国生 Soft Capsules 国上认连 ©The types of vehicles ©Enteric Capsules .Water-immiscible liquids The shell of enteric capsules is soluble in ·Vegetable oils intestine and insoluble in stomach .Aliphatic and aromatic hydrocarbons The content of enteric capsules is soluble in .Water-miscible,nonvolatile liquids intestine and insoluble in stomach ·PEG All liquids used for filling must flow by gravity at a temperature of 35C or less 国一 圈上生 Manufacture of softgels ·Rotary die process Evaluation of capsules Bubble method ·Appearance Weight variation ·Disintegration test ·Dissolution test ·Water content 国达建 国生 Learning Objectives Compatibility and stability concerns of softgels Shell composition of capsules Increased interaction due to intimate contact Size of hard capsule shells between the shell and its liquid contents Compatibility of drug and shell Loss of drug due to migration from vehicle Manufacture methods of soft capsules into the shell. 55 Shanghai Jiao Tong University Soft Capsules The types of vehicles • Water-immiscible liquids • Vegetable oils • Aliphatic and aromatic hydrocarbons • Water-miscible, nonvolatile liquids • PEG All liquids used for filling must flow by gravity at a temperature of 35℃ or less. Shanghai Jiao Tong University Manufacture of softgels • Rotary die process • Bubble method Shanghai Jiao Tong University Compatibility and stability concerns of softgels • Increased interaction due to intimate contact between the shell and its liquid contents • Loss of drug due to migration from vehicle into the shell. Shanghai Jiao Tong University Enteric Capsules • The shell of enteric capsules is soluble in intestine and insoluble in stomach • The content of enteric capsules is soluble in intestine and insoluble in stomach Shanghai Jiao Tong University Evaluation of capsules • Appearance • Weight variation • Disintegration test • Dissolution test • Water content Shanghai Jiao Tong University Learning Objectives Shell composition of capsules Size of hard capsule shells Compatibility of drug and shell Manufacture methods of soft capsules