Slow and controlled release coating tablet dissolution degree stability improving method

A technology of coated tablets and dissolution rate, which is applied in sugar-coated pills, devices for making drugs into special physical or taking forms, material inspection products, etc. Problems such as inability to control the quality of the production process

Active Publication Date: 2015-06-03
CANSINO BIOLOGICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the quality of the obtained product, especially the dissolution property, is extremely unstable, and the difference between batches is large, so it is impossible to carry out quality control on the production process.

Method used

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  • Slow and controlled release coating tablet dissolution degree stability improving method
  • Slow and controlled release coating tablet dissolution degree stability improving method
  • Slow and controlled release coating tablet dissolution degree stability improving method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Add 0.625 mg solid sustained-release preparation tablet cores into the coating pan, adjust the gas flow to make the solid tablet core temperature reach 42°C, and then start to gradually spray the pre-prepared 8% Opadry and Coating solution of ethanol solvent. Start timing with a stopwatch, and record the time from the beginning of adding the coating solution to the end of adding the coating solution and the time of adding calcium sulfate powder. A total of 2.26 L of coating solution was added after 32 seconds. After adding the coating solution, the operator observed the dryness of the tablet core, and added the calcium sulfate powder at 192 seconds. When the coating starts, the ethanol measuring device starts to measure the concentration of ethanol in the tail gas in the coating pan, and records the data every 5 seconds until it is completed at 350 seconds. Experimental results such as figure 1 with figure 2 shown. Experiments have shown that the best time to add ...

Embodiment 2

[0042] Add the solid sustained-release preparation tablet core with a specification of 1.25 mg into the coating pan, adjust the gas flow to make the solid tablet core temperature reach 42°C, and then start to gradually spray the pre-prepared tablet core containing 8% Opadry and Coating solution of ethanol solvent. Start timing with a stopwatch, and record the time from the beginning of adding the coating solution to the end of adding the coating solution and the time of adding calcium sulfate powder. A total of 2.46 L of coating solution was added after 37 seconds. After adding the coating solution, the dryness of the tablet core was observed by the operator, and the calcium sulfate powder was added in 200 seconds. At the same time when the coating starts, use the ethanol measuring device to start measuring the concentration of ethanol in the tail gas in the coating pan, and record the data every 5-10 seconds until it is completed at 420 seconds. Experimental results such as...

Embodiment 3

[0044]Add the solid sustained-release preparation tablet core with a tablet weight of 300 mg into the coating pan, adjust the gas flow to make the temperature of the solid tablet core reach 42°C, and then start to gradually spray the pre-prepared 8% Oubadi into the core. Alternative and ethanol solvent coating solution. Start timing with a stopwatch, and record the time from the beginning of adding the coating solution to the end of adding the coating solution and the time of adding calcium sulfate powder. When the empirical operation method is used, there is tablet adhesion during the coating process, and about 10% of the prepared coated tablets have cracks and breakages on the surface. After applying the method of the present invention, there is no adhesion phenomenon in the tablet during the coating process, and the surface of the prepared coated tablet is intact without damage.

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PUM

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Abstract

The invention provides a slow and controlled release coating tablet dissolution degree stability improving method. When the coating agent is of organic solvent, the optimal time for adding coating dry powder can be acquired by detecting the change of the emission concentration of organic solvent vapor of the exhausted gas of a coating machine with the time. The method is convenient to operate, the accuracy of the result is high, the preparation quality of slow and controlled release coating tablets can be improved effectively, and the stable solution degree is provided.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for improving the dissolution stability of a sustained and controlled release coated tablet. Background technique [0002] The film coating process has been widely used in the pharmaceutical manufacturing process in recent years. The film coating has the functions of moisture-proof, light-proof, and improved appearance, color and taste. In addition, the film coating can also be used to control the release rate of the drug. Mandatory process steps for release tablets or controlled release tablets. [0003] Coating materials commonly used in film coating are generally polymer compounds (such as hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (PC)) or other coating materials, and the solvent of the coating solution is usually purified water or organic solvents. If the product is easily soluble in water, an organic solvent is generally selected as t...

Claims

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Application Information

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IPC IPC(8): A61J3/00A61K9/28G01N33/15
Inventor 毛慧华邱东旭
Owner CANSINO BIOLOGICS INC
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