An Interactive Tool for the Optimization of Freeze-Drying Cycles Based on Quality Criteria

REFERENCES

• Leuenberger , H. ; Plitzko , M. ; Puchkov , M. Spray freeze drying in a fluidized bed at normal and low pressure . Drying Technology 2006 , 24 , 711 – 719 .
   Web of Science ®Google Scholar
• Pikal , M.J. Use of a laboratory data in freeze drying process design: Heat and mass transfer coefficients and the computer simulation of freeze drying . Journal of Parenteral Science & Technology 1985 , 39 , 115 – 138 .
   PubMedGoogle Scholar
• Chang , B.S. ; Fisher , N.L. Development of an efficient single-step freeze-drying cycle for protein formulations. Pharmaceutical Research 1995, 12, 831–837.
   PubMed Web of Science ®Google Scholar
• Tang , X.L. ; Pikal , M.J. Design of freeze-drying processes for pharmaceuticals: Practical advice . Pharmaceutical Research 2004 , 21 , 191 – 200 .
   PubMed Web of Science ®Google Scholar
• Pikal , M.J. ; Shah , S. The collapse temperature in freeze-drying: Dependence on measurement methodology and rate of water removal from the glassy state . International Journal of Pharmacy 1990 , 62 , 165 – 186 .
   Web of Science ®Google Scholar
• Alves , O. ; Roos , Y.H. Advances in multi-purpose drying operations with phase and state transitions . Drying Technology 2006 , 24 , 383 – 396 .
   Web of Science ®Google Scholar
• Chouvenc , P. ; Vessot , S. ; Andrieu , J. ; Vacus , P. Optimization of the freeze-drying cycle: A new model for pressure rise analysis . Drying Technology 2004 , 22 , 1577 – 1601 .
   Web of Science ®Google Scholar
• Sadikoglu , H. Optimal control of the secondary drying stage of freeze drying of solutions in vials using variational calculus . Drying Technology 2005 , 23 , 33 – 57 .
   Web of Science ®Google Scholar
• Sadikoglu , H. ; Ozdemir , M. ; Seker , M. Optimal control of the primary drying stage of freeze drying of solutions in vials using variational calculus . Drying Technology 2003 , 21 , 1307 – 1331 .
   Web of Science ®Google Scholar
• Nam , J.H. ; Song , C.S. An efficient calculation of multidimensional freeze-drying problems using fixed grid method . Drying Technology 2005 , 23 , 2491 – 2511 .
   Web of Science ®Google Scholar
• Hottot , A. ; Peczalski , R. ; Vessot , S. ; Andrieu , J. Freeze-drying of pharmaceutical proteins in vials: Modeling of freezing and sublimation steps . Drying Technology 2006 , 24 , 561 – 570 .
   Web of Science ®Google Scholar
• Song , C.S. ; Nam , J.H. ; Kim , C.J. ; Ro , S.T. A finite volume analysis of vacuum freeze drying process of skim milk solution in trays and vials . Drying Technology 2002 , 20 , 283 – 305 .
   Web of Science ®Google Scholar
• Mascarenhas , W.J. ; Akay , H.U. ; Pikal , M.J. A computational model for finite element analysis of the freeze-drying process . Computer Methods in Applied Mechanics and Engineering 1997 , 148 , 105 – 124 .
   Web of Science ®Google Scholar
• Passot , S. ; Fonseca , F. ; Alarcon-Lorca , M. ; Rolland , D. ; Marin , M. Physical characterisation of formulations for the development of two stable freeze-dried proteins during both dried and liquid storage . European Journal of Pharmaceutics and Biopharmaceutics 2005 , 60 , 335 – 348 .
   PubMed Web of Science ®Google Scholar
• Sadikoglu , H. ; Liapis , A.I. Mathematical modelling of the primary and secondary drying stages of bulk solution freeze-drying in trays: Parameter estimation and model discrimination by comparison of theoretical results with experimental data . Drying Technology 1997 , 15 , 791 – 810 .
   Web of Science ®Google Scholar
• Nastaj , J.F. ; Ambrozek , B. Modeling of vacuum desorption in freeze-drying process . Drying Technology 2005 , 23 , 1693 – 1709 .
   Web of Science ®Google Scholar
• Gan , K.H. ; Crosser , O.K. ; Liapis , A.I. Lyophilization in vials on trays: Effects of tray side . Drying Technology 2005 , 23 , 341 – 363 .
   Web of Science ®Google Scholar
• Hua , Z.Z. ; Li , B.G. ; Liu , Z.J. ; Sun , D.W. Freeze-drying of liposomes with cryoprotectants and its effect on retention rate of encapsulated ftorafur and vitamin A . Drying Technology 2003 , 21 , 1491 – 1505 .
   Web of Science ®Google Scholar
• Gan , K.H. ; Bruttini , R. ; Crosser , O.K. ; Liapis , A.I. Heating policies during the primary and secondary drying stages of the lyophilization process in vials: Effects of the arrangement of vials in clusters of square and hexagonal arrays on trays . Drying Technology 2004 , 22 , 1539 – 1575 .
   Web of Science ®Google Scholar
• Adams , G.D.J. ; Ramsay , J.R. Optimizing the lyophilization cycle and the consequences of collapse on the pharmaceutical acceptability of Erwinia L-Asparaginase . Journal of Pharmaceutical Sciences 1996 , 85 , 1301 – 1305 .
   PubMed Web of Science ®Google Scholar
• Ronzi , E. ; Capalongo , A. ; Rovero , G. ; Bucci , E. ; Mondini , S. ; Falbo , A. Optimisation of a freeze-drying process of high purity Factor VIII and Factor IX concentrates . Chemical Engineering and Processing 2003 , 42 , 751 – 757 .
   Web of Science ®Google Scholar