Semi-solid topical composition which contains pirfenidone and modified diallyl disulphide oxide (m-ddo) for eliminating or preventing acne

Abstract

The instant invention relates to a semi-solid topical composition containing Pirfenidone and an antimicrobial/antiseptic agent such as Modified Diallyl Disulfide Oxide (M-DDO) and its preparation process, offering advantages compared to other pharmaceutical forms of topical administration known in the state of the art, useful as antifibrotic, anti-inflammatory and antiseptic agent in the prevention, treatment and reversion of acne and post acne lesions. Said compositions is also useful for reducing skin redness, detaining the formation of new acne outbreaks, reversing already existing outbreaks and regenerating skin damage caused by acne.

1 . A semi-solid topical composition for eliminating, reducing or preventing skin acne occurrence, comprising 2%, 4%, 6%, 8% or 10% in weight of pirfenidone, 0.016% in weight of Modified Diallyl Disulfide Oxide (M-DDO), and 91.984% in weight of a gelling agent and other excipients or additives. 
     
     
         2 . The semi-solid topical composition according to  claim 1 , comprising 8% in weight of pirfenidone, 0.016% in weight of Modified Diallyl Disulfide Oxide (M-DDO) and 91.984% in weight a gelling agent and other excipients or additives. 
     
     
         3 . The semi-solid topical composition according to  claim 1 , wherein the gelling agent is selected from the group consisting of methylcellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, polyvinyl alcohol, polyvinylpirrolidone, carboxyvinyl polymers, carbomer and acrylic polymers. 
     
     
         4 . The semi-solid topical composition according to  claim 3 , wherein the gelling agent is carbomer. 
     
     
         5 . The semi-solid topical composition according to  claim 1 , wherein the excipients or additives are selected from the group consisting of propylene glycol as solubilizer, macrogol-glycerol hydroxystearate as non-ionic solubilizer and triethanolamine as neutralizing agent. 
     
     
         6 . The semi-solid topical composition according to  claim 1 , wherein the Modified Diallyl Disulfide Oxide (M-DDO) acts as an antimicrobial and antiseptic agent. 
     
     
         7 . The semi-solid topical composition according to  claim 1 , wherein said composition is in gel, cream or ointment form. 
     
     
         8 . The semi-solid topical composition according to  claim 1 , having a pH of 5 to 6.4. 
     
     
         9 . The semi-solid topical composition according to  claim 1 , for preventing chronic inflammation caused by acne. 
     
     
         10 . The semisolid topical composition according to  claim 1 , for reducing skin redness. 
     
     
         11 . The semi-solid topical composition according to  claim 1 , for preventing new acne outbreaks. 
     
     
         12 . The semi-solid topical composition according to  claim 1 , for reversing existing outbreaks. 
     
     
         13 . The semi-solid topical composition according to  claim 1 , for regenerating skin damage caused by acne. 
     
     
         14 . The semi-solid topical composition according to  claim 1 , for avoiding or removing acne scars. 
     
     
         15 - 16 . (canceled) 
     
     
         17 . A method for eliminating, reducing or preventing acne, comprising administering a semi-solid topical composition according to  claim 1  to the skin of a person in need thereof. 
     
     
         18 . A method for avoiding chronic inflammation caused by acne, reducing skin redness, preventing new acne outbreaks, reversing existing outbreaks, regenerating skin damage caused by acne and/or avoiding and removing post-acne scars, comprising administering a semi-solid topical composition according to  claim 1  to the skin of a person in need thereof. 
     
     
         19 . A process for manufacturing a semi-solid topical composition containing Pirfenidone and Modified Diallyl Disulfide Oxide (M-DDO), wherein the process comprises the following stages:
 1.-In a container, place 90% of the total water and add:
 Carbomer (1 g) 
 Leave till complete moisturizing. (IDENTIFY MIXTURE “A”) 
   2.-In another container, place and heat at 40° C. (IDENTIFY SOLUTION “A”)
 Propylene glycol (50 g)
 Add slowly, under constant stirring till complete dissolution, maintaining at 40° C. 
 
 1-phenyl-5-methyl-2-(1H)-pyridone (8 g)
 Add slowly and under constant stirring, maintaining at 40° C. 
 
 Macrogol-glycerol Hydroxystearate (13 g)
 Add under constant stirring, maintaining at 40° C. 
 
 Modified Diallyl Disulfide Oxide (M-DDO) (0.8 g) 
   3.-In another container, place 10% of the total water and under constant stirring add:
 Triethanolamine (1 g) 
 Stir till homogenization (IDENTIFY SOLUTION “B”) 
   4.-Add to the container (step 1), one by one, under constant stirring till homogenization each time and in the indicated order.
 SOLUTION “A” 
 SOLUTION “B” 
   5.-Sample and analyze the topical composition.