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Hydrochloric acid Ivabradine solid pharmaceutical composition and method for preparing the same

A technology of ivabradine hydrochloride and its composition, which is applied in the field of new solid pharmaceutical composition and its preparation, can solve the problems of poor taste and high price, improve the curative effect, improve the rapid disintegration and dissolution rate, and expand the application of dosage forms range effect

Inactive Publication Date: 2008-04-02
BEIJING D VENTUREPHARM TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The co-dried granules of lactose and starch selected by US20050106238 are a specific commodity, namely STARLAC  , in view of its high price and poor taste when used in orally disintegrating tablets

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1 : 100mg tablet

[0021] Component Quantity (mg)

[0022] Ivabradine 5

[0023] Povidone 5

[0024] lactose 54

[0025] Croscarmellose Sodium 5

[0026] microcrystalline cellulose 30

[0027] Magnesium stearate 1

[0028] crafting process:

[0029] Preparation of active pharmaceutical ingredient granules: Weigh a prescribed amount of active pharmaceutical ingredients and solubilizer, mix them uniformly, add a binder to granulate, and obtain Granule I;

[0030] Preparation of diluent granules: Weigh the specified amount of lactose and microcrystalline cellulose, mix them evenly, add an appropriate amount of water and granulate to obtain Granule II;

[0031] Preparation of disintegrating agent granules: Weigh and mix the specified amount of disintegrating agent, add appropriate amount of water to obtain granule III;

[0032] Mix granules I, II, III and their lubricant evenly, and press into tablets.

Embodiment 2

[0033] Example 2 : 100mg tablet

[0034] Component Quantity (mg)

[0035] Ivabradine 5

[0036] PEG6000 15

[0037] lactose 44

[0038] Croscarmellose Sodium 5

[0039] microcrystalline cellulose 30

[0040] Magnesium stearate 1

[0041] crafting process:

[0042] Preparation of pharmaceutical active ingredient granules: Weigh a specified amount of pharmaceutical active ingredient, make a solid dispersion with a solubilizer solution, add water to granulate, and obtain Granule I; preparation of diluent granules: weigh a specified amount of lactose and microcrystalline Cellulose, mix it, add water to granulate to obtain granule II; preparation of disintegrating agent granules: weigh a specified amount of disintegrating agent and mix, add water to obtain granule III; granule I, II, III and their lubricant The agent is mixed evenly and pressed into tablets.

Embodiment 3

[0043] Example 3 : 180mg capsule

[0044] Component Quantity (mg)

[0045] Ivabradine 5

[0046] Povidone 5

[0047] lactose 136

[0048] Croscarmellose Sodium 3

[0049] microcrystalline cellulose 30

[0050] Magnesium stearate 1

[0051] crafting process:

[0052] Preparation of pharmaceutical active ingredient granules: weigh a specified amount of pharmaceutical active ingredient and solubilizer and mix evenly, add binder to granulate to obtain Granule I; preparation of diluent granules: weigh specified amount of lactose and microcrystalline cellulose , mix it, add water to granulate to obtain granule II; preparation of disintegrating agent granules: weigh a specified amount of disintegrating agent and mix, add water to obtain granule III; mix granules I, II, III and their lubricant Evenly, fill the capsules.

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PUM

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Abstract

The invention discloses an oral drug combination and the preparation method. The combination of the invention contains Ivabradine Hydrochloride and medically acceptable vector and exists in forms of tablets, capsules or particles. The preparation process of the combination is simple and is suitable for industrial production. And the combination is used to cure cardiovascular diseases including angina pectoris.

Description

technical field [0001] The invention relates to a novel solid pharmaceutical composition and a preparation method thereof, in particular to a pharmaceutical composition of ivabradine hydrochloride for treating chronic stable angina pectoris and a preparation method thereof. Background technique [0002] Chronic stable angina pectoris refers to certain factors that cause coronary artery insufficiency, acute and temporary myocardial ischemia and hypoxia, and cause paroxysmal, short-lasting, chest squeezing pain that is relieved after rest or nitrate preparations. clinical syndrome. Ivabradine is a selective and specific If channel blocker, which acts by selectively inhibiting the If channel responsible for controlling the automatic depolarization of the sinus node and regulating heart rate. Ivabradine acts selectively on the sinoatrial node and has no effect on intracardiac conduction, myocardial contractility, or ventricular repolarization. Unlike β-blockers, commonly used ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/48A61K31/55A61P9/10
Inventor 袁筝
Owner BEIJING D VENTUREPHARM TECH DEV
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