Mannitol hemihydrate in lyophilized protein formulations: Impact of its dehydration during storage on sucrose crystallinity and protein stability

Author:

Sonje Jayesh,Thakral Seema,Mayhugh Brendan,Sacha Gregory,Nail Steve,Srinivasan Jayasree,Suryanarayanan Raj

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference34 articles.

1. The formation and effect of mannitol hemihydrate on the stability of monoclonal antibody in the lyophilized state;Anko;International journal of pharmaceutics,2019

2. Vacuum Induced Surface Freezing as an effective method for improved inter-and intra-vial product homogeneity;Arsiccio;Eur J Pharm Biochem,2018

3. The Ice-Water Interface and Protein Stability: A Review;Arsiccio;J Pharm,2020

4. Differentiation and quantitative determination of surface and hydrate water in lyophilized mannitol using NIR spectroscopy;Cao;J Pharm Sci,2006

5. Rational design of stable lyophilized protein formulations: theory and practice;Carpenter;Rational design of stable protein formulations,2002

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