Orally Disintegrating Tablet Formulation For Enhanced Bioavailability

Abstract

In some aspects of the present invention is a formulation comprising a solid dispersion or intimate mixture of a poorly water soluble drug and an ionic polymer surprisingly exhibiting fast disintegration of tablet.

1 . An orally disintegrating tablet comprising:
 an amorphous solid dispersion comprising a hot-melt extrudate comprising a poorly water soluble drug and an ionic polymer,   wherein the ionic polymer is selected from the group consisting of: a copolymer of methacrylic acid, ethyl acrylate, and methyl methacrylate; hypromellose acetate succinate; and a copolymer of dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate,   wherein the ionic polymer is present in an amount of at least 55% by weight of the amorphous solid dispersion,   wherein the poorly water soluble drug and the ionic polymer are present in a weight ratio of between 20:80 and 45:55,   wherein the poorly water soluble drug in amorphous form is present in the amount of at least 80% by weight of the poorly soluble drug, and   wherein the tablet disintegrates in water within 40 seconds or less.   
     
     
         2 . The orally disintegrating tablet of  claim 1 , wherein an amount of the ionic polymer is at least about 65% by weight of said dispersion. 
     
     
         3 . The orally disintegrating tablet of  claim 1 , wherein the poorly water soluble drug is megestrol or a pharmaceutically acceptable salt thereof. 
     
     
         4 . The orally disintegrating tablet of  claim 1 , wherein the poorly water soluble drug is ziprasidone or a pharmaceutically acceptable salt thereof. 
     
     
         5 . The orally disintegrating tablet of  claim 1 , wherein the poorly water soluble drug is eszopiclone or a pharmaceutically acceptable salt thereof. 
     
     
         6 . The orally disintegrating tablet of  claim 1 , wherein the poorly water soluble drug is prednisolone or a pharmaceutically acceptable salt thereof. 
     
     
         7 . The orally disintegrating tablet of  claim 1 , wherein the poorly water soluble drug is clarithromycin or a pharmaceutically acceptable salt thereof. 
     
     
         6 . The orally disintegrating tablet of  claim 1 , wherein the poorly water soluble drug is sumatriptan or a pharmaceutically acceptable salt thereof. 
     
     
         7 . The orally disintegrating tablet of  claim 1 , wherein the drug and the ionic polymer are present in a weight ratio of 20:80, and wherein the tablet disintegrates in 40 seconds or less. 
     
     
         8 . The orally disintegrating tablet of  claim 1 , wherein the drug and the ionic polymer are present in a weight ratio of 45:55, and wherein the tablet disintegrates in 30 seconds or less.