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 (<1000 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.
- Grinding and filling (not well accepted in the pharmaceutical industry)
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.
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