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Eltrombopag liquid capsule and preparation method thereof

A technology of liquid capsules and capsule shells, which can be used in capsule delivery, blood diseases, pharmaceutical formulations, etc., and can solve problems such as increasing product complexity and not being authorized in China

Inactive Publication Date: 2017-02-01
ZHEJIANG WAN SHENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In short, it increases the complexity of the product
This patent is currently not authorized in China

Method used

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  • Eltrombopag liquid capsule and preparation method thereof
  • Eltrombopag liquid capsule and preparation method thereof
  • Eltrombopag liquid capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The content takes the hydrophilic solution type as an example

[0033] prescription

[0034] name Proportion / % effect Eltrombopag 10 Main drug PEG400 50 solvent Diethylene glycol monoethyl ether 23.4 solvent glycerin 5 co-surfactant Tween 80 2.5 Surfactant BHT 0.15 Antioxidants Monoethanolamine 0.5 pH regulator purified water Appropriate amount solvent

[0035] Process:

[0036] (1) Take PEG400 according to the prescription amount, place diethylene glycol monoethyl ether, glycerin, Tween 80, and monoethanolamine in a liquid mixing tank, stir and mix evenly;

[0037] (2) Weigh BHT and Eltrombopag according to the prescription amount, add to the above mixed solution and stir until dissolved to form a solution;

[0038] (3) Measure the moisture of the above solution, and add an appropriate amount of purified water according to the result to adjust the final moisture to about 8%;

[0039] ...

Embodiment 2

[0048] The content is self-emulsifying type as an example

[0049] prescription

[0050]

[0051]

[0052] Process:

[0053] (1) Weigh PPG-11, RH40, glyceryl triacetate, PEG400, and monoethanolamine according to the prescription quantity and place them in the liquid preparation tank, stir and mix evenly;

[0054] (2) Take tocopherol and eltrombopag according to the prescription amount, add to the above mixed solution and stir until dissolved to form a solution;

[0055] (3) Fill the above-mentioned solution as the content in a special hard capsule shell to obtain.

[0056] The samples prepared according to Examples 1 and 2 were compared with the original research product (RLD: Eltrombopag tablets were jointly developed by U.S. Ligand Pharmaceutical Co., Ltd. and U.K. Glaxo Smith Clay Pharmaceutical Co., Ltd.), and the results are as follows: Figure 1-4 . Due to the obvious solubilization effect of Tween-80, in order to obtain a dissolution profile with better distin...

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PUM

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Abstract

The invention relates to an eltrombopag liquid capsule and a preparation method thereof. The eltrombopag liquid capsule is prepared by dissolving eltrombopag in an auxiliary material to obtain content, and then filling a hard capsule shell with the content. The auxiliary material includes a solvent, a surfactant, a co-surfactant, an anti-oxidant, a pH regulator, a proper amount of water, etc. The liquid capsule overcomes the defects that the eltrombopag is low in dissolubility and is difficult to dissolve, and has many specifications and complex production process, thereby bringing better selection on medicine dosage forms for patients.

Description

technical field [0001] The invention relates to the field of preparations of medicines for reducing platelets, in particular to Eltrombopag liquid capsules and a preparation method thereof. Background technique [0002] Eltrombopag tablets were jointly developed by Ligand Pharmaceutical Company of the United States and Glaxo Smith Clay Pharmaceutical Co., Ltd. of the United Kingdom, and were approved by the FDA in 2008. The existing specifications are 12.5mg, 25mg, 50mg, 75mg, 100mg (all in the form of C25H22N4O4 count) 5 specifications. [0003] The patented process of the original research company is relatively complicated, and it needs to go through the following steps: micronization of Eltrombopag; mixing of Eltrombopag with a small part of excipients, wet granulation, drying, and sizing; mixing of dry granules with most of the excipients; adding lubricant Total blending; tableting; coating. [0004] The process described in the above patent is complicated, that is, af...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/02A61K47/26A61K47/10A61K31/4152A61P7/00A61P7/06
CPCA61K9/4808A61K9/4816A61K9/4866A61K31/4152
Inventor 孙克郑淑芳桂盼鲍毅
Owner ZHEJIANG WAN SHENG PHARMA CO LTD
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