Question

Hard gelatin capsules stored at \(<20%\) RH will _______

• A. Become brittle and crack
• B. Shrink
• C. Stick together
• D. Disintegration time increases

Hint:

Low humidity makes gelatin capsules brittle, while high humidity may make them soft and sticky.

Answer 1

The Correct Option is A

Step 1: Understanding the Concept:
Gelatin is a hygroscopic material. The mechanical properties of hard gelatin capsules are highly dependent on their moisture content, which is normally between 13% and 16%.
Step 2: Detailed Explanation:
1. Low Humidity (<20% RH): When capsules are stored in very dry environments, the gelatin loses its chemically bound water to the atmosphere.
2. Brittleness: As moisture content drops below 10%, the gelatin loses its elasticity. The capsule shell becomes extremely brittle and can shatter or crack even with light handling or during the filling process.
3. High Humidity: Conversely, at high RH (>60%), capsules absorb moisture, become soft, sticky, and lose their shape.
Step 3: Final Answer:
Low relative humidity causes the loss of critical moisture from the capsule shell, leading directly to brittleness and cracking.