Hydroxypropyl methyl cellulose hard capsules and process of manufacture

Abstract

A composition for manufacture of hard hydroxypropyl methyl cellulose capsules comprising a film forming material of hydroxypropyl methyl cellulose having a methoxy content of 27.0-30.0% (w/w), and a hydroxypropoxy content of 4.0-7.5% and as a 2% weight solution, a viscosity of 3.5-6.0 cPs at 20° C. dipping compositions, process for manufacture of hard hydroxypropyl methyl cellulose capsules according to a dip coating process and hard capsule shells.

We claim: 
     
         1 . A hydroxypropyl methyl cellulose hard capsule shell comprising:
 a thermogelled hard capsule shell comprising hydroxypropyl methyl cellulose 2906 having a methoxy content of 27.0-30.0% (w/w), a hydroxypropoxy content of 4.0-7.5% (w/w) and a viscosity of 3.5-6.0 cPs as a 2% weight solution in water at 20° C., wherein the 2906 hydroxypropyl methyl cellulose is present in an amount ranging from 70% to 99% by weight of the shell weight, wherein the hard capsule shell contains less than 1% of a gelling system.   
     
     
         2 . The capsule shell of  claim 1  wherein the hydroxypropoxy methyl cellulose is present in an amount between 70% and 90% by weight on the shell weight. 
     
     
         3 . The capsule shell of  claim 1 , wherein the hard capsule shell is free of a gelling system. 
     
     
         4 . The capsule shell of  claim 1 , wherein the gelling system comprises
 (i) at least one cation selected from the group consisting of K + , Na + , Li + , NH4 + , Ca ++ , and Mg ++ ; and/or   (ii) at least one gelling agent selected from the group consisting of alginates, agar gum, guar gum, locust bean gum (carob), carrageenan, tara gum, gum Arabic, ghatti gum, khaya grandifolia gum, tragancanth gum, karaya gum, pectin, arabian (araban), xanthan, gellan gum, konjac mannan, galactomannan, and funoran.   
     
     
         5 . The capsule shell of  claim 1 , wherein the capsule shell does not contain any film-forming polymer in addition to hydroxypropyl methyl cellulose. 
     
     
         6 . The capsule shell of  claim 1  wherein the capsule shell has a transmittance and the transmittance of the capsule shell measured by UV at 650 nm is at least 80%. 
     
     
         7 . The capsule shell of  claim 1  further comprising at least 1% water, based on the capsule shell weight. 
     
     
         8 . The capsule shell of  claim 1  further comprising from 1 wt % water to 8 wt % water based on the capsule shell weight. 
     
     
         9 . The capsule shell of  claim 1  further comprising 0.001 wt % to 10 wt % of one or more plasticizers based on the capsule shell weight. 
     
     
         10 . The capsule shell of  claim 1  further comprising an antibacterial agent in the capsule shell composition. 
     
     
         11 . The capsule shell of  claim 1 , wherein the capsule shell forms an interior compartment and the capsule shell further comprising a pharmaceutical, vitamin, and/or nutrient in the interior compartment of the capsule shell. 
     
     
         12 . A hydroxypropyl methyl cellulose hard capsule shell comprising:
 a thermogelation hard capsule shell comprising hydroxypropyl methyl cellulose 2906, having a methoxy content of 27.0-30.0% (w/w), a hydroxypropoxy content of 4.0-7.5% (w/w) and a viscosity of 3.5-6.0 cPs as a 2% weight solution in water at 20° C., wherein the hydroxypropyl methyl cellulose 2906 is present in an amount of about 70% or more by weight of the shell weight, wherein the hard capsule shell contains less than 1% of a gelling system.   
     
     
         13 . The capsule shell of  claim 12  wherein the hydroxypropoxy methyl cellulose is present in an amount between 70% and 90% by weight on the shell weight. 
     
     
         14 . The capsule shell of  claim 12 , wherein the hard capsule shell is free of a gelling system. 
     
     
         15 . The capsule shell of  claim 12 , wherein the gelling system comprises
 (i) at least one cation selected from the group consisting of K + , Na + , Li + , NH4 + , Ca ++ , and Mg ++ ; and/or   (ii) at least one gelling agent selected from the group consisting of alginates, agar gum, guar gum, locust bean gum (carob), carrageenan, tara gum, gum Arabic, ghatti gum, khaya grandifolia gum, tragancanth gum, karaya gum, pectin, arabian (araban), xanthan, gellan gum, konjac mannan, galactomannan, and funoran.   
     
     
         16 . The capsule shell of  claim 12 , wherein the capsule shell does not contain any film-forming polymer in addition to hydroxypropyl methyl cellulose. 
     
     
         17 . The capsule shell of  claim 12  wherein the capsule shell has a transmittance and the transmittance of the capsule shell measured by UV at 650 nm is at least 80%. 
     
     
         18 . The capsule shell of  claim 12  further comprising at least 1% water, based on the capsule shell weight. 
     
     
         19 . The capsule shell of  claim 12  further comprising from 1 wt % water to 8 wt % water based on the capsule shell weight. 
     
     
         20 . The capsule shell of  claim 12  further comprising 0.001 wt % to 10 wt % of one or more plasticizers based on the capsule shell weight.