PEER REVIEWED JOURNAL ARTICLES

  • Hibler S, Wagner C, Gieseler H * . 2012. Vial Freeze-Drying, 1: New Insights Into Heat Transfer Characteristics of Tubing and Molded Vials. J Pharm Sci, in press.
  • Beirowski J, Inghelbrecht S, Arien A, Gieseler H *. 2012. Freeze-drying of nanosuspensions, part 3: Investigation of factors compromising storage stability of highly concentrated drug nanosuspensions. J Pharm Sci 101(1):354-362.
  • Beirowski J, Inghelbrecht S, Arien A, Gieseler H  *. 2011. 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 100(10):4471-4481.
  • Beirowski J, Inghelbrecht S, Arien A, Gieseler H  *. 2011. Freeze-drying of nanosuspensions, 1: Freezing rate versus formulation design as critical factors to preserve the original particle size distribution. J Pharm Sci 100(5):1958-1968.
  • Schneid S, Stärtzel P, Lettner P, Gieseler H  *. 2011. Robustness Testing in Pharmaceutical Freeze-Drying: Interrelation of Process Conditions and Product Quality Attributes Studied for a Vaccine Formulation. Pharm Dev Technol 16(6): 583-90.
  • Schneid S, Gieseler H  *, Kessler WJ, Luthra SA, Pikal MJ. 2011. Optimization of the Secondary Drying Step in Freeze Drying Using TDLAS Technology. AAPS PharmSciTech 12(1):379-387.
  • Johnson RE  *, Oldroyd ME, Ahmed SS, Gieseler H, Lewis LM  *. 2010. Use of Manometric Temperature Measurements (MTM) to Characterize the Freeze- Drying Behavior of Amorphous Protein Formulations. J Pharm Sci 99(6):2863-2873.
  • Gieseler H, Lee GWL  *. 2009. Gravimetric measurement of drying rate of spray freeze dried powders in vials. J Pharm Sci 98(9):3447-3455.
  • Schneid S, Gieseler H  * , Kessler WJ, Pikal MJ. 2009. Non-Invasive Product Temperature Determination during Primary Drying using Tunable Diode Laser Absorption Spectroscopy. J Pharm Sci 98(9):3406-3418.
  • Meister E, Gieseler H  * . 2009. Freeze-Dry Microscopy of Protein/Sugar Mixtures: Drying Behavior, Interpretation of Collapse Temperatures and a Comparison to Corresponding Glass Transition Data. J Pharm Sci 98(9):3072-3087.
  • Meister E, Šašić S, Gieseler H  * . 2009. Freeze-Dry Microscopy: Impact of Nucleation Temperature and Excipient Concentration on Collapse Temperature Data. AAPS PharmSciTech 10(3):582-588.
  • Gieseler H  * , Kramer T, Schneid S. 2008. Quality by Design in Freeze-Drying: Cycle Design and Robustness Testing in the Laboratory Using Advanced Process Analytical Technology. Pharm Technol, October Issue: 88-95.
  • Schneid S, Riegger X, Gieseler H  * . 2008. Influence of Some Common Excipients on the Crystalline Modification of Freeze-Dried Mannitol. Pharm Technol, March Issue:178-184.
  • Gieseler H, Lee GWJ  * . 2008. Effect of Freeze-Dryer Design on Drying Rate of an Amorphous Protein-Formulation Determined with a Vial-Weighing Technique. Pharm Dev Technol 13(6):463-472.
  • Schneid S, Gieseler H  * . 2008. Evaluation of a New Wireless Temperature Remote Interrogation System (TEMPRIS) to Measure Product Temperature during Laboratory and Production Scale Freeze Drying. AAPS PharmSciTech 9(3):729-739.
  • Gieseler H, Lee GWJ  * . 2008. Effects of vial packing density on momentary freeze-drying rate of carbohydrates or a model protein measured using a microbalance technique. Pharm Res 25(2):302-312.
  • Gieseler H  * , Kramer T, Pikal MJ. 2007. The Use of Manometric Temperature Measurement (MTM) and SMART Freeze-Dryer Technology for Development of an Optimized Freeze-Drying Cycle. J Pharm Sci 96(12) : 3402-3418.
  • Gieseler H  * , Kessler WJ, Finson M, Davis S, Mulhall P, Bons V, Debo D, Pikal MJ. 2007. Evaluation of Tunable Diode Laser Absorption Spectroscopy for In-Process Water Vapor Mass Flux Measurements during Freeze Drying. J Pharm Sci 96(7):1776-1793.
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ARTICLES IN NON-PEER REVIEWED JOURNALS

  • Pohl U  * , Führling C, Gieseler H. 2012. Schmelztabletten zur Migränetherapie. Deutsche Apotheker Zeitung, in press.
  • Beirowski J, Gieseler H  *. 2011. Stabilization of Nanoparticles during Freeze Drying: The Difference to Proteins. Eur Pharm Rev 16(4):11-14.
  • Schneid S  *, Gieseler H. 2011. Rational approaches and transfer strategies for the scale-up of freeze- drying cycles. Chimica Oggi/Chemistry Today 29(1):10-13.
  • Hibler S, Gieseler H  *. 2010. Primary Packing Materials for Pharmaceutical Freeze-Drying: Molded vs. Serum Tubing Vials. Eur Pharm Rev 15(4):10-16.
  • Johnson RE, Gieseler H, Teagarden DL, Lewis LM  * . 2009. Analytical Accessories for Formulation and Process Development in Freeze-Drying. Am Pharm Rev 4:54-60.
  • Schneid S, Gieseler H  *. 2009. Process Analytical Technology (PAT) in Freeze Drying: Tunable Diode Laser Absorption Spectroscopy as an Evolving Tool for Cycle Monitoring. Eur Pharm Rev 13(6):18-25.
  • Beirowski J, Gieseler H  *. 2008. Application of DSC and MDSC in the development of freeze dried pharmaceuticals. Eur Pharm Rev 13(6):63-70.
  • Meister E, Gieseler H  * . 2008. Evaluation of the Critical Formulation Temperature in Freeze-Drying: A Comparison Between Collapse and Glass Transition Temperatures. Eur Pharm Rev 13(5):73-79.
  • Schneid S, Gieseler H  * . 2008. Effect of Concentration, Vial Size and Fill Depth on Product Resistance of Sucrose solutions during Freeze Drying. The Pharmaceutical Solutions Update, Spring Edition.
  • Gieseler H  * . 2007. Process Analytical Technology for Freeze-Drying: Cycle Optimization in the Laboratory. Eur Pharm Rev 12(1):62-67.
  • Meister E, Dringenberg B, Gieseler H  * . 2007. Die Schlüsselstellung der Gefriertrocknungsmikroskopie in der Entwicklung parenteraler Formulierungen. GIT Laborfachzeitschrift:51(6):476-478.
  • Gieseler H  * , von Graberg S, Arpagaus C  * , Kleinhans S. 2007. Freeze drying with enhanced process control in the Buchi Glass Oven B-585. Best@Buchi, No. 44. 
  • Meister E, Klerner S, Gieseler H  * . 2006. Gefriertrocknungsmikroskopie: Proteine und Peptide zwischen Kollaps und Kristallisation. Deutsche Apotheker Zeitung:146(24):2552-2557.
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Book Chapters

  • Gieseler H  *. 2012. Quality by Design (QbD) in Freeze Drying. In: Encyclopedia of Pharmaceutical Technology, Fourth Edition; J. Swarbrick, Ed. Informa Healthcare: London, UK. (in press)
  • Gieseler H * . 2009. Einsatz der DSC in der Entwicklung gefriergetrockneter Arzneimittel. In: Anwendungen der Thermischen Analyse, Mikro- kalorimetrie und Rheologie im Bereich der Pharmazie, Biotechnologie, Lebensmitteltechnologie und Kosmetik; Kunze W., Ed.; TA Instruments: Eschborn, pp. 45-59. ISBN: 978-3-940184-04-7.
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