Over-encapsulation is a popular, cost-effective technique that involves the blinding of a solid dosage form into a capsule shell in order to eliminate bias from comparative clinical trials, while maintaining study integrity and efficacy. If the blinding of the material is not adequately done, clinical trial participants may be able to tell the difference between the real drug and the placebo, resulting in a biased trial and a loss on your investment.
You need a partner that understands the intricacies of over-encapsulation and blinded study materials, and has the manufacturing capabilities to implement the technique efficiently. Our experts have decades of experience with innovative approaches to blinding study materials, consistently providing the most cost-effective and compliant solutions.
Several factors are involved in properly over-encapsulating a solid oral dosage form to maintain product performance and the integrity of the study:
Visual Appearance ― The exterior appearance of the actual drug and the over-encapsulate placebo must be exactly the same.
Selection of Capsule Shell — The capsule shell should be specifically designed for the process, which includes double-locking the body and cap and using opaque coloring so the dosage form is not visible through the shell of the capsule. The design and size of the capsule are also important factors to consider to simplify the delivery of the dosage form (by making it easy to swallow for example) and ensure overall patient compliance, especially for pediatric trials.
Back-fill component — To ensure the drug products cannot be differentiated by weight or the sensation of the dosage form inside the capsule when shaken, it is important that a backfill be present in the over-encapsulated capsule, with minimal use of additional lubricants, so that all products have the same weight and effect when shaken. Using a backfill can also prevent the patient from feeling a difference between the actual drug and the over-encapsulated product when squeezing them to feel the dosage form inside.
Over-Encapsulation Method — Based on the characteristics of the drug product, there are many manual, semi-automatic, and fully automatic options to choose from.
We are also equipped to use less common blinding methods, such as the removal of commercial logo and/or identifier from the tablet or capsule, and over-printing with confusion print.
We utilize the Qualicaps Model 10, semi-automatic capsule filler for the majority of over-encapsulation projects which can also be used for the straight fill of powders. To accommodate smaller scale projects (<10,000 units), we have bench-top capsule filling equipment.
Benefits of Over-Encapsulation/Blinded Studies
Eliminating Bias ― A properly over-encapsulated drug can effectively blind the study and eliminate any bias from both the investigator and the study participant by removing any elements that could reveal the drug’s source and potentially impact the placebo effect.
Tamper-Resistant ― With the use of advanced technology, tamper-resistant capsules are developed that prevent patients from breaking open the capsule to see if they are being dosed with the real drug or a placebo.