Effect of freeze-dryer design on drying rate of an amorphous protein-formulation determined with a gravimetric technique.
A freeze-drying balance was used to determine momentary drying-rate, m(t), of a sucrose/BSA formulation contained in a vial with varying shelf packing density, Ø2. A comparison between two different laboratory-scale freeze-dryers was made. The effects of Ø2 on m(t) differed between the two units, attributed to drying chamber design and its effects on heat transfer. At high Ø2 the differences are annulled because of the shielding effects of surrounding vials. Parallel effects of Ø2 were also found on product temperature, Tb, measured in the balance vial. Tb was used to calculate vial heat transfer coefficient, Kv. Kv was strongly reduced with increasing Ø2, but reached a plateau value at high Ø2.
Gieseler
Henning
H
Division of Pharmaceutics, Friedrich-Alexander-University Erlangen, Germany.
Lee
Geoffrey
G
D000465:Algorithms; D002152:Calorimetry, Differential Scanning; D005612:Freeze Drying / Q000295:instrumentation / Q000379:methods*; D011506:Proteins / Q000737:chemistry*; D012710:Serum Albumin, Bovine / Q000737:chemistry; D013395:Sucrose / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D013696:Temperature; D013816:Thermodynamics; D013818:Thermogravimetry; D044366:Transition Temperature; D014618:Vacuum; D014867:Water / Q000737:chemistry
D011506:Proteins; D014867:Water; D012710:Serum Albumin, Bovine; D013395:Sucrose