As part of the clinical trial process, patients are often given a placebo or an active drug under double-blind conditions, where neither the patient nor the research team know which treatment the patient is receiving. To maintain this blinding, over-encapsulation is used, where a capsule containing the drug or placebo is placed inside another capsule that looks identical. However, this approach can be challenging when the active ingredient is a colored or opaque, as it can be difficult to match with the placebo.
To address these challenges, Lonza Capsules and Health Ingredients has introduced HPMC double-blinded capsules for clinical trials. These capsules, known as Capsugel DBcaps, are designed to be used as an over-encapsulation solution with a tamper-evident design, addressing the clinical need to remove the brand name.
HPMC, or hydroxypropyl methylcellulose, is a non-animal-based ingredient used to make capsules for pharmaceutical and nutraceutical products. It is widely used in the industry due to its safety profile, biocompatibility, and stability. HPMC capsules are also suitable for use by people who are vegan, vegetarian, or have religious or cultural restrictions on animal-based products.
Capsugel DBcaps are made from high-quality HPMC material, which is transparent and able to match the color of the active ingredient. This makes it easy to have a consistent appearance across the placebo and active capsules, ensuring the blinding is maintained throughout the clinical trial. The capsules feature a tamper-evident design, which ensures that the blinding is not unintentionally broken during the trial, enhancing the integrity and reliability of the data collected.
In addition to these benefits, Capsugel DBcaps offer pharmaceutical companies a cost-effective solution for conducting clinical trials. The capsules are available in a variety of sizes suitable for different dosages, making it easy to ensure accurate dosing levels. They are also manufactured to high-quality standards, ensuring that the capsules are consistent in size, shape, and quality, reducing variability in the data collected.
Overall, the introduction of Capsugel DBcaps by Lonza Capsules and Health Ingredients provides a significant advancement in the conduct of clinical trials. These HPMC double-blinded capsules offer a solution to the challenges of over-encapsulation when using colored or opaque active ingredients. The tamper-evident design and consistent appearance also improve the reliability and accuracy of the data collected in clinical trials. With these benefits, pharmaceutical companies can conduct clinical trials with greater confidence and efficiency, ultimately leading to the faster development of safe and effective medical treatments.