Over-Encapsulation / Blinded Study Materials
Over-encapsulation involves the blinding of a solid dosage form such as a capsule or tablet into a capsule shell. Key aspects of the over-encapsulation process include:
- Selection of Capsule Shell—Particular emphasis should be placed on the selection of a capsule specifically designed for the process including double locking body and cap and appropriate opaque coloring.
- Selection of Back-fill Component—This should ideally be a component present in the dosage form to be over-encapsulated with the use of additional lubricants minimized.
- Selection of Over-Encapsulation Method—There are many manual, semi-, and fully automatic options.
At ACP, we utilize a Qualicaps Model 10 semi-automatic capsule filler. This equipment can also be used for the straight fill of powders as well. For smaller scale projects (<10,000 units) we have bench top capsule filling equipment available.
Other blinding methods less commonly used include:
- Removal of commercial logo and/or identifier from the tablet of capsule.
- Over-printing with confusion print.
We have experience with these and other creative approaches to blinding study materials. Give us your challenge, and we’ll propose the most cost-effective and compliant solution.