PROCESS FOR PREPARING PRAMIPEXOLE DIHYDROCHLORIDE TABLETS
First Claim
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1. A process for preparing pramipexole dihydrochloride tablets comprising intra-granular tableting ingredients, pramipexole dihydro chloride or a pharmaceutically acceptable solvate thereof, a binder and extra-granular tableting agents, wherein the process is performed in a closed system and comprises the steps of:
- (a) loading particles of the intra-granular tableting ingredients into a fluid bed granulator,(b) dissolving the pramipexole dihydrochloride or pharmaceutically acceptable solvate thereof in water and povidone to form an aqueous pramipexole dihydrochloride solution and spraying the pramipexole dihydrochloride solution to the particles of intra-granular tableting ingredients in the fluid bed granulator,(c) preparing a binder solution and adding the binder solution to the fluid bed granulator,(d) mixing the particles of intra-granular tableting ingredients, pramipexole dihydrochloride solution and binder solution in the fluid bed granulator to form a premix,(e) granulating said premix to form a granulated premix,(f) drying said granulated premix to an endpoint moisture content of from about 1.0% to about 2.5%,(g) mixing said granulated premix of step (f) with the extra-granular tableting agents and blending to form a final blend,(h) compressing the final blend into tablets using a tablet press.
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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.
19 Citations
14 Claims
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1. A process for preparing pramipexole dihydrochloride tablets comprising intra-granular tableting ingredients, pramipexole dihydro chloride or a pharmaceutically acceptable solvate thereof, a binder and extra-granular tableting agents, wherein the process is performed in a closed system and comprises the steps of:
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(a) loading particles of the intra-granular tableting ingredients into a fluid bed granulator, (b) dissolving the pramipexole dihydrochloride or pharmaceutically acceptable solvate thereof in water and povidone to form an aqueous pramipexole dihydrochloride solution and spraying the pramipexole dihydrochloride solution to the particles of intra-granular tableting ingredients in the fluid bed granulator, (c) preparing a binder solution and adding the binder solution to the fluid bed granulator, (d) mixing the particles of intra-granular tableting ingredients, pramipexole dihydrochloride solution and binder solution in the fluid bed granulator to form a premix, (e) granulating said premix to form a granulated premix, (f) drying said granulated premix to an endpoint moisture content of from about 1.0% to about 2.5%, (g) mixing said granulated premix of step (f) with the extra-granular tableting agents and blending to form a final blend, (h) compressing the final blend into tablets using a tablet press. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A pharmaceutical tablet formulation comprising pramipexole dihydrochloride or a pharmaceutically acceptable solvate thereof, wherein the average amount of pramipexole dihydrochloride or pharmaceutically acceptable solvate thereof remaining in the tablet at 18 months under storage conditions of 25°
- C. and a relative humidity of 60% is at least about 97% of the labeled amount.
- View Dependent Claims (10)
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11. A pharmaceutical tablet formulation comprising pramipexole dihydrochloride, wherein the average amount of pramipexole dihydrochloride remaining in the tablet at 24 months under storage conditions of 25°
- C. and a relative humidity of 60% is at least about 95% of the labeled amount.
- View Dependent Claims (12, 13)
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14. A pharmaceutical tablet formulation comprising pramipexole dihydrochloride or a pharmaceutically acceptable solvate thereof, wherein the average amount of total degradation product present in the tablet at 18 months under storage conditions of 25°
- C. and a relative humidity of 60% is less than about 1.0%.
Specification