When choosing a contract research organization to help with your company’s clinical research, you must ensure they have the right capabilities. Ideally, your CRO also offers pharmaceutical CDMO capabilities for over-encapsulation and creating blinded study materials. These are vital during clinical trials. A CRO/CDMO that can run the study and create the dosage form can drastically reduce your timelines. Here is everything you need to know about over-encapsulation and why it might be worth partnering with a CRO with CDMO services and expertise in this area for your next clinical study.
What Is Over-Encapsulation?
Over-encapsulation is a cost-effective, popular technique involving blinding a solid dosage form into a capsule shell. This eliminates bias from comparative clinical studies while maintaining the study’s efficacy and integrity. Without adequate blinding, clinical trial participants may be able to tell the difference between a placebo and the real drug. This creates a biased trial and a loss on your organization’s investment. Finding a CRO partner with CDMO pharma capabilities means you have a partner that thoroughly understands the intricacies of blinded study materials and over-encapsulation.
Visual Appearance
The importance of your drug’s visual appearance, both real and placebo, shouldn’t be understated. Several factors are involved in the proper over-encapsulation of a solid oral dosage form in order to maintain product performance and protect the integrity of the clinical trial. As such, the exterior appearance of the real drug and the over-encapsulate placebo need to be exactly the same to prevent bias.
Capsule Shell Selection
Ideally, the capsule shell will be specifically designed for the process. This includes a double-locking body and cap and using an opaque color, so the dosage form isn’t visible through the shell. Other important factors include the design and size of the capsule. This can simplify the delivery of the dosage form, like making it easier to swallow, and helps ensure overall patient compliance. These details can be especially important in pediatric trials.
Including Backfill
The placebo and real drugs should also have the same weight and sensation as the opposite dosage form when shaken. This makes backfill essential in the over-encapsulated capsule. Minimal use of additional lubricants is also a consideration. Backfill can help prevent participants from squeezing the dosage form to test if they can feel a difference.
Eliminating Bias
Over-encapsulation of the drug you are testing can help effectively blind your clinical trial. It helps eliminate any bias from either the study participant and the investigator, removing elements that could help reveal the drug’s source. This is especially important because any indicators that contribute to bias could potentially impact the placebo’s effect.
Tamper-Resistant Capsules
The CRO/CDMO should also use advanced technology to enable tamper-resistant capsules. This helps prevent study participants from breaking open the capsule to see whether they are being dosed with a placebo or the real drug.
Over-Encapsulation Method
There are multiple ways to achieve over-encapsulation. Based on the characteristics of your organization’s drug product, you may need manual, semi-automatic, or fully automatic options. Finding a CDMO with the right methods for your specific drug is essential. There are also less common blinding methods that your CDMO partner might use, such as removing a commercial logo or identifier from the capsule or tablet or over-printing on the dosage form with confusion print.
About Altasciences
Altasciences, a mid-sized contract research organization, understands drug development is a complex process. Their fully integrated team helps keep their sponsors’ drug development projects smooth and streamlined. Altasciences is a fully integrated CRO with pharmaceutical CDMO capabilities, bioanalytical services, and all their teams share access to a proprietary database. Pharmaceutical and biotechnology companies of all sizes count on Altasciences’ innovative, integrated approach for preclinical studies and clinical trials. Partnering with the Altasciences team means you gain expertise in a wide variety of therapeutic indications and study types, including first-in-human clinical trials and CNS clinical trials.
Partner with Altasciences for over-encapsulation capabilities at https://www.altasciences.com/
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