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Pharmaceutical composition for oral administration

A pharmaceutical composition and oral technology, which are applied in the field of pharmaceutical compositions for oral administration, can solve the problems of effectiveness or quick-acting effect, reduction of drug amount, etc., and achieve the effect of rapid drug dissolution.

Pending Publication Date: 2021-04-09
ASTELLAS PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is because there is a problem that if the dissolution of the drug from the preparation is delayed when the preparation is administered, the amount of the drug absorbed through the mucous membrane of the gastrointestinal tract decreases, thereby affecting the effectiveness or immediate effect

Method used

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  • Pharmaceutical composition for oral administration
  • Pharmaceutical composition for oral administration
  • Pharmaceutical composition for oral administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] 1 part by weight of Compound A and 99 parts by weight of L-HPC99 were put into a glass bottle, capped, and shaken vigorously by hand to make a physical mixture.

Embodiment 2

[0126] According to the formulation in Table 2, 1.00 parts by weight of pulverized compound A, 69.20 parts by weight of lactose hydrate, 27.00 parts by weight of crystalline cellulose (UF-711), 27.00 parts by weight of L-HPC, 2.70 parts by weight of Light anhydrous silicic acid in parts by weight, sodium stearyl fumarate in 6.75 parts by weight, and magnesium stearate in 1.35 parts by weight were mixed to obtain a mixture before tableting. The obtained pre-tabletting mixture was shaped using a tableting machine to obtain round tablets weighing 135.00 mg and having a diameter of 7 mm.

Embodiment 3

[0128] According to the formula in Table 2, 25.00 parts by weight of pulverized compound A, 326.00 parts by weight of lactose hydrate, 135.00 parts by weight of crystalline cellulose (UF-711), 135.00 parts by weight of L-HPC, 13.50 parts by weight of Light anhydrous silicic acid in parts by weight, sodium stearyl fumarate in 33.75 parts by weight, and magnesium stearate in 6.75 parts by weight were mixed to obtain a mixture before tableting. The obtained pre-tabletting mixture was molded using a tableting machine to obtain oval tablets with a weight of 675.00 mg and a major diameter of 16 mm×short diameter of 8 mm.

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Abstract

Provided is a stable pharmaceutical composition for oral administration that exhibits rapid drug elution in a pharmaceutical composition for oral administration containing 6-(4,4-dimethylcyclohexyl)-4-[(1,1-dioxo-1[lambda]6-thiomorpholin-4-yl)methyl]-2-methylthieno[2,3-d]pyrimidine or a pharmacologically acceptable salt thereof. The pharmaceutical composition for oral administration contains a water-swellable substance, and the water-swellable substance is a polymer compound obtained by condensation polymerization of [beta]-glucose, a polymer compound obtained by condensation polymerization of [alpha]-glucose, or a polymer compound having a pyrrolidone functional group.

Description

technical field [0001] The present invention relates to a compound comprising 6-(4,4-dimethylcyclohexyl)-4-[(1,1-dioxo-1λ 6 -thiomorpholin-4-yl)methyl]-2-methylthieno[2,3-d]pyrimidine or a pharmaceutically acceptable salt thereof, and exhibits rapid drug dissolution and stable oral Pharmaceutical composition for administration. [0002] In particular, the present invention relates to compounds comprising 6-(4,4-dimethylcyclohexyl)-4-[(1,1-dioxo-1λ 6 -Thiomorpholin-4-yl)methyl]-2-methylthieno[2,3-d]pyrimidine or a pharmaceutically acceptable salt thereof, and a water-swellable substance for oral administration Pharmaceutical composition. Background technique [0003] 6-(4,4-Dimethylcyclohexyl)-4-[(1,1-dioxo-1λ 6 -thiomorpholin-4-yl)methyl]-2-methylthieno[2,3-d]pyrimidine (hereinafter sometimes referred to as compound A. In addition, "1,1-dioxo-1λ 6 -thiomorpholin-4-yl" is also called "1,1-dioxythiomorpholin-4-yl".) is a compound represented by the following chemical stru...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61K9/20A61K9/48A61K47/32A61K47/38A61P21/02A61P25/04A61P25/08A61P25/18A61P25/28A61P29/02A61K9/14A61P43/00
CPCA61P43/00A61P25/08A61P29/02A61P25/28A61P25/18A61P21/02A61P25/04A61K9/2054A61K9/2018A61K9/2059A61K9/2027A61K31/54A61K9/4866A61K31/546A61K31/519A61P25/00A61K9/2095A61K31/541
Inventor 小岛竜坂井敏郎东亮太田中茉里奈
Owner ASTELLAS PHARMA INC
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