The development and advantages of dry granulation technology

Dry granulation is a new granulation process developed after traditional wet mixing granulation. It is a granulation process that uses the crystallization water of the material itself to directly compress the raw material powder by mechanical extrusion-forming, crushing-granulation. Its characteristics: raw material powder is directly formed and granulated continuously, omitting the humidification and drying process, saving a lot of electric energy: environmentally friendly granulation process, without adding adhesive, saving and no pollution. The dry granulator is an energy-saving and environment-friendly equipment with less investment, high efficiency, and saving manpower, material resources and financial resources. In this paper, the comparison between dry granulation and wet granulation is used to illustrate the energy saving and consumption reduction of dry granulation.

  • Dry granulator overview

The pharmaceutical industry involves the processing of various active pharmaceutical raw materials and one or more excipients, most of which are fine powders, and these powders vary in size, density, and fluidity. Easy to mold. Therefore, it is necessary to go through a key granulation process in order to carry out the next tableting, capsule filling or direct packaging of the drug substance in the form of granules. There are four main types of granulation processes:

1.1 Traditional wet granulation

That is, the trough mixer is first mixed into a wet "soft material" and then granulated by a rocking particle mechanism. At present, this method is still used by some manufacturers, but such equipment has problems such as uneven mixing, unclean cleaning, poor sealing and oil leakage.

1.2 The new wet mixing granulation is high-efficiency wet mixing granulation. He uses a mixing paddle to mix the powder and the binder into a wet soft material, and cuts it into a wet "soft material" by a high-speed crushing knife. Granules, this method is currently widely used. The equipment and process are not perfect: a large amount of adhesives and sewage generated by cleaning are required to pollute the environment. In addition, the produced wet granules have a wide range of distribution, and are not uniform, and are finely powdered, and are generally used for filling of compressed tablets.

1.3 one step boiling granulation

This process combines spray technology and fluidization technology to make the traditional mixing, granulating and drying processes complete in the same closed container. Similarly, the equipment and process require a large amount of binder, which requires sewage treatment after washing, and the granulation time is long.

The technology of the dry granulator can be accomplished by a flat press pelletizer. The traditional Chinese medicine extract with a certain relative density is spray-dried to obtain a dry extract powder, and after adding certain auxiliary materials, it is pressed into a thin sheet by a dry extrusion granulator, and then pulverized into granules. Dry granulator This method requires less auxiliary materials, which is beneficial to improve the stability, disintegration and dispersibility of the particles. Generally dry extract powder plus 0.5-1 times auxiliary materials can be used. However, it should also be noted that the dry extract obtained by spray drying has strong wettability. Therefore, the key to the application of this method is to find suitable excipients. The excipients must have certain adhesive properties and are not easy to absorb moisture, such as lactose, pregelatinized starch, mannitol, water-soluble acrylic resin and cellulose derivatives. Wait.

Second, the purpose of the dry granulator dry granulation operation the following points:

1. Make the material into the desired structure and shape;

2. For accurate quantification, formulation and management;

3. Reduce the dust pollution of the powder;

4. A non-segregation mixture of different types of particle systems;

5. Improve the appearance of the product;

6. Prevent agglomeration during the production of certain solid phase materials;

7. Improve the flow characteristics of the separated raw materials;

8. Increase the volumetric quality of the powder for easy storage and transportation;

9. Reduce the risk during handling of toxic and corrosive materials;

10. Control the dissolution rate of the product;

11. Adjust the void ratio and specific surface area of ​​the finished product;

12. Improve heat transfer and help burn;

13. Adapt to different biological processes.

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