Simethicone solid oral dosage form

Abstract

The present invention provides a composition for forming a compressed solid dosage form that is a free-flowing compressible admixture of simethicone, an adsorbant, and an optional active agent, wherein the weight ratio of simethicone to adsorbent is at least 1:2.22. Also included are solid dosage forms made from a free-flowing compressible admixture of simethicone, an adsorbant, and an optional active agent, wherein the weight ratio of simethicone to adsorbent is at least 1:2.22.

1 - 28 . (canceled) 
   
   
       29 . A solid oral dosage form comprising a compressed admixture of simethicone, silicified microcrystalline cellulose, and magnesium aluminometasilicate, wherein the simethicone is adsorbed on the silicified microcrystalline cellulose and magnesium aluminometasilicate, and wherein the weight ratio of simethicone to adsorbent is from about 1:1.68 to about 1:1.78. 
   
   
       30 . The solid oral dosage form of  claim 29 , wherein the composition has about 17 wt % to about 35 wt % simethicone. 
   
   
       31 . The solid oral dosage form of  claim 29 , further comprising at least one additional active agent. 
   
   
       32 . The solid oral dosage form of  claim 31 , wherein the active agent is selected from the group consisting of a bisacodyl, a famotidine, a prucalopride, a diphenoxylate, a loperamide, a lactase, a mesalamine, a bismuth, and pharmaceutically acceptable salts and mixtures thereof 
   
   
       33 . The solid oral dosage form of  claim 32 , wherein the active agent is loperamide, or pharmaceutically acceptable salts thereof. 
   
   
       34 . The solid oral dosage form of  claim 29 , wherein the silicified microcrystalline cellulose is about 19 wt % to about 27 wt % and the magnesium aluminometasilicate is about 31 wt % to about 39 wt %. 
   
   
       35 . The solid oral dosage form of  claim 34 , wherein the silicified microcrystalline cellulose is about 23 wt % to about 27 wt % and the magnesium aluminometasilicate is about 33 wt % to about 37 wt %. 
   
   
       36 . The solid oral dosage form of  claim 29 , wherein the composition is compressed into a tablet having a hardness value of at least about 2 kp/cm 2 . 
   
   
       37 . The solid oral dosage form of  claim 36 , wherein the composition is compressed into a tablet having a hardness value of from about 5 to about 10 kp/cm 2 . 
   
   
       38 . A composition for forming a compressed solid dosage form comprising:
 a free-flowing compressible admixture of simethicone, and   an adsorbent comprising silicified microcrystalline cellulose and magnesium aluminometasilicate, and   wherein the weight ratio of simethicone to adsorbent is from about 1:1.68 to about 1:1.78.   
   
   
       39 . The composition of  claim 38 , wherein the simethicone is from about 17 wt % to about 35 wt %. 
   
   
       40 . The composition of  claim 38 , further comprising at least one additional active agent. 
   
   
       41 . The composition of  claim 40 , wherein the active agent is selected from the group consisting of a bisacodyl, a famotidine, a prucalopride, a diphenoxylate, a loperamide, a lactase, a mesalamine, a bismuth, and pharmaceutically acceptable salts and mixtures thereof. 
   
   
       42 . The composition of  claim 41 , wherein the active agent is loperamide, or pharmaceutically acceptable salts thereof 
   
   
       43 . The composition of  claim 38 , wherein the silicified microcrystalline cellulose is about 19 wt % to about 27 wt % and the magnesium aluminometasilicate is about 31 wt % to about 39 wt %. 
   
   
       44 . The composition of  claim 43 , wherein the silicified microcrystalline cellulose is about 23 wt % to about 27 wt % and the magnesium aluminometasilicate is about 33 wt % to about 37 wt %. 
   
   
       45 . The composition of  claim 38 , wherein the composition is compressed into a tablet having a hardness value of at least about 2 kp/cm 2 . 
   
   
       46 . The composition of  claim 45 , wherein the composition is compressed into a tablet having a hardness value of from about 5 to about 10 kp/cm 2 . 
   
   
       47 . The composition of  claim 41 , wherein the active agent is bisacodyl, or pharmaceutically acceptable salts thereof. 
   
   
       48 . The composition of  claim 40 , wherein the active agent is selected from the group consisting of acetaminophen, ibuprofen, naproxen, ketoprofen, cyclobenzaprine, meloxicam, rofecoxib, celecoxib, and pharmaceutically acceptable salts and mixtures thereof.