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Study provides first substantive reference data on key quality attributes of empty capsules
A recent study, published in AAPS PharmSciTech, confirmed that Capsugel's capsules are suitable excipients for product development and manufacturing using quality-by-design (QbD) principles. 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.
QbD is gaining considerable acceptance throughout the pharmaceutical industry. The concept was designed to ensure the highest level of quality by establishing a robust understanding of products and process.
Hard capsules form a major component of pharmaceutical products. It is essential that the development and manufacturing of hard capsules follow QbD principles because of their impact on the final product’s quality and performance. 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 demonstrated that Capsugel’s hard capsules meet the requirements for pharmaceutical product development in accordance with QbD principles. Based on 42 batches of capsules, produced over a two-year period, Capsugel’s capsules maintained in-specification performance for key CQAs such as dimensional characteristics and weight variability; sulfur dioxide, sulfated ash, lubricant levels, and water content; and disintegration time, using the automatic endpoint. 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.