The components in Softgel shell are similar to those of hard capsule, and the composition of the shell consists mainly of rubber material, plasticizer, water and additive four. The quality of gelatin in addition to the requirements of the Pharmacopoeia, but also in accordance with the gel strength (freezing force) and viscosity, such as the requirements such as 150 viscosity for the 25 (Bali), a strong moisture absorption of drugs, it is advisable to use high-strength low strength gelatin. The masking agent uses titanium dioxide, and its dosage is 2 12 per kg gelatin. Can add seasoning such as 5% sucrose, can increase sweet, delicious chew, and adjust the hardness. A mixture of P-hydroxybenzoate (1.6%) and P-hydroxybenzoate (0.04%) is used in preservatives, and a certain amount of water is contained in the capsule shell, and the general finished product is 13.
Softgel can be filled with a variety of oil or gelatin insoluble liquid drug or suspension, can also be filled with solid drugs, filled with liquid content can be divided into three categories:
1 volatile or non-volatile liquids, such as vegetable oil or aromatic oils, that are not miscible with water.
2 volatile liquids, such as polyethylene glycol and nonionic surfactants, Softgel that can be miscible with water.
3 The compounds that can dissolve with water and have small volatile, such as glycerol, propylene glycol and isopropanol.
Usually, the drug may absorb water, which often causes the water to change in the soft shell if the drug is hydrophilic, the drug should keep 5% of the water, oil generally as a drug of the solvent or suspension of the media, the soft capsule filled with oil although there is no moisture, but moisture or the water in the shell can penetrate through the wall of the capsule. If the drug is hydrophilic, it should also retain 3% water. The volatile solvents, such as ethanol, acetone, amine, acid and ester, which contain more than 50% water or contain low molecular weight and water miscible with each other, can soften or dissolve Softgel, so it is not suitable to make Softgel. In the filling of liquid drugs, Softgel ph should be controlled between 2.5, otherwise Softgel during storage can be due to the acid hydrolysis of gelatin leakage, strong alkaline can make gelatin degeneration and affect the solubility of Softgel, Softgel of raw materials in gelatin can not exceed 0.0015% iron content, Prevent the iron-sensitive drugs from deteriorating.