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研究领域

Pharmacy and Food Chemistry

Der Forschungsschwerpunkt der Arbeitsgruppe Dr. Henning Gieseler (Freeze-Drying Focus Group) umfasst alle Aspekte der Gefriertrocknung von pharmazeutischen Produkten, insbesondere mit Ausrichtung auf die Stabilisierung von Proteinen und Peptiden. Kernexpertise der Arbeitsgruppe ist die Weiterentwicklung von prozessanalytischen Technologien (PAT) für die Gefriertrocknung und darauf aufbauend die Etablierung eines „Quality by Design“ Konzeptes für die Lyophilisation. Arbeitsbereiche von Dr. Gieseler sind neben PAT die Formulierungsentwicklung von Proteinen, Peptiden und „small molecules“ (inkl. Nanomaterialien), thermoanalytische Verfahren zur Evaluierung der kritischen Formulierungstemperatur bei der Lyophilisation (Schwerpunkt: Gefriertrocknungsmikroskopie und DSC), Prozessoptimierung in der Gefriertrocknung, Trocknung aus atypischen Primärpackmitteln (z.B. PCR-Platten), und Scale-up von Laborgefriertrocknungszyklen auf den Produktionsmaßstab. Der Arbeitskreis hat in den letzten Jahren im Bereich der Gefriertrocknungsforschung eine weltweite Führungsposition eingenommen.

近期论文

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R. E. Johnson *, M. E. Oldroyd, S. S. Ahmed, H. Gieseler, L. M. Lewis *. Use of Manometric Temperature Measurements (MTM) to Characterize the Freeze-Drying Behavior of Amorphous Protein Formulations. J. Pharm. Sci., Vol. 99, No. 6, pp. 2863-2873, 2010. S. Hibler, H. Gieseler *. Primary Packing Materials for Pharmaceutical Freeze-Drying: Molded vs. Serum Tubing Vials. European Pharmaceutical Review, 15(4): 10-16, 2010. J. Beirowski, S. Inghelbrecht, A. Arien, H. Gieseler *. Freeze-Drying of Nanosuspensions, 1: Freezing Rate versus Formulation Design as Critical Factors to Preserve the Original Particle Size Distribution. J. Pharm. Sci., in press, 2010. S. Schneid *, H. Gieseler. Rational approaches and transfer strategies for the scale-up of freeze-drying cycles. Chimica Oggi/Chemistry Today 29(1):10-13, 2011. J. Beirowski, S. Inghelbrecht, A. Arien, H. Gieseler *. Freeze-Drying of Nanosuspensions, 2: The Role of Vitrification on Stability of Drug-Nanosuspensions and Its Practical Implication on Process Design. J. Pharm. Sci., submitted for publication, 2010. S. Schneid, H. Gieseler *, W.J. Kessler, S.A. Luthra, M. J. Pikal. Optimization of the Secondary Drying Step in Freeze Drying Using TDLAS Technology. AAPS PharmSciTech, submitted for publication, 2010. S. Schneid, P. Stärtzel, P. Lettner, H. Gieseler *. Robustness Testing in Pharmaceutical Freeze-Drying: Interrelation of Process Conditions and Product Quality Attributes Studied for a Vaccine Formulation. Pharm. Dev. Technol., submitted for publication, 2010. S. Schneid *, H. Gieseler. Rational approaches and transfer strategies for the scale-up of freeze-drying cycles. Chimica Oggi/Chemistry Today, Vol. 29, No. 1, pp. 10-13, 2011. S. Schneid, H. Gieseler *, W.J. Kessler, S.A. Luthra, M. J. Pikal. Optimization of the Secondary Drying Step in Freeze Drying Using TDLAS Technology. AAPS PharmSciTech, Vol. 12, No. 1, pp. 379-387, 2011. J. Beirowski, S. Inghelbrecht, A. Arien, H. Gieseler *. Freeze-Drying of Nanosuspensions, 1: Freezing Rate versus Formulation Design as Critical Factors to Preserve the Original Particle Size Distribution. J. Pharm. Sci., Vol. 100, No. 5, pp. 1958-1968, 2011. J. Beirowski, S. Inghelbrecht, A. Arien, H. Gieseler *. Freeze Drying of Nanosuspensions, 2: the Role of the Critical Formulation Temperature on Stability of Drug Nanosuspensions and Its Practical Implication on Process Design. J. Pharm. Sci., Vol. 100, No. 10, pp. 4471–4481, 2011. S. Schneid, P. Stärtzel, P. Lettner, H. Gieseler *. Robustness Testing in Pharmaceutical Freeze-Drying: Interrelation of Process Conditions and Product Quality Attributes Studied for a Vaccine Formulation. Pharm. Dev. Technol., Vol. 16, No. 6, pp. 583-590, 2011. J. Beirowski, H. Gieseler *. Stabilization of Nanoparticles during Freeze Drying: The Difference to Proteins. European Pharmaceutical Review, 16(4): 11-14, 2011. J. Beirowski, S. Inghelbrecht, A. Arien, H. Gieseler *. Freeze Drying of Nanosuspensions, Part 3: Investigation of Factors Compromising Storage Stability of Highly Concentrated Drug Nanosuspensions. J. Pharm. Sci., Vol. 101, No. 1, pp. 354–362, 2012. S. Hibler, C. Wagner, H. Gieseler *. Vial Freeze-Drying, Part 1: New Insights Into Heat Transfer Characteristics of Tubing and Molded Vials. J. Pharm. Sci., Vol. 101, No. 3, pp. 1189-1201, 2012. U. Pohl *, C. Führling, H. Gieseler. Neue Schmelztablette zur Migränetherapie. Deutsche Apotheker Zeitung: 152 (14): 96 - 101, 2012. A. Al-Hussein, H. Gieseler *. The Effect of Mannitol Crystallization in Mannitol/Sucrose Systems on LDH-Stability during Freeze Drying. J. Pharm. Sci., in press, 2012. A. Al-Hussein, H. Gieseler *. The Effect of Mannitol Crystallization in Mannitol / Sucrose Systems on LDH-Stability during Freeze Drying. J. Pharm. Sci., Vol. 101, No. 7, pp. 2534-2544, 2012. S. Hibler, H. Gieseler *. Heat Transfer Characteristics of Current Primary Packaging Systems for Pharmaceutical Freeze-Drying. J. Pharm. Sci., Vol. 101, No. 11, pp. 4025-4031, 2012. S. Hibler, H. Gieseler *. Freeze-Drying Process Optimization for a Small Molecule. Pharm. Technol. June Issue, pp.: 2-5, 2012.

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