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Oral solid preparation of regorafenib and preparation method of oral solid preparation

A solid preparation, regorafenib technology, applied in the field of medicine, can solve the problems of less regorafenib preparations and the like

Inactive Publication Date: 2017-06-23
PEKING UNIV FOUNDER GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are few domestic patents on regorafenib preparations

Method used

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  • Oral solid preparation of regorafenib and preparation method of oral solid preparation
  • Oral solid preparation of regorafenib and preparation method of oral solid preparation
  • Oral solid preparation of regorafenib and preparation method of oral solid preparation

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Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0022] The following examples are used to further illustrate the present invention, to further understand a kind of regorafenib oral solid preparation and its preparation method, but the present invention is not limited thereto.

[0023] The tablets compressed in the following examples and comparative examples, unless otherwise specified, were all compressed with the same type of tablet press, and the hardness was controlled within the range of 60-100N.

[0024] 1. Test

[0025] Table 1

[0026]

[0027]

[0028] Preparation Process:

[0029] (1) Grinding regorafenib to a particle size of less than 30 μm, mixing the pulverized raw material with mannitol / lactose, microcrystalline cellulose, and croscarmellose sodium (CC-Na);

[0030] (2) granulate the mixture obtained in step (1) with 2% povidone (PVP K30) / hydroxypropyl cellulose (HPC) / hypromellose (HPMC) aqueous solution;

[0031] (3) mix the mixture obtained in step (2) with partially croscarmellose sodium, silicon d...

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PUM

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Abstract

The invention discloses an oral solid preparation of regorafenib. The preparation contains a water-soluble filler, an adhesive, a disintegrating agent, a lubricant, a coating material and the like. The preparation has the features of constant dissolution property, good oral administration compliance and the like, and is suitable for treatment of patients suffering from metastatic colorectal cancer (CRC) after receiving the EGFR-resistant treatment. The invention further relates to a preparation method of the preparation, and the method is simple in process and low in cost, and has the excellent preparation property.

Description

technical field [0001] The invention relates to an oral solid preparation of an anti-cancer and anti-angiogenesis agent and a preparation method thereof. The active ingredient is regorafenib. The preparation process of the preparation is simple and controllable, and it still has the same and stable The dissolution characteristics of the active ingredient, rapid oral onset and good compliance, belong to the field of medical technology. Background technique [0002] Regorafenib (regorafenib), the chemical name is 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N -Methylpyridine-2-carboxamide monohydrate, mostly in the form of salts, such as hydrochloride, methanesulfonate and phenylsulfonate, is an effective anticancer and antiangiogenic agent, Inhibitory activity on VEGFR, PDGFR, raf, p38 and / or flt-3 kinase signaling molecules is included and is useful in the treatment of various diseases and conditions, such as hyperproliferative diseases, such...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/44A61P35/00A61P35/02
CPCA61K9/2866A61K31/44
Inventor 易崇勤王海超冀蕾
Owner PEKING UNIV FOUNDER GRP CO LTD
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