US2005186284A1PendingUtilityA1

Taste-masking oral dosage form and method of preparing the same

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Assignee: PHARMACEUTICAL IND TECH & DEVPriority: Feb 25, 2004Filed: May 6, 2004Published: Aug 25, 2005
Est. expiryFeb 25, 2024(expired)· nominal 20-yr term from priority
Inventors:Chih-Chiang YangWen-Che WangHui-Yu Chen
A61K 9/1652A61K 9/2027A61K 9/1617A61K 31/717A61K 9/1635A61K 9/2018A61P 43/00
58
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Claims

Abstract

A taste-masking oral dosage form. The taste-masking oral dosage form comprises a pharmaceutically active ingredient, and a starch, wherein the pharmaceutically active ingredient is packaged by the starch to form a microparticle. A method of preparing the taste-masking oral dosage form is also disclosed.

Claims

exact text as granted — not AI-modified
1 . A taste-masking oral dosage form, comprising: 
 a pharmaceutically active ingredient; and    a starch, wherein the pharmaceutically active ingredient is packaged by the starch to form a microparticle;.    
     
     
         2 . The taste-masking oral dosage form as claimed in  claim 1 , wherein the pharmaceutically active ingredient comprises any optional orally administrated drugs.  
     
     
         3 . The taste-masking oral dosage form as claimed in  claim 1 , wherein the starch comprises amylodextrin, hydroxyethyl starch, hydropropyl starch, carboxymethyl starch, acetylated starch, or phosphorylated starch.  
     
     
         4 . The taste-masking oral dosage form as claimed in  claim 1 , wherein the package percentage exceeds 95%.  
     
     
         5 . The taste-masking oral dosage form as claimed in  claim 1 , wherein the microparticle is a co-crystal structure comprising the pharmaceutically active ingredient and the starch.  
     
     
         6 . The taste-masking oral dosage form as claimed in  claim 1 , wherein the diameter of the microparticle is about 150˜350 μm.  
     
     
         7 . The taste-masking oral dosage form as claimed in  claim 1 , wherein the tablet further comprises a hydrophilic polymer, a surfactant, excipients, or combinations thereof.  
     
     
         8 . The taste-masking oral dosage form as claimed in  claim 7 , wherein the hydrophilic polymer comprises PEG, PVP, carbopol, polysaccharide, agar, MC, or HPMC.  
     
     
         9 . The taste-masking oral dosage form as claimed in  claim 7 , wherein the surfactant comprises edible surfactants.  
     
     
         10 . The taste-masking oral dosage form as claimed in  claim 7 , wherein the surfactant comprises lecithin.  
     
     
         11 . The taste-masking oral dosage form as claimed in  claim 7 , wherein the excipient comprises disintegrating agents, effervescent, lubricants, or sweeteners.  
     
     
         12 . The taste-masking oral dosage form as claimed in  claim 7 , wherein the excipient comprises saccharide, alcohol, or sugar alcohol.  
     
     
         13 . The taste-masking oral dosage form as claimed in  claim 12 , wherein saccharide comprises monosaccharide or disaccharide.  
     
     
         14 . The taste-masking oral dosage form as claimed in  claim 12 , wherein sugar alcohol comprises mannitol, sorbitol, xylitol, or glycerol.  
     
     
         15 . The taste-masking oral dosage form as claimed in  claim 1 , wherein the pharmaceutically active ingredient in a proportion is generally about 5˜45% by weight.  
     
     
         16 . The taste-masking oral dosage form as claimed in  claim 1 , wherein the starch in a proportion is generally about 20˜30% by weight.  
     
     
         17 . The taste-masking oral dosage form as claimed in  claim 7 , wherein the hydrophilic polymer in a proportion is generally about 2˜10% by weight.  
     
     
         18 . The taste-masking oral dosage form as claimed in  claim 7 , wherein the surfactant in a proportion is generally about 2˜10% by weight.  
     
     
         19 . The taste-masking oral dosage form as claimed in  claim 7 , wherein the excipient in a proportion is generally about 40˜50% by weight.  
     
     
         20 . The taste-masking oral dosage form as claimed in  claim 1 , wherein the porosity of the tablet is about 30˜70%.  
     
     
         21 . The taste-masking oral dosage form as claimed in  claim 1 , wherein the brittleness of the tablet is less than 2%.  
     
     
         22 . A method of preparing a taste-masking oral dosage form, comprising: 
 providing a first solution comprising a pharmaceutically active ingredient and a starch;    providing a second solution comprising a hydrophilic polymer and a surfactant;    blending the first and second solution to form a plurality of microparticles by a granulating process; and    performing a compression-molding process to form the tablet.    
     
     
         23 . The method as claimed in  claim 22 , wherein the pharmaceutically active ingredient comprises any optional orally administrated drugs.  
     
     
         24 . The method as claimed in  claim 22 , wherein the starch comprises amylodextrin, hydroxyethyl starch, hydropropyl starch, carboxymethyl starch, acetylated starch, or phosphorylated starch.  
     
     
         25 . The method as claimed in  claim 22 , wherein the package percentage exceeds 95%.  
     
     
         26 . The method as claimed in  claim 22 , wherein the microparticle is a co-crystal structure comprising the pharmaceutically active ingredient and the starch.  
     
     
         27 . The method as claimed in  claim 22 , wherein the diameter of the microparticle is about 150˜350 μm.  
     
     
         28 . The method as claimed in  claim 22 , wherein the hydrophilic polymer comprises PEG, PVP, carbopol, polysaccharide, agar, MC, or HPMC.  
     
     
         29 . The method as claimed in  claim 22 , wherein the surfactant comprises edible surfactants.  
     
     
         30 . The method as claimed in  claim 22 , wherein the surfactant comprises lecithin.  
     
     
         31 . The method as claimed in  claim 22 , after the first and second solution is blended, further comprising adding excipients into the blended solution.  
     
     
         32 . The method as claimed in  claim 31 , wherein the excipient comprises disintegrating agents, effervescent, lubricants, or sweeteners.  
     
     
         33 . The method as claimed in  claim 31 , wherein the excipient comprises saccharide, alcohol, or sugar alcohol.  
     
     
         34 . The method as claimed in  claim 33 , wherein saccharide comprises monosaccharide or disaccharide.  
     
     
         35 . The method as claimed in  claim 33 , wherein sugar alcohol comprises mannitol, sorbitol, xylitol, or glycerol.  
     
     
         36 . The method as claimed in  claim 22 , wherein a molding pressure of the compression-molding is about 800˜1200 lb/cm 2 .  
     
     
         37 . The method as claimed in  claim 22 , wherein a molding speed of the compression-molding is about 15˜20 rpm.  
     
     
         38 . The method as claimed in  claim 22 , wherein the pharmaceutically active ingredient in a proportion is generally about 5˜45% by weight.  
     
     
         39 . The method as claimed in  claim 22 , wherein the starch in a proportion is generally about 20˜30% by weight.  
     
     
         40 . The method as claimed in  claim 22 , wherein the hydrophilic polymer in a proportion is generally about 2˜10% by weight.  
     
     
         41 . The method as claimed in  claim 22 , wherein the surfactant in a proportion is generally about 2˜10% by weight.  
     
     
         42 . The method as claimed in  claim 31 , wherein the excipient in a proportion is generally about 40˜50% by weight.  
     
     
         43 . The method as claimed in  claim 22 , wherein the porosity of the tablet is about 30˜70%.  
     
     
         44 . The method as claimed in  claim 22 , wherein the brittleness of the tablet is less than 2%.

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