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Last Updated: December 22, 2024

Claims for Patent: 4,808,610


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Summary for Patent: 4,808,610
Title: Mometasone furoate anti-inflammatory cream composition using hexylene glycol
Abstract:Disclosed is an elegant, stable, self-preserving cream formulation containing mometasone furoate, 9.alpha., 21-dichloro-16.alpha.-methyl-1,4-pregnadiene-11.beta.,17.alpha.-diol-3,20- dione-17-(2'-furoate), useful as a topical anti-inflammatory product.
Inventor(s): Munayyer; Farah J. (West Caldwell, NJ), Sequeira; Joel A. (New York, NY)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:06/914,227
Patent Claims: 1. A topical pharmaceutical composition for the treatment of inflammation comprising:

(a) 0.01 to 0.25 percent Mometasone Furoate

(b) 5 to 20 percent hexylene glycol

(c) 1.0 to 5 percent water

(d) 2.0 to 10.0 percent white wax

(e) 4 to 12 percent of a lipophilic emulsifier having a HLB below 5

(f) 0.7 to 4 percent of a hydrophilic emulsifier having a HLB above 11

(g) 0.2 to 2.0 percent Titanium dioxide

(h) 5 to 20 percent aluminum starch octenylsuccinate

(i) 40 to 70 percent white petrolatum

(j) sufficient acid to adjust the pH of the water to pH 2.5 to .+-.0.2.

2. The topical pharmaceutical composition of claim 1 wherein:

(a) 0.05 to 0.15 percent Mometasone Furoate

(b) 9 to 15 percent hexylene glycol

(c) 2 to 4 percent water Purified

(d) 4 to 6 percent white wax

(e) 6 to 10 percent of a lipophilic emulsifier having a HLB below 5

(f) 1.2 to 2.5 percent of a hydrophilic emulsifier having a HLB above 11

(g) 0.75 to 1.25 percent titanium dioxide

(h) 8 to 12 percent aluminum starch octenylsuccinate

(i) 50 to 60 percent white petrolatum

(j) sufficient acid to adjust the pH of the water to pH 2.5.+-.0.2.

3. The topical pharmaceutical composition of claim 1 wherein the acid utilized to adjust the pH of the water of phosphoric acid, hydrochloric acid or acetic acid.

4. The topical pharmaceutical composition of claim 3 wherein the lipophilic emulsifier is propylene glycol stearate, ethylene glycol monolaurate, ethylene glycol monostearate, propylene glycol monolaurate or glyceryl monoricinolate.

5. The topical pharmaceutical composition of claim 4 wherein the hydrophilic emulsifier is stearyl alcohol and ceteareth-20, polyethylene glycol monolaurate, polyethylene glycol distearate, P.O.E. cetyl alcohol, P.O.E. sorbitan monostearate or P.O.E. sorbitan monooleate.

6. The topical pharmaceutical composition for the treatment of inflammation comprising:

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