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|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)|
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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