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Prasugrel hydrobromide tablets and preparation method thereof

A technology of hydrobromic acid and thunder tablets, applied in the field of medicine, can solve problems such as unguaranteed product quality, demanding packaging requirements, and complicated production processes

Active Publication Date: 2012-05-09
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In view of the common problems of poor product stability, complex production process, easy hydrolysis and oxidation of prasugrel hydrobromide in the prior art, strict packaging requirements, and difficulty in mass production in China, or in coating A large amount of water is used in the process, and the product quality cannot be guaranteed

Method used

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  • Prasugrel hydrobromide tablets and preparation method thereof
  • Prasugrel hydrobromide tablets and preparation method thereof
  • Prasugrel hydrobromide tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The preparation of embodiment 1 prasugrel hydrobromide tablet:

[0023]

[0024] Preparation Process:

[0025] Pass prasugrel hydrobromide through a 100-mesh sieve, add crospovidone, hydroxypropyl cellulose, and magnesium stearate, mix evenly, and press into tablets to obtain this product.

Embodiment 2

[0026] The preparation of embodiment 2 prasugrel hydrobromide tablet:

[0027]

[0028] Preparation Process:

[0029] Pass prasugrel hydrobromide through a 100-mesh sieve, add crospovidone, microcrystalline cellulose, and magnesium stearate, mix evenly, and press into tablets to obtain this product.

Embodiment 3

[0030] The preparation of embodiment 3 prasugrel hydrobromide tablet:

[0031]

[0032] Preparation Process:

[0033] Prasugrel hydrobromide passes through a 100-mesh sieve, dissolves in acetone, removes acetone by rotary evaporation, dries, controls the final content of acetone at 0.5, adds crospovidone, microcrystalline cellulose, magnesium stearate and mixes evenly, Press into tablets to get this product.

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PUM

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Abstract

The invention belongs to the technical field of medicines, and specifically relates to prasugrel hydrobromide tablets and a preparation method thereof. The tablets and the preparation method are characterized in that: raw materials are pretreated or not pretreated before the preparation of the tablets, such that the raw materials contain a certain amount of an organic solvent; other auxiliary materials are added to the raw materials; and the materials are pressed into tablets, such that the prasugrel hydrobromide tablets are prepared. With the prasugrel hydrobromide tablets provided by the invention, the medicine stability is substantially improved, the dissolution rate and the bioavailability are good, and the adverse reaction of the medicine is reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a tablet of prasugrel hydrobromide, in particular to a preparation method of the prasugrel hydrobromide tablet. Background technique [0002] Prasugrel hydrobromide is an oral antiplatelet drug jointly developed by Eli Lilly and Daiichi Sankyo. It was approved for marketing by the US FDA in 2009, and its trade name is Efient. Chinese patent CN200680020528.9 provides a preparation of prasugrel hydrobromide encapsulated in a gas inert blister pack not affected by air and moisture; Chinese patent CN200780042978.2 provides a prasugrel product, which Tablets, capsular tablets, capsules or other solid dosage forms containing prasugrel hydrobromide are packaged in air or moisture impermeable containers under positive pressure; Chinese patent CN201010146002.3 provides a hydrobromic acid Prasugrel and its acid addition salt cyclodextrin inclusion compound, has a stable inclusion structu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4365A61P7/02
Inventor 赵志全马庆文郝贵周
Owner SHANDONG NEWTIME PHARMA
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