Process for preparing a coated hard shell capsule

Patent metadata

Field	Value
Publication number	US-11980692-B2
Application number	US-201815733083-A
Country	US
Kind code	B2
Filing date	Nov 14, 2018
Priority date	Nov 17, 2017
Publication date	May 14, 2024
Grant date	May 14, 2024

Abstract

A process prepares a polymer-coated hard shell capsule, suitable as container for pharmaceutical or nutraceutical biologically active ingredients. The hard shell capsule can include a body and a cap. In the closed state, the cap overlaps the body either in a pre-locked state or in a final-locked state. The hard shell capsule can be provided in the pre-locked state and spray-coated with a coating solution, suspension, or dispersion that includes a polymer or a mixture of polymers to create a coating layer which covers the outer surface of the hard shell capsule in the pre-locked state.

First claim

The invention claimed is:

1. A process for preparing a polymer-coated hard shell capsule, comprising:
providing a hard shell capsule comprising a body and a cap, in a pre-locked state;
spray coating said hard shell capsule with a coating solution, suspension or dispersion to form a polymer-coated hard shell capsule;
separating said body and said cap;
filling said body with a fill comprising a pharmaceutical or nutraceutical biologically active ingredient; and
rejoining said body and cap in a final-locked state,
wherein the polymer-coated hard shell capsule is suitable as a container for pharmaceutical or nutraceutical biologically active ingredients,
said coating solution, suspension, or dispersion comprises:
a polymer or a mixture of polymers selected from the group consisting of:
i) copolymer polymerized from 25 wt. % of methyl methacrylate, 65 wt. % of methyl acrylate and 10 wt. % of methacrylic acid, and a copolymer polymerized from 50 wt. % of ethyl acrylate and 50 wt. % of methacrylic acid;
ii) a copolymer polymerized from 50 wt. % of ethyl acrylate and 50 wt. % of methacrylic acid;
iii) a copolymer polymerized from 50 wt. % of ethyl acrylate and 50 wt. % of methacrylic acid, acid a copolymer polymerized from 30 wt. % of methyl methacrylate and 70 wt. % of ethyl acrylate; and
iv) a copolymer polymerized from 25 wt. % of methyl methacrylate, 25 wt. % of butyl methacrylate and 50 wt. % dimethylaminoethyl methacrylate, and
a plasticizer selected from the group consisting of alkyl citrates, glycerol esters, alkyl phthalates, alkyl sebacates, sucrose esters, sorbitan esters, diethyl sebacate, dibutyl sebacate, propylene glycol and polyethylene glycol,
to create a coating layer which covers the outer surface of the polymer-coated hard shell capsule in the pre-locked state and wherein the body and the cap are separable by a conventional capsule filling machine, and
said coating layer is applied in an amount of from 1 to 8 mg/cm 2 and has an average thickness of from 5 to 75 μm,
wherein said coating layer has a moisture protection effect.

2. The process according to claim 1 , wherein the polymer-coated hard shell capsule in the pre-locked state is provided to a capsule-filling machine, which performs:
opening,
filling with a till comprising:
a pharmaceutical or a nutraceutical biologically active ingredient, and closing to the final-locked state.

3. The process according to claim 1 , wherein a material of the body and the cap is selected from the group consisting of hydroxypropyl methyl cellulose, starch, gelatin, pullulan, and a copolymer of a C1- to C4-alkylester of (meth)acrylic acid and (meth)acrylic acid.

4. The process according to claim 1 , wherein the body and the cap comprise:
encircling notches or dimples in an area where the cap overlaps the body, that allow the capsule to be closed by a snap-into-place mechanism either in the pre-locked state or in the final-locked state.

5. The process according to claim 1 , wherein the body comprises:
a tapered rim.

6. The process according to claim 1 , wherein the coating layer is applied in an amount of from 1 to 5 mg/cm 2 .

7. A polymer-coated hard shell capsule, obtained from the process according to claim 1 .

8. A process for preparing a polymer-coated hard shell capsule, comprising:
providing a hard shell capsule comprising a body and a cap, in a pre-locked state;
spray coating said hard shell capsule with a coating solution, suspension or dispersion to form a polymer-coated hard shell capsule;
wherein the polymer-coated hard shell capsule is suitable as a container for pharmaceutical or nutraceutical biologically active ingredients,
said coating solution, suspension, or dispersion comprises:
a polymer or a mixture of polymers selected from the group consisting of:
i) a copolymer polymerized from 25 wt. % of methyl methacrylate, 65 wt. % of methyl acrylate and 10 wt. % of methacrylic acid, and a copolymer polymerized from 50 wt. % of ethyl acrylate and 50 wt. % of methacrylic acid;
ii) a copolymer polymerized from 50 wt. of ethyl acrylate and 50 wt. % of methacrylic acid;
iii) a copolymer polymerized from 50 wt. % of ethyl acrylate and 50 wt. % of methacrylic acid, and a copolymer polymerized from 30 wt. % of methyl methacrylate and 70 wt. % of ethyl acrylate; and
iv) a copolymer polymerized from 25 wt. % of methyl methacrylate, 25 wt. % of butyl methacrylate and 50 wt. % dimethylaminoethyl methacrylate, and
a plasticizer selected from the group consisting of alkyl citrates, glycerol esters, allyl phthalates, alkyl sebacates, sucrose esters, sorbitan esters, diethyl sebacate, dibutyl sebacate, propylene glycol and polyethylene glycol,
to create a coating layer which covers the outer surface of the polymer-coated hard shell capsule in the pre-locked state and wherein the body and the cap are separable by a conventional capsule tilling machine, and
said coating layer is applied in an amount of from 1 to 8 mg/cm 2 and has an average thickness of from 5 to 75 μm,
wherein said coating layer has a moisture protection effect.

Assignees

• Evonik Operations Gmbh

Inventors

• Guha Ashish
• Kaneria Vishal
• Jain Vinay
• Joshi Shraddha
• Robota Miriam
• Hofmann Felix
• Arndt Marcel
• Bär Hans

Classifications

• A61K47/32

  Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} · CPC title

• A61K9/4808

  characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084) · CPC title

• A61K9/4816

  Wall or shell material · CPC title

• A61K47/38

  Cellulose; Derivatives thereof · CPC title

• A61K9/4891 Primary

  Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004) · CPC title