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Studies of 42 batches of capsules over a two-year period, reportedly showed that the capsules maintained specs for key critical quality attributes
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 col...
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