RT Journal Article
SR Electronic
T1 The effect of formulation, process and method variables on the reconstitution time in dual chamber syringes
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2015.006387
DO 10.5731/pdajpst.2015.006387
A1 Werk, Tobias
A1 Ludwig, Imke Sonja
A1 Mahler, Hanns-Christian
A1 Luemkemann, Joerg
A1 Huwyler, Joerg
A1 Hafner, Mathias
YR 2016
UL http://journal.pda.org/content/early/2016/06/18/pdajpst.2015.006387.abstract
AB Reconstitution time of dried products is influenced by various factors including formulation, process and reconstitution method itself. This manuscript describes factors affecting reconstitution in a dual chamber syringe using highly concentrated huMAb and BSA model formulations. Freezing and drying conditions had only minor impact on the reconstitution time, whereas the primary container and thus the geometry of the lyphilization cake played a major role. Pre-warmed diluent and agitation decreased reconstitution time. For effective agitation, short displacements and high agitation frequencies were found to be desirable conditions to minimize reconstitution time for a given lyophilization cake while foam formation was minimized. The article also provides general strategies (e.g. reduction of lyophilized cake density, use of an optimized fill finish process and suitable method parameters) to reduce reconstitution time, especially for drug product presented in a dual chamber syringe configuration.