Gel containing pirfenidone

Abstract

The invention relates to a gel composition containing pirfenidone, which is advantageous over other cutaneously administered pharmaceutical forms known in the prior art and which can be used in treatment for the restoration of tissues with fibrotic lesions and for the prevention of fibrotic lesions.

1 . A method of making a composition of a Pirfenidone gel, comprising the following steps:
 a) mixing 50% of the total water to be used with a viscous agent and allowing complete humectation of the viscous agent;   b) mixing Pirfenidone and a solubilizer agent separately and with constant agitation;   c) dissolving separately a non ionic solubilizer agent in 25% of total water at 40° C. and once dissolved, adding 15% of total water;   d) adding the solution from part c) to the mix from part b), and agitating until homogenous;   e) diluting a neutralizer agent in 10% of total water to be used, and agitating until homogenous; and   f) combining the solutions of subparts (a)-(e).   
     
     
         2 . A method for treating fibrotic lesions in a patient by administering to the patient a composition of Pirfenidone gel consisting of 8% Pirfenidone, 0.5% of a viscous agent, 20% of a solubilizer, 11.5% of a non ionic solubilizer, 0.5% of a conserving agent, 0.5% of a neutralizer agent and 59% of purified water, thereby treating the fibrotic lesions. 
     
     
         3 . The method of  claim 2 , wherein
 (a) the viscous agent is selected from the group consisting of a Carbomer 940 (MR), Carbomer Homopolymer Type A, a cellulose derivative, a gum, and a poloxamer;   (b) the solubilizer is selected from the group consisting of N-methylpyrrolidone, ethyl alcohol, and propylene glycol;   (c) the conserving agent is selected from the group consisting of diazolidinyl urea, iodopropynyl butylcarbamate, methylparaben, propylparaben, and mixes of these conserving agents; and   (d) the neutralizer agent is selected from the group consisting of primary, secondary and tertiary mono-, bi-, and triethanolamine aliphatic amines, and a hydroxide alkaline metal.   
     
     
         4 . The method of  claim 3 , wherein the viscous agent is Carbomer 940 (MR), the solubilizer is N-methylpyrrolidone, the conserving agent is diazolidinyl urea, and the neutralizer agent is triethanolamine. 
     
     
         5 . The method of  claim 3 , wherein the viscous agent is Carbomer 940 (MR), the solubilizer is N-methylpyrrolidone, the conserving agent is iodopropynyl butylcarbamate, and the neutralizer agent is triethanolamine. 
     
     
         6 . The method of  claim 3 , wherein the hydroxide alkaline metal is sodium hydroxide.