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Pharmaceutical composition for treating excessive proliferation diseases

A technology of composition and medicine, applied in the field of pharmaceutical composition containing Ibrutinib and its preparation, and pharmaceutical composition for treating hyperproliferative diseases, which can solve the problems such as no Ibrutinib preparations

Inactive Publication Date: 2015-04-22
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is no literature related to Ibrutinib preparations

Method used

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  • Pharmaceutical composition for treating excessive proliferation diseases
  • Pharmaceutical composition for treating excessive proliferation diseases

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0027] Wet granulation is a widely used method of preparing capsules or compressed tablets. The steps required to prepare capsules or tablets by this method are divided into the following: (1) weighing and mixing the pharmaceutical ingredients; (2) preparing wet granules; (3) sieving the wet granules into pellets or granules, drying the wet granules; (4) Sieve dry granules; (5) Lubricate and mix; (6) Fill into capsules or compress into tablets. In weighing the active ingredient and mixing the active ingredient with the disintegrant, not always the entire amount of the disintegrant is added to the mixture of drug and other excipients, but a portion is reserved, along with the lubricant Add to the prepared drug granules. The granulation is accomplished by adding a granulation solution to the powder mixture, passing the wet material through a sieve of the desired mesh size, drying the granules, and then passing through a second sieve with a smaller mesh size to further reduce th...

specific Embodiment approach

[0046] In order to enable those skilled in the art to better understand the technical solutions of the present invention, some non-limiting examples are further disclosed below to further describe the present invention in detail.

[0047] The reagents used in the present invention can be purchased from the market or can be prepared by the methods described in the present invention.

[0048] In the present invention, min means minute, mg means milligram, and mL means milliliter.

Embodiment 1

[0050] prescription

[0051] components

Prescription ratio (%)

Prescription amount (mg)

Ibrutinib

75.0

140.0

Mannitol

10.7

20.0

microcrystalline cellulose

5.8

10.8

Croscarmellose Sodium

6.6

12.3

Sodium dodecyl sulfate

1.1

2.1

Magnesium stearate

0.8

1.5

[0052] Preparation:

[0053] (1) Mix 140.0mg Ibrutinib, 20.0mg mannitol, 10.8mg microcrystalline cellulose, 12.3mg croscarmellose sodium and 2.1mg sodium lauryl sulfate in a high shear granulator;

[0054] (2) Use pure water as the granulation fluid to granulate;

[0055] (3) drying the granules in a fluidized bed granulator;

[0056] (4) Grinding the dried particles with a vibrating sieve to achieve a suitable particle size;

[0057] (5) Mix the sieved granules with 1.5 mg of magnesium stearate in an appropriate size;

[0058] (6) packed into capsules, and prepared into capsules.

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Abstract

The invention relates to a pharmaceutical composition for treating excessive proliferation diseases, and belongs to the field of pharmaceutical preparations. The pharmaceutical composition comprises active ingredients which include 1-[(3R)-3-[4-amino-3-(4-phenoxy phenyl)-1H-pyrazol[3,4-D]pyrimidine-1-group]-1-piperidyl]-2-propylene-1-ketone, a solvate of 1-[(3R)-3-[4-amino-3-(4-phenoxy phenyl)-1H-pyrazol[3,4-D]pyrimidine-1-group]-1-piperidyl]-2-propylene-1-ketone, a hydrate and salt acceptable in pharmacy or a composition of the salt and at least one excipient acceptable in pharmacy; and the active ingredients at least occupies 30% of the composition. The pharmaceutical composition is easy to swallow; the number of times of drug feeding is decreased; the compliance of a patient can be obviously improved; in addition, the pharmaceutical composition has the good dissolution characteristic, the excellent bioavailability, the high stability and the sufficient hardness; and the pharmaceutical composition is suitable for clinic treatment of cancers. The preparation method of the pharmaceutical composition is simple and practical, and the pharmaceutical composition is suitable for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating hyperproliferative diseases, in particular to a pharmaceutical composition containing Ibrutinib and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Ibrutinib is a small molecule tyrosine kinase (BTK) inhibitor with the chemical name 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyridine Azolo[3,4-D]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one, the specific structure is as follows: [0003] [0004] Ibrutinib can selectively inhibit tyrosine kinase (BTK), an important protein in cell physiological activities, involved in mediating intracellular signaling pathways that regulate B cell maturation and survival. In malignant B cells, the B cell receptor signaling pathway is hyperactive, and Ibrutinib inhibits hyperactivity in malignant B cells by forming a strong covalent bond with the cysteine ​​residue in the active center...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K9/20A61K9/48A61P35/00
CPCA61K31/519A61K9/1652A61K9/2054A61K9/2059
Inventor 刘一浓汪东峨
Owner SUNSHINE LAKE PHARM CO LTD
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