A kind of ivabradine hydrochloride osmotic pump controlled-release tablet and preparation method thereof

A technology of ivabradine hydrochloride and osmotic pump controlled release, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, cardiovascular system diseases, etc. The effect of reducing the number of doses, maturing the process, improving compliance and safety

Active Publication Date: 2018-01-12
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the preparation process adopted by this invention is relatively complicated, which is not suitable for current industrial production.

Method used

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  • A kind of ivabradine hydrochloride osmotic pump controlled-release tablet and preparation method thereof
  • A kind of ivabradine hydrochloride osmotic pump controlled-release tablet and preparation method thereof
  • A kind of ivabradine hydrochloride osmotic pump controlled-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Tablet prescription:

[0032]

[0033] Coating prescription

[0034] composition

Dosage / g

Cellulose acetate

100

polyethylene glycol 4000

10

acetone

Appropriate amount

water

Appropriate amount

[0035] Preparation Process:

[0036] Pass the drug and polyoxyethylene in the prescription amount of the drug-containing layer through a 80-mesh sieve, add a lubricant and mix evenly; pass the prescription amount of polyoxyethylene, sodium chloride and magnesium stearate in the booster layer through a 80-mesh sieve, and add a lubricant Mix evenly, use the No. 8 punch twice to pressurize to get the tablet core. Cellulose acetate and polyethylene glycol were dissolved in acetone and distilled water respectively and mixed evenly, and the tablet core was coated with a coating pan with a weight gain of 6%. After coating, it was cured in an oven at 40°C for 12 hours. Then prepare and punch a 0.6mm diameter release hole o...

Embodiment 2

[0038] Tablet prescription:

[0039]

[0040] Coating film prescription:

[0041] composition

Dosage / g

Ethyl cellulose

100

polyethylene glycol 4000

12.5

acetone

Appropriate amount

distilled water

Appropriate amount

[0042] Preparation Process:

[0043] Pass the drug, polyoxyethylene, and lactose in the prescription amount of the drug-containing layer through a 80-mesh sieve, add lubricant, and mix evenly; pass the prescription amount of polyoxyethylene and sodium chloride in the booster layer through an 80-mesh sieve, add lubricant and mix evenly , Use the No. 8 punch to pressurize twice to get the tablet core. Dissolve ethyl cellulose and polyethylene glycol in acetone and distilled water respectively and mix evenly, coat the tablet core with a coating pan, with a weight gain of 6%, and cure in an oven at 40°C for 12 hours after coating . Then prepare a 0.6mm diameter drug release hole on the drug-containing ...

Embodiment 3

[0045]Tablet prescription:

[0046]

[0047] Coating film prescription:

[0048] composition

Dosage / g

Cellulose acetate

100

polyethylene glycol 4000

12.5

acetone

Appropriate amount

water

Appropriate amount

[0049] Preparation Process:

[0050] Pass the drug, polyoxyethylene, and mannitol in the prescription amount of the drug-containing layer through a 80-mesh sieve, add lubricant and mix evenly, pass the prescription amount of polyoxyethylene and sodium chloride in the booster layer through an 80-mesh sieve, add lubricant and mix evenly , Use the No. 8 punch to pressurize twice to get the tablet core. Cellulose acetate and polyethylene glycol were dissolved in acetone and distilled water respectively and mixed evenly, and the tablet core was coated with a coating pan, with a weight gain of 8%. After coating, it was cured in an oven at 40°C for 12 hours. Then prepare a 0.6mm diameter release hole on the side of...

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Abstract

The invention provides an ivabradine hydrochloride osmotic pump controlled-release tablet and a preparation method thereof. The osmotic pump controlled-release tablet of the invention is characterized in that it contains the active ingredient of ivabradine hydrochloride, and is composed of a double-layer tablet core compressed by a polymer material, an osmotic pressure active substance and the like, and a semi-permeable coating film. The preparation enables ivabradine hydrochloride to achieve a constant-speed slow release within 0-24 hours, and the release rate exceeds 90%, and has the characteristics of long-acting zero-order drug release. The invention is used for treating patients with chronic angina pectoris, can stabilize blood drug concentration, reduce adverse reactions caused by large fluctuation of blood drug concentration, and improve drug safety; meanwhile, it reduces the number of patients taking the drug and improves the patient's compliance.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations. Specifically relates to an ivabradine hydrochloride osmotic pump controlled-release tablet and a preparation method thereof. Background technique [0002] The speed of the heart rate reflects the excitability of the human sympathetic nerve to a certain extent. Studies have confirmed that heart rate is an independent risk predictor for various cardiovascular diseases such as coronary heart disease, hypertension, and heart failure. Tachycardia exerts a toxic effect on the myocardium by increasing myocardial oxygen consumption, reducing diastolic myocardial blood perfusion, increasing arterial blood pressure and catecholamine levels, and increasing the hospitalization rate and mortality of patients. Therefore, effectively controlling the heart rate is an important clinical decision in the treatment of cardiovascular diseases, and a variety of heart rate-lowering drugs, mainly β-blockers,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/44A61K31/55A61K47/38A61K47/36A61K47/26A61K47/10A61K47/04A61P9/10
Inventor 梁静阁冯小路周秋香杨波周静
Owner WUHAN WUYAO SCI & TECH
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