Welcome to freeze-drying.eu

Publications

On this page you will find a list of selected publications (abstracts, invited talks, articles) from Henning Gieseler which are, in part, available for download. If you are interested in publications which are not provided here for download, please send me your contact information and article request by using the “Contact” sheet on our website!

before 2004

Henning Gieseler. Product Morphology and Drying Behavior delineated by a New Freeze-Drying Microbalance. Doctoral Thesis, University of Erlangen, July 2004. (download) 

If you are interested in any publication before 2004, please contact me by using the “Contact” page on our website!

 

2004 - present

Abstracts :

  • H. Gieseler, H. Lee, B. Mulherkar, M. J. Pikal. Applicability of Manomentric Temperature Measurement (MTM) and SMART Freeze-Dryer Technology to Development of an Optimized Freeze-Drying Cycle: Prelim-inary Investigation of Two Amorphous Systems. Proc. 1st European Congress on Life Science Process Technology, Nuremberg, Germany, Oct. 11-13, 2005. (download)
  • H. Gieseler, S. Seyferth, S. von Graberg, A. Eberle, G. Lee. Freeze Drying in a New Laboratory Glass Oven System: Enhancement of Process Control and Direct Comparison with a Laboratory Scale Freeze Dryer. Proc. 1st European Congress on Life Science Process Technology, Nuremberg, Germany, Oct. 11-13, 2005. (download)
  • S. M. Patel, H. Gieseler, W. Kessler, M. J. Pikal. Choked Flow and Importance of Mach 1 Delineated by Tunable Diode Laser Absorption Spectroscopy (TDLAS) in a Laboratory Scale Freeze Dryer. Proc. CPPR Annual Meeting, Puerto Rico, May 20-22, 2005. (download)
  • E. Meister, H. Gieseler. Evaluation of Collapse Temperatures by Freeze-Dry Microscopy: Impact of Excipient Concentration on Measured Transition and the Overall Dependence on Measurement Methodology. Proc. 5th World Meeting on Pharmaceutics and Pharmaceutical Technology, Geneva, March 27-30, 2006. (download)
  • H. Gieseler, L. Mather, M. J. Pikal. SMART Freeze-Dryer Technology: Impact of Water Re-Adsorption of Poly-vinylpyrrolodone (PVP) on Manomentric Temperature Measurements (MTM) during Primary Drying. Proc. 5th World Meeting on Pharmaceutics and Pharmaceutical Technology, Geneva, March 27-30, 2006. (download)
  • E. Meister, H. Gieseler. Measurement of Collapse Temperature by Freeze-Dry Microscopy: Dependence of Collapse Temperatures on Total Solid Content and Correlation to Physical Properties of the Measured Excipient Solution. Proc. CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Partenkirchen, Germany, Oct. 3-6, 2006. (download)
  • S. von Graberg, H. Gieseler. Freeze Drying in Non-Vial Container Systems: Evaluation of Heat Transfer Coefficients of PCR-Plates and Correlation to Freeze-Drying Cycle Design. Proc. CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Partenkirchen, Germany, Oct. 3-6, 2006. (download)
  • S. Schneid, H. Gieseler, W. Kessler, M. J. Pikal. Position Dependent Vial Heat Transfer Coefficient: A Comparison of Tunable Diode Laser Absorption Spectroscopy and Gravimetric Measurements. Proc. CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Partenkirchen, Germany, Oct. 3-6, 2006. (download)
  • E. Meister, M. Ellnain, H. Gieseler. Collapse Temperature Measurement by Freeze-Dry Microscopy and Transferability to Freeze Drying Processes: Influence of Solute Concentration on Collapse Behavior and Effect on Cycle Design. Proc. AAPS Annual Meeting and Exposition, San Antonio (TX), USA, Oct. 29 - Nov. 2, 2006. (download)
  • S. Schneid, H. Gieseler, W. Kessler, M. J. Pikal. Process Analytical Technology in Freeze-Drying: Accuracy of Mass Balance Determination using Tunable Diode Laser Absorption Spectroscopy (TDLAS). Proc. AAPS Annual Meeting and Exposition, San Antonio (TX), USA, Oct. 29 - Nov. 2, 2006. (download)
  • H. Gieseler, T. Kramer. PAT in Laboratory Scale Freeze Drying: Cycle Design and Robustness Testing by Using Manometric Temperature Measurement Technology. Proc. AAPS Annual Meeting and Exposition, San Diego (CA), USA, Nov. 11-15, 2007.
  • T. Kramer, S. Luthra, S. Graunke, S. Schneid, H. Gieseler. Dry Layer Resistance of Freeze-Dried Amorphous Formulations Determined by Smart Freeze Dryer Technology. Proc. AAPS Annual Meeting and Exposition, San Diego (CA), USA, Nov. 11-15, 2007. (download)
  • T. Kramer, H. Gieseler, M. J. Pikal. Evaluation of Water Readsorption Effects of Dried Product during Manometric Temperature Measurements (MTM). Proc. AAPS Annual Meeting and Exposition, San Diego (CA), USA, Nov. 11-15, 2007.
  • E. Meister, H. Gieseler. Freeze-Dry Microscopy: Correlation between Physical Properties and Collapse Behavior of Excipients Frequently Used for Freeze-Drying. Proc. AAPS Annual Meeting and Exposition, San Diego (CA), USA, Nov. 11-15, 2007. (download)
  • E. Meister, H. Gieseler. Freeze-Dry Microscopy: Drying and Collapse Behavior of Human Serum Albumine and Bovine Serum Albumine Based Formulations. Proc. AAPS Annual Meeting and Exposition, San Diego (CA), USA, Nov. 11-15, 2007. (download)
  • S. von Graberg, H. Gieseler. Freeze Drying from 96-Well PCR-Plates: Transferability of Heat Transfer Coefficients Obtained from Sublimation Tests to Product Runs and Considerations for Cycle Design. Proc. AAPS Annual Meeting and Exposition, San Diego (CA), USA, Nov. 11-15, 2007. (download)
  • S. Schneid, H. Gieseler, W. Kessler, M. J. Pikal. PAT in Freeze Drying: Non-Invasive Product Temperature Determination based on Tunable Diode laser Absorption Spectroscopy (TDLAS). Proc. AAPS Annual Meeting and Exposition, San Diego (CA), USA, Nov. 11-15, 2007. (download)
  • S. Schneid, H. Gieseler, W. Kessler, M. J. Pikal. Tunable Diode Laser Absorption Spectroscopy (TDLAS) as a Residual Moisture Monitor for the Secondary Drying Stage of Freeze-Drying. Proc. AAPS Annual Meeting and Exposition, San Diego (CA), USA, Nov. 11-15, 2007. (download)
  • W. Ibrahim, H. Gieseler, I. Zimmermann. Impact of Mannitol Crystallization on the Physical Properties of Freeze Dried Midazolam Hydrochloride Tablets. Proc. 6th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Barcelona, Spain, Apr. 07-10, 2008. (download)
  • S. Schneid, H. Gieseler. Effect of Concentration, Vial Size and Fill Depth on Product Resistance of Sucrose Solutions During Freeze Drying. Proc. 6th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Barcelona, Spain, Apr. 07-10, 2008 (download)
  • S. von Graberg, H. Gieseler, S. Edelburg, S. Kock, V. Nölle. Amorphous and Partially Crystalline Formulation Strategies for a Human Cytokine: A Case Study. Proc. CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Breckenridge (CO), USA , Aug. 6-9, 2008. (download)
  • S. von Graberg, W. Hyla, H. Gieseler. Freeze-Drying from Small Product Containers and its Implication on Freeze-Drying Process De-sign: Evaluation of Heat Transfer Coefficients of a New 96-Well Freeze Drying System in Compari-son to 2R Tubing Vials and Polypropylene 96-Well PCR-Plates. Proc. CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Breckenridge (CO), USA , Aug. 6-9, 2008. (download)
  • S. Schneid, H. Gieseler. A New Generation of Battery-Free Wireless Temperature Probes as an Alternative to Thermocouples for Vial Freeze Drying. Proc. CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Breckenridge (CO), USA , Aug. 6-9, 2008. (download)
  • S. Schneid, E. Meister, H. Gieseler. Design Space in Freeze-Drying: A Robustness Testing Procedure in the Laboratory to Delineate the Impact of Product Temperature Variability on Product Quality Attributes. Proc. CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Breckenridge (CO), USA , Aug. 6-9, 2008. (download)
  • E. Meister, H. Gieseler, S. Luthra, E. Shalaev, L. Gattlin. Evaluation of The Critical Formulation Temperature of Protein and Protein/Sucrose Mixtures: A Comparison between Freeze-Dry Microscopy, Differential Scanning Calorimetry and Laboratory Freeze-Drying Cycles. Proc. CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Breckenridge (CO), USA , Aug. 6-9, 2008. (download)
  • W. Ibrahim, H. Gieseler, I. Zimmermann. Impact of Gelatin Type and pH on the Disintegration Time and Dissolution of Lyophilised Midazolam-HCl Tablets, Biopharmaceutics and Pharmaceutical Technology. Proc. Chem-SySt Meeeting, Wuerzburg, Germany, Dec. 2, 2008. (download)
  • J. Beirowski, A. Passos, S. Inghelbrecht, T. Arien, I. van Asche, H. Gieseler. Freeze Drying of Nanosuspensions without Cryo- and Lyoprotectants. Proc. AAPS National Biotechnology Conference, Seattle (WA), USA, June 21-24, 2009. (download)
  • J. Beirowski, A. Passos, S. Inghelbrecht, T. Arien, I. van Asche, H. Gieseler. Impact of Steric Stabilizer Concentration on Particle Size Distribution in Nanosuspensions for Freeze Drying in the Presence of Trehalose. Proc. AAPS National Biotechnology Conference, Seattle (WA), USA, June 21-24, 2009. (download)
  • J. Beirowski, A. Passos, S. Inghelbrecht, T. Arien, I. van Asche, H. Gieseler. The Importance of an Optimum Freezing Rate when Freeze Drying Nanosuspensions. Proc. AAPS National Biotechnology Conference, Seattle (WA), USA, June 21-24, 2009. (download)
  • J. Beirowski, H. Gieseler, S. Inghelbrecht, T. Arien, I. van Asche. Investigation of various Poloxamers as freeze-drying stabilizers in freeze-drying of nanosuspensions. Proc. 2009 PDA Pharmaceutical Freeze Drying Technology, Frankfurt, Germany, September 29-30, 2009. (download)
  • A. Kauppinen, R. Pellinen, M. Reinisalo, O. Korhonen, H. Gieseler, K. Järvinen, J. Ketolainen. Freeze drying of gene delivery vehicles. Proc. 2009 Annual Congress of the European Society of Gene & Cell Therapy, Hannover, Germany, November 21-25, 2009.
  • S. Rutzinger, C. Wagner, H. Gieseler. Evaluation of the Heat Transfer Characteristics of a New Container System for Pharmaceutical Freeze-Drying. Proc. 7th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Valetta, Malta, March 8-11, 2010. (download)
  • W. Ibrahim, H. Gieseler, I. Zimmermann. Stability Study of Oral Lyophilisate of Midazolam-HCL in Different Packing Material. Proc. 7th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Valetta, Malta, March 8-11, 2010. (download)
  • J. Beirowski, S. Inghelbrecht, T. Arien, I. van Asche, H. Gieseler. Stabilization of Nanosuspensions During Freeze-Drying: The Role of Vitrification (Part 1). Proc. 7th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Valetta, Malta, March 8-11, 2010. (download)
  • J. Beirowski, S. Inghelbrecht, T. Arien, I. van Asche, H. Gieseler. Stabilization of Nanosuspensions During Freeze-Drying: The Role of Vitrification and Its Practical Implications (Part 2). Proc. 7th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Valetta, Malta, March 8-11, 2010. (download)
  • S. Schneid, P. Lettner, S. Rutzinger, H. Gieseler. Robustness Testing in Lyophilization: Influence of Process Conditions on Properties of a Vaccine Formulation. Proc. 7th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Valetta, Malta, March 8-11, 2010. (download)
  • S. Schneid, H. Gieseler. PAT in Freeze Drying: Monitoring of Product Resistance Using Non-Invasive NIR-Spectroscopic TDLAS Measurements. Proc. 7th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Valetta, Malta, March 8-11, 2010. (download)
  • J. Beirowski, H. Gieseler. Critical Factors for Freeze-Drying Cycle Design When Using the Gore™ Lyoguard® Vial Isolator System. Proc. CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Partenkirchen, Germany, Sept. 28 - Oct. 1, 2010. (download)
  • S. Hibler, C. Wagner, H. Gieseler. The Vial Heat Transfer Coefficient: Methodology of Evaluation and Impact of Vial Design on Heat Transfer Characteristics. Proc. CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Partenkirchen, Germany, Sept. 28 - Oct. 1, 2010. (download)
  • P. Stärtzel, M. Gieseler, H. Gieseler. Rational Freeze-Drying Cycle Optimization Using Two Innovative Technologies: SMARTTM Freeze-Dryer and ControLyoTM Nucleation On-Demand. Proc. Controlled Release Society Germany Local Chapter Meeting, Wuerzburg, Germany, March 29 – 30, 2012.
  • U. Pohl, C. Führling, H. Gieseler. Taste Masking of Naproxen Sodium. Proc. Controlled Release Society (CRS) German Chapter Meeting, Wuerzburg, Germany, March 29-30, 2012 (download).
  • U. Pohl, C. Führling, H. Gieseler. Lyophilized Orally Disintegrating Tablets Containing Taste Masked Naproxen Sodium Granules. Proc. Controlled Release Society (CRS) German Chapter Meeting, Wuerzburg, Germany, March 29-30, 2012 (download).
  • A. Al-Hussein, H. Gieseler. Protein Stability in Partially Crystalline Systems During Freeze-Drying: The Effect of Annealing. Proc. Controlled Release Society (CRS) German Chapter Meeting, Wuerzburg, Germany, March 29-30, 2012 (download).
  • U. Pohl, C. Führling, H. Gieseler. Formulation of Freeze Dried Orally Disintegrating Tablets Containing a Non-Water-Soluble Drug Delivery SystemMasking of Naproxen Sodium. Proc. APV Oral Multiparticulate Dosage Forms - What´s New? Prague, Czech Republic, November 13-14, 2012 (download).
  • A. Al-Hussein, H. Gieseler. Thermal Behavior of Histidine Solutions in the Frozen state: The Effect of pH, Histidine Concentration, Annealing, and Additional Excipients. Proc. DPhG Annual Meeting, Greifswald, Germany, October 11-13, 2012 (download).

 

Invited Talks:

  • H. Gieseler. Neue Prozess Analytische Technologie (PAT) in der Gefriertrocknung: Das Prinzip des “SMART Freeze-Dryer”. Biotechnica, Hannover, October 9, 2005.
  • H. Gieseler. PAT in Freeze Drying: Application of a New Mass Flux Monitor Based on Tunable Diode Laser Absorption Spectroscopy (TDLAS). 1st European Congress on Life Science Process Technology, Nuremberg, Germany, October 11–13, 2005. (download)
  • H. Gieseler. PAT in the Laboratory: Case Studies in the Testing of the SMART Freeze-Dryer Technology. Invited Talk, CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Partenkirchen, Germany, October 3-6, 2006. (download)
  • W. Kessler, H. Gieseler. Advances in Laser Doppler Shift Spectroscopy to Determine Real Time In-Process mass Flow Rate. Invited talk, CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Partenkirchen, Germany, October 3-6, 2006.
  • H. Gieseler. Exploring Process Analytical Technology in the Laboratory Involving Testing of SMART Freeze-Dryer Technology. Invited talk, SWE Enterprises Conference, San Diego (CA), USA, December 7-8, 2006.
  • H. Gieseler. Process Analytical Technology in Drying Operations: Applications to Freeze Drying and Beyond. Invited talk, AAPS National Biotechnology Conference, San Diego, June 24-27, 2007.
  • H. Gieseler. The Current State of PAT in Freeze-Drying. Invited talk, Lyophilization of Pharmaceuticals, Informa Life Science Seminar, Dec 3-5, 2007.
  • H. Gieseler. Process analytical technology in freeze drying: the “desired” state vs. reality. Invited talk, CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Breckenridge (CO), USA, Aug 6-9, 2008.
  • H. Gieseler. PAT & Quality by Design in Freeze Drying: a Quick Review. Invited talk, AAPS National Biotechnology Conference, Seattle (WA), USA, June 21-24, 2009.
  • H. Gieseler. Freeze-Drying of Nanosuspensions: From Theory to Practical Formulation and Process Design. Invited Talk, CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Partenkirchen, Germany, Sept. 28 - Oct. 1, 2010.
  • H. Gieseler. Process Analytical Technology (PAT) in Freeze-Drying. Invited Talk, AAPS National Biotechnology Conference, San Francisco (CA), USA, May 16-19, 2011.
  • H. Gieseler. The Freezing Stage in Freeze Drying. Invited Talk, LYO SUMMIT, Rottach-Egern, Germany, September 18-20, 2013.
  • H. Gieseler. Freeze Drying: A General Introduction. Invited Talk, SSIP FBK 2013 – Lyophilisation, Basle, Switzerland, November 21, 2013.
  • H. Gieseler. The Current State of Scale-up in Freeze Drying. Invited Talk, XXVI Symposium of the Finnish Society of Physical Pharmacy, University of Eastern Finland, Kuopio, Finnland, February 5, 2015.
  • H. Gieseler. Challenges in Freeze Drying of Pharmaceuticals: A Survey of Accomplished Research, Ongoing Projects, and Future Outlook. Invited Talk, University of Connecticut, Storrs, USA, September 8, 2015.

 

Webinars:

  • L. Mather, H. Gieseler. Reducing Cycle Optimization Time and Costs using SMART Freeze Dryer Technology. SP Industries LyoLearn Webinar Series, Jan 28, 2009.
  • H. Gieseler. The Freezing Stage in Freeze Drying: Fundamental Concepts. SP Industries LyoLearn Webinar Series, April 29, 2009.
  • H. Gieseler. PAT in der Gefriertrocknung – Ein Überblick über MTM und das Konzept des „SMART Freeze Dryer™“ (German). SP Industries LyoLearn Webinar Series, February 10, 2011.

 

Selected Articles:

  • E. Meister, S. Klerner, H. Gieseler *. Gefriertrocknungsmikroskopie: Proteine und Peptide zwischen Kollaps und Kristallisation. Deutsche Apotheker Zeitung: 146 (24): 2552-2557, 2006.
  • W. Kessler *, H. Gieseler, V. Bons, M. J. Pikal. Lyophilizer Sublimation Rate Monitoring using Tunable Diode Laser Absorption Spectroscopy. PAT - The Journal of Process Analytical Technology, September/October Issue, 2006.
  • H. Gieseler *. Process Analytical Technology for Freeze-Drying: Cycle Optimization in the Laboratory. European Pharmaceutical Review: Issue 1, 2007.
  • H. Gieseler *, S. von Graberg, C. Arpagaus *, S. Kleinhans. Freeze drying with enhanced process control in the Buchi Glass Oven B-585. Best@Buchi, No. 44, 2007.
  • H. Gieseler *, W. Kessler, M. Finson, S. Davis, P. Mulhall, V. Bons, D. Debo, M. J. Pikal. Evaluation of Tunable Diode Laser Absorption Spectroscopy for In-Process Water Vapor Mass Flux Measurements during Freeze Drying. J. Pharm. Sci., Vol.: 96, No. 7, 2007.
  • H. Gieseler *, T. Kramer, M. J. Pikal. The Use of Manometric Temperature Measurement (MTM) and SMART Freeze-Dryer Technology for Development of an Optimized Freeze-Drying Cycle. J. Pharm. Sci., Vol. 96, No. 12, 2007.
  • E. Meister, B. Dringenberg, H. Gieseler *. Die Schlüsselstellung der Gefriertrocknungsmikroskopie in der Entwicklung parenteraler Formulierungen. GIT Laborfachzeitschrift: 51 (6), 476-478, 2007.
  • H. Gieseler, G. W. J. Lee *. Effects of vial packing density on momentary freeze-drying rate of carbohydrats or a model protein measured using a microbalance technique. Pharm. Res., Vol. 25, No. 2, pp. 302-312, 2008.
  • S. Schneid, H. Gieseler *. Evaluation of a New Wireless Temperature Remote Interrogation System (TEMPRIS) to Measure Product Temperature during Laboratory and Production Scale Freeze Drying. AAPS PharmSciTech, Vol. 9, No. 3, pp. 729-739, 2008.
  • S. Schneid, X. Riegger, H. Gieseler *. Influence of Some Common Excipients on the Crystalline Modification of Freeze-Dried Mannitol. Pharmaceutical Technology, March Issue: 178-184, 2008.
  • S. Schneid, H. Gieseler *. Effect of Concentration, Vial Size and Fill Depth on Product Resistance of Sucrose solutions during Freeze Drying. The Pharmaceutical Solutions Update, Spring 2008 Edition, 2008.
  • H. Gieseler, G. W. J. Lee *. Effect of Freeze-Dryer Design on Drying Rate of an Amorphous Protein-Formulation Determined with a Vial-Weighing Technique. Pharm. Dev. Technol., Vol. 13, Issue 6, pp. 463 - 472, 2008.
  • H. Gieseler *, T. Kramer, S. Schneid. Quality by Design in Freeze-Drying: Cycle Design and Robustness Testing in the Laboratory Using Advanced Process Analytical Technology. Pharmaceutical Technology, October 2008, 2008.
  • E. Meister, H. Gieseler *. Evaluation of the Critical Formulation Temperature in Freeze-Drying: A Comparison Between Collapse and Glass Transition Temperatures. European Pharmaceutical Review, Issue 5/08, 2008.
  • J. Beirowski, H. Gieseler *. Application of DSC and MDSC in the development of freeze dried pharmaceuticals. European Pharmaceutical Review, Issue 6/08, 2008.
  • E. Meister , S. Šašić, H. Gieseler *. Freeze-Dry Microscopy: Impact of Nucleation Temperature and Excipient Concentration on Collapse Temperature Data. AAPS PharmSciTech, Vol. 10, No. 3, pp. 582-588, 2009.
  • E. Meister, H. Gieseler *. Freeze-Dry Microscopy of Protein/Sugar Mixtures: Drying Behavior, Interpretation of Collapse Temperatures and a Comparison to Corresponding Glass Transition Data. J. Pharm. Sci., Vol. 98, No. 9, pp. 3072-3087, 2009.
  • S. Schneid, H. Gieseler *, W. J. Kessler, M. J. Pikal. Non-Invasive Product Temperature Determination during Primary Drying using Tunable Diode Laser Absorption Spectroscopy. J. Pharm. Sci., Vol. 98, No. 9, pp. 3406-3418, 2009
  • H. Gieseler, G. W. J. Lee *. Gravimetric measurement of drying rate of spray freeze dried powders in vials. J. Pharm. Sci., Vol. 98, No. 9, pp. 3447-3455, 2009.
  • S. Schneid, H. Gieseler *. Process Analytical Technology (PAT) in Freeze Drying: Tunable Diode Laser Absorption Spectroscopy as an Evolving Tool for Cycle Monitoring. European Pharmaceutical Review, Issue 6, pp. 18-25, 2009. 
  • R. E. Johnson, H. Gieseler, D. L. Teagarden, L.M. Lewis *. Analytical Accessories for Formulation and Process Development in Freeze-Drying. American Pharmaceutical Review, Issue 4, pp. 54-60, 2009.
  • 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.
  • P. Stärtzel, H. Gieseler *. Controlled Nucleation in Freeze-Drying. Eur. Pharm. Rev. 17(5): 63-68. 2012.
  • S. Hibler, C. Wagner, H. Gieseler *. Comparison of Product Drying Performance in Molded and Serum Tubing Vials Using Gentamicin Sulfate as a Model System. Pharm. Dev. Technol., Vol. 17, No. 5, pp. 541-551, 2012.
  • A. Al-Hussein, H. Gieseler *. Investigation of Histidine Stabilizing Effects on LDH during Freeze-Drying. J. Pharm. Sci. Vol. 102, No. 3, pp. 813-826, 2013.
  • U. Stange, C. Führling, H. Gieseler *. Influence of Non-Water-Soluble Placebo Pellets of Different Sizes on the Characteristics of Orally Disintegrating Tablets Manufactured by Freeze-Drying. J. Pharm. Sci., Vol. 102, No. 6, pp. 1786-1799, 2013.
  • U. Stange, M. Scherf-Clavel, H. Gieseler *. Application of Gas Pycnometry for the Density Measurement of Freeze-Dried Products. J. Pharm. Sci., Vol. 102, No. 11, pp. 4087-4099, 2013.
  • U. Stange, C. Führling, H. Gieseler *. Taste Masking of Naproxen Sodium Granules by Fluid-Bed Coating. Pharm. Dev. Technol. 19(2):137-147, 2014.
  • U. Stange, C. Führling, H. Gieseler *. Formulation, Preparation, and Evaluation of Novel Orally Disintegrating Tablets Containing Taste-Masked Naproxen Sodium Granules and Naratriptan Hydrochloride. J. Pharm. Sci. 103(4):1233-1245, 2014.
  • M. Hofmann, M. Winzer, C. Weber, H. Gieseler *. A Low-Volume Screening Tool to Optimize Colloidal Stability for Highly Concentrated Protein Formulations. Am. Pharm. Rev. 17(6):36-42., 2014.
  • A. Braun, D. Ilko, B. Merget, H. Gieseler, O. Germershaus, U. Holzgrabe, L. Meinel *. Predicting critical micelle concentration and micelle molecular weight of polysorbate 80 using compendial methods. Eur. J. Pharm. Biopharm. 94:559-568, 2015.
  • U. Stange, C. Fuehrling, H. Gieseler *. Freeze Drying of Orally Disintegrating Tablets Containing Taste Masked Naproxen Sodium Granules in Blisters. Pharm. Dev. Technol. 20(8): 1018-1024, 2015.
  • A. Al-Hussein, H. Gieseler *. Investigation of the Stabilizing Effects of Hydroxyethyl Cellulose on LDH During Freeze Drying and Freeze Thawing Cycles. Pharm. Dev. Technol. 20(1):50-59, 2015.
  • S. Schneid, R. Johnson, L. Levis, P. Stärtzel, H. Gieseler *. Application of Process Analytical Technology for Monitoring Freeze-Drying of an Amorphous Protein Formulation: Use of Complementary Tools for Real-Time Product Temperature Measurements and Endpoint Detection. J. Pharm. Sci. 104(5):1741-17, 2015.
  • P. Stärtzel, H. Gieseler, M. Gieseler, A. Abdul-Fattah, M. Adler, HC Mahler, P. Goldbach*. Freeze Drying of l-Arginine / Sucrose-Based Protein Formulations, Part I: Influence of Formulation and Arginine Counter Ion on the Critical Formulation Temperature, Product Performance and Protein Stability. J. Pharm. Sci. 104(7):2345-2358, 2015.
  • P. Stärtzel, H. Gieseler, M. Gieseler, A. Abdul-Fattah, M. Adler, HC Mahler, P. Goldbach*. Freeze Drying of L-Arginine / Sucrose-Based Protein Formulations, Part 2: Optimization of Formulation Design and Freeze Drying Process Conditions for an L-Arginine Chloride-Based Protein Formulation System. J. Pharm. Sci. 104(12):4241-4256, 2015.
  • C. Kunz, H. Gieseler*. Dynamic Vapor Sorption of Freeze Dried Pharmaceuticals: Linking Final Product Quality Attributes to Moisture Sorption Behavior. Eur. Pharm. Rev. 20(5):76-80, 2015.

 

Book Chapters:

H. Gieseler. Einsatz der DSC in der Entwicklung gefriergetrockneter Arzneimittel. In: Anwendungen der Thermischen Analyse, Mikrokalorimetrie und Rheologie im Bereich der Pharmazie, Biotechnologie, Lebensmitteltechnologie und Kosmetik; Kunze W., Ed.; TA Instruments: Eschborn, 2009, 45-59. ISBN: 978-3-940184-04-7.

H. Gieseler. Quality by Design (QbD) in Freeze Drying. In: Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition; J. Swarbrick, Ed. Informa Healthcare: London, UK. 2013. ISBN: 1-84184-819-0; eISBN: 1-84184-820-4.

 

 


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