PROCESS FOR PREPARING PRAMIPEXOLE DIHYDROCHLORIDE TABLETS
First Claim
Patent Images
1. A process for preparing pramipexole dihydrochloride tablets comprising intra-granular tableting ingredients, pramipexole dihydrochloride or a pharmaceutically acceptable salt thereof, a binder suspension and extra-granular tableting agents, wherein at least a portion of the process is performed in a closed system and comprises the steps of:
- (a) sizing the intra-granular tableting ingredients to form uniformly sized particles of intra-granular tableting ingredients,(b) mixing the particles of intra-granular tableting ingredients in a granulator-mixer,(c) dissolving the pramipexole dihydrochloride or a pharmaceutically acceptable salt thereof, in water to form an aqueous pramipexole dihydrochloride solution and adding the pramipexole dihydrochloride solution to the particles of intra-granular tableting ingredients in the granulator-mixer,(d) preparing a binder ssuspension and adding the binder suspension to the granulator-mixer,(e) mixing the particles of intra-granular tableting ingredients, pramipexole dihydrochloride solution and binder suspension in the granulator-mixer to form a premix,(f) granulating said premix to form a granulated premix,(g) drying said granulated premix to an endpoint moisture content of from about 1.5% to about 2.5,(h) mixing said granulated premix of step (g) with the extra-granular tableting agents and blending to form a final blend,(i) compressing the final blend into tablets using a tablet press.
1 Assignment
0 Petitions
Accused Products
Abstract
The present invention relates to a process for preparing tablets of pramipexole dihydrochloride. In particular, the present invention relates to a process for preparing tablets of pramipexole dihydrochloride wherein the tablets exhibit enhanced storage stability properties.
-
Citations
9 Claims
-
1. A process for preparing pramipexole dihydrochloride tablets comprising intra-granular tableting ingredients, pramipexole dihydrochloride or a pharmaceutically acceptable salt thereof, a binder suspension and extra-granular tableting agents, wherein at least a portion of the process is performed in a closed system and comprises the steps of:
-
(a) sizing the intra-granular tableting ingredients to form uniformly sized particles of intra-granular tableting ingredients, (b) mixing the particles of intra-granular tableting ingredients in a granulator-mixer, (c) dissolving the pramipexole dihydrochloride or a pharmaceutically acceptable salt thereof, in water to form an aqueous pramipexole dihydrochloride solution and adding the pramipexole dihydrochloride solution to the particles of intra-granular tableting ingredients in the granulator-mixer, (d) preparing a binder ssuspension and adding the binder suspension to the granulator-mixer, (e) mixing the particles of intra-granular tableting ingredients, pramipexole dihydrochloride solution and binder suspension in the granulator-mixer to form a premix, (f) granulating said premix to form a granulated premix, (g) drying said granulated premix to an endpoint moisture content of from about 1.5% to about 2.5, (h) mixing said granulated premix of step (g) with the extra-granular tableting agents and blending to form a final blend, (i) compressing the final blend into tablets using a tablet press. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
-
Specification