Atorvastatin calcium oral disintegrating tablet and preparation method thereof

A technology of atorvastatin calcium and orally disintegrating tablets, which is applied in the field of orally disintegrating tablets, can solve the problems of high encapsulation rate, poor production feasibility, large particle size of pellets or particles, and achieve short disintegration time, The effect of convenience

Inactive Publication Date: 2010-08-04
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among these methods, physical and chemical methods are widely used in experimental research, but their production feasibility is relatively poor; physical methods are more feasible for large-scale production, but the pellets or granules produced by the fluidized bed method have a large particle size and are difficult to disintegrate in the oral cavity. It may cause a gritty feeling during application; the particle size produced by the spray drying method is small, and the oral disintegration tablet does not cause a gritty feel, but the drug loading and encapsulation efficiency are low
Our experimental research shows that using spray drying technology, the bitter taste is already felt when the drug content reaches more than 10%, and the high encapsulation rate can only reach 34%.

Method used

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  • Atorvastatin calcium oral disintegrating tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Weigh 40g of atorvastatin calcium, 60g of gastric-soluble polyacrylic acid resin EPO and 2g of diethyl phthalate and dissolve them in 20ml of absolute ethanol, stir to dissolve and suspend evenly, pour into the mixture at a stirring speed of 400-600rpm , the concentration is 0.01M NaOH aqueous solution, after the precipitation is complete, suction filtration, the obtained powder is dried in a vacuum oven for 24 hours, taken out, and stored in a closed container in a cool place to obtain atorvastatin calcium taste-masked microcapsules.

[0023] Tablet prescription:

[0024] Atorvastatin Calcium Taste Masked Microcapsules 25g

[0025] Mannitol 100g

[0026] L-HPC 15g

[0027] Calcium carbonate 7.5g

[0028] Micronized silica gel 1g

[0029] Magnesium stearate 0.5g

[0030] Weigh the above materials (except magnesium stearate) into a three-dimensional mixer and mix for 30 minutes, then add magnesium stearate and mix for 1 to 2 minutes; pour the mixed materials into th...

Embodiment 2

[0032]Weigh 20g of atorvastatin calcium, 80g of gastric-soluble polyacrylic acid resin EPO and 2g of diethyl phthalate and dissolve in 20ml of absolute ethanol, stir to dissolve and suspend evenly, pour in and stir at a speed of 400-600rpm After the precipitation is complete, filter with suction, place the obtained powder in a vacuum drying oven to dry for 24 hours, take it out, and store it in an airtight container in a cool place to obtain the taste-masked microcapsules of atorvastatin calcium.

[0033] Tablet prescription:

[0034] Atorvastatin Calcium Taste Masked Microcapsules 50g

[0035] Mannitol 160g

[0036] L-HPC 10g

[0037] Croscarmellose Sodium 10g

[0038] Calcium carbonate 10g

[0039] Micronized silica gel 2g

[0040] Flavoring agent 0.01g

[0041] Magnesium stearate 0.5g

[0042] Weigh the above materials (except magnesium stearate) into a three-dimensional mixer and mix for 30 minutes, then add magnesium stearate and mix for 1 to 2 minutes; pour the mi...

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Abstract

The invention provides an atorvastatin calcium oral disintegrating tablet prescription and a preparation method thereof. The atorvastatin calcium oral disintegrating tablet prescription comprises atorvastatin calcium, a bitter covering agent, a filling agent, a disintegrant, a lubricant, and the like. The invention is technically characterized by providing a particle preparing technology which not only can effectively cover the bitter of the atorvastatin calcium, but also can lead the atorvastatin calcium oral disintegrating tablet to be disintegrated in the mouth. The atorvastatin calcium oral disintegrating tablet with pressure of above 4kg and disintegrating time within 30 seconds can be prepared by adding normal supplementary materials of filling agents, disintegrants, lubricants, and the like of oral disintegrating tablets and is easy to realize industrial scale production.

Description

technical field [0001] The invention relates to a technology for preparing orally disintegrating atorvastatin calcium tablets, specifically a method of preparing atorvastatin calcium into orally disintegrating tablets by wrapping atorvastatin calcium into odorless microcapsule particles with polymer materials, which is used in medical technology field. Background technique [0002] Due to the improvement of people's living standards, more and more people are troubled by hyperlipidemia (commonly known as hyperlipidemia), and the incidence of hyperlipidemia tends to be younger and younger, extending from the original elderly to 35 years old Middle-aged people around. Hyperlipidemia is very dangerous. If it is not treated for a long time, it will lead to cardiovascular and cerebrovascular diseases such as atherosclerosis, stroke, hypertension and coronary heart disease. It is known as the "invisible killer". Hyperlipidemia, also known as dyslipidemia, mainly refers to the inc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/40A61P3/06
Inventor 周建平吕慧侠朱玛张振海姜慧
Owner CHINA PHARM UNIV
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