Capsugel Study Provides First Substantive Reference Data on Key Quality Attributes of Empty Capsules

Capsugel recently published a study in AAPS’ PharmSciTech journal confirming that Capsugel 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,” said study lead author, Sven Stegemann, PhD, 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 ensure 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 throughout 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 2-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, PhD, 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.”

Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions to its customers in the healthcare industry. The company’s Hard Capsule business offers customers the broadest portfolio of gelatin, vegetarian, and other specialized capsule technologies. Capsugel’s Dosage Form Solutions (DFS) business utilizes an array of proprietary technologies and specialized manufacturing capabilities to solve customers’ most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutic processing, and inhalation formulation. The company’s fast-to-clinic program streamlines product development from pre-formulation through clinical and commercial supply for finished dosage forms. Headquartered in Morristown, NJ, Capsugel serves more than 4,000 customers in more than 100 countries. For additional information, visit www.capsugel.com.