Immediate disintegration polyvalent polymeric matrix for modified release solid oral preparations and method of preparation thereof

Abstract

An immediate disintegrating polymeric matrix for oral administration with modified release is disclosed, obtained without using inert supports such as sugar spheres, comprising particles of active substance directly covered with a release regulating membrane. Use of such a matrix to prepare various administration forms for oral use as well as the method of its preparation are also disclosed.

1 . A prompt disintegration polymeric matrix for oral administration with modified release, comprising particles of active substance directly covered with a release regulating membrane where use of inert supports is eliminated. 
   
   
       2 . The polymeric matrix of  claim 1 , wherein the cover membrane comprises a solution of shellac in ethanol and talc. 
   
   
       3 . The polymeric matrix of  claim 1 , wherein the matrix blended with excipients is compressed directly to obtain tablets with immediate disintegration. 
   
   
       4 . The polymeric matrix according to  claim 1 , wherein the matrix is blended with flavoring and other excipients masking the taste of the active substance, for a better compliance of users. 
   
   
       5 . The polymeric matrix according to  claim 1 , wherein the active substance is a pharmaceutical substance. 
   
   
       6 . The polymeric matrix according to  claim 5 , wherein the matrix is a medicament comprising one or more active substances. 
   
   
       7 . The polymeric matrix according to  claim 1 , wherein the active substance is a food supplement. 
   
   
       8 . The polymeric matrix according to  claim 7 , wherein the food supplement is thioptic or alpha-lipoic acid. 
   
   
       9 . Use of the matrix according to  claim 1 , to prepare a homogeneous and uniform extemporaneous suspension in a reduced amount of liquid. 
   
   
       10 . Use of the matrix according  claim 1 , to prepare hard gelatine capsules. 
   
   
       11 . Use of the matrix according to  claim 1 , to prepare single dose oral soluble sachets. 
   
   
       12 . A method of preparing a disintegrating polymeric matrix for oral use with modified release according to  claim 1 , comprising the steps of:
 charging in a rotary pan a starting material comprising an active substance with particle size between 200 and 700 μm;   rotating the pan directly covering the particles of active substance in one or more stages with one or more layers of release regulating polymeric membrane;   at the end of the covering step, sieving the product with a mesh of 790 μm and dusting with a mesh of 425 μm; and   drying the product in the pan at room temperature.   
   
   
       13 . The method according to  claim 12 , wherein the polymeric matrix is blended with excipients to make disintegrating tablets and single dose oral soluble sachets. 
   
   
       14 . The method according to claim, wherein the polymeric matrix is blended with flavoring and other excipients for masking the taste of the active substance. 
   
   
       15 . The method according to  claim 12 , wherein two or more active substances are mixed for a combination therapy or food integration. 
   
   
       16 . The polymeric matrix according to  claim 2 , wherein the matrix is blended with flavoring and other excipients masking the taste of the active substance, for a better compliance of users. 
   
   
       17 . The polymeric matrix according to  claim 3 , wherein the matrix is blended with flavoring and other excipients masking the taste of the active substance, for a better compliance of users. 
   
   
       18 . The polymeric matrix according to  claim 17 , wherein the active substance is a pharmaceutical substance. 
   
   
       19 . The polymeric matrix according to  claim 16 , wherein the active substance is a pharmaceutical substance. 
   
   
       20 . The polymeric matrix according to  claim 15 , wherein the active substance is a pharmaceutical substance.