Prasugrel hydrobromide tablet

Abstract

The invention relates to a Prasugrel hydrobromide tablet suitable for preparation by a direct compression process. In addition to containing the active component Prasugrel hydrobromide, the tablet also contains a filling agent, a disintegrating agent and a lubricant. And the tablet has the advantages of high dissolution rate, good stability, high safety, and simple preparation process.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a tablet of prasugrel hydrobromide. Background technique [0002] Prasugrel was initially jointly developed by Eli Lilly, a large US biopharmaceutical company, and Japan's Daiichi Pharmaceutical Sankyo. It is an adenosine diphosphate (ADP) receptor antagonist. As an anticoagulant, it is a prodrug and has no activity itself. It is converted into its active metabolite R-138727 in the body; R-138727 It reduces the dependence on cytochrome P-450 enzyme, and rapidly, specifically and irreversibly binds to the purine base receptor of platelet P2Y12, inhibits the activity and aggregation of platelets regulated by ADP. Primarily used in patients requiring percutaneous coronary syndrome, including those requiring stenting. [0003] Generally, pharmaceutically acceptable salts of medicinal compounds are used. U.S. Patent 6693115B2 discloses the preparation of prasugrel hydrochl...

AI Technical Summary

Problems solved by technology

The disadvantage is that the antioxidant layer can only reduce the oxidation of prasugrel, while the influence of factors such as humidity and heat in the coating process increases the hydrolyzate faster; the preparation process is complicated; at the same time, the application of a large number of antioxidants and colorants has potential harm to the human body the harm of

[0008] Chinese invention patent application CN101568339 discloses a prasugrel product, which comprises a tablet, caplet, capsule or other solid dosage form of prasugrel packaged in an air and / or moisture impermeable container under positive liquefied gas pressure. In the container, in order to solve the stability problem of prasugrel, the production operation is difficult and the cost is high

[0009] Chinese invention patent application CN101919823 discloses a pharmaceutical composition for treating thrombus. In the coating process, water or other non-aqueous solvents are inevitably used and heating is required, and the solvents used will also have residues. These factors will accelerate the hydrolysis and oxidation of prasugrel, resulting in tablet instability.

In addition, the dissolution of the tablet prepared by the examples in this patent is too slow, and the dissolution curve is not similar to that of foreign marketed preparations (Efient) (f 2 <50)

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