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Process for Preparing Pramipexole Dihydrochloride Tablets

  • US 20100252949A1
  • Filed: 06/18/2010
  • Published: 10/07/2010
  • Est. Priority Date: 04/10/2007
  • Status: Abandoned Application
First Claim
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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 suspension 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.

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