The composition of empty capsules is gelatin (the main encapsulation material), plasticizer (glycerol, sorbitol, HPC, etc.), thickener (agar), sunscreen (titanium dioxide), food coloring, preservative (paraben), etc. Not all empty capsules have the above components, which should be determined according to the actual situation.
The preparation process of empty capsules
Bolting method: sol-dipping glue-drying-pulling-cutting-arranging
Generally, it is produced by a special factory and completed by an automatic production line. The cleanliness of the operating environment should reach 10,000 grades, the temperature should be 10 °C~25C, and the relative humidity should be 35%~45%. For identification purposes, the empty capsule shells can also be printed with edible ink.
Preparation, filling, and sealing of filling materials
If the pure drug is crushed to the appropriate particle size and can meet the filling requirements of hard capsules, it can be directly filled; in more cases, an appropriate amount of excipients is added to the drug to make a mixture. Most drugs need to be filled due to poor fluidity and other reasons. Adding certain diluents, lubricants and other auxiliary materials can be formed to meet the filling (or clinical medication) requirements. Generally, sucrose, lactose, microcrystalline cellulose, silicon dioxide, magnesium stearate, talc, HPC can be added to improve the fluidity of the material or avoid stratification. It can also be filled with auxiliary materials to make granules.