Understanding and Reducing Long and Variable Reconstitution Time for Highly Concentrated Therapeutic Protein Formulations

Understanding and Reducing Long and Variable Reconstitution Time for Highly Concentrated Therapeutic Protein Formulations

Prof. Robin H. Bogner (University of Connecticut)

Highly concentrated protein formulations are notoriously difficult to reconstitute. Methods to reduce recon times in the literature include i) lyophilizing a lower concentration solution and reconstituting to half the volume, and ii) formulating with mannitol and processing to promote its crystallization. These and other suggested methods will be discussed. More importantly, elucidation of the underlying causes of slow reconstitution will allow additional strategies to be developed. Wettability of the lyophilized cake, assessed by contact angle of a saturated aqueous drop, and drop penetration times, distinguish between very fast reconstituting cakes from all others, but does not predict rank order of longer recon times. Oddly, crushing resistance of the dry cake, a sign of partial crystallization in the largely amorphous solid, can herald lower reconstitution time. Viscosity of higher concentrations of the pre-lyo solutions and accurate quantification of the pore size distribution within the lyophilized cakes are key factors for reconstitution.

Date and Location

Thurs Apr 18th, 2019

Registration & social hour: 5:30 PM
Dinner & presentation: 6:30 PM

Meeting Sponsors

Fuji Chemical Industries USA

 

Hanover Marriott

1401 Rt 10 E, Whippany, NJ 07981

About the speaker

Dr. Bogner is Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut where she is also a member of the Institute of Materials Science. She received her B.S. in Pharmacy from Rutgers University, M.S. from the University of Iowa, and Ph.D. from Rutgers University. Dr. Bogner is completing her 30th academic year at UConn in May. Dr. Bogner’s research interests are focused on the characterization and dissolution of pharmaceutical solids, both freeze-dried parenterals and oral dosage forms. She teaches a courses in mass transfer and in freeze-drying. Dr. Bogner is the Director of the Kildsig Center for Pharmaceutical Processing Research – an industry/university consortium. She has served on several editorial boards, a USP committee, an FDA advisory committee and in various leadership roles in the American Association of Pharmaceutical Scientists (AAPS). She is a Teaching Fellow at the University of Connecticut, and Fellow of the AAPS.

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