METHOD FOR MANUFACTURING ACID PELLETS
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.