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Hot-melt extrusion preparation of pazopanib hydrochloride and preparation method of hot-melt extrusion preparation

A technology for pazopanib hydrochloride and solid pazopanib hydrochloride is applied in the field of hot-melt extrusion preparation of pazopanib hydrochloride and its preparation, which can solve the problems of limiting wide application, thermal decomposition of drugs and carriers, etc. The preparation process is simple, the dosage is reduced, and the effect of no solvent residue

Inactive Publication Date: 2015-05-06
SHANDONG BOMAIKANG PHARMA RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the melting point of pazopanib hydrochloride is above 285-289°C. For such a drug with a higher melting point, the hot-melt extrusion method is likely to cause thermal decomposition of the drug and carrier, thereby limiting the wide application of this method.

Method used

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  • Hot-melt extrusion preparation of pazopanib hydrochloride and preparation method of hot-melt extrusion preparation
  • Hot-melt extrusion preparation of pazopanib hydrochloride and preparation method of hot-melt extrusion preparation
  • Hot-melt extrusion preparation of pazopanib hydrochloride and preparation method of hot-melt extrusion preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0044] Pazopanib hydrochloride 1 part

[0045] PVP-S630 12 copies

[0046] Macrogol 4000 2 parts

[0047] Preparation process: mix uniformly to prepare a physical mixture, set the temperature of the extruder at 180°C, after the temperature rises to the set value and stabilize, add the physical mixture at a uniform speed, melt, extrude to obtain strips, cool, and crush for 40 mesh sieve to obtain pazopanib hydrochloride solid dispersion particles.

Embodiment 2

[0049] Pazopanib hydrochloride 1 part

[0050] PVP-VA64 7 copies

[0051] Macrogol 4000 2 parts

[0052] Preparation process: mix uniformly to prepare a physical mixture, set the temperature of the extruder at 150°C, after the temperature rises to the set value and stabilize, add the physical mixture at a uniform speed, melt, extrude to obtain strips, cool, and crush for 40 mesh sieve to obtain pazopanib hydrochloride solid dispersion particles.

Embodiment 3

[0054] Pazopanib hydrochloride 1 part

[0055] PVP-VA64 10 copies

[0056] Macrogol 4000 4 parts

[0057] Preparation process: mix evenly to prepare a physical mixture, set the temperature of the extruder at 165°C, after the temperature rises to the set value and stabilize, add the physical mixture at a uniform speed, melt, extrude to obtain strips, cool, and crush for 40 mesh sieve to obtain pazopanib hydrochloride solid dispersion particles.

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PUM

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Abstract

The invention discloses a hot-melt extrusion preparation of pazopanib hydrochloride and a preparation method of the hot-melt extrusion preparation. The hot-melt extrusion preparation is characterized by comprising the following components in parts by weight: 1 part of pazopanib hydrochloride, 10 parts of a hydrophilic polymer material and 3 parts of polyethylene glycol.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a hot-melt extrusion preparation and a hot-melt extrusion method thereof, in particular to a hot-melt extrusion preparation of pazopanib hydrochloride and a preparation method thereof. Background technique [0002] Pazopanib Hydrochloride (GW 786034) is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR), developed by GlaxoSmithKline. In October 2009, GlaxoSmithKline was the first to be approved for listing in the United States. In June 2010, Glaxo Group Ltd. was approved to launch this product in the European Union, and in September 2012, it was launched in Japan under the trade name: VOTRIENT. In October 2009, the earliest indication of pazopanib approved in the United States was advanced renal cell carcinoma. In April 2012, a new indication was approved in the United States: soft tissue sarcoma. [0003] The chemical name of pazopanib hydrochloride is 5-[...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/16A61K31/506A61K47/34A61K47/32A61P35/00
Inventor 谢晓涛姜斌张庆刚娄焕军李宝玉王欢
Owner SHANDONG BOMAIKANG PHARMA RES
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