Topical formulations comprising montelukast and combinations with mussel adhesive proteins

Abstract

There is provided topical pharmaceutical formulations comprising montelukast, or a pharmaceutical acceptable salt of solvate thereof, as well as combination products comprising (a) at least one mussel adhesive protein or a derivative thereof; and (b) montelukast, or a pharmaceutically-acceptable salt or solvate thereof. The formulations and combination products find particular utility in direct topical administration for the treatment of inflammation, of inflammatory disorders and/or of condition characterized by inflammation, including wounds, burns, psoriasis, acne and atopic dermatitis.

1 - 26 . (canceled) 
     
     
         27 . A method of promoting healing or recovery of a wound of a patient, said wound being an ulcer of the skin or the mucosa, the method comprising:
 providing a pharmaceutical formulation that is in the form of a gel, a cream or an ointment and comprises a therapeutically effective amount of montelukast, or a pharmaceutically acceptable salt of solvate thereof, in admixture with a pharmaceutically-acceptable topical adjuvant, diluent, or carrier;   topically applying the pharmaceutical formulation directly to an ulcer wound of a patient,   wherein the ulcer wound comprises injury to the skin or mucosa, damage to and/or below the epidermis or the dermis, or damage to a subcutaneous tissue, a submucosal tissue, or an internal organ, and   wherein said topically applying promotes healing or recovery of the ulcer wound.   
     
     
         28 . The method of  claim 27 , wherein the ulcer wound is a consequence of a disease or a disorder. 
     
     
         29 . The method of  claim 27 , wherein the ulcer wound comprises injury to the mucosa. 
     
     
         30 . The method of  claim 29 , wherein said topically applying is carried out on a mucosal surface. 
     
     
         31 . The method of  claim 28 , wherein the disease or disorder is selected from the group of esophagitis, gastritis, enteritis, and enterocolitis (including bacillary dysentery, chronic amoebic dysentery, schistosomiasis, ulcerative colitis, nonspecific ulcerative colitis and regional enteritis). 
     
     
         32 . The method of  claim 31 , wherein the disease or disorder is enterocolitis. 
     
     
         33 . The method of  claim 31 , wherein the disease or disorder is ulcerative colitis. 
     
     
         34 . The method of  claim 32 , wherein said topically applying is carried out by rectal administration of the pharmaceutical formulation to a mucosal surface. 
     
     
         35 . The method of  claim 33 , wherein said topically applying is carried out by rectal administration of the pharmaceutical formulation to a mucosal surface. 
     
     
         36 . The method of  claim 27 , wherein the ulcer wound is an ulcer of the skin. 
     
     
         37 . The method of  claim 36 , wherein the ulcer of the skin is a hard to heal ulcer of the skin. 
     
     
         38 . The method of  claim 37 , wherein said topically applying is carried out on the skin. 
     
     
         39 . The method of  claim 36 , wherein said topically applying the pharmaceutical formulation further prevents the exudation of body fluids and/or the risk of infection resulting from the ulcer wound, and/or further prevents physiological reactions that result from the ulcer wound healing processes.