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Disintegrants for deodoring effectively and their preparation

A technology of orally disintegrating tablets and disintegrants, applied in the field of pharmaceutical preparations, can solve the problems of drug taste masking, inappropriate drug production, and complicated control

Active Publication Date: 2006-09-13
PHARMA CHANGZHOU PHARMA FACTORY NO 4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the problem of drug taste masking has always been a difficult problem to be solved in the preparation of orally disintegrating tablets
[0008] (1) The granulation yield is low, only 50-70%
[0009] (2) The rotary fluidized bed granulator has a large amount of one-time feeding, which is not suitable for the production of small batches and expensive drugs.
[0010] (3) There are many control points in the production process parameters, the control is complicated, and the production process control is difficult

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 Preparation of taste-masked risperidone granules

[0029] Airflow pulverized risperidone raw material medicine, corn starch passed through No. 6 sieve (Chinese Pharmacopoeia 2000 edition standard), microcrystalline cellulose passed through No. 6 sieve, ingredients according to Table 1, fully mixed, and then passed through No. 6 sieve.

[0030] Name

Quantity

Risperidone

20g

corn starch

80g

Microcrystalline cellulose

20g

[0031] Use 50 g of 8% starch slurry as a binder to granulate, dry at 60° C., and sieving to obtain 115 g of particles between No. 3 and No. 6 sieve. In a small sugar-coated pan, use 120ml of anhydrous alcohol solution containing Eudragit E 100 at 10% and triethyl citrate at 1.5% to fully moisten 115g granules, dry at 60°C, and sieving to obtain No. 3 sieve and The granules between No. 6 sieve are 120g. On an experimental fluidized bed coating machine, 120g of granules were coated with a s...

Embodiment 2

[0033] Example 2 Preparation of taste-masked risperidone granules

[0034] In Example 1, 40 g of calcium sulfate was used instead of 40 g of corn starch for granulation, and the other auxiliary materials and the granulation process were unchanged. The total yield of the obtained taste-masked risperidone granules was 86% (calculated as risperidone), and the dissolution rate was 88% (20 minutes).

Embodiment 3

[0035] Example 3 Preparation of taste-masked risperidone granules

[0036] In Example 1, 20 g of microcrystalline cellulose was replaced with 20 g of low-substituted hydroxypropyl cellulose, and the other auxiliary materials and the granulation process were unchanged. The yield of the obtained taste-masked risperidone particles was 72% (calculated as risperidone), and the dissolution rate was 92% (20 minutes).

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PUM

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Abstract

An oral disintegrating tablet for effectively shielding the odor of oral cavity is prepared from the granulare odor-shielding medicine (estazolam, etc) and medicinal additive. Its advantages are short disintegrating time (less than 45 S) and high effect.

Description

Technical field [0001] The invention relates to the technical field of pharmaceutical preparations. Specifically, it relates to an orally disintegrating tablet with effective taste masking and a preparation method. Background technique [0002] In order to further improve the compliance of patients with medication, research on orally disintegrating tablets is very active, and the number of products on the market continues to increase. Orally disintegrating tablets can disintegrate in a few seconds in the oral cavity. After swallowing saliva several times, the medicine can enter the stomach and the medicine is absorbed in the stomach and intestines. [0003] There are two main problems that need to be solved in the preparation of orally disintegrating tablets. One problem is how to eliminate the discomfort caused by the bitter, astringent or other peculiar smell of the drug, especially for some drugs even if a small amount remains in the oral cavity. , And its taste does not disap...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/30A61P25/00
Inventor 葛纪龙房燕冬刘建安屠永锐
Owner PHARMA CHANGZHOU PHARMA FACTORY NO 4
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