Production method for easy-to-take solid preparation (nucleated tablet), and easy-to-take solid preparation

Patent metadata

Field	Value
Publication number	US-10959916-B2
Application number	US-201615737956-A
Country	US
Kind code	B2
Filing date	Jun 28, 2016
Priority date	Jun 29, 2015
Publication date	Mar 30, 2021
Grant date	Mar 30, 2021

Abstract

The purpose of present invention to provide a method for the production of an easy-to-take solid preparation, which is mainly characterized in that an outer layer-forming processing to provide an easy-to-take property is simply performed in a dry process without going through a wet condition so as to make the formed outer layer thicker; the easy-to-take solid preparation and the like.
The present invention relates to a dry-process method for the production of an easy-to-take solid preparation wherein an inner core tablet is coated with a compression-molded outer layer-forming agent comprising a gelling agent that will show slipperiness when it is brought into contact with water, comprising loading separately or simultaneously the inner core tablet and powder of the outer layer-forming agent to a mortar inner surface, the bottom end surface of an upper-pestle, and the top end surface of a lower-pestle, and subsequently compression-molding them; a powder composition for coating a solid preparation for use in the above method, which comprises the water-soluble polymer and water-soluble sugar or sugar alcohol.

First claim

The invention claimed is:

1. A dry-process method for the production of an easy-to-take solid preparation, comprising:
loading separately or simultaneously an inner core tablet and powder of an outer layer-forming agent comprising a gelling agent to a mortar inner surface, a bottom end surface of an upper-pestle, and a top end surface of a lower-pestle, and
compression-molding the outer layer forming agent comprising the gelling agent onto the inner core tablet so that the gelling agent shows slipperiness when brought into contact with water,
wherein the outer layer-forming agent further comprises a water-soluble sugar or sugar alcohol and wherein the gelling agent comprises at least one kind of a water-soluble polymer.

2. The method according to claim 1 , wherein a core-molding material in the inner core tablet is subjected to compression-molding in a dry process.

3. The method according to claim 1 , wherein the inner core tablet and the powder of the outer layer-forming agent are loaded after a lubricant has been applied to the mortar inner surface and the surfaces of the upper-pestle and the lower-pestle.

4. The method according to claim 1 , wherein the water-soluble polymer is selected from the group consisting of sodium carboxylmethylcellulose, sodium alginate, carrageenan, xanthan gum and gelatin.

5. The method according to claim 4 , wherein the water-soluble polymer is sodium carboxylmethylcellulose.

6. The method according to claim 1 , wherein the outer layer-forming agent further comprises a lubricant.

7. The method according to claim 6 , wherein the lubricant is selected from the group consisting of calcium stearate, magnesium stearate and sucrose fatty acid ester.

8. The method according to claim 1 , wherein the sugar or sugar alcohol is erythritol, xylitol, mannitol or maltitol.

Assignees

• Daicel Corp

Inventors

• Hamasaki Momoko
• SAKAGUCHI Anan
• Okabayashi Tomohito
• Hiramura Takahiro

Classifications

• A61K9/286

  Polysaccharides, e.g. gums; Cyclodextrin · CPC title

• B30B15/0011

  lubricating means · CPC title

• A61K9/2893 Primary

  Tablet coating processes (mechanical aspects A61J3/06) · CPC title

• A61K47/14

  Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters · CPC title

• B30B11/34

  for coating articles, e.g. tablets · CPC title