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Solid drug for oral use

一种药物、剂型的技术，应用在口服形式的固体药物领域，能够解决没有教导或提示等问题

Inactive Publication Date: 2006-01-25
KISSEI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, Patent Document 2 has no teaching or prompting effect on the present invention at all

Method used

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  • Solid drug for oral use
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  • Solid drug for oral use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0129] Capsules containing 2.0 mg KMD-3213

[0130] Thoroughly mix 2.0 parts of KMD-3213, 134.4 parts of D-mannitol, 26.0 parts of partially pregelatinized starch (PCS (registered trademark), Asahi Chemical Industry Co., Ltd) and 9.0 parts of partially pregelatinized starch (Starch 1500 (registered trademark) trademark), Japan Colorcon Co., Ltd). An appropriate amount of water is added, and the mixture is granulated. The particles were dried with a fluidized bed dryer at an inlet temperature of 60°C until the exhaust temperature reached 40°C, and then sieved. A mixture of 1.8 parts of magnesium stearate and 1.8 parts of sodium lauryl sulfate was added to the sieved granules, mixed for 5 minutes, and the mixture was filled into capsule shells to prepare capsules containing 2.0 mg of KMD-3213.

Embodiment 2

[0132] Capsules containing 4.0 mg KMD-3213

[0133] Thoroughly mix 4.0 parts of KMD-3213, 132.4 parts of D-mannitol, 26.0 parts of partially pregelatinized starch (PCS (registered trademark), Asahi Chemical Industry Co., Ltd) and 9.0 parts of partially pregelatinized starch (Starch 1500 (registered trademark) trademark), Japan Colorcon Co., Ltd). An appropriate amount of water is added, and the mixture is granulated. The particles were dried with a fluidized bed dryer at an inlet temperature of 60°C until the exhaust temperature reached 40°C, and then sieved. A mixture of 1.8 parts of magnesium stearate and 1.8 parts of sodium lauryl sulfate was added to the sieved granules, mixed for 5 minutes, and the mixture was filled into capsule shells to prepare capsules containing 4.0 mg of KMD-3213.

Embodiment 3

[0135] Tablets containing 4.0 mg KMD-3213

[0136] 4.0 parts of KMD-3213, 117.0 parts of D-mannitol, and 7.0 parts of low-substituted hydroxypropylcellulose (L-HPC (registered trademark), Shin-Etsu Chemical Co., Ltd.) were thoroughly mixed. A 12% aqueous solution of hydroxypropylcellulose (4 parts of hydroxypropylcellulose and about 30 parts of water) was added and the mixture was granulated. Dry the particles with a fluidized bed dryer at an inlet temperature of 60°C until the exhaust temperature reaches 40°C, dry and sieve and pass through a sieve. Add 1.0 parts magnesium stearate to the granules and mix for 3 minutes. The mixture was compressed into tablets and coated with a coating agent to prepare tablets containing 4.0 mg of KMD-3213.

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PUM

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Abstract

The present invention provides a solid oral dosage form pharmaceutical for the treatment of dysuria, which comprises, as an active ingredient, an indoline compound having an alpha 1 -adrenoceptor blocking activity and represented by the formula: a prodrug thereof, pharmaceutically acceptable salt or pharmaceutically acceptable solvate thereof, wherein said pharmaceutical is prepared to have 85% dissolution time of not more than 60 minutes in a dissolution test according to method 2 (paddle method) of Japanese pharmacopoeia in a condition using water.

Description

technical field [0001] The present invention relates to solid medicaments in oral form for the treatment of dysuria. More specifically, the present invention relates to a solid oral dosage form medicine for treating dysuria, which comprises an indoline compound having α 1 - Adrenergic receptors (hereinafter referred to as "α 1 -AR") blocking activity, can be represented by chemical formula (I) (hereinafter referred to as "KMD-3213"): [0002] [0003] Also relate to its drug prodrug, pharmaceutically acceptable salt or pharmaceutically acceptable solvate, according to Japanese Pharmacopoeia method 2 (paddle method), under the condition that water is used as test medium and paddle speed is 50rpm, they are in dissolution test The time to dissolve 80% in the medium should not exceed 60 minutes. [0004] The present invention also relates to a solid oral dosage form medicine for treating dysuria, said medicine comprising 1) KMD-3213, its prodrug, pharmaceutically acceptable ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4045A61K45/00A61K47/10A61K47/12A61K9/20A61K9/28A61K9/48A61P13/00A61P13/02A61P43/00A61K9/16
CPCA61K31/4045A61K9/1652A61K9/1623A61K9/2018A61K9/2054A61K9/4866A61P13/00A61P13/02A61P13/04A61P13/08A61P13/10A61P25/02A61P29/00A61P31/04A61P43/00A61P7/12A61K9/20A61K9/28A61K9/48
Inventor 永沼剛村松三夫
Owner KISSEI PHARMA
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