Capsugel recently published a study  in AAPS’ PharmSciTech journal confirming that Capsugel hard gelatin capsules are suitable excipients for Quality by Design (QbD)-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.

“Capsugel is committed to driving advances in pharmaceutical quality and manufacturing sciences for our customers,” stated study lead author, Sven Stegemann, Ph.D., Director of Pharmaceutical Business Development for Capsugel. “Partnering with a global pharmaceutical company was critical to better understand the potential variations of empty hard capsules and the related impact on finished product quality. The resulting data provide important insights for QbD-verified sources of raw materials for new development projects, as well as for line extensions of existing drugs.”

QbD is becoming a global regulatory requirement for pharmaceutical product development. It was designed to assure the highest level of quality by establishing a robust understanding of products and process. 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. Based on 42 batches of capsules, produced over a two-year period, Capsugel capsules maintained in-specification performance for key CQAs including:

• Dimensional characteristics and weight variability;
• Sulfur dioxide, sulfated ash, lubricant levels, and water content;
• Disintegration time, using the automatic endpoint.

Importantly, the study’s findings confirm that Capsugel capsules enable our customers’ products to meet all finished dosage form specifications within the defined design space for QbD-based development.

“Quality is the hallmark of Capsugel’s business and one of our core principles,” commented Keith Hutchison, Ph.D., Senior Vice President, R&D, Capsugel. “The data in this study provide a heightened level of confidence to our customers when selecting a capsule for their products. By providing consistently superior quality, driven by continuous improvement and innovation, we are helping our pharmaceutical customers turn their molecules into better medicines for patients.”