Method for manufacturing acid pellets

Abstract

The invention relates to an improved method of manufacturing substantially spherical/ball-shaped tartaric acid starter pellets which are suitable for preparing active substance-containing medicament formulations, as well as the pellets as such that may be obtained in this way, and their use as starting material for the preparation of active substance-containing medicament formulations.

1 . A method of preparing insulated tartaric acid pellets  3 , comprising the steps of first preparing tartaric acid pellets  1  and then spraying an ethanolic insulating suspension  2  comprising hydroxypropylmethylcellulose onto the tartaric acid pellets  1  to form insulated tartaric acid pellets  3 . 
     
     
         2 . The method of preparing insulated tartaric acid pellets  3  according to  claim 1 , wherein the tartaric acid pellets  1  having a particle size in the range from 0.2-0.8 mm are prepared by spraying a solution of tartaric acid and binder and then sprinkling with fine tartaric acid powder with a particle size of <100 microns. 
     
     
         3 . The method of preparing insulated tartaric acid pellets  3  according to  claim 2 , wherein at least 90% of the tartaric acid pellets 1 have a particle size in the range from 0.2-0.8 mm 
     
     
         4 . The method of preparing insulated tartaric acid pellets  3  according to  claim 2 , wherein at least 85% of the tartaric acid pellets  1  has have a particle size of <100 microns. 
     
     
         5 . The method of preparing insulated tartaric acid pellets  3  according to  claim 1 , wherein the ethanolic insulating suspension  2  used contains further comprises talc. 
     
     
         6 . The method of preparing insulated tartaric acid pellets  3  according to  claim 5 , wherein the ethanolic insulating suspension  2  further comprises dimethylpolysiloxane. 
     
     
         7 . Isolated tartaric acid pellets  3  made by the method according to  claim 1 . 
     
     
         8 . A method for manufacturing an active substance-containing pharmaceutical formulation comprising the step of using the insulated tartaric acid pellets  3  prepared in  claim 1 . 
     
     
         9 . The method according to  claim 8 , wherein the active substance-containing pharmaceutical formulations is one in which the active substance is dipyridamole, dabigatran, acetylsalicylic acid or combinations thereof. 
     
     
         10 . An ethanolic insulating suspension  2  comprising hydroxypropylmethylcellulose. 
     
     
         11 . The ethanolic insulating suspension  2  according to  claim 10 , further comprising dimethylpolysiloxane. 
     
     
         12 . The ethanolic insulating suspension  2  according to  claim 10  or  11 , further comprising talc. 
     
     
         13 . The method according to  claim 2 , wherein the binder is gum arabic.