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Controlled release solid preparation

A technology of solid preparation and controlled release, which is applied in the direction of pill delivery, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as difficult pharmacological effects

Inactive Publication Date: 2009-03-18
TAKEDA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is difficult for these preparations to maintain the pharmacological effects over a long period of time

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0204] Preparation of sustained-release part (core matrix tablet)

[0205] Lansoprazole (hereinafter sometimes referred to as compound A; 6.0 g), hydroxypropylmethylcellulose (trade name: Metolose 90SH-100SR, manufactured by Shin-Etsu Chemical Co., Ltd., 6.67 g), D-mannose Sugar alcohol (5.07 g), crystalline cellulose (trade name: Ceolus PH-101, manufactured by Asahi Kasei Chemicals, 4.59 g), magnesium stearate (0.23 g), and Aerosil (1.1 g) were mixed in a mortar. The resulting mixture (170 mg) was compressed into tablets using a hydraulic pump press (manufactured by Riken Seiki) (Tablet pressure: 1 ton / cm 2 ), thereby obtaining a core skeleton sheet with a diameter of 7 mm. It is used as the sustained-release part of the solid preparation of the present invention.

preparation example 2

[0207] Preparation of Immediate Release Partial Granular Powders

[0208] Compound A (10g), calcium carbonate (166.67g) and D-mannitol (155.8g) were loaded in a fluidized bed granulator, and hydroxypropyl cellulose (13.87g) was dissolved in purified water (231.11g) The aqueous solution in ® was sprayed, the mixture was granulated, and the granules were dried to obtain a granulated powder (340 g) for the immediate release portion.

preparation example 3

[0210] Preparation of granular powders containing antacids

[0211] Magnesium hydroxide (96.67g), magnesium oxide (133.33g), D-mannitol (121.87g) and crospovidone (10.68g) were loaded in a fluidized bed granulator, and the hydroxypropyl fiber An aqueous solution of ketone (13.42 g) in purified water (223.67 g) was sprayed, the mixture was granulated, and the granules were dried to obtain a granulated powder (370 g) containing an antacid.

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Abstract

Disclosed is a controlled release solid preparation which is excellent in stability of an active ingredient, can exert a pharmacological effect steadily and rapidly after administration and can retain the pharmacological effect for a prolonged period of time. The controlled release solid preparation comprises a combination of a rapid release part and a controlled release part, wherein the rapid release part comprises an antacid (1), a compound unstable under acidic conditions (2) and a basic substance and the controlled release part comprises a compound unstable under acidic conditions (3) and a pH-independent base material.

Description

technical field [0001] The invention relates to a solid preparation. More specifically, the present invention relates to a controlled-release solid preparation, which has excellent stability of active ingredients, can exhibit pharmacological effects stably and rapidly after administration, and can exhibit sustained pharmacological effects over a long period of time. Background technique [0002] Since proton pump inhibitors (hereinafter sometimes referred to as PPIs) such as benzimidazole compounds (eg, lansoprazole, omeprazole, rabeprazole, pantoprazole, ilaprazole, etc.) have gastric acid Secretion-inhibiting action, gastric mucosa-protecting action, etc., they have been widely used as peptic ulcer therapeutic agents. [0003] However, these compounds have poor stability and are unstable to humidity, temperature, light, acid, and the like. These compounds are especially unstable to acids and become extremely unstable when the pH of their aqueous solutions or suspensions ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/26A61K9/14A61K31/4439A61K47/02A61K47/32A61K47/34A61K47/38A61P1/04A61P35/00
CPCA61K9/16A61K31/4439A61K9/5084A61K9/2077A61K9/209A61P1/04A61P35/00A61K9/20A61K47/32
Inventor 坂东博人仓泽卓
Owner TAKEDA PHARMA CO LTD
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