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Sustained release preparation of dronedarone hydrochloride

A dronedarone hydrochloride and slow-release preparation technology, which is applied in the field of medicine, can solve the problems of affecting the steady-state blood drug concentration of the drug, inconvenient use for patients, and short biological half-life, so as to achieve less medication times, high safety, and bioavailability high degree of effect

Inactive Publication Date: 2012-09-19
CGENETECH (SUZHOU CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
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Problems solved by technology

[0005] Dronedarone hydrochloride is a drug with a short biological half-life. The dosage for one administration is 400mg, and it needs to be administered 2-3 times a day, which brings inconvenience to patients. At the same time, due to the influence of sleep time and other factors, it affects the quality of the drug. Steady-state blood drug concentration, which affects drug efficacy

Method used

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  • Sustained release preparation of dronedarone hydrochloride
  • Sustained release preparation of dronedarone hydrochloride

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Embodiment Construction

[0031] The sustained-release preparation containing dronedarone hydrochloride as an active ingredient of the present invention is further specifically described by the following examples, but it is not intended to limit the present invention.

[0032] prescription

[0033]

[0034] Preparation

[0035] (1) Preparation of granules: Hypromellose and microcrystalline cellulose were sieved separately and mixed evenly. Then add dronedarone hydrochloride, mix well, use 5% povidone K3O aqueous solution as binder to make soft material, sieve with 20 mesh to prepare wet granules, dry at 50°C, sieve with 18 mesh for granulation, and set aside.

[0036] (2) Preparation of coating liquid: add Opadry to pure water, and add pure water to 100ml, stir for 1 hour, set aside.

[0037] (3) Coating the granules of (1) to obtain coated granules.

[0038] (4) Add an appropriate amount of magnesium stearate to the granules obtained in (3), mix well, and press into tablets to obtain tablets.

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Abstract

The invention discloses a sustained release preparation of dronedarone hydrochloride, aiming to maintain an optimal steady state plasma concentration better, improve a pharmaceutical effect and bring convenience for use and reduce hospitalization risk of patients. Active components are released slowly to obtain prospected drug release behavior in vivo and in vitro. Therefore, the sustained release preparation of dronedarone hydrochloride, disclosed by the invention, has the advantages of low drug use time, slow release of drug in vivo, steady plasma concentration, low fluctuation, high bioavailability and high safety.

Description

technical field [0001] The invention relates to a sustained-release preparation of dronedarone hydrochloride and a preparation method thereof, belonging to the field of medicine. Background technique [0002] The research and development of sustained-release preparations has a history of more than 40 years. It releases slowly and at a non-constant rate as required in a prescribed environment. Prolonged formulation. This kind of preparation can make the human body maintain this kind of blood drug concentration for a long time, instead of dropping rapidly like ordinary preparations, so as to avoid the "peak and valley" phenomenon that occurs when common preparations are frequently administered, and ensure the safety of the drug. Sexuality, effectiveness or adaptability have been improved, thereby reducing the number of medications, which greatly facilitates patients, especially patients who have been taking medication for a long time. Commonly used oral dosage forms include ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/28A61K9/52A61K31/343A61P9/06
Inventor 殷时杰余强丁炬平张仁延
Owner CGENETECH (SUZHOU CHINA) CO LTD
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