Modified Release Tranexamic Acid Formulation

Abstract

A modified release dosage form for the oral administration of tranexamic acid.

1 - 24 . (canceled) 
     
     
         25 . A modified release dosage form consisting essentially of:
 (A) a compressed matrix core which comprises:
 (i) tranexamic acid; 
 (ii) a release controlling material; and 
 (iii) a tableting excipient selected from the group consisting of binders, fillers, disintegrants, glidants, lubricants or mixtures thereof; 
   (B) a functional coating applied to and surrounding the compressed matrix core which comprises:
 (i) a coating agent which is insoluble in water but soluble in aqueous media with a pH below 4; and 
 (ii) a processing aid selected from the group consisting of a binder, filler, pigment, lubricant, plasticizer and mixtures thereof; and 
   (C) optionally an aesthetic coating.   
     
     
         26 . The modified release dosage form as defined in  claim 25  wherein the dosage form is a tablet or mini tablet. 
     
     
         27 . The modified release dosage form as defined in  claim 25  wherein the coating agent which is insoluble in water but soluble in aqueous media with a pH below 4 is an aminoalkyl methacrylate copolymer. 
     
     
         28 . The modified release dosage form as defined in  claim 25  wherein the compressed matrix core has a hardness of 13-20 kp. 
     
     
         29 . A modified release tablet consisting essentially of:
 (A) a compressed matrix core which comprises:
 (i) tranexamic acid; 
 (ii) a release controlling material; and 
 (iii) a tableting excipient selected from the group consisting of binders, fillers, disintegrants, glidants, lubricants or mixtures thereof; 
   (B) a functional coating applied to and surrounding the compressed matrix core which comprises:
 (i) an aminoalkyl methacrylate copolymer that is insoluble in water but soluble in aqueous media with a pH below 4; and 
 (ii) a processing aid selected from the group consisting of a binder, filler, pigment, lubricant, plasticizer and mixtures thereof; and 
   (C) optionally an aesthetic coating, wherein the compressed matrix core has a hardness of 13-20 kp.