An article of manufacture for prasugrel

A product and moisture technology, applied in the field of products of thienopyridine platelet aggregation inhibitor, can solve the problems of low oxygen concentration, difficult application and the like

Inactive Publication Date: 2009-10-28
ELI LILLY & CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, often conventional gas inert bottles are difficult to fit on a standard high speed bottle packaging line and get the minimum required oxygen concentration in the bottle

Method used

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  • An article of manufacture for prasugrel
  • An article of manufacture for prasugrel
  • An article of manufacture for prasugrel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] Prasugrel HCl salt (10.98 mg equivalent to 10 mg base), mannitol, hydroxypropyl methylcellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate were mixed and rolled Machine compaction to produce granules. To the resulting granulate is added additional croscarmellose sodium, microcrystalline cellulose and magnesium stearate, and the material is mixed and compressed to form tablets weighing from about 175 mg to about 250 mg. Opadry The beige coating mixture was added to the water and sprayed onto the tablets in a side vented coating pan.

[0109] The tablets are then packaged with a molecular sieve desiccant in a barrier bottle, then inertized with a liquefied gas such as liquid nitrogen, capped and then sealed by methods known to those skilled in the art. The table below shows some representative parameters that have been successfully used to inert bottles with liquid nitrogen.

[0110] Table 5 - Liquid Nitrogen Inertization - Prasugrel 10...

Embodiment 2

[0120] Prasugrel HCl salt (5.49 mg equivalent to 5 mg base), mannitol, hydroxypropyl methylcellulose, croscarmellose sodium, microcrystalline cellulose and magnesium stearate were mixed and rolled Machine compaction to produce granules. To the resulting granulate is added additional croscarmellose sodium, microcrystalline cellulose and magnesium stearate, and the material is mixed and compressed to form tablets weighing from about 125 mg to about 250 mg. Opadry The beige film coating mixture was added to the water and sprayed onto the tablets in a side vented coating pan.

[0121] The tablets are then packaged with a molecular sieve desiccant in a barrier bottle and then inertized with a liquefied gas such as liquid nitrogen, capped and then sealed by methods known to those skilled in the art. The table below shows some representative parameters for bottles that have been successfully inertized with liquid nitrogen.

[0122] Table 7 - Liquid Nitrogen Inertization - Prasugr...

Embodiment 3

[0132] Mix prasugrel HCl salt (8.24 mg equivalent to 7.5 mg base), mannitol, hydroxypropyl methylcellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate, then roll The press crushes to produce pellets. To the resulting granulate is added additional croscarmellose sodium, microcrystalline cellulose and magnesium stearate, and the material is mixed and compressed to form tablets weighing from about 125 mg to about 250 mg. Opadry The beige film coating mix was added to the water and then sprayed onto the tablets in the side vent coating process.

[0133] The tablets are then packaged with a molecular sieve desiccant in a barrier bottle, then inertized with a liquefied gas such as liquid nitrogen, capped and then sealed by methods known to those skilled in the art. See Tables 4 and 5 for examples of settings that might be used to inert these barrier bottles with liquid nitrogen. The tablets, caplets or capsules are then placed in boxes for storage ...

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Abstract

An article of manufacture comprising packaging prasugrel tablets, caplets, capsule or other solid form of prasugrel in an air and / or moisture impervious container under a positive liquid gas pressure.

Description

field of invention [0001] The present invention relates to prasugrel, a preparation of thienopyridine platelet aggregation inhibitor. Background of the invention [0002] Thienopyridines such as ticlopyridine and clopidogrel (as registered trademarks of Sanofi-Aventis S.A. or Sales) have been used in the treatment of thrombosis. [0003] Prasugrel is a next-generation thienopyridine currently being studied clinically for the treatment or prevention of thrombosis and / or related diseases, including as an adjunct to percutaneous coronary intervention. [0004] US Patent 6,688,468 B2 discloses the use of oxygen scavengers to increase the stability and shelf life of drugs. [0005] Prolonged exposure of prasugrel to air and / or moisture can lead to some stability-linked degradation and further to a shorter shelf life. Previously, containers including bottles were filled with tablets, caplets, capsules under an inert atmosphere. The bottle can be inerted with conventional ga...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/435A61K31/44A61K9/20A61K9/28A61K9/48
CPCA61K9/2054A61K31/435B65B61/20A61K9/2018A61K31/4365A61K31/44A61P7/02A61K9/20A61K9/48
Inventor M·J·穆恩P·L·奥伦
Owner ELI LILLY & CO
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