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Pharmaceutical composition containing poorly-soluble basic medicine

A composition and basic substance technology, applied in the direction of drug combination, medical preparations containing active ingredients, organic active ingredients, etc., can solve the problems of dissolution, oral absorption, etc.

Pending Publication Date: 2021-02-19
CHUGAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the other hand, in the case of a poorly water-soluble or insoluble drug, if it is compression-molded (tabletized) at a high dosage, the poorly water-soluble or insoluble drug tends to become stronger as its characteristics. Therefore, the dissolution, Problems with oral absorbability

Method used

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  • Pharmaceutical composition containing poorly-soluble basic medicine
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  • Pharmaceutical composition containing poorly-soluble basic medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0213] Examples are given below, and the present invention will be described in more detail, but the present invention is not limited to these Examples. In Examples 1-20, NIKKOL SLS (Nikko Chemicals Co., Ltd.) was used as sodium lauryl sulfate.

reference example 1

[0214] Reference Example 1: Formation of an impermeable coating

[0215] (manufacturing of preparations)

[0216] Tablets were prepared according to the amount of each component described in Table 1. The hydrochloride salt of the compound of formula (I) (hereinafter referred to as compound A), sodium lauryl sulfate, and magnesium stearate were mixed manually using a polyethylene container, respectively. The blended powder was compressed with a static compression tablet press (P-16, Riken Seiki Co., Ltd.) at a compression pressure (500 kgf) to produce a tablet (φ=9.0 mm) containing 150 mg of Compound A in terms of free form.

[0217] [Table 1]

[0218]

[0219] (Formulation evaluation and results)

[0220] For reference example 1, the test liquid uses 900mL of the Japanese Pharmacopoeia dissolution test liquid first solution comprising polyoxyethylene (10) octylphenyl ether 4%, and utilizes the Japanese Pharmacopoeia dissolution test paddle method to carry out the dissolu...

Embodiment 1-7

[0222] Examples 1-7: Research on disintegration of alkaline substances

[0223] (manufacturing of preparations)

[0224] Tablets were prepared according to the amount of each component of the tablet formulation described in Table 2. Each substance shown in Table 3 was used for X contained in the final powder component in the prescription. Mix the ingredients of the granule formulation, put the premixed powder into a stainless steel beaker, add purified water while stirring with a metal spatula, perform wet granulation, and use a vacuum dryer (VOS-301SD, Tokyo Rikaki Co., Ltd. ) to dry at room temperature. Next, it was sized by a sieve having a particle size diameter of 850 μm to form granules, and further mixed with the post-powder component to obtain a compounded powder. Tablets (15.9 x 8.4 mm) containing 300 mg of Compound A in terms of free form were produced by compressing each blended powder with a static compression tablet press (P-16, Riken Seiki Co., Ltd.) at a comp...

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Abstract

The purpose of the present invention is to provide a poorly-soluble basic medicine, in particular, a high-dose medical preparation having improved characteristics of a pharmaceutical composition including a compound represented by formula (I) or a salt thereof. This can be solved by providing a pharmaceutical composition containing a compound represented by formula (I) or a salt thereof, a surfactant, and a basic substance.

Description

technical field [0001] The present invention relates to a pharmaceutical composition suitable for poorly soluble basic medicaments, especially suitable for high-dosage preparations of compounds represented by formula (I), high-dosage tablets thereof, and the like. Background technique [0002] Anaplastic Lymphoma Kinase (ALK) is one of the receptor-type tyrosine kinases belonging to the insulin receptor family (non-patent literature 1, non-patent literature 2), and it has been reported that ALK gene abnormality can cause Production of abnormal kinases resulting from fusions of other genes. [0003] As diseases accompanied by ALK abnormality, for example, cancer and cancer metastasis (Non-Patent Document 1, Patent Document 1), depression, cognitive dysfunction (Non-Patent Document 2), etc. are known, and the provision of ALK inhibitors will provide support for these diseases. Effective treatment and preventive medicine. [0004] As a compound with ALK inhibitory effect, the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5377A61K9/20A61K47/02A61K47/18A61K47/20A61K47/32A61K47/38A61P25/24A61P25/28A61P35/00A61P35/04A61P43/00
CPCA61P43/00A61K31/5377A61P25/24A61P35/00A61P25/28A61P35/04A61K9/2009A61K9/2013A61K9/20A61K47/02A61K47/18A61K47/20A61K47/32A61K47/38A61K9/205A61K9/2027A61K9/2059A61K9/2018A61K9/2054
Inventor 北山明佐宗毅
Owner CHUGAI PHARMA CO LTD
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