Wet Granulation Process: Steps, Advantages, and Applications
The mainstream pharmaceutical dosage forms in the market are tablets and capsules, and the most acceptable dosage form for most patients is tablets. And pharmaceutical tablets have more advantages:
① Accurate dosage, uniform content, with the number of tablets as the unit of dosage;
② Better chemical stability, because the volume is smaller, dense, less affected by external factors such as air, light, moisture, etc., if necessary, protected by coating;
③ Carrying, transportation, taking are more convenient;
④ The degree of mechanization and automation of production is higher, the output is large, and the cost and selling price are lower;
⑤ Can be made into different types of tablets, such as dispersible (fast-acting) tablets, controlled-release (long-acting) tablets, enteric-coated tablets, chewable tablets and oral tablets, etc., in order to satisfy the needs of different clinical treatments.
Before the drugs are made into tablets and capsules, they need to be granulated in order to make the filling of tablets or capsules smooth. Then granulation is divided into wet granulation, dry granulation, fluidized granulation and melt granulation, etc. This article will focus on the wet granulation process and working principle.
Wet Mixing Granulator: Structure and Features
Main Components: Conical pot, stirring paddle, granulation knife, feeding system, discharge system, control system, and auxiliary features like water cooling and cleaning mechanisms.
The steps of the wet granulation process are premixing, binder addition, and granulation.
▲Wet granulation process - pre-mixing: put the pre-mixed materials into the wet mixing granulator, set the pre-mixing mixing paddle speed, granulation knife speed and mixing time, open the granulator for pre-mixing.
▲Wet granulation process-formulate binder, add binder: add the binder into the liquid and stir to make the binder dissolve, set the stirring paddle speed, granulation knife speed and liquid addition time to start adding liquid.
▲Wet granulation process-granulation: set the stirring paddle speed, granulation knife speed and granulation time of wet mixing granulator to granulate.
The granules made by the mixing and granulating machine have irregular character, wide range of particle size distribution, looser structure than the traditional method, strong compressibility, good solubility and medium permeability. Under different granulation speeds, the particle size of the finished product is about 12 mesh to 100 mesh, and the particle size range can be adjusted by choosing different speeds of granulation knives and mixing paddles. (When the granulation knife speed is slow when the particle size is large, the speed is gradually increased and the particle size is gradually reduced, when the stirring paddle speed is slow when the particle size is small, the speed is gradually increased and the particle size is gradually increased, the two play just the opposite role).
Advantages of Wet Granulation
1. Enhanced Mixing: Ensures a uniform mix of powdered materials, improving the quality of final products.
2. Adjustable Particle Size: Enables precise control of granule size by adjusting the speeds of mixing paddles and granulation knives.
3. Improved Compressibility: Granules produced have better compressibility and solubility.
4. Wide Applicability: Suitable for pharmaceutical, food, and chemical industries.
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