Non-gelatin capsule shell formulation

Abstract

A film-forming hydrocolloid composition comprising kappa carrageenan, iota carrageenan, a bulking agent, plasticizer and water is described. The ratio of bulking agent to total carrageenan is from about 1:1 to 20:1. Kappa carrageenan is present in an amount of less than or equal to 50% by weight of total carrageenan present. To form the composition, all dry materials are mixed and added to a heated mixture of all liquid materials. The final mixture is heated until a composition free of particulate materials is formed. The formed composition can be cast or extruded into ribbons, films, sheets, tubes or the like, for encapsulating wet or dry materials including medicinal dosage forms, nutritional supplements, cosmetics, bath oils and gels, and paint balls.

1 - 85 . (canceled)  
   
   
       86 . A capsule formed from film-forming composition comprising: 
 a) iota carrageenan in an amount of from about 1% to about 15% by weight of the composition;    b) kappa carrageenan in an amount less than 100% by weight of the iota carrageenan;    c) a bulking agent, wherein the ratio of bulking agent to the combined total of iota and kappa carrageenan is from about 1:1 to about 20:1;    d) a plasticizer in an amount of from about 10% to about 50% by weight of the composition; and    e) water.    
   
   
       87 . The capsule of  claim 86 , wherein the total amount of all carrageenan is less than or equal to about 20% by weight of the film-forming composition.  
   
   
       88 . The capsule of  claim 86 , wherein the kappa carrageenan is present in an amount of from 0.1% to about 15% by weight of the composition.  
   
   
       89 . The capsule of  claim 86 , wherein the kappa carrageenan is present in an amount of from about 0.5% to about 7.5% by weight of the composition.  
   
   
       90 . The capsule of  claim 86 , wherein the iota carrageenan is present in an amount of between about 2.3% and about 10.0% by weight of the composition.  
   
   
       91 . The capsule of  claim 86 , wherein the total amount of all carrageenan is less than or equal to about 10% by weight of the composition.  
   
   
       92 . The capsule of  claim 86 , wherein the ratio of bulking agent to total carrageenan is from about 2:1 to about 15:1.  
   
   
       93 . The capsule of  claim 86 , wherein the water is present in an amount of from about 10% to about 90% by weight of the composition.  
   
   
       94 . The capsule of  claim 86 , wherein the bulking agent is an esterified starch.  
   
   
       95 . The capsule of  claim 86 , wherein the plasticizer is selected from the group consisting of sorbitol, non-crystallizing sorbitol, maltitol, glycerin, polyethylene glycol, and combinations thereof.  
   
   
       96 . The capsule of  claim 86 , wherein the film-forming composition is substantially free of buffers.  
   
   
       97 . The capsule of  claim 86 , wherein the film-forming composition has a viscosity of from about 100 cP to about 1200 cP as measured at 90° C.  
   
   
       98 . The capsule of  claim 86 , formed from a wet ribbon formed from the film-forming composition and having a moisture content of at least about 20%.  
   
   
       99 . The capsule of  claim 86 , formed from a dry ribbon formed from the film-forming composition and having a moisture content of between about 5% and about 20%.  
   
   
       100 . The capsule of  claim 99 , wherein the dry ribbon has a tensile strength at rupture of between about 5 N and about 40 N.  
   
   
       101 . The capsule of  claim 99 , wherein the dry ribbon has an extensibility at rupture from about 20 mm to about 80 mm.  
   
   
       102 . The capsule of  claim 99 , wherein from about 80% to about 95% by weight of the dry ribbon is solids.  
   
   
       103 . The capsule of  claim 86 , wherein the capsule is formed from a film, ribbon, sheet or tube comprising the film-forming composition in the form of a uniform dispersion.  
   
   
       104 . The capsule of  claim 103 , wherein said uniform dispersion has a solids content in the range of about 40% to about 90% by weight.  
   
   
       105 . The capsule of  claim 103 , wherein said uniform dispersion has a solids content in the range of about 50% to about 80% by weight.  
   
   
       106 . A capsule formed from a film-forming composition comprising: 
 a) iota carrageenan in an amount of from about 1% to about 15% by weight of the composition;    b) kappa carrageenan in an amount less than 100% by weight of the iota carrageenan;    c) a bulking agent in an amount of from about 10% to about 60% by weight of the composition;    d) a plasticizer in an amount of from about 10% to about 50% by weight of the composition; and    e) water.    
   
   
       107 . The capsule of  claim 106 , wherein the total amount of all carrageenan is less than or equal to about 20% by weight of the film-forming composition.  
   
   
       108 . The capsule of  claim 106 , wherein the kappa carrageenan is present in an amount of from about 0.1% to about 15% by weight of the film-forming composition.  
   
   
       109 . The capsule of  claim 106 , wherein the kappa carrageenan is present in an amount of from about 0.5% to about 7.5% by weight of the film-forming composition.  
   
   
       110 . The capsule of  claim 106 , wherein the water is present in an amount of from about 10% to about 90% by weight of the film-forming composition.  
   
   
       111 . The capsule of  claim 106 , wherein the iota carrageenan is present in an amount of from about 2.3% to about 10% by weight of the film-forming composition.  
   
   
       112 . The capsule of  claim 106 , wherein the total amount of all carrageenan is less than or equal to about 20% by weight of the film-forming composition.  
   
   
       113 . The capsule of  claim 106 , wherein the total amount of all carrageenan is less than or equal to about 10% by weight of the film-forming composition.  
   
   
       114 . The capsule of  claim 106 , wherein the plasticizer is selected from the group consisting of sorbitol, non-crystallizing sorbitol, maltitol, glycerin, polyethylene glycol, and combinations thereof.  
   
   
       115 . The capsule of  claim 106 , wherein the film-forming composition is substantially free of buffers.  
   
   
       116 . The capsule of  claim 106 , wherein the viscosity of the film-forming composition is from about 100 cP to about 1200 cP as measured at 90° C.  
   
   
       117 . The capsule of  claim 106 , formed from a wet ribbon formed from the film-forming composition and having a moisture content of at least about 20%.  
   
   
       118 . The capsule of  claim 106 , formed from a dry ribbon formed from the film-forming composition and having a moisture content of between about 5% and about 20%.  
   
   
       119 . The capsule of  claim 106 , wherein from about 80% to about 95% by weight of the dry ribbon is solids.  
   
   
       120 . The capsule of  claim 106 , wherein the dry ribbon has a tensile strength at rupture of between about 5 N and about 40 N.  
   
   
       121 . The capsule of  claim 106 , wherein the dry ribbon has an extensibility at rupture from about 20 mm to about 80 mm.  
   
   
       122 . A capsule formed from a film-forming composition prepared by a method comprising: 
 a) mixing iota carrageenan in an amount of from about 1% to about 15% by weight of the composition, kappa carrageenan in an amount less than 100% by weight of the iota carrageenan and a bulking agent in a ratio of bulking agent to total carrageenan of from about 1:1 to about 20:1 to form a dry mixture;    b) mixing a plasticizer and water to form a liquid mixture;    c) heating the liquid mixture to a temperature of from about 75° C. to about 90° C.;    d) adding the dry mixture to the heated mixture with stirring to form a dispersion; and    e) heating the dispersion with stirring to a temperature of from about 85° C. to about 95° C. to form a uniform dispersion; and    f) forming a capsule from the uniform dispersion.    
   
   
       123 . A capsule formed from a film-forming composition prepared by a method comprising: 
 a) adding a mixture of iota carrageenan in an amount of from about 1% to about 15% by weight of the composition, kappa carrageenan in an amount less than 100% by weight of the iota carrageenan, a bulking agent in a ratio of bulking agent to total carrageenan of from about 1:1 to about 20:1, a plasticizer and water to an extruder;    b) forming a uniform dispersion of the mixture.    
   
   
       124 . The method of  claim 123 , wherein the mixture of iota carrageenan, kappa carrageenan, bulking agent, plasticizer and water are pre-mixed before adding them to the extruder.  
   
   
       125 . The method of  claim 123 , wherein the mixture of iota carrageenan, kappa carrageenan, bulking agent, plasticizer and water are added to the extruder in the form of a dry mix and a liquid mix, wherein the dry mix comprises iota carrageenan, kappa carrageenan and bulking agent, and the liquid mix comprises water and plasticizer.  
   
   
       126 . The method of  claim 123 , further comprising extruding the uniform dispersion.  
   
   
       127 . A ribbon comprising iota carrageenan, kappa carrageenan in an amount less than 100% by weight of the iota carrageenan, a bulking agent, a plasticizer and water, having a moisture content of between about 5% and about 20%, a tensile strength at rupture between about 5 N and about 40 N, and an extensibility at rupture from about 20 mm to about 80 mm.  
   
   
       128 . A capsule made with the ribbon of  claim 127 .  
   
   
       129 . A capsule formed from a film-forming composition comprising from about 80% to about 95% by weight of solids and the remainder being about 20% to about 5% water, wherein the solids comprise by weight: 
 a) iota carrageenan in an amount in the range of from about 2% to about 20% of the total composition;    b) kappa carrageenan in an amount that is (i) in the range of from about 0.4% to about 20% of the total composition and (ii) less than 100% of the amount of the iota carrageenan;    c) a bulking agent in an amount in the range of from about 10% to about 80% of the total composition; and    d) a plasticizer in an amount in the range of from about 15% to about 40% of the total composition.    
   
   
       130 . The capsule of  claim 129 , wherein the iota carrageenan is present in an amount in the range of from about 2.5% to about 10% of the total composition; the kappa carrageenan is present in an amount in the range of from about 0.5% to about 10% of the total composition; and the bulking agent is present in an amount in the range of from about 40% to about 70% of the total composition.  
   
   
       131 . The capsule of  claim 129 , wherein the capsule is an encapsulated dosage form selected from the group consisting of a softgel dosage form and a caplet dosage form.  
   
   
       132 . The capsule of  claim 129 , wherein a mixture of iota carrageenan, kappa carrageenan, bulking agent, plasticizer and water are heated with stirring to a temperature of from about 85° C. to about 95° C. before adding them to an extruder.