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, wherein said dosage form is suitable for both sublingual and oral administration. 
     
     
         2 . (canceled) 
     
     
         3 . The pharmaceutical dosage form according to  claim 1 , further comprising cross-linked polyvinylpyrrolidone as a disintegrant. 
     
     
         4 . The pharmaceutical dosage form according to  claim 1 , further comprising at least two disintegrants. 
     
     
         5 . The pharmaceutical dosage form according to  claim 4 , wherein at least one of said disintegrants is a cross-linked carboxymethylcellulose. 
     
     
         6 . The pharmaceutical dosage form according to  claim 4 , wherein said disintegrants use at least two different mechanisms of disintegration. 
     
     
         7 . The pharmaceutical dosage form according to  claim 6 , wherein said mechanisms of disintegration are selected from the group consisting of swelling, porosity and capillary action, and deformation. 
     
     
         8 . The pharmaceutical dosage form according to  claim 4 , wherein said disintegrants are superdisintegrants. 
     
     
         9 . The pharmaceutical dosage form according to  claim 1 , further comprising a starch as a disintegrant. 
     
     
         10 . The pharmaceutical dosage form according to  claim 9 , further comprising at least one superdisintegrant. 
     
     
         11 . The pharmaceutical dosage form according to  claim 1 , further comprising an excipient selected from the group consisting of maize starch, potato starch, pea starch, rice starch, tapioca starch, wheat starch, and modified starch. 
     
     
         12 . The pharmaceutical dosage form according to  claim 11 , wherein said excipient is maize starch. 
     
     
         13 . The pharmaceutical dosage form according to  claim 1 , further comprising a disintegrant in an amount of 6-50% by weight. 
     
     
         14 . The pharmaceutical dosage form according to  claim 1 , further comprising a superdisintegrant in an amount of 6-50% by weight. 
     
     
         15 . The pharmaceutical dosage form according to  claim 1 , further comprising croscarmellose sodium in an amount of 6-50% by weight. 
     
     
         16 . The pharmaceutical dosage form according to  claim 1 , further comprising crospovidone in an amount of 6-50% by weight. 
     
     
         17 . The pharmaceutical dosage form according to  claim 1 , further comprising starch in an amount of 1-50% by weight. 
     
     
         18 . The pharmaceutical dosage form according to  claim 1 , further comprising microcrystalline cellulose in an amount of 1-99% by weight. 
     
     
         19 . The pharmaceutical dosage form according to  claim 1 , wherein said misoprostol or pharmaceutically acceptable salt thereof is present in an amount of 0.5-1000 μg. 
     
     
         20 . The pharmaceutical dosage form according to  claim 1  that has a disintegration time of less than 1 minute. 
     
     
         21 . The pharmaceutical dosage form according to  claim 1  that disperses in 100 ml water at 25° C. within 15 minutes upon stirring, thereby providing a dispersion, said dispersion passing through a sieve screen with a nominal mesh aperture of 710 μm. 
     
     
         22 . The pharmaceutical dosage form according to  claim 1  that disperses in 100 ml water at 25° C. within 15 minutes substantially without stirring, thereby providing a dispersion, said dispersion passing through a sieve screen with a nominal mesh aperture of 710 μm. 
     
     
         23 . The pharmaceutical dosage form according to  claim 1  that is a dispersible tablet. 
     
     
         24 . The pharmaceutical dosage form according to  claim 1 , further comprising at least one excipient selected from the group consisting of diluents, disintegrants, binders, glidants, lubricants, and coatings. 
     
     
         25 . The pharmaceutical dosage form according to  claim 1  that is suitable for cervical ripening or the induction of labor upon administration to a subject. 
     
     
         26 . A method for obtaining cervical ripening or the induction of labor, the method comprising administering the pharmaceutical dosage form according to  claim 1  to a subject in need thereof. 
     
     
         27 . (canceled) 
     
     
         28 . A method for the manufacture of the pharmaceutical dosage form according to  claim 1 , the method comprising compressing a composition comprising misoprostol or a pharmaceutically acceptable salt thereof. 
     
     
         29 . The method according to  claim 28 , wherein said compression is direct compression. 
     
     
         30 . The method according to  claim 28 , further comprising dry mixing of ingredients to form said composition. 
     
     
         31 . The pharmaceutical dosage form according to  claim 1 , wherein said misoprostol or pharmaceutically acceptable salt thereof is present in an amount of less than 1% by weight of the pharmaceutical dosage form. 
     
     
         32 . The pharmaceutical dosage form according to  claim 1 , wherein said dosage form is further suitable for vaginal administration.