The Development and Advantages of Dry Granulation (Roller Compactor) Technology
Dry granulation is a new granulation process developed following traditional wet granulation. People also call it Roller Compactor, or roller compacting technology. It is a granulation process that uses the crystal water of the material itself to directly compress, form, crush, and granulate the raw material powder through the extrusion of a dry granulator press roller.
The characteristics of the dry granulator: the raw material powder is directly formed and granulated continuously, and humidification and drying processes are omitted, and a large amount of electric energy is saved: the environmentally-friendly granulation process does not need to add a binder, which is economical and pollution-free. Dry granulator, Roller Compactor is an energy-saving and environmentally friendly equipment with low investment, high efficiency and saving manpower, material and financial resources. Roller Compactor is the best next generation for Granulation Process.
Overview of Dry Granulator (Roller Compactor)
The pharmaceutical industry involves the processing of various active pharmaceutical Ingredients (APIs)and one or more excipients. Most of these raw materials are fine powders, and these powders have different particle sizes, uneven densities, and poor fluidity. Easy to shape. Therefore, a key granulation process must be carried out before the next stage of tablet compression, capsule filling, or direct packaging of raw materials in granular form. At present, there are mainly 4 kinds of granulation processes:
1. Traditional wet granulation:
a. Z Type Through Mixer---Swaying Granulator(Oscillating Granulator)
That is, the through mixer first mixes into a wet "soft material", and then granulates it by shaking the granulator. At present, this method is still used by some manufacturers, but this type of equipment has problems such as uneven mixing, unclean cleaning, poor sealing, and oil leakage.
b. Wet Method Rapid Mixing Granulator
This is most popular technology nowadays for doing granulation, especially for tablet and capsule production. People call it RMG or high shear mixer Pour dry powder into mixing barrel and machine spray binder inside for granulation process. The inconvenience to use this machine is this process requires Drying process after granulation. Even during granulation, it requires binder solvent.
2. Fluid Bed Granulation (FBG):
This process is a comprehensive application of spray technology and fluidization technology, so that the traditional mixing, granulation, and drying process can be completed in the same airtight container at one time. Similarly, its equipment and process requires a large amount of adhesives, sewage treatment after cleaning, and the granulation time is too long. Fluid Bed Granulation process requires higher energy consumption and this is a batch type granulation which may cause risk of Different Granulation batches quality variable.
3. Dry granulation (Roller Compactor):
The technology of dry granulator can be completed by roller flat pressing granulator. A Chinese medicine extract with a certain relative density is spray-dried to obtain a dry extract powder. After adding certain auxiliary materials, it is pressed into thin slices by a dry extrusion granulator, and then crushed into granules. Dry granulator This method requires less auxiliary materials, which is beneficial to improve the stability, disintegration and dispersibility of the granules. Generally, add 0.5-1 times of auxiliary materials to dry extract powder. However, it should also be noted that the dry extract obtained by spray drying is highly hygroscopic. Therefore, the key to the application of this method is to find suitable auxiliary materials, which must have a certain degree of adhesion and are not easy to absorb moisture, such as lactose, pregelatinized starch, mannitol, water-soluble acrylic resin and cellulose derivatives Wait.
The purpose of dry granulation operation of dry granulator
1. Make the material into an ideal structure and shape;
2. In order to accurately quantify, dispense and manage;
3. Reduce fly dust pollution of powder;
4. Make a segregation-free mixture of different types of particle systems;
5. Improve product appearance;
6. Prevent agglomeration during the production of certain solid phases;
7. Improve the flow characteristics of separated raw materials;
8. Increase the volume and mass of the powder, which is convenient for storage and transportation;
9. Reduce the hazards in the handling of toxic and corrosive materials;
10. Control the dissolution rate of the product;
11. Adjust the porosity and specific surface area of the finished product;
12. Improve heat transfer effect and help combustion;
13. Adapt to different biological processes.
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