Misoprostol Dispersible Tablet

Abstract

The present invention relates to a solid pharmaceutical formulation comprising misoprostol or a pharmaceutically acceptable salt thereof. In particular, the invention relates to a dispersible tablet comprising misoprostol or a pharmaceutically acceptable salt thereof.

1 . A pharmaceutical dosage form comprising misoprostol, or a pharmaceutically acceptable salt thereof, as the sole active ingredient, and at least a first disintegrant;
 wherein the dosage form is suitable for use in a treatment comprising cervical ripening or the induction of labor upon administration to a subject;   wherein the dosage form has a content of 0.5-50 μg misoprostol, or an equivalent amount of pharmaceutically acceptable salt thereof   wherein the dosage form is suitable for sublingual or oral administration; and   wherein the dosage form disperses in 100 ml water at 25° C. within 3 minutes upon stirring, thereby providing a dispersion that passes through a sieve screen with a nominal mesh aperture of 710 μm.   
     
     
         2 . The pharmaceutical dosage form according to  claim 1  that is suitable for sublingual administration. 
     
     
         3 . The pharmaceutical dosage form according to  claim 1 , wherein the first disintegrant is cross-linked polyvinylpyrrolidone (PVP). 
     
     
         4 . The pharmaceutical dosage form according to  claim 1 , further comprising a second disintegrant. 
     
     
         5 . The pharmaceutical dosage form according to  claim 4 , wherein the first and second disintegrants are cross-linked PVP and crospovidone. 
     
     
         6 . The pharmaceutical dosage form according to  claim 4 , wherein at least one of said first and second disintegrants is a cross-linked carboxymethylcellulose. 
     
     
         7 . The pharmaceutical dosage form according to  claim 4 , wherein at least one of said first and second disintegrants is croscarmellose sodium. 
     
     
         8 . The pharmaceutical dosage form according to  claim 4 , wherein the first and second disintegrants use different mechanisms of disintegration. 
     
     
         9 . The pharmaceutical dosage form according to  claim 4 , wherein the first and second disintegrants use mechanisms of disintegration selected from the group consisting of swelling, porosity and capillary action, and deformation. 
     
     
         10 . The pharmaceutical dosage form according to  claim 1 , wherein the first disintegrant is starch. 
     
     
         11 . The pharmaceutical dosage form according to  claim 1 , wherein the first disintegrant is present in an amount of 1-50% by weight. 
     
     
         12 . The pharmaceutical dosage form according to  claim 11 , wherein the first disintegrant is crospovidone. 
     
     
         13 . The pharmaceutical dosage form according to  claim 1 , further comprising starch in amount of 1-50% by weight. 
     
     
         14 . The pharmaceutical dosage form according to  claim 13 , wherein the starch is maize starch. 
     
     
         15 . The pharmaceutical dosage form according to  claim 1 , wherein the content of misoprostol, or an equivalent amount of pharmaceutically acceptable salt thereof, is 5-50 μg. 
     
     
         16 . The pharmaceutical dosage form according to  claim 1 , having a disintegration time of less than 2 minutes. 
     
     
         17 . The pharmaceutical dosage form according to  claim 16 , having a disintegration time of less than 20 seconds. 
     
     
         18 . The pharmaceutical dosage form according to  claim 1  that disperses in 100 ml water at 25° C. within 1 minute upon stirring, thereby providing a dispersion that passes through a sieve screen with a nominal mesh aperture of 710  m.