US2014360404A1PendingUtilityA1

Acid resistant banding solution for acid resistant two piece hard capsules

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Assignee: CAPSUGEL BELGIUM NVPriority: Nov 9, 2011Filed: Nov 8, 2012Published: Dec 11, 2014
Est. expiryNov 9, 2031(~5.3 yrs left)· nominal 20-yr term from priority
Inventors:Xiongwei HeDominique Nicolas Cade
A61K 9/4816A23V 2002/00A61K 31/167A23P 10/30A61K 9/4891A61K 9/4883A61K 9/4808
58
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Claims

Abstract

The present disclosure relates to acid resistant banding solutions for two piece hard capsules endowed with acid resistant properties, and methods of making and using acid resistant banding solutions. The present disclosure also relates, in part, to methods for banding such acid resistant capsules which provides an acid resistant seal between the capsules parts and achieves increased acid resistance in vitro.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An acid resistant banding composition for acid resistant two piece hard capsules, comprising at least one acid resistant polymer, at least one alkaline compound, and water. 
     
     
         2 . The composition according to  claim 1 , wherein the acid resistant polymer is selected from the group consisting of methacrylic acid copolymers, cellulose acetate phthalate (CAP), cellulose acetate trimellitate (CAT), hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methylcellulose phthalate (HPMCP), carboxy methyl ethyl cellulose (CMEC), polyvinyl derivatives, and mixtures thereof. 
     
     
         3 . The composition according to  claim 1 , wherein the at least one alkaline compound is selected from the group consisting of sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate, sodium hydroxide, tri sodium phosphate, sodium perborate, potassium hydroxide, lithium hydroxide, lithium carbonate, lithium bicarbonate, ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, ammonia, and mixtures thereof. 
     
     
         4 . The composition according to any one of  claims 1  to  3 , further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. 
     
     
         5 . The composition according to any one of  claims 1  to  3 , wherein the composition has a viscosity from about 50 cP to about 10,000 cP at room temperature. 
     
     
         6 . The composition according to  claim 5 , wherein the viscosity is from about 100 cP to about 5000 cP. 
     
     
         7 . The composition according to  claim 6 , wherein the viscosity is from about 1500 cP to about 3100 cP. 
     
     
         8 . The composition according to  claim 1 , wherein the at least one acid resistant polymer is hydroxypropyl methylcellulose phthalate (HPMCP), and the at least one alkaline compound is ammonia. 
     
     
         9 . The composition according to  claim 8 , further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. 
     
     
         10 . The composition according to  claim 1 , wherein the at least one acid resistant polymer is cellulose acetate phthalate (CAP), and the at least one alkaline compound is ammonia. 
     
     
         11 . The composition according to  claim 10 , further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. 
     
     
         12 . The composition according to  claim 1 , wherein the at least one acid resistant polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS), and the at least one alkaline compound is ammonia. 
     
     
         13 . The composition according to  claim 12 , further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. 
     
     
         14 . An acid resistant banding composition for acid resistant two piece hard capsules, comprising:
 at least one acid resistant polymer selected from the group consisting of hydroxypropyl methylcellulose phthalate (HPMCP), cellulose acetate phthalate (CAP), and hydroxypropyl methylcellulose acetate succinate (HPMCAS);   ammonia; and   water.   
     
     
         15 . A method for the preparation of an acid resistant banding solution, comprising:
 dispersing at least one acid resistant polymer in water under mixing; and   adding at least one alkaline compound progressively under gentle stirring until the at least one acid resistant polymer is dissolved.   
     
     
         16 . The method according to  claim 15 , wherein the preparation of the banding solution is carried out at room temperature. 
     
     
         17 . The method according to  claim 15  or  16 , further comprising the step of adjusting viscosity of the banding solution by adjusting the polymer concentration of the solution. 
     
     
         18 . The method according to  claim 17 , wherein the viscosity is from about 50 cP to about 10,000 cP at room temperature. 
     
     
         19 . The method according to  claim 18 , wherein the viscosity is from about 100 cP to about 5000 cP. 
     
     
         20 . The method according to  claim 19 , wherein the viscosity is from about 1500 cP to about 3100 cP. 
     
     
         21 . The method according to any one of  claims 16  to  20 , further comprising adding to the banding solution at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. 
     
     
         22 . An acid resistant hard capsule comprising an acid resistant banding composition according to any one of  claims 1  to  14  for use for oral administration of at least one of pharmaceuticals, veterinary products, foods, and dietary supplements to humans or animals. 
     
     
         23 . The capsule according to  claim 22 , wherein the capsule comprises a dip molded or injection molded hydroxypropylmethylcellulose (HPMC) acid resistant hard capsule. 
     
     
         24 . A method for banding an acid resistant hard capsule with an acid resistant banding composition comprising at least one acid resistant polymer, at least one alkaline compound, and water comprising:
 determining the desired banding composition amount;   measuring the banding composition required; and   applying the banding composition to the acid resistant capsule.   
     
     
         25 . The method according to  claim 24 , wherein the capsule comprises a dip molded or injection molded hydroxypropylmethylcellulose (HPMC) acid resistant hard capsule. 
     
     
         26 . The method according to  claim 24 , wherein the acid resistant polymer is selected from the group consisting of methacrylic acid copolymers; cellulose acetate phthalate (CAP), cellulose acetate trimellitate (CAT), hydroxypropylmethylcellulose acetate succinate (HPMCAS), hydroxypropylmethylcellulose phthalate (HPMCP), carboxy methyl ethyl cellulose (CMEC), polyvinyl derivatives, and mixtures thereof. 
     
     
         27 . The method according to  claim 24 , wherein the at least one alkaline compound is selected from the group consisting of sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate, sodium hydroxide, tri sodium phosphate, sodium perborate, potassium hydroxide, lithium hydroxide, lithium carbonate, lithium bicarbonate, ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, ammonia, and mixtures thereof. 
     
     
         28 . The method according to  claim 24 , wherein the at least one acid resistant polymer is hydroxypropylmethylcellulose phthalate (HPMCP), and the at least one alkaline compound is ammonia. 
     
     
         29 . The method according to  claim 28 , further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. 
     
     
         30 . The method according to  claim 24 , wherein the at least one acid resistant polymer is cellulose acetate phthalate (CAP), and the at least one alkaline compound is ammonia. 
     
     
         31 . The method according to  claim 30 , further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. 
     
     
         32 . The method according to  claim 24 , wherein the at least one acid resistant polymer is hydroxypropylmethylcellulose acetate succinate (HPMCAS), and the at least one alkaline compound is ammonia. 
     
     
         33 . The method according to  claim 32 , further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. 
     
     
         34 . The method according to  claim 24 , wherein the banding composition is applied to the capsule at room temperature.

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