Extended Release Tablet Formulation Containing Pramipexole or a Pharmaceutically Acceptable Salt Thereof

Abstract

An extended release tablet formulation comprising pramipexole or a pharmaceutically acceptable salt thereof in a matrix comprising at least one water swelling polymer other than pregelatinized starch.

We claim: 
     
         1 . An extended release tablet formulation comprising pramipexole or a pharmaceutically acceptable salt thereof in a matrix comprising one water swelling polymer other than pregelatinized starch, whereby said one water swelling polymer other than pregelatinized starch represents one hydrophilic water swelling polymer constituting the matrix and wherein starch is completely excluded from the tablet formulation. 
     
     
         2 . The extended release tablet formulation of  claim 1 , wherein there is no coating on the tablet. 
     
     
         3 . The extended release tablet formulation of  claim 1 , wherein the tablet comprises a nonfunctional coating. 
     
     
         4 . The extended release tablet formulation according to  claim 1 , wherein said water swelling polymer is a water swelling substantially neutral polymer or a water swelling anionic polymer. 
     
     
         5 . The extended release tablet formulation according to  claim 1 , whereby the matrix optionally comprises excipients and
 (a) the resulting tablet providing a pH-independent in vitro release characteristic in the range from pH 1 to 7.5, or   (b) at least one water swelling anionic polymer and the resulting tablet providing a pH-dependent release characteristic with a faster release characteristic in the range of pH<4.5, and a slower and further on pH-independent release characteristic in the range from pH 4.5 to 7.5.   
     
     
         6 . The extended release tablet formulation according to any of  claim 1 , wherein said water swelling polymer is a water swelling anionic polymer which is selected from the group of acrylic acid polymerisate, methacrylic acid copolymers, alginates, carrageenans, acacia, xanthan gum, chitin derivates, carmellose sodium and carmellose calcium. 
     
     
         7 . The extended release tablet formulation according to  claim 6 , wherein said water swelling polymer is an optionally crosslinked acrylic acid polymer, and wherein the content of the optionally crosslinked acrylic acid polymer in the matrix is preferably from about 0.25 wt.-% to about 25 wt.-%. 
     
     
         8 . The extended release tablet formulation according to  claims 1 , wherein said water swelling polymer is a water swelling substantially neutral polymer which is selected from the group of alkylcelluloses, hydroxyalkylcelluloses, hydroxyalkyl alkylcelluloses, carboxyalkylcellulose esters, natural, semi-synthetic, or synthetic di-, oligo- and polysaccharides, polyvinylalcohol, polyvinylpyrrolidone, copolymers of polyvinylpyrrolidone with vinyl acetate, combinations of polyvinylalcohol and polyvinylpyrrolidone, polyalkylene oxides and copolymers of ethylene oxide and propylene oxide. 
     
     
         9 . The extended release tablet formulation according to any of  claim 1 , wherein the amount of the water swelling polymer ranges from about 10 to about 80% by weight. 
     
     
         10 . The extended release tablet formulation according to  claim 1 , wherein the contained amount of pramipexole or pharmaceutically acceptable salt thereof is sufficient to provide a daily dose administered at one time. 
     
     
         11 . The extended release tablet formulation according to  claim 1 , wherein the amount of pramipexole or pharmaceutically acceptable salt thereof is from about 0.1 to about 10 mg. 
     
     
         12 . The extended release tablet formulation according to  claim 1 , wherein the tablet consists of pramipexole-dihydrochloride monohydrate, carbomer 941, lactose monohydrate, colloidal silicon dioxide, magnesium stearate and calcium phosphate dibasic hydrate.