Dip coating compositions containing cellulose ethers

Abstract

Water soluble, gelatin-free dip coatings for pharmaceutical solid dosage forms such as tablets comprising HPMC and xanthan gum, carrageenan, and mixtures thereof, or HPMC and castor oil or maltodextrin.

We claim:  
     
         1 . A water soluble composition for dip-coating a substrate comprised of: 
 a) hydroxypropylmethyl cellulose; and    b) a thickener selected from the group consisting of xanthan gum, carrageenan, and mixtures thereof, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.    
     
     
         2 . The composition of  claim 1 , wherein the composition is comprised of, based upon the total dry weight of the composition, 
 a) from about 95 percent to less than about 100 percent of hydroxypropylmethyl cellulose; and    b) from about 0.5 percent to about 5 percent of a thickener selected from the group consisting of xanthan gum, carrageenan, and mixtures thereof,.    
     
     
         3 . The composition of  claim 1 , wherein the composition is comprised of, based upon the total dry weight of the composition, 
 a) from about 95 percent to about 99.5 percent of hydroxypropylmethyl cellulose; and    b) from about 0.5 percent to about 5 percent of xanthan gum.    
     
     
         4 . The composition of  claim 2  further comprising, based upon the total dry weight of the composition, up to about 40% plasticizers.  
     
     
         5 . The composition of  claim 4  wherein the plasticizers are selected from the group consisting of polyethylene glycol, glycerin, sorbitol, triethyl citrate, tribuyl citrate, dibutyl sebecate, vegetable oils, surfactants, propylene glycol, mono acetate of glycerol, diacetate of glycerol, triacetate of glycerol, natural gums, and mixtures thereof.  
     
     
         6 . The composition of  claim 4 , wherein the plasticizers are selected from the group consisting of glycerin, polyethylene glycol, propylene glycol, castor oil, and mixtures thereof.  
     
     
         7 . The composition of  claim 2  further comprising, based upon the total dry weight of the composition, up to about 14% of a coloring agent.  
     
     
         8 . The composition of  claim 7  wherein the coloring agent is selected from the group consisting of azo dyes, quinopthalone dyes, triphenylmethane dyes, xanthene dyes, indigoid dyes, iron oxides, iron hydroxides, titanium dioxide, natural dyes, and mixtures thereof.  
     
     
         9 . A dosage form for delivering an active agent, the form comprising an outer coating, said outer coating comprising the composition of  claim 2 .  
     
     
         10 . A pharmaceutical dosage form comprising an outer coating of the composition of  claim 2 .  
     
     
         11 . A pharmaceutical dosage form comprising a core, a subcoating substantially covering said core, and an outer coating substantially covering said subcoating, wherein the outer coating is comprised of the composition of  claim 2 .  
     
     
         12 . The coated dosage form of  claim 11  wherein the subcoating comprises materials selected from the group consisting of cellulose ethers, plasticizers, polycarbohydrates, pigments, opacifiers, and mixtures thereof.  
     
     
         13 . The coated dosage form of  claim 11  wherein the subcoating comprises materials selected from the group consisting of hydroxypropylmethylcellulose, castor oil, polyethylene glycol, polysorbate 80, maltodextrin, and mixtures thereof.  
     
     
         14 . The dosage form of  claim 11  wherein the subcoating is comprised of, based upon the total dry weight of the subcoating, 
 a) from about 2 percent to about 8 percent of a water-soluble cellulose ether selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, and mixtures thereof.  
 b) from about 0.1 percent to about 1 percent castor oil.  
 
     
     
         15 . The dosage form of  claim 11  wherein the subcoating is comprised of, based upon the total dry weight of the subcoating, 
 a) from about 4 percent to about 6 percent hydroxypropylmethylcellulose; and  
 b) from about 0.1 percent to about 1 percent castor oil.  
 
     
     
         16 . The dosage form of  claim 15  wherein the hydroxypropylmethylcellulose has a viscosity of about 5000 cps in an aqueous solution containing 2 weight percent hydroxypropylmethylcellulose.  
     
     
         17 . The dosage form of  claim 11  wherein the subcoating is comprised of, based upon the total dry weight of the subcoating, 
 a) from about 20 percent to about 50 percent hydroxypropylmethylcellulose;  
 b) from about 45 percent to about 75 percent maltodextrin;  
 c) from about 1 percent to about 10 percent PEG 400.  
 
     
     
         18 . The coated dosage form of  claim 11 , wherein the coating is comprised of, based upon the total dry weight of the subcoating, 
 a) from about 25 percent to about 40 percent hydroxyethylcellulose;    b) from about 50 percent to about 70 percent maltodextrin;    c) from about 5 percent to about 10 percent PEG 400.    
     
     
         19 . A tablet coated with the film forming composition according to  claim 2 .  
     
     
         20 . The coated dosage form of  claim 11 , further comprising an effective amount of a pharmaceutical active ingredient, wherein said dosage form meets USP dissolution requirements for immediate release forms of said pharmaceutical active ingredient.  
     
     
         21 . An aqueous dispersion of the composition of  claim 2  for the manufacture of dip-coated tablets.  
     
     
         22 . The aqueous dispersion of  claim 21  comprised of, based upon the total weight of the aqueous dispersion, 
 a) from about 10 percent to about 14 percent of hydroxypropylmethylcellulose; and  
 b) from about 0.1 percent to about 0.14 percent of xanthan gum.  
 
     
     
         23 . The composition of  claim 1  which is substantially free of gelatin.  
     
     
         24 . Use of the aqueous dispersion of  claim 21  for the manufacture of dip coated tablets.  
     
     
         25 . A pharmaceutical dosage form comprising a core and a coating, said coating substantially covering said core and having a surface gloss of at least 150; wherein said coating comprises the composition of  claim 1 .  
     
     
         26 . The composition of  claim 2  further comprising a weight enhancer selected from the group consisting of simethicone, polysorbate 80, and mixtures thereof.  
     
     
         27 . A simulated capsule-like medicament comprising: 
 a. a core having a first end and a second end,    b. a first coating layer having a first color provided on said first end of said core;    c. a second coating layer having a second color on said second end of said core, said first color is different from said second color; wherein at least one of said first coating layer and second coating layer comprises the composition of  claim 1 .    
     
     
         28 . The medicament of  claim 27  wherein at least one of said first coating layer and said second coating layer is comprised of a coating composition, said coating composition comprised of, based upon the total dry weight of the coating composition, 
 a) from about 95 percent to less than about 100 percent of hydroxypropylmethyl cellulose; and  
 b) from about 0.5 percent to about 5 percent of xanthan gum.  
 
     
     
         29 . The medicament of  claim 28  further comprising a subcoating layer substantially covering said core, said subcoating layer provided between said core and said first coating layer and said second coating layer.  
     
     
         30 . The medicament of  claim 29  wherein the subcoating comprises materials selected from the group consisting of cellulose ethers, plasticizers, polycarbohydrates, pigments, opacifiers, and mixtures thereof.  
     
     
         31 . A water soluble composition for dip-coating a substrate comprised of: 
 a) hydroxypropylmethyl cellulose; and    b) castor oil,    wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.    
     
     
         32 . A pharmaceutical dosage form comprising a core and a coating, said coating substantially covering said core; wherein said coating comprises the composition of  claim 31 .  
     
     
         33 . Use of the composition of  claim 31  for the manufacture of dip coated tablets.  
     
     
         34 . A water soluble composition for dip-coating a substrate comprised of: 
 a) hydroxypropylmethyl cellulose; and    b) maltodextrin,    wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.    
     
     
         35 . The composition of  claim 34  further comprising polyethylene glycol.  
     
     
         36 . A pharmaceutical dosage form comprising a core and a coating, said coating substantially covering said core; wherein said coating comprises the composition of  claim 34 .  
     
     
         37 . Use of the composition of  claim 34  for the manufacture of dip coated tablets.  
     
     
         38 . The water soluble composition of  claim 1 , wherein the composition is comprised of, based upon the total dry weight of the composition: 
 a) greater than about 95 percent and less than about 99.5 percent of hydroxypropylmethyl cellulose; and    b) greater than about 0.5 percent and less than about 5 percent of carrageenan,    wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.    
     
     
         39 . A pharmaceutical dosage form comprising a core and a coating, 
 said coating substantially covering said core; wherein said coating comprises the composition of  claim 38 .    
     
     
         40 . Use of the composition of  claim 38  for the manufacture of dip coated tablets.