Characterization of a Novel Cross-Linked Lipase: Impact of Cross-Linking on Solubility and Release from Drug Product

• Published in: Molecular pharmaceutics Vol. 11; no. 4; pp. 1189 - 1200
• Main Authors: Hetrick, Evan M, Sperry, David C, Nguyen, Hung K, Strege, Mark A
• Format: Journal Article
• Language: English
• Published: United States American Chemical Society 07.04.2014
• Subjects: Chromatography, Gel; Cross-Linking Reagents - chemistry; Crystallization; Hydrogen-Ion Concentration; Lipase - chemistry; Lipase - metabolism; Solubility; enzyme; liprotamase; cross-linking; lipase; dissolution; solubility; Apparatus 4

Liprotamase is a novel non-porcine pancreatic enzyme replacement therapy containing purified biotechnology-derived lipase, protease, and amylase together with excipients in a capsule formulation. To preserve the structural integrity and biological activity of lipase (the primary drug substance) thro...