| CPC A61K 9/4891 (2013.01) [A61K 9/0053 (2013.01); A61K 9/4816 (2013.01); A61K 47/32 (2013.01); A61K 47/38 (2013.01)] | 18 Claims |
|
1. An enteric hard capsule, comprising a film containing a first component and a second component, and further containing at least one component selected from the group consisting of a third component, and a fourth component,
wherein the first component is a nonionic water-soluble cellulose compound having a viscosity value within a range of from 100 mPa·s to 100,000 mPa·s,
the viscosity value is obtained by measuring a viscosity value of a 2 mass % aqueous solution of the nonionic water-soluble cellulose compound at 20° C.±0.1° C. using an Ubbelohde method in the case of the viscosity value of less than 600 mPa·s or a Brookfield type viscometer in the case of the viscosity value of 600 mPa·s or more, and
the nonionic water-soluble cellulose compound is at least one kind selected from the group consisting of hydroxypropyl methylcellulose, methylcellulose, and hydroxypropyl cellulose;
the second component is at least one enteric methacrylic acid copolymer selected from the group consisting of a copolymer of methacrylic acid, methyl methacrylate and methyl acrylate; a copolymer of methacrylic acid and ethyl acrylate; and salts thereof which are pharmaceutically acceptable or acceptable as a food additive, wherein the enteric methacrylic acid copolymer contains 5 mass % to 70 mass % of a methacrylic acid monomer unit when the total number of units or total number of groups of monomers forming the copolymer is set to 100 mass %;
the third component is at least one enteric cellulose compound selected from the group consisting of hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate, and salts thereof which are pharmaceutically acceptable or acceptable as a food additive; and
the fourth component is a water-insoluble (meth) acrylic acid alkyl ester copolymer which is a copolymer of methyl methacrylate and ethyl acrylate, wherein the water-insoluble (meth) acrylic acid alkyl ester copolymer is formed of 20 mass % to 40 mass % of methyl methacrylate and 60 mass % to 80 mass % of ethyl acrylate,
the film optionally comprises at least one component selected from the group consisting of polyvinyl alcohol, triethyl citrate, polyethylene glycol, and propylene glycol,
wherein the enteric hard capsule is prepared by a cold gelation method, and the method comprises:
immersing a mold pin in an enteric hard capsule-preparing solution, the mold pin having a surface temperature lower than a temperature of the enteric hard capsule-preparing solution; and
pulling up the mold pin from the enteric hard capsule-preparing solution and drying the enteric hard capsule-preparing solution adhering to the mold pin,
wherein the enteric hard capsule-preparing solution comprises the first component, the second component, at least one component selected from the group consisting of the third component and the fourth component, a basic neutralizer that is pharmaceutically acceptable or is acceptable as a food additive, and a solvent, and
optionally comprises at least one component selected from the group consisting of polyvinyl alcohol, triethyl citrate, polyethylene glycol, and propylene glycol.
|