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Cisapride dispersible tablet and preparation method thereof

A technology of dispersible tablets and hydroxypropyl, which is applied in the field of cisapride dispersible tablets and its preparation, which can solve the problems of complexity, low permeability of cisapride, and decreased permeability of cisapride, and achieve improved bioavailability , Improve the effect of bioavailability

Inactive Publication Date: 2014-07-30
QINGDAO MUNICIPAL HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The permeability of cisapride is very low and also depends on the pH environment. In the gastrointestinal tract, the permeability of cisapride decreases when the pH of the environment increases from acidic to neutral
Due to the complex biopharmaceutical properties of cisapride, it is challenging to develop dosage forms of cisapride with less individual variation and improved bioavailability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Cisapride 10g

[0035] Hydroxypropyl-β-cyclodextrin 40g

[0036] Mannitol 150g

[0037] Compressible starch 75g

[0038] Microcrystalline Cellulose 75g

[0039] Low-substituted hydroxypropyl cellulose 30g

[0040] 2% polyvinylpyrrolidone aqueous solution 600g

[0041] Talc powder 2g

[0042] Made in 1000 pieces.

[0043] Preparation Process:

[0044] Take the prescribed amount of hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water to make a saturated aqueous solution. Pass cisapride through a 120-mesh sieve, dissolve it in an appropriate amount of ethanol, and slowly dissolve the ethanol solution of cisapride under magnetic stirring. Add the saturated aqueous solution of hydroxypropyl cyclodextrin, continue to stir at room temperature for 3 hours after all the addition is complete, and remove most of the ethanol by rotary evaporation at 45°C. Put it into a shallow tray and put it in the freezer of the refrigerator. The pre-freezing tim...

Embodiment 2

[0048] Cisapride 10g

[0049] Hydroxypropyl-β-cyclodextrin 10g

[0050] Mannitol 150g

[0051] Compressible starch 75g

[0052] Microcrystalline Cellulose 75g

[0053] Low-substituted hydroxypropyl cellulose 30g

[0054] 2% polyvinylpyrrolidone aqueous solution 600g

[0055] Magnesium stearate 2g

[0056] Magnesium Lauryl Sulfate 3g

[0057] Made in 1000 pieces.

[0058] Preparation Process:

[0059] Take the prescribed amount of hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water to make a saturated aqueous solution. Pass cisapride through a 120-mesh sieve, dissolve it in an appropriate amount of ethanol, and slowly dissolve the ethanol solution of cisapride under magnetic stirring. Add the saturated aqueous solution of hydroxypropyl-β-cyclodextrin, continue to stir at room temperature for 4 hours after all the addition is complete, and remove most of the ethanol by rotary evaporation at 45°C. Put it into a shallow tray and put it in the fr...

Embodiment 3

[0063] Cisapride 10g

[0064] Hydroxypropyl-β-cyclodextrin 40g

[0065] Mannitol 150g

[0066] Compressible starch 75g

[0067] Microcrystalline Cellulose 75g

[0068] Croscarmellose Sodium 30g

[0069] 2% polyvinylpyrrolidone aqueous solution 600g

[0070] Magnesium stearate 2g

[0071] Made in 1000 pieces.

[0072] Preparation Process:

[0073] Take the prescribed amount of hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water to make a saturated aqueous solution. Pass cisapride through a 120-mesh sieve, dissolve it in an appropriate amount of ethanol, and slowly dissolve the ethanol solution of cisapride under magnetic stirring. Add the saturated aqueous solution of hydroxypropyl cyclodextrin, continue to stir at room temperature for 2 hours after all the addition is complete, and remove most of the ethanol by rotary evaporation at 40°C. Put it into a shallow tray and put it in the freezer of the refrigerator. The pre-freezing time is 12 hou...

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a cisapride dispersible tablet and a preparation method thereof. As the cisapride is low in bioavailability via oral administration and the difference between the pharmacy individuals is relatively large, the invention provides the cisapride dispersible tablet which comprises cisapride, hydroxypropyl-beta-cyclodextrin, a filling agent, a disintegrating agent, a binding agent and a lubricant. The cisapride is extremely easily dissolved in water after being included by the hydroxypropyl-beta-cyclodextrin (HP-beta-CD), so that the drug stability is improved, the release of the drug in vivo is promoted, the absorption is increased, the bioavailability is improved and the difference between the pharmacy individuals is reduced.

Description

field of invention [0001] The invention relates to the field of chemical pharmacy, in particular to a cisapride dispersible tablet and a preparation method thereof. Background of the invention [0002] Due to the accelerated pace of life in modern society, changes in diet and many other factors, the number of people suffering from gastric hypomotility is increasing day by day. Hypogastric motility often leads to functional dyspepsia, gastroesophageal reflux and other diseases, which greatly affects people's quality of life. According to statistics, the incidence of gastric disease in my country is about The number of cases is about 300 million people, ranking first in the world. According to reports, gastrointestinal drugs have always occupied a large market share, and the annual sales of gastrointestinal drugs in the world are about 13 billion US dollars, making it the third largest drug market. According to domestic epidemiological surveys, gastric motility problems acc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/48A61K31/445A61P1/00A61P1/04
Inventor 赵丽萍冯励安志洁曲海霞
Owner QINGDAO MUNICIPAL HOSPITAL
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