Hard capsules
The present disclosure concerns embodiments of new hard pullulan capsule shells and capsules comprising (I) moisture, (II) a mono-, di-, and oligosaccharides free pullulan and (III) a setting system. Also provided are an aqueous composition and a dip-molding manufacturing method for the manufacture of such shells and capsules.
1. A hard capsule shell comprising a setting system, and at least one pullulan, wherein the pullulan is substantially free of mono-, di-, and oligosaccharides, wherein the amount of mono-, di-, and oligosaccharides in the pullulan is less than 2.5% by weight of pullulan on a dry solid basis, and wherein the shell comprises between 65% and 99% of the pullulan by weight of the shell.
2. The hard capsule shell according to claim 1 , wherein the pullulan has an average molecular weight ranging from about 100 KDa to about 400 KDa.
3. The hard capsule shell according to claim 1 , wherein the pullulan has a melt viscosity at about 60° C. ranging from about 500 cPs to about 1500 cPs.
4. The hard capsule shell according to claim 1 , wherein the pullulan comprises less than about 1.0% of mono-, di- and oligosaccharides by weight of pullulan, on a dry solid basis.
5. The hard capsule shell according to claim 1 , wherein the pullulan is produced from corn or tapioca starch.
6. The hard capsule shell according to claim 1 , further comprising at least one ingredient selected from the group consisting of pharmaceutically or food acceptable dyes and/or colouring agents, pharmaceutically or food acceptable sequestering agents, pharmaceutically or food acceptable plasticisers, pharmaceutically or food acceptable sweeteners and/or flavouring agents, pharmaceutically or food acceptable surfactants, and mixtures thereof.
7. A hard capsule comprising the hard capsule shell according to claim 1 filled with one or more substances, wherein at least one substance is in solid, semi-solid and/or liquid form.
8. The hard capsule shell according to claim 1 , wherein the shell has a shell thickness less than about 500 μm.
9. The hard capsule shell according to claim 8 , wherein the shell has a shell thickness less than about 250 μm.
10. The hard capsule shell according to claim 1 , wherein the pullulan comprises less than about 0.7% of mono-, di-, and oligosaccharides by weight of pullulan, on a dry solid basis.
11. The hard capsule shell according to claim 1 , wherein the pullulan comprises less than about 0.6% of mono-, di-, and oligosaccharides by weight of pullulan, on a dry solid basis.