Ivabradine hydrochloride single-layer osmotic pump controlled release tablet and preparation method thereof

An ivabradine hydrochloride, single-layer osmotic pump technology, applied in osmotic delivery, coating, pharmaceutical formulations, etc., can solve the problems of high requirements for equipment, complicated preparation process, slow release rate of sustained-release matrix tablets, etc.
CN112618506AInactive Publication Date: 2021-04-09南京康川济医药科技有限公司
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
南京康川济医药科技有限公司
Publication Date
2021-04-09
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention provides an ivabradine hydrochloride single-layer osmotic pump controlled release tablet and a preparation method thereof. The single-layer osmotic pump controlled release tablet comprises three parts, namely a tablet core, a semipermeable coating film and a drug release pore, wherein the tablet core comprises the following components in percentage by weight: 5-30% of ivabradine hydrochloride, 0-60% of a suspending agent, 30-90% of a penetration enhancer and 0.1-3% of a lubricant; the semipermeable coating film comprises the following components in percentage by weight: 80-99% of a semipermeable film forming material and 1-20% of a pore-foaming agent; the weight gain of the coating is 3-15% of the weight of the tablet core; and the pore diameter of the drug release pore is 0.4-1.2mm. The ivabradine hydrochloride single-layer osmotic pump controlled release tablet is orally taken once a day, is stable in blood concentration and is not easily influenced by gastrointestinal tract environments.
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Description

technical field

[0001] The invention relates to the field of pharmaceutical preparations, in particular to an ivabradine hydrochloride single-layer osmotic pump controlled-release tablet and a preparation method thereof. Background technique

[0002] Resting heart rate is an important indicator of cardiovascular morbidity and mortality. Increased myocardial oxygen consumption caused by elevated heart rate (greater than 70 beats / min) is a risk factor for heart failure and angina. Reducing heart rate is an important goal of heart failure treatment, thereby alleviating cardiovascular complications and reducing prognostic mortality.

[0003] Ivabradine, chemical name 7,8-dimethoxy-3-(3-[[(1S)(4,5-dimethoxybenzocyclobutan-1-yl)methyl]-methoxy Amino]propyl)-1,3,4,5-tetrahydro-2hydro-benzazepin-2-one in patients with chronic heart failure with normal sinus rhythm or when contraindicated or intolerable During beta-blocker therapy.

[0004] Ivabradine hydrochloride is the first s...

Claims

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