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Bisoprolol fumarate dispersible tablet and preparation method thereof

A technology of bisoprolol fumarate and dispersible tablets, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, and pharmaceutical formulas, etc. question

Active Publication Date: 2009-07-01
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention aims to overcome the defects of the existing bisoprolol fumarate preparations, such as poor patient compliance, slow onset of action, and the instability of the drug in a humid and hot environment during the preparation process, resulting in relatively large related substances, and provides a disintegration solution for clinical treatment. Dispersible tablet of bisoprolol fumarate with fast dispersion, fast dissolution, rapid effect and good stability and preparation method thereof

Method used

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  • Bisoprolol fumarate dispersible tablet and preparation method thereof
  • Bisoprolol fumarate dispersible tablet and preparation method thereof
  • Bisoprolol fumarate dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024]

[0025] Preparation:

[0026] Weigh half of the prescription amount of microcrystalline cellulose PH101 and crospovidone and the prescription amount of calcium hydrogen phosphate; after mixing, make soft material with water, granulate with 18 mesh sieve, bake in an oven at 50°C for 2 hours, take out Use a 30-mesh sieve to sieve the granules, mix the obtained granules with the prescribed amount of bisoprolol fumarate, micropowder silica gel, magnesium stearate, and the remaining microcrystalline cellulose PH101 and crospovidone, and then use a 6mm dimple Punching tablets are available.

Embodiment 2

[0028]

[0029] Preparation:

[0030] Weigh half of the prescription amount of microcrystalline cellulose PH101 and crospovidone and the prescription amount of calcium hydrogen phosphate; after mixing, make soft material with water, granulate with 18 mesh sieve, bake in an oven at 50°C for 2 hours, take out Use a 30-mesh sieve to sieve the granules, mix the obtained granules with the prescribed amount of bisoprolol fumarate, micropowder silica gel, magnesium stearate, and the remaining microcrystalline cellulose PH101 and crospovidone, and then use a 6mm dimple Punching tablets are available.

Embodiment 3

[0032]

[0033] Preparation:

[0034] Weigh half of the prescription amount of microcrystalline cellulose PH101 and crospovidone and the prescription amount of calcium hydrogen phosphate; after mixing, make soft material with water, granulate with 18 mesh sieve, bake in an oven at 50°C for 2 hours, take out Use a 30-mesh sieve to sieve the granules, mix the obtained granules with the prescribed amount of bisoprolol fumarate, micropowder silica gel, magnesium stearate, and the remaining microcrystalline cellulose PH101 and crospovidone, and then use a 6mm dimple Punching tablets are available.

[0035] Comparative example 1 compares with the dissolution rate of embodiment 1, 2, 3 and commercially available tablet at 5 minutes:

[0036] Measure the dissolution rate in 5 minutes by the 2005 edition Chinese Pharmacopoeia appendix XC dissolution test method, the results are as follows:

[0037]

[0038] From the results, it can be seen that the dissolution rate of the pharm...

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Abstract

The invention discloses a bisoprolol fumarate dispersible tablet for the treatment of essential hypertension and angina pectoris diseases and preparation process for same. The tablet is obtained by pelletizing at least part of accessories by wet method, mixing the accessories with bisoprolol fumarate, and tabletting the mixture. Inventive medicament has high bioavailability, good stability, quickdisintegration and dissolution, quick action, and good compliance for patient.

Description

technical field [0001] The invention relates to a dispersible tablet and a preparation method thereof, in particular to a dispersible tablet containing bisoprolol fumarate and a preparation method thereof. Background technique [0002] Hypertension and angina pectoris are the most common cardiovascular diseases in the world today and the leading causes of death and disability in adults. In recent years, with the progress of society, the improvement of people's living standards and the continuous acceleration of the pace of work, the number of patients with hypertension has increased significantly. The prevalence rate of hypertension and angina pectoris has also increased significantly in China, and my country has become one of the countries with the most serious harm of these two diseases in the world. Moreover, damage to the heart, brain, kidney and other organs caused by high blood pressure seriously threatens human health and life. [0003] Bisoprolol fumarate is a card...

Claims

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Application Information

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IPC IPC(8): A61K31/138A61K9/20A61K47/34A61K47/36A61K47/38A61P9/12A61K47/32
Inventor 刘海
Owner AVENTIS PHARMA HAINAN
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