The disintegration time limit is an important control indicator for tablets, capsules and dropping pills. The time limit for disintegration is generally checked by a disintegrator. According to the Chinese Pharmacopoeia, different capsules have different disintegration time limits. The main requirements are as follows:
- Hard capsule disintegration time limit is 30 minutes;
- Soft capsules need to be disintegrated completely within 1 hour;
- The enteric-coated capsules should be checked in hydrochloric acid solution (9→1000) for 2 hours. The shell of each capsule should not have cracks or disintegration. Then it should be checked in artificial intestinal fluid and should be completely disintegrated within 1 hour.
- Colonic enteric-coated capsules were first examined in hydrochloric acid solution (9→1000) for 2 hours, and the capsule shells should not be cracked or disintegrated. Then they are checked in phosphate buffer solution (pH 6.8) for 3 hours, and same requirements should be reached. Finally, they should be examined in phosphate buffer solution (pH 7.8) and be completely disintegrated within 1 hour.
Pic from Nicepik
Factors affecting the disintegration time of hard capsules:
- Features of the glidant or lubricant;
- Methods of granulation;
- Types of filling material;
- Storage conditions and time;
- Whether or not a disintegrant is present.
- In addition, the problem of disintegration of hard capsules has certain relationship with factors such as packaging materials, preparation processes, and pharmaceutical excipients.