Selection of granulation method

Granulation methods widely used in pharmaceutical production can be divided into agglomeration method, extrusion method and spray method. When selecting a specific granulation method, it is first necessary to clarify the problems that need to be solved by granulation, and then compare them according to the following factors. For a specific application, it is generally possible to refer to a similar material processing technique when determining a suitable and simple granulation method.

Feeding characteristics

Whether the material is in powder form or in solution, slurry and paste materials can be pumped and atomized, whether the material has heat sensitivity, etc., must be considered when selecting.

2. Requirements for production capacity

If the required production capacity is large, there are many ways to apply it.

3. Requirements for particle size and particle size distribution in the group

Some methods, such as jet granulation, can only obtain very fine particles, and the powder agglomeration method can only obtain smaller particles, while other methods such as pressing can obtain large agglomerates.

4. Shape of the pellet

Rolling, agitation granulation, spray granulation to obtain approximately spherical particles; shot peening and solidification granulation can obtain completely spherical particles; extrusion granulation can produce column granules. The possible effects of differently shaped particles on subsequent processes should be estimated.

5. Strength of the pellet

The particles obtained by powder agglomeration granulation have a weak mechanical strength. If high-strength particles are required, it is necessary to use a pressing method or sintering, baking and strengthening, and a high-strength bonding agent is selected by extrusion molding.

6. Porosity and density of pellets

Porosity and density are closely related to strength. Some extrusion granulation processes can better control the gap ratio and density to suit a certain application.

7. Wet and dry methods

Dry granulation is a method in which a drug powder is directly compressed into a large tablet or tablet and re-pulverized into particles of a desired size. This method does not add any liquid, and the binding force is generated between the particles by the compression force. Dry granulation is carried out by tableting and rolling. Dry granulation is often used for heat-sensitive materials, drugs that are easily decomposed by water, and granulation of drugs that are easily compressed and formed. The method is simple, labor-saving and time-saving. When dry granulation is used alone, attention should be paid to the flatness of the compression week and the decrease in activity due to compression. Dry granulation is prone to dust and is not suitable for handling toxic chemicals and other hazardous materials.

Wet granulation requires solvent and needs to be post-dried, which may cause solvent loss. Some materials (such as drugs) are not suitable for wet method because they are sensitive to solvents, and some materials may be recrystallized in different forms in the drying chamber. Also, you cannot use the wet method. However, the wet method adds a binder to the drug powder, and the powder is agglomerated by the bridging or bonding of the binder to prepare a granule. Since the wet-processed particles are wetted by the surface, the surface is well modified, and has the advantages of beautiful appearance, strong wear resistance, and good compression moldability, and is widely used in the pharmaceutical industry.

8. Is it possible to simultaneously carry out several processes (such as granulation and drying, chemical reactions)?

Certain methods and equipment, such as cylindrical granulators, are well suited for granulation processes that have a chemical reaction at the same time.

9. Space restrictions

For example, extrusion can result in higher throughput with smaller units, while other methods, such as shot granulation, require a higher vertical space to install the tower equipment.

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