Aqueous enteric coating composition

Abstract

An aqueous enteric coating composition including hydroxypropylmethylcellulose, acetate succinate, and a basic amino acid.

That which is claimed: 
     
         1 . An aqueous enteric coating composition comprising:
 a) hydroxypropylmethylcellulose acetate succinate; and   b) a basic amino acid.   
     
     
         2 . The aqueous enteric coating composition according to  claim 1 , further comprising a plasticizer, a surfactant, and an anti-tacking agent. 
     
     
         3 . The aqueous enteric coating composition according to  claim 1 , wherein the basic amino acid is selected from group consisting of L-alginine, L-histidine and L-lysine. 
     
     
         4 . The aqueous enteric coating composition according to  claim 2 , wherein the plasticizer comprises triethyl citrate (TEC), triacetin, tributyl citrate, acetyl triethyl citrate (ATEC), acetyl tributyl citrate (ATBC), dibutyl phthalate, dibutyl sebacate (DBS), diethyl phthalate, vinyl pyrrolidone glycol triacetate, polyethylene glycol, polyoxyethylene sorbitan monolaurate, propylene glycol, propylene carbonate, castor oil, and combinations or mixtures thereof. 
     
     
         5 . The aqueous enteric coating composition according to  claim 2 , wherein the surfactant is selected from the group consisting of sodium lauryl sulfate, sucrose fatty acid esters, lecithin, and d-alpha-tocopheryl polyethylene glycol, and combinations and mixtures thereof. 
     
     
         6 . The aqueous enteric coating composition according to  claim 2 , wherein the anti-tacking agent is selected from the group consisting of stearyl alcohol, stearic acid, glycerol monostearate (GMS), talc, magnesium stearate, silicon dioxide, amorphous silicic acid, and fumed silica, and combinations or mixtures thereof. 
     
     
         7 . A pharmaceutical composition comprising a tablet, pellet, granule, hard capsule or soft capsule coated with the aqueous enteric coating composition of  claims 1  and a pharmaceutical or nutraceutical. 
     
     
         8 . An aqueous enteric coating composition comprising:
 a) 5 to 20 percent hydroxypropylmethylcellulose acetate succinate;   b) 0.05 to 1.0 percent L-alginine, L-histidine or L-lysine;   c) 0.5 to 10 percent plasticizer;   d) 0.1 to 10 percent anti-tacking agent;   e) 0.05 to 0.5 percent surfactant; and   65 to 95 percent water.   
     
     
         9 . The aqueous enteric coating composition according to  claim 8 , wherein the surfactant is selected from the group consisting of sodium lauryl sulfate, sucrose fatty acid esters, lecithin, and d-alpha-tocopheryl polyethylene glycol, and combinations and mixtures thereof. 
     
     
         10 . The aqueous enteric coating composition according to  claim 8 , wherein the anti-tacking agent is selected from the group consisting of stearyl alcohol, stearic acid, glycerol monostearate (GMS), talc, magnesium stearate, silicon dioxide, amorphous silicic acid, and fumed silica, and combinations or mixtures thereof. 
     
     
         11 . A pharmaceutical composition comprising a tablet, pellet, granule, hard capsule or soft capsule coated with the aqueous enteric coating composition of  claim 8  and a pharmaceutical or nutraceutical.