Petrolatum-based delivery systems and for active ingredients

Abstract

The present disclosure is broadly concerned with petrolatum-based compositions as a suspension matrix for the active ingredients. The disclosure is also concerned with processes for forming stable emulsions of active ingredients in petrolatum.

What is claimed is: 
     
         1 . A method for preparing a stable suspension comprising water, petrolatum, and at least one ionic biocide compound, the method comprising:
 separately heating petrolatum and a mixture of water and at least one ionic biocide compound, each to a temperature of from about 40° C. up to about 50° C.; wherein the mixture of water and the at least one ionic biocide is heated to a temperature higher than the temperature of the petrolatum;   mixing the heated components to give a melted mixture, wherein the mixing comprises subjecting the mixture to high RPM mixing or homogenization; and   cooling the melted mixture to give the stable suspension comprising nanodroplets containing the at least one biocide compound suspended in the petrolatum;   wherein the suspension contains no added emulsifier, and all ionic biocide compounds present are either all cationic or all anionic,   wherein the at least one ionic biocide is contained within nanodroplets having a diameter of from about 10 nm to about 10,000 nm.   
     
     
         2 . The method of  claim 1 , wherein all ionic biocide compounds present are all cationic biocides. 
     
     
         3 . The method of  claim 1 , wherein all ionic biocide compounds present are all anionic biocides. 
     
     
         4 . The method of  claim 1 , wherein the at least one ionic biocide compound is selected from the group consisting of polyhexanide (PHMB), polyaminopropyl biguanide (PAPB), benzalkonium chloride, stearalkonium chloride, sodium hypochlorite and ethylenediaminetetracetic acid (EDTA). 
     
     
         5 . The method of  claim 4 , wherein the at least one ionic biocide compound is a combination of PHMB and benzalkonium chloride. 
     
     
         6 . The method of  claim 1 , wherein the suspension further comprises at least one non-ionic biocide compound selected from the group consisting of mupirocin, amoxicillin, tetracycline HCl, and demeclocycline HCl. 
     
     
         7 . The method of  claim 1 , wherein the suspension further comprises at least one additional active ingredient. 
     
     
         8 . The method of  claim 7 , wherein the at least one additional active ingredient is a steroid selected from the group consisting of progesterone USP, pregnenolone acetate, dehydroepiandrosterone, and hydrocortisone. 
     
     
         9 . The method of  claim 8 , wherein the steroid is hydrocortisone.