OPTIMIZATION OF FREEZE-DRYING CYCLES OF IBUPROFEN WITH ORGANIC CO-SOLVENT FORMULATIONS (TBA) BY USING THE DESIGN SPACE METHODOLOGY
The Design Space concept is presented as an envelope in a graph - with sublimation rates and total gas chamber pressures on main (x,y) axis – illustrating the functional relationships between the sublimation rates,the mean product temperatures and the two principal independent process variables,namely the shelf heat transfer fluid temperature and the total gas pressure.The limits of this design space are determined by the influence of product and process variables on quality attributes of the freeze-dried drug,more precisely by the failure of this attributes under aggressive cycle conditions.As an illustration,we present a case study concerning the methodology of construction of the Design Space for an ibuprofen organic co-solvent (tert-butanol,TBA) formulation realized with a pilot laboratory freeze-dryer.This methodology can reduce the development and the cycle optimisation costs of drugs freeze-drying processes especially in the case of costly active principle ingredients that are only available in small quantities.
design space ibuprofen freeze-drying sublimation rates optimization tertbutanol
E.Bogdani S.Vessot J.Andrieu
University of Lyon,University of Lyon 1,Laboratoire Automatiqueet de Génie des Procédés.LAGEP.UMR CNRS 5007,Bat.308 G43,Bd du 11 novembre 1918.F-69622 Villeurbanne,France
国际会议
The 18th International Drying Symposium Conference(第十八届国际干燥学术大会(IDS2012))
厦门
英文
1-6
2012-01-11（万方平台首次上网日期，不代表论文的发表时间）