Comparison of product drying performance in molded and serum tubing vials using gentamicin sulfate as a model system.
In a previous study, heat transfer coefficients of different 10 mL tubing and molded vials were determined gravimetrically via sublimation tests with pure water. Contrary to "conventional wisdom", only small differences in K(v) values between tubing and molded vials were found in the pressure range relevant for pharmaceutical freeze-drying. In order to investigate the impact of these relatively small differences on the primary drying time of an actual product, freeze-drying experiments with 5% gentamicin sulfate solution as a model system were performed at 68, 100 and 200 mTorr. The primary drying times of the API in recently developed molded (EasyLyo™), tubing (TopLyo™) and polymer vials (TopPac™) were compared. At 68 and 100 mTorr the primary drying time of the drug in the glass vials only differed by 3% to 4%, while the polymer vial took around 9% longer. At 200 mTorr, the API in the EasyLyo™ vials dried approximately 15% faster compared to the other vial types. The present study suggest that molded vials that have been modified in design to have better heat transfer properties can achieve drying times comparable to tubing vials.
Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen, Cauerstrasse, Erlangen, Germany.
Susanne
S
Hibler
Christophe
C
Wagner
Henning
H
Gieseler
D000900:Anti-Bacterial Agents / Q000737:chemistry*; D004349:Drug Packaging; D005612:Freeze Drying / Q000191:economics / Q000379:methods; D005839:Gentamicins / Q000737:chemistry*; D011312:Pressure; D013997:Time Factors
D000900:Anti-Bacterial Agents; D005839:Gentamicins