Rivastigmine orally disintegration tablet and preparation method thereof

A technology of rivastigmine bitartrate and orally disintegrating tablets, which can be applied to pharmaceutical formulas, medical preparations of non-active ingredients, drug combinations, etc., and can solve problems such as research reports on rivastigmine bitartrate orally disintegrating tablets. , to achieve the effects of stable and easy-to-control preparation quality, good medication compliance, and appropriate hardness

Active Publication Date: 2010-08-11
泰州骏道立同生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After searching, there is no relevant research report on rivastigmine bitartrate orally disintegrating tablets

Method used

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  • Rivastigmine orally disintegration tablet and preparation method thereof
  • Rivastigmine orally disintegration tablet and preparation method thereof
  • Rivastigmine orally disintegration tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] prescription

[0049]

[0050] method All the components in the prescription are crushed into fine powder with a fineness of more than 100 mesh; the prescription amount of rivastigmine bitartrate, lactose, mannitol, microcrystalline cellulose, citric acid, orange essence and menthol are mixed with 4g Mix cross-linked povidone, pass through a 100-mesh sieve three times to make the mixture uniform, then add a soft material made of povidone K30 aqueous solution with a concentration of 2% by mass, pass through a 24-mesh sieve to granulate, dry at 50°C, and dry granules Pass through a 24-mesh sieve for granulation; then add 2 g of crospovidone, sodium bicarbonate and magnesium stearate in the prescribed amount to the granulated dry granules, mix evenly, and compress into tablets to make rivastigmine bitartrate 1000 orally disintegrating tablets, each containing 1.5 mg rivastigmine bitartrate.

[0051] quality The obtained orally disintegrating tablet has a smooth ...

Embodiment 2

[0053] prescription

[0054]

[0055] method All the components in the prescription were crushed into fine powder with a fineness above 100 meshes; the prescription amount of rivastigmine bitartrate, lactose, mannitol, microcrystalline cellulose, tartaric acid, orange essence and menthol were mixed with 6.7g Mix polyvidone, pass through a 100-mesh sieve three times to make the mixture uniform, then add 2% povidone K30 aqueous solution to make a soft material, pass through a 24-mesh sieve to granulate, dry at 50°C, and dry granules Pass through a 24-mesh sieve for granulation; then add 3.3g of crospovidone, sodium bicarbonate and magnesium stearate in the prescribed amount to the granulated dry granules, mix evenly, and compress into tablets to make Kabbalah tartrate 1000 orally disintegrating tablets, each containing rivastigmine bitartrate 1.5mg.

[0056] quality The obtained orally disintegrating tablet has a smooth and beautiful surface; a hardness of 25-40 Newto...

Embodiment 3

[0058] prescription

[0059]

[0060] method All the components in the prescription are crushed into fine powders with a fineness of more than 100 mesh; the prescription amount of rivastigmine bitartrate, mannitol, microcrystalline cellulose, citric acid, aspartame and menthol are mixed with 10g Mix cross-linked povidone, pass through a 100-mesh sieve three times to make the mixture uniform, then add a soft material made of povidone K30 aqueous solution with a concentration of 2% by mass, pass through a 24-mesh sieve to granulate, dry at 50°C, and dry granules Sieve through a 24-mesh sieve for granulation; then add 5g of crospovidone, sodium bicarbonate and magnesium stearate in the prescribed amount to the granulated dry granules, mix evenly, and compress into tablets to make rivastigmine bitartrate altogether 1000 orally disintegrating tablets, each containing 1.5 mg rivastigmine bitartrate.

[0061] quality The obtained orally disintegrating tablet has a smooth a...

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Abstract

The invention discloses a rivastigmine orally disintegration tablet and a preparation method thereof. The orally disintegration tablet comprises the following components by mass percent: 0.2 to 5 percent of rivastigmine, 60 to 90 percent of filler, 5 to 30 percent of disintegrating agent, 0.1 to 2 percent of lubricant and 0.2 to 5 percent of correctant. The invention has smooth and attractive appearance, proper hardness, quick disintegration in oral cavity, absorption and response, high bioavailability, small thrill on gastrointestinal tract, good taste, convenient administration and is particularly applicable to the Alzheimer disease or Parkinson disease dementia patient who has difficult deglutition or inconvenient drinking problem. The orally disintegration tablet is prepared through a wet granulation wafer method or a powder direct wafer method, has the advantages of simple technology, stable and controllable preparation quality and low cost and is applicable to industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a rivastigmine bitartrate orally disintegrating tablet, and also relates to a preparation method of the orally disintegrating tablet. Background technique [0002] Senile dementia, cerebrovascular disease, and malignant tumors are known as the three major diseases that cause disability and death to the elderly. With the acceleration of population aging in my country, the incidence of senile dementia accounts for about 10% of the elderly aged around 65, and approximately 47% of the elderly aged over 85. The fourth killer after stroke. The prevention and treatment of senile dementia is an international problem, which has attracted great attention from governments and medical circles all over the world. [0003] Senile dementia is mainly manifested as memory loss and cognitive impairment, and is a progressive neurodegenerative disease. Senile dementia can be divided into Alzheimer's...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/27A61K47/38A61K47/36A61K47/32A61P25/28
Inventor 罗永煌刘艳玲田朋鑫聂延君罗雷乔彦茹雷曙光陈君
Owner 泰州骏道立同生物科技有限公司
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