QRM Process

Study Confirms Suitability of Hard Capsules as Raw Material in QbD Development and Manufacturing

Aug 05, 2014


Capsugel recently published a study in AAPS’ PharmSciTech journal confirming that Capsugel capsules are suitable excipients for Quality by Design-based product development and manufacturing.

The study examined the Critical Quality Attributes (CQA) within, and between, different batches of empty hard capsules to better understand these variabilities and their impact on the desired quality and performance of the final dosage form. The results provide the first comprehensive collection of relevant QbD data for hard capsules, which researchers can use to design capsule product development programs that adhere to the QbD principles for modern pharmaceutics.

Hard capsules are a major component of the pharmaceutical product and play an important role in the final product’s quality and performance. Therefore, capsules must follow the same QbD principles during their own development and manufacturing. CQA variabilities such as weight and moisture content, need to be understood and evaluated for their impact on design space for both product and process, to achieve the desired quality and performance every time.

The study confirmed that Capsugel’s hard capsules meet the requirements, allowing pharmaceutical product development in accordance with QbD principles.

Read the Capsugel press release