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Claims for Patent: 6,127,353

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Claims for Patent: 6,127,353

Title: Mometasone furoate monohydrate, process for making same and pharmaceutical compositions
Abstract:The invention relates to the novel compound mometasone furoate monohydrate, process for its preparation and pharmaceutical compositions containing said compound.
Inventor(s): Yuen; Pui-Ho (Princeton Junction, NJ), Eckhart; Charles (Kenilworth, NJ), Etlinger; Teresa (Bloomfield, NJ), Levine; Nancy (Flemington, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:07/984,573
Patent Claims: 1. 9.alph a.,21-dichloro-16.alpha.-methyl-1,4-pregnadiene-11.beta.,17.alpha.-diol-3,2 0-dione-17-(2'-furoate) monohydrate.

2. A pharmaceutical composition comprising an antiinflammatory amount of mometasone furoate monohydrate in a pharmaceutically acceptable carrier.

3. The composition of claim 2, further comprising the following ingredients:

4. The composition of claim 3 comprising 0.5 mg of mometasone furoate

monohydrate.

5. The compound 9.alpha.,21-dichloro-16.alpha.-methyl-1,4-pregnadiene-11.beta.,17.alpha.-d iol-3,20 dione-17-(2'-furoate) monohydrate exhibiting a x-ray crystallographic powder diffraction pattern having essentially the following values:

6. A pharmaceutical composition comprising mometasone furoate monohydrate in a carrier consisting essentially of water.

7. The pharmaceutical composition of claim 6 wherein said mometasone furoate monohydrate is present in an amount of from about 0.1 mg. to about 10.0 mg per gram of water.

8. The pharmaceutical composition of claim 6 wherein said mometasone furoate monohydrate is present in the form of micronized particles.

9. The pharmaceutical composition of claim 6 wherein said composition has a pH of from about 4.0 to 5.0.

10. The pharmaceutical composition of claim 6 further comprising one or more additional components selected from the group consisting essentially of excipients, suspending agents, buffers, surfactants, preservatives and mixtures thereof.

11. The pharmaceutical composition of claim 6 formulated as a nasal spray.

12. The pharmaceutical composition of claim 6 wherein said mometasone furoate monohydrate is suspended in said aqueous carrier.
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