Film coating for tablets and caplets

Abstract

The present invention relates to novel coating compositions for application to solid dosage forms such as tablets or caplets, solid dosage forms coated with the composition, and methods of preparing said coating compositions.

1 - 10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . A tamper-proof capsule comprising at least one capsule shell part and enclosing a solid dosage form core caplet, said core being coated with a coating composition comprising a film forming agent in an amount from about 20% by weight to about 85% by weight, an adhesion enhancing agent in an amount from about 10% by weight to about 90% by weight, and a glidant in an amount from about 5% by weight to about 50% by weight, based on the weight of the coating composition, wherein said film forming agent is selected from the group consisting of methylcellulose, gum arabic, carboxymethylcellulose, hydroxyethylcellulose methylcellulose, hydroxypropyl methylcellulose, and mixtures thereof; said adhesion enhancing agent is selected from the group consisting of sucrose, polyvinylpyrrolidone, ethylcellulose, maltodextrins, hydroxypropylcellulose, and mixtures thereof; and said glidant is selected from the group consisting of polypropylene glycol, triethyl citrate, mono-, di- or tri-acetates of glycerol, 1,2-propyleneglycol, polyethylene glycol, and mixtures thereof. 
     
     
         13 . The tamper-proof capsule according to  claim 12 , wherein the film forming agent is hydroxypropyl methylcellulose. 
     
     
         14 . The tamper-proof capsule according to  claim 13 , wherein the hydroxypropyl methylcellulose is present in an amount ranging from about 20% to about 40% by weight of the coating composition. 
     
     
         15 . The tamper-proof capsule according to  claim 12 , wherein the adhesion enhancing agent is hydroxypropylcellulose. 
     
     
         16 . The tamper-proof capsule according to  claim 15 , wherein the hydroxypropylcellulose is present in an amount ranging from about 35% to about 60% by weight of the coating composition. 
     
     
         17 . The tamper-proof capsule according to  claim 12 , wherein the glidant is polyethylene glycol. 
     
     
         18 . The tamper-proof capsule according to  claim 17 , wherein the polyethylene glycol is present in an amount ranging from about 20% by weight to about 25% by weight of the coating composition. 
     
     
         19 . A method of making tamper-proof capsules, comprising:
 providing a solid dosage form core caplet;   coating the solid dosage form core caplet with a composition comprising a film forming agent in an amount from about 20% by weight to about 85% by weight, an adhesion enhancing agent in an amount about 10% by weight to about 90% by weight, and a glidant in an amount from about 5% by weight to about 50% by weight, based on the weight of the coating composition, wherein said film forming agent is selected from the group consisting of methylcellulose, gum arabic, carboxymethylcellulose, hydroxyethylcellulose methylcellulose, hydroxypropyl methylcellulose and mixtures thereof; said adhesion enhancing agent is selected from the group consisting of sucrose, polyvinylpyrrolidone, ethylcellulose, maltodextrins, hydroxypropylcellulose, and mixtures thereof; and said glidant is selected from the group consisting of polypropylene glycol, triethyl citrate, mono-, di- or tri-acetates of glycerol, 1,2-propyleneglycol, polyethylene glycol, and mixtures thereof;   inserting the coated solid dosage form core caplet into capsule shell parts; and   obtaining capsules.   
     
     
         20 . The method according to  claim 19 , wherein the capsule shell parts are treated by cold shrinking following insertion of the coated solid dosage form core caplet into capsule shell parts.