Pharmaceutical composition containing ibrutinib

A technology of ibrutinib and composition, applied in the field of pharmaceutical preparation, can solve the problems of propylene glycol dosage limitation, safety problems, etc., and achieve the effects of excellent emulsification, good low-temperature washing performance and good solubility

Inactive Publication Date: 2017-05-10
ABA CHEM SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the pharmaceutical composition containing ibrutinib of this patent uses ethanol or propylene glycol or a mixture of eth

Method used

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  • Pharmaceutical composition containing ibrutinib
  • Pharmaceutical composition containing ibrutinib
  • Pharmaceutical composition containing ibrutinib

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] This embodiment contains the pharmaceutical composition of ibrutinib, which comprises the following components in parts by weight: 13 parts of ibrutinib, 50 parts of glycerol formal solvent, 30 parts of solubilizer, N-methylcarbamoyl chloride 12 parts of filler, 10 parts of disintegrating agent and 26 parts of medicinal organic acid; among them, the solubilizer is selected from hydrophilic surfactant with HLB value of 15-18, and the hydrophilic surfactant is polyoxyethylene fatty alcohol ether; The disintegrant is a mixture of carboxymethylcellulose calcium and microcrystalline cellulose, with 3.23 parts of carboxymethylcellulose calcium and 6.77 parts of microcrystalline cellulose; the medicinal organic acid is a mixture of oleic acid and glyceryl oleate , and 16.37 parts of oleic acid, 9.63 parts of glyceryl oleate.

Embodiment 2

[0020] This embodiment contains the pharmaceutical composition of ibrutinib, which comprises the following components in parts by weight: 13 parts of ibrutinib, 50 parts of glycerol formal solvent, 30 parts of solubilizer, N-methylcarbamoyl chloride 12 parts of filler, 10 parts of disintegrating agent and 26 parts of medicinal organic acid; among them, the solubilizer is selected from hydrophilic surfactant with HLB value of 15-18, and the hydrophilic surfactant is polyoxyethylene fatty alcohol ether; The disintegrant is a mixture of carboxymethylcellulose calcium and microcrystalline cellulose, with 2.86 parts of carboxymethylcellulose calcium and 7.14 parts of microcrystalline cellulose; the medicinal organic acid is a mixture of oleic acid and glyceryl oleate , and 17.61 parts of oleic acid, 8.39 parts of glyceryl oleate.

Embodiment 3

[0022] This embodiment contains the pharmaceutical composition of ibrutinib, which comprises the following components in parts by weight: 13 parts of ibrutinib, 50 parts of glycerol formal solvent, 30 parts of solubilizer, N-methylcarbamoyl chloride 12 parts of filler, 10 parts of disintegrating agent and 26 parts of medicinal organic acid; among them, the solubilizer is selected from hydrophilic surfactant with HLB value of 15-18, and the hydrophilic surfactant is polyoxyethylene fatty alcohol ether; The disintegrating agent is composed of carboxymethylcellulose calcium and microcrystalline cellulose, with 3.03 parts of carboxymethylcellulose calcium and 6.97 parts of microcrystalline cellulose; the medicinal organic acid is a mixture of oleic acid and glyceryl oleate , and 17.03 parts of oleic acid, 8.97 parts of glyceryl oleate.

[0023] Table 1 is a comparison table of the mass ratio of oleic acid and glyceryl oleate in the disintegrant in Examples 1-3, croscarmellose sodi...

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PUM

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Abstract

The invention relates to a pharmaceutical composition containing ibrutinib. The pharmaceutical composition is prepared from, by weight, 13-15 parts of ibrutinib, 30-50 parts of solvent, 20-30 parts of solubilizer, 8-12 parts of filler, 6-10 parts of disintegrant and 21-26 parts of officinal organic acid, wherein the solvent is glycerolformal, and the officinal organic acid is a mixture of oleic acid and glyceryl monooleate based on the mass ratio of (1.7-2.1):1. The pharmaceutical composition containing ibrutinib has the advantages that compared with traditional pharmaceutical compositions, the variety of the solvent in the formula is changed, glycerolformal which is high in safety performance serves as the solvent with dosage unlimited, and multiple medicines are soluble in glycerolformal; meanwhile, due to the fact that the officinal organic acid is a mixture of oleic acid and glyceryl monooleate, the pharmaceutical composition containing ibrutinib is more stable and simpler than traditional pharmaceutical compositions adopting single officinal organic acid.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, in particular to a medicine composition containing ibrutinib. Background technique [0002] Ibrutinib is a small molecule BTK inhibitor that can covalently bind to the cysteine ​​residue in the active center of BTK, thereby inhibiting its activity. The full name of BTK is Bruton’styrosinekinase, which transmits signals in the BCR signaling pathway and cytokine receptor signaling pathway, and mediates the migration, chemotaxis and adhesion of B cells. Preclinical studies have shown that ibrutinib can inhibit the proliferation and survival of malignant B cells. [0003] After searching, it was found that the patent CN 105640961 A disclosed a pharmaceutical composition containing ibrutinib, the active component of which is ibrutinib, which is characterized by the selection of medium and long-chain saturated or unsaturated fatty acids, substituted carboxylic acids, etc. The pharmaceuti...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K47/22A61K47/12A61K47/14A61K47/10A61K47/18A61K47/38
CPCA61K31/519A61K47/10A61K47/12A61K47/14A61K47/18A61K47/22A61K47/38
Inventor 胡治国徐萌石炜张敏华
Owner ABA CHEM SHANGHAI
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