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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.

Inactive Publication Date: 2021-04-09
南京康川济医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] CN102908327 discloses ivabradine slow-release preparation, selects a variety of matrix materials to slow down the drug dissolution, but the release rate of the slow-release matrix tablet will gradually slow down and is easily affected by the gastrointestinal environment
[0008] CN104398486 discloses ivabradine hydrochloride double-layer osmotic pump controlled-release tablets, which respectively prepare a drug-containing layer and a booster layer, which have high requirements for instruments and equipment, complicated preparation process and high production cost

Method used

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

Examples

Experimental program
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Effect test

Embodiment 1～ Embodiment 11

[0025] Example 1-Example 11 Preparation method: Take the prescribed amount of medicine and auxiliary materials (except magnesium stearate), pass through a 30-mesh sieve and mix evenly. Add an appropriate amount of wetting agent absolute ethanol to granulate, pass through a 20-mesh sieve for wet granulation, dry in an oven at 40°C for 2 hours, pass through a 20-mesh sieve to dry and granulate. Add magnesium stearate and mix. Circular dimpled film-pressed tablets with a diameter of 8mm and a hardness of 5-9kg. Weigh cellulose acetate and polyethylene glycol 3350 according to the prescription, heat in a constant temperature water bath at 35°C, and add them into acetone-water solution (99.5:0.5) under magnetic stirring. After completely dissolving, the coating solution is clear and transparent. The tablet core is placed in the coating pan, the temperature of the tablet bed is controlled at 22-28° C., and the weight gain of the coating is 5-6%. After the coating is completed, pla...

Embodiment 1

[0028] Tablet core prescription

[0029] composition Dosage (per tablet) Ivabradine Hydrochloride 10.8mg Hydroxyethyl Cellulose LR 30mg Hypromellose E5 10mg Mannitol 147.2mg Magnesium stearate 2mg

[0030] Coating prescription

[0031] composition Dosage (per 100 tablets) Cellulose acetate 0.9g polyethylene glycol 3350 0.1g acetone 19.9g water 0.1g

Embodiment 2

[0033] Tablet core prescription

[0034] composition Dosage (per tablet) Ivabradine Hydrochloride 10.8mg Hypromellose E50 30mg Hypromellose E5 10mg Mannitol 147.2mg Magnesium stearate 2mg

[0035] Coating prescription

[0036] composition Dosage (per 100 tablets) Cellulose acetate 0.9g polyethylene glycol 3350 0.1g acetone 19.9g water 0.1g

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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.

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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Application Information

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IPC IPC(8): A61K9/28A61K47/10A61K47/38A61K47/32A61K31/55A61P9/04
CPCA61K9/0004A61K9/2054A61K9/2018A61K9/2853A61K9/2866A61K9/2031A61K9/2027A61K9/2059A61K31/55A61P9/04
Inventor 朱春莉陈金脱冯婧劼
Owner 南京康川济医药科技有限公司
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