)]-16,17-[(cyclohexylmethylen)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxoprop-oxy)pregna-1,4-dien-3,20-dione.

4. A process for preparing a sterile aqueous suspension according to claim 1 comprising the steps of

(i) forming a microgel after performing sterilization by filtration of a water soluble polymer solution capable of microgelation,

(ii) predispersing ciclesonide in an aqueous ionic polymer solution sterilized by filtration,

(iii) mixing the microgel and the aqueous ionic polymer solution in which ciclesonide is predispersed.

5. A method for treating allergic rhinitis in a patient comprising administering to a patient in need thereof a sterile aqueous suspension according to claim 1 in a therapeutically effective amount.

Assignments (17)