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Claims for Patent: 4,489,071

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Claims for Patent: 4,489,071

Title: Betamethasone dipropionate cream
Abstract:An elegant topical cream composition, containing betamethasone dipropionate, for the treatment of inflammation.
Inventor(s): Florance; Richard K. (Boonton, NJ), Sequeira; Joel A. (New York, NY)
Assignee: Schering Corporation (Madison, NJ)
Application Number:06/559,671
Patent Claims: 1. An elegant topical composition for the treatment of inflammation comprising by weight based on the total weight of the composition:

(a) 0.02 to 0.1 percent betamethasone dipropionate,

(b) 15 to 40 percent white petrolatum,

(c) 3 to 15 percent white wax,

(d) 5 to 25 percent solution of 70% sorbitol in water,

(e) 2.5 to 15 percent propylene glycol,

(f) buffer to maintain the pH of the composition within the range of 3 to 6,

(g) sufficient amounts at least one hydrophilic emulsifier and at least one lipophilic emulsifier to stabilize the emulsion and disperse the betamethasone dipropionate, wherein the HLB of the emulsifier is within the range of 2 to 8,

(h) sufficient dermatologically acceptable preservative to prevent degradation of the composition by microorganisms, and

(i) water.

2. The composition of claim 1 wherein:

the amount of white petrolatum is 20 to 30 percent,

the amount of white wax is 7 to 12 percent,

the amount of sorbitol solution is 10 to 20 percent,

the amount of propylene glycol is 3 to 8 percent, and

the HLB of the emulsifiers is within the range of 4 to 6.

3. The composition of claim 2 further comprising:

(j) 3 to 15 percent cyclomethicone.

4. The composition of claim 1 further comprising:

(j) 3 to 15 percent cyclomethicone.

5. The composition of claim 4 comprising:

(a) 0.06 percent betamethasone dipropionate,

(b) 25 percent white petrolatum,

(c) 10 percent white wax,

(d) 15 percent solution of 70% sorbitol in water,

(e) 5 percent propylene glycol,

(f) 0.3 percent monobasic sodium phosphate monohydrate and 0.001 percent phosphoric acid,

(g) 0.05 percent ceteth 20 and 3 percent glycerol oleate,

(h) 0.1 percent 4-chloro-m-cresol,

(i) water, and

(j) 7 percent cyclomethicone.

6. The composition of claim 4 comprising:

(a) 0.06 percent betamethasone dipropionate,

(b) 30 percent white petrolatum,

(c) 7 percent white wax,

(d) 15 percent solution of 70% sorbitol in water,

(e) 5 percent propylene glycol

(f) 0.07 percent citric acid monohydrate and 0.2 percent trisodium citrate dihydrate,

(g) 0.05 percent ceteth 20 and 3 percent glyceryl oleate,

(h) 0.1 percent 4-chloro-m-cresol,

(i) water, and

(j) 5 percent cyclomethicone

7. The composition of claim 4 comprising:

(a) 0.06 percent betamethasone dipropionate,

(b) 20 percent white petrolatum,

(c) 10 percent white wax,

(d) 15 percent solution of 70% sorbitol in water,

(e) 5 percent propylene glycol,

(f) 0.001 phosphoric acid and 0.3 percent monobasic sodium phosphate monohydrate,

(g) 0.05 percent ceteth 20 and 3 percent glycerol oleate,

(h) 1 percent benzyl alcohol,

(i) water, and

(j) 10 percent cyclomethicone.

8. The composition of claim 4 comprising:

(a) 0.06 percent betamethasone dipropionate,

(b) 30 percent white petrolatum,

(c) 5 percent white wax,

(d) 10 percent solution of 70% sorbitol in water,

(e) 5 percent propylene glycol,

(f) 0.001 percent phosphoric acid and 0.3 percent monobasic sodium phosphate monohydrate,

(g) 1 percent polysorbate 60 and 4 percent sorbitan sesqui oleate,

(h) 0.1 percent 4-chloro-m-cresol,

(i) water, and

(j) 5 percent cyclomethicone.
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