Topical pharmaceutical compositions

Abstract

Topical pharmaceutical compositions are described comprising, based on the total weight of the composition: a) 0.01 to 0.2 wt. % of mometasone furoate, b) 5 to 18 wt. % of hexylene glycol, c) 20 to 40 wt. % of water, and d) 25 to 70 wt. % of an oil phase. Said compositions are stable and can be safely and easily applied over large surface areas of the skin in an acceptable way by the general patient population for the treatment or prevention of psoriasis, atopic dermatitis (atopic eczema) and other skin disorders or diseases.

1 . A topical pharmaceutical composition comprising, based on the total weight of the composition:
 a) 0.01 to 0.2 wt. % of mometasone furoate,   b) 5 to 18 wt. % of hexylene glycol,   c) 20 to 40 wt. % of water, and   d) 25 to 70 wt. % of an oil phase.   
     
     
         2 . The composition according to  claim 1 , wherein the total amount of a) mometasone furoate is in the range of 0.05 to 0.15 wt. %, based on the total weight of the composition. 
     
     
         3 . The composition according to  claim 1 , wherein the total amount of b) hexylene glycol is in the range of 7 to 15 wt. %, based on the total weight of the composition. 
     
     
         4 . The composition according to  claim 1 , wherein the total amount of c) water is in the range of 25 to 40 wt. %, based on the total weight of the composition. 
     
     
         5 . The composition according to  claim 1 , wherein the total amount of d) oil phase is in the range of 30 to 65 wt. %, based on the total weight of the composition. 
     
     
         6 . The composition according to  claim 1 , comprising, based on the total weight of the composition:
 a) 0.05 to 0.15 wt. % of mometasone furoate,   b) 7 to 15 wt. % of hexylene glycol,   c) 25 to 35 wt % of water, and   d) 30 to 65 wt. % of an oil phase.   
     
     
         7 . The composition according to  claim 6 , comprising, based on the total weight of the composition:
 a) 0.05 to 0.15 wt. % of mometasone furoate,   b) 7 to 15 wt. % of hexylene glycol,   c) 25 to 35 wt. % of water,   d1) 32 to 50 wt. % of petroleum hydrocarbons,   d2) 5 to 12 wt. % of C 6 -C 24  fatty alcohols, and   d3) 0.1 to 5 wt. % of polyols other than hexylene glycol.   
     
     
         8 . The composition according to  claim 7 , comprising, based on the total weight of the composition:
 a) 0.08 to 0.12 wt. % of mometasone furoate,   b) 8 to 13 wt. % of hexylene glycol,   c) 26 to 34 wt. % of water,   d1) 35 to 48 wt % of petroleum hydrocarbons chosen from liquid paraffin, white soft paraffin and mixtures thereof,   d2) 7 to 10 wt. % of C 6 -C 24  fatty alcohols chosen from lauryl alcohol, miristyl alcohol, palmityl alcohol, stearyl alcohol, oleyl alcohol and mixtures thereof, and   d3) 0.5 to 3 wt. % of glycerol.   
     
     
         9 . The composition according to  claim 1 , wherein the composition further comprises anti-irritants agents, antioxidants agents, buffering agents, chelating agents, emollients, penetration enhancing agents, preservative agents, solubilizing agents, thickening agents, wetting agents or mixtures thereof. 
     
     
         10 . The composition according to  claim 1 , wherein the composition has a pH value in the range of 3.0 to 6.0. 
     
     
         11 . The composition according to  claim 1 , wherein the composition is formulated in the form of a cream. 
     
     
         12 . (canceled) 
     
     
         13 . (canceled) 
     
     
         14 . A method for treating a subject afflicted with psoriasis, atopic dermatitis or other skin disorders or diseases, comprising applying to the affected area of skin of said subject an effective amount of the composition of  claim 1 . 
     
     
         15 . The composition according to  claim 2 , wherein the total amount of a) mometasone furoate is in the range of 0.08 to 0.12 wt. %, based on the total weight of the composition. 
     
     
         16 . The composition according to  claim 3 , wherein the total amount of b) hexylene glycol is in the range of 8 to 13 wt. %, based on the total weight of the composition. 
     
     
         17 . The composition according to  claim 4 , wherein the total amount of c) water is in the range of 25 to 35 wt. %, based on the total weight of the composition. 
     
     
         18 . The composition according to  claim 17 , wherein the total amount of c) water is in the range of 26 to 34 wt. %, based on the total weight of the composition. 
     
     
         19 . The composition according to  claim 7 , comprising, based on the total weight of the composition:
 a) 0.08 to 0.12 wt. % of mometasone furoate,   b) 8 to 13 wt. % of hexylene glycol,   c) 26 to 34 wt. % of water,   d1) 35 to 48 wt. % of petroleum hydrocarbons,   d2) 7 to 10 wt. % of C 6 -C 24  fatty alcohols, and   d3) 0.5 to 3 wt. % of polyols other than hexylene glycol.