Techniques for masking the bitterness of roxithromycin and azithromycin

It is well known that the resistance of azithromycin, roxithromycin oral granules, and dispersible tablets in clinical applications is due to the bitter taste of the drug itself. The azithromycin raw material tastes extremely bitter, and the roxithromycin raw material tastes bitter and hemp. Due to the nature of the raw materials, there are many ways for the manufacturers to adjust the taste of the products. There are also many reports on the taste-masking patents, but it is difficult to achieve the degree of patient acceptance.

After years of unremitting efforts and research, we have successfully made roxithromycin and azithromycin bulk drugs into almost odorless white powder. This innovative technology can be used to make products that are no longer bitter and improve the quality of the product itself. The technology is also applicable to other drugs to mask taste.

Technical introduction:

1Technical principle The powder coating principle is used to encapsulate the drug powder to isolate the bitterness. All the coating liquids are made of national legal pharmaceutical grade excipients.

2 The specific method operation can be combined with a bottom spray type one-stage granulator, a wet fast stirring granulator, an ordinary trough mixer and a rocking type granulator. All of the above three methods can be applied to the masking treatment of Aqi, Luohong raw materials and other raw materials with strange taste.

3 features

3.1 The operation is simple, and the workshops that meet the manufacturing conditions of the granules can handle the above two kinds of raw materials.

3.2 The weight gain of the coated powder is about 10%, and the cost will increase accordingly. However, due to the proper treatment of the coated powder, other auxiliary materials and fillers for flavoring or disintegration can be reduced to a low level, and a certain amount can be saved. Cost; can also be made into a sugar-free preparation, suitable for diabetics. .

3.3 The taste-masking effect is good. The dissolution rate of Luohong and Aqi's granules or dispersible tablets is in compliance with the 2005 edition of the Pharmacopoeia standard, which is more than 90%. The taste-masking powder can also be made into a dry suspension, and the effect is still good; The warm water is almost tasteless for a short time, and it has a bitter taste after half an hour.

3.4 In principle, the current prescription may not be changed, and only the coating auxiliary materials (national statutory pharmaceutical grade auxiliary materials) may be added. As for whether or not to declare the national filing, the application party decides itself.

Application of Dihydrate Instead of Ethanol Technology in Preparation of Granules, Tablets, etc.

After years of production practice and painstaking research, the application technology of water instead of ethanol in the granulation process has finally been successfully solved. It has strong practical value in the production of Chinese and Western medicine granules and tablets:

1 Eliminate safety hazards, and the flammable and explosive environment of the operating environment can be completely solved.

2 Improve the air quality in the operating environment and reduce the pollution to the atmospheric environment.

3 Reduce production costs and simplify operating procedures.

The application of this technology usually does not require the purchase of new equipment (not using boiling granulation technology); basically does not change the original prescription composition or is very likely to simplify the original prescription, to eliminate safety hazards, improve the operating environment air quality, reduce the atmospheric environment The pollution, reducing production costs and simplifying the operation steps are very important.

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