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 a first step of preparing tartaric acid pellets 1 comprising alternatively spraying tartaric acid particles with a solution of tartaric acid and a binder followed by sprinkling the tartaric acid particles with a fine tartaric acid powder having a particle size of <100 microns, wherein at least 90% of the tartaric acid particles have a particle size in the range from 0.4-0.6 mm, and in a second step, spraying an ethanolic insulating suspension 2 comprising hydroxypropylmethylcellulose onto the tartaric acid pellets 1 to form insulated tartaric acid pellets 3 having substantially uniform, sphere-like shapes.
2. The method of preparing insulated tartaric acid pellets 3 according to claim 1 , wherein at least 85% of the fine tartaric acid powder has a particle size of <75 microns.
3. The method of preparing insulated tartaric acid pellets 3 according to claim 1 , wherein the ethanolic insulating suspension 2 further comprises talc.
4. The method of preparing insulated tartaric acid pellets 3 according to claim 3 wherein the ethanolic insulating suspension 2 further comprises dimethylpolysiloxane.
5. Insulated tartaric acid pellets 3 made by the method according to claim 1 .
6. A method for manufacturing an active substance-containing pharmaceutical formulation comprising applying an active substance to the insulated tartaric acid pellets 3 prepared in claim 1 .
7. The method according to claim 6 , wherein active substance is dipyridamole, dabigatran, acetylsalicylic acid or a combination thereof.