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Abstract
This work focused on pre-formulation studies for freeze-dried protein formulations, using albumin as a model protein. Two aminoacids and two sugars were selected as lyoprotectors and studied according a mixture design (simplex-lattice). Sample characterization included total protein content, collapse temperature and visual inspection. Sugar formulations collapsed, but not aminoacids, which indicate non sugar excipients as the best choice under the studied conditions.
Highlights
Proteins in aqueous diluents can be denatured by heat, pH changes, deamination and others; dehydration by freeze-drying is the most used process to preserve biological drugs from water related instabilities[1]
The collapse temperature of individual excipients was superior to -40 oC, the combination between two excipients showed a collapse temperature inferior to -55 oC
Bovine serum albumin was combined with excipient mixtures and the freezedrying process was carried in a 96 well plate in the pilot lyophilizer Lyostar III (SPscientific)
Summary
Proteins in aqueous diluents can be denatured by heat, pH changes, deamination and others; dehydration by freeze-drying is the most used process to preserve biological drugs from water related instabilities[1]. Most solutions before freeze-drying must contain suitable excipients to protect the drug during dehydration[2]. The ingredient’s suitability is analyzed in pre-formulation studies, which evaluate physical and chemical properties of drugs and excipients, isolated and combined. This analysis provides scientific foundation for the development of effective and stable pharmaceutical forms[3].
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