Homogeneously Formulating microdosed active principles

Abstract

A microdose of at least one active principle is essentially homogeneously formulated within at least one excipient therefor, via the following steps: 1. weighing the at least one active principle in a receptacle lined with a petroleum jelly; 2. encapsulating the active principle with additional petroleum jelly; 3. introducing the receptacle confining the active principle(s) and the petroleum jelly into a mixer, the receptacle being provided with perforations of a size and shape as to permit diffusion of the active principle(s) and petroleum jelly therethrough and the mixer containing at least one excipient in heated liquid state; and 4. melting said petroleum jelly by immersion of the receptacle within the at least one excipient in heated liquid state and thence diffusing and microdosing the active principle(s) therein.

1 . A method for essentially homogeneously formulating a microdose of at least one active principle within at least one excipient therefor, comprising the following steps: 
 1. weighing said at least one active principle in a receptacle lined with a petroleum jelly;    2. encapsulating said active principle with additional petroleum jelly;    3. introducing the receptacle confining said active principle(s) and the petroleum jelly into a mixer, said receptacle being provided with perforations of a size and shape as to permit diffusion of said active principle(s) and petroleum jelly therethrough and said mixer containing at least one excipient in heated liquid state; and    4. melting said petroleum jelly by immersion of said receptacle within said at least one excipient in heated liquid state and thence diffusing and microdosing said active principle(s) therein.    
   
   
       2 . The method as defined by  claim 1 , said weighing being carried out in a fume cupboard with vertical laminar flow or in a sealed enclosure, to avoid risk of contamination with a toxic active principle.  
   
   
       3 . The method as defined by  claim 1 , said receptacle having frustoconical dimensions.  
   
   
       4 . The method as defined by  claim 1 , said petroleum jelly having a viscosity ranging from 130,000 and 550,000 Cps.  
   
   
       5 . The method as defined by  claim 1 , said petroleum jelly permitting maximal limitation of the paraffin oil exudation phenomena.  
   
   
       6 . The method as defined by  claim 1 , said active principle(s) comprising calcitriol.  
   
   
       7 . The method as defined by  claim 1 , said at least one excipient comprising mixture of white petroleum jelly and paraffin.  
   
   
       8 . The method as defined by  claim 7 , said at least one excipient comprising mixture of from 50% to 60% white petroleum jelly and from 40% to 50% paraffin.  
   
   
       9 . The method as defined by  claim 1 , said step 4 comprising rotating said receptacle within said at least one excipient in heated liquid state.  
   
   
       10 . The method as defined by  claim 1 , said step 4 comprising constantly diffusing and microdosing said active principle(s) within said at least one excipient in heated liquid state.  
   
   
       11 . The method as defined by  claim 11 , the calcitriol being at a final concentration of 3 ppm.  
   
   
       12 . A pharmaceutical/cosmetic formulation, comprising the product of the method as defined by  claim 1 .  
   
   
       13 . The pharmaceutical/cosmetic formulation as defined by  claim 12 , comprising an ointment.  
   
   
       14 . A microdose of calcitriol essentially homogeneously dispersed within at least one excipient therefor.  
   
   
       15 . A microdose of calcitriol essentially homogeneously dispersed within a mixture of petroleum jelly and paraffin, at a concentration on the order of 3 ppm.