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A method for preparing composite granules and quick-release tablet

A technology of composite granules and tablets, which is applied in the directions of pill delivery, pharmaceutical formulations, and food forming to achieve high tablet hardness, excellent stability, and excellent disintegration.

Inactive Publication Date: 2017-08-18
曹炜
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method can significantly improve the disintegration and formability of composite particles, but its disintegration and formability still need to be improved to meet higher requirements

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] To 316 g of purified water were added 8 g of a 10% by weight aqueous solution of polyacrylamide and 60 g of D-mannitol. The resulting mixture was stirred with a paddle to obtain an aqueous solution. Next, 16 g of low-substituted hydroxypropylcellulose having a hydroxypropyl substitution degree of 8% by weight was added to the obtained aqueous solution and mixed to prepare an aqueous dispersion. Then, 323.2g of D-mannitol was put into the fluidized bed granulator, and the temperature of the inlet air was 60°C, the exhaust temperature was 25 to 28°C, the ventilation rate was 50m3 / hr, and the spray rate was 12g / hr. min and a spray pressure of 150 kPa, granulation was performed while spraying the aqueous dispersion thereto.

[0059] After adding 0.5 parts by weight of magnesium stearate as a lubricant to 100 parts by weight of the obtained composite granules and mixing, the resulting mixture was compressed into tablets by using a rotary tablet press at a tableting pressure...

Embodiment 2

[0061]To 324 g of purified water were added 8 g of a 10% by weight aqueous solution of polyacrylamide having a degree of saponification of 98.5 mol % and a degree of polymerization of 1700, and 60 g of D-mannitol. The resulting mixture was stirred with a paddle to obtain an aqueous solution. Next, 8 g of low-substituted hydroxypropylcellulose having a hydroxypropyl substitution degree of 8% by weight was added to the obtained aqueous solution and mixed to prepare an aqueous dispersion. Then, 331.2g of D-mannitol was put into the fluidized bed granulator, and the temperature of the inlet air was 60°C, the exhaust temperature was 25 to 28°C, the ventilation rate was 50m3 / hr, and the spray rate was 12g / hr. min and a spray pressure of 150 kPa, granulation was performed while spraying the aqueous dispersion thereto.

[0062] The composite granules thus obtained were tableted in the same manner as in Example 1 and the tablets thus obtained were also evaluated in the same manner. T...

Embodiment 3

[0064] To 528 g of purified water were added 8 g of a 10% by weight aqueous solution of polyacrylamide having a degree of saponification of 98.5 mol % and a degree of polymerization of 1700, and 60 g of D-mannitol. The resulting mixture was stirred with a paddle to obtain an aqueous solution. Next, 40 g of low-substituted hydroxypropylcellulose having a hydroxypropyl substitution degree of 8% by weight was added to the obtained aqueous solution and mixed to prepare an aqueous dispersion. Then, 299.2g of D-mannitol was put into the fluidized bed granulator, and at an inlet temperature of 60°C, an exhaust temperature of 25 to 28°C, an air flow of 50m3 / hr, and a spray rate of 12g / min and a spray pressure of 150 kPa, granulation was performed while spraying the aqueous dispersion thereto.

[0065] The composite granules thus obtained were tableted in the same manner as in Example 1 and the tablets thus obtained were also evaluated in the same manner. The results are shown in Ta...

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Abstract

The invention discloses a method for preparing composite particles. The method comprises the following step: pelletizing second sugar or sugar alcohol while adding an aqueous dispersion into second sugar or sugar alcohol, wherein the aqueous dispersion comprises low-substituted hydroxypropyl cellulose with hydroxypropyl degree of substitution being 5-16wt%, polyacrylamide, first sugar or sugar alcohol and water. Compared with the prior art, the composite particles prepared by the method disclosed by the invention has more excellent disintegrative property and forming property.

Description

technical field [0001] The present invention relates to a composite particle comprising low-substituted hydroxypropyl cellulose, which brings disintegration or adhesiveness in the production of a preparation for medicine or food; and a quick-release preparation. In particular, the present invention relates to an orally rapidly disintegrating tablet excellent in adhesiveness and disintegration. Background technique [0002] In recent years, there has been a demand for the development of orally rapidly disintegrating tablets that can be easily taken without water by patients with poor swallowing ability such as the elderly and children. For example, WO01 / 064190 discloses a method of preparing such tablets by forming a drug, sugar and a water-soluble polymer such as polyacrylamide into a shape in a wet state and then drying it. [0003] There is also a need for the development of methods for preparing oral rapidly disintegrating tablets without the use of special techniques or...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/20A61K47/32A61K47/38A61K47/26A23P10/30A23P10/20A23P10/28
Inventor 曹炜
Owner 曹炜