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.
We utilize a Qualicaps Model 10, semi-automatic capsule filler. This equipment can also be used for the straight fill of powders. For smaller scale projects (<10,000 units), we have bench-top capsule filling equipment.
Other blinding methods less commonly used include:
- Removal of commercial logo and/or identifier from the tablet or 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 will propose the most cost-effective and compliant solution.