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Formulation

 

Figure 1 Schematic illustration of a particle stabilised by a steric stabiliser. Note that it has been reported that both the degree of adsorption and the density / thickness of the steric barrier are essential factors to mitigate freezing and drying stresses
Figure 1 Schematic illustration of a particle stabilised by a steric stabiliser. Note that it has been reported that both the degree of adsorption and the density / thickness of the steric barrier are essential factors to mitigate freezing and drying stresses
article

Stabilisation of nanoparticles during freeze drying: The difference to proteins

31 August 2011 | By Jakob Beirowski and Henning Gieseler, University of Erlangen-Nuremberg, Division of Pharmaceutics, Freeze Drying Focus Group

The underlying concept for the stabilisation of proteins during freeze drying is the formation of a glassy matrix in which the macromolecules remain isolated and immobilised. The concept relies on the so-called ‘vitrification hypothesis’ which assumes that the formation of an amorphous phase by lyoprotectants is mandatory to interact with…

Figure 1 Examples of chemical structures of antibodies for targeted pulmonary inhalation aerosol
Figure 1 Examples of chemical structures of antibodies for targeted pulmonary inhalation aerosol
article

Pulmonary inhalation aerosols for targeted antibiotics drug delivery

16 February 2011 | By Chun-Woong Park & Heidi M. Mansour, University of Kentucky, College of Pharmacy and Don Hayes Jr, University of Kentucky, College of Medicine

Targeted pulmonary drug delivery of antibiotics by inhalation aerosols can play significant roles in the treatment of cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD) and in other pulmonary diseases where chronic airway infections exist. Direct administration to the lung as targeted pulmonary inhalation aerosol delivery is uniquely able to…

Figure 1 Kv values at different pressure settings (centre vials, average from two experiments per pressure setpoint). Symbols represent: upper solid line = curve fit TopLyoTM vial, upper dotted line = curve fit ‘standard serum tubing’ vial, lower solid line = curve fit EasyLyoTM vial, lower dotted line = curve fit ‘standard moulded’ vial.
Figure 1 Kv values at different pressure settings (centre vials, average from two experiments per pressure setpoint). Symbols represent: upper solid line = curve fit TopLyoTM vial, upper dotted line = curve fit ‘standard serum tubing’ vial, lower solid line = curve fit EasyLyoTM vial, lower dotted line = curve fit ‘standard moulded’ vial.
article

Primary packaging materials for pharmaceutical freeze-drying: Moulded vs. serum tubing vials

19 August 2010 | By Susanne Hibler and Dr. Henning Gieseler, University of Erlangen-Nuremberg, Division ofPharmaceutics, Freeze Drying Focus Group

Pharmaceutical freeze-drying is used to stabilise delicate drugs which are typically unstable in solution over a longer shelf life. The liquid formulation is converted into a solid, highly porous cake which can be easily reconstituted prior to administration. The majority of freeze-dried products in the pharmaceutical industry are used for…

Stefan Schneid
Stefan Schneid
article

Process Analytical Technology (PAT) in Freeze Drying: Tunable Diode Laser Absorption Spectroscopy as an evolving tool for Cycle Monitoring

12 December 2009 | By Stefan Schneid, Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen-Nuremberg and Dr. Henning Gieseler, Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen-Nuremberg

The most important critical product parameter during a freeze-drying process is the product temperature at the ice sublimation interface, Tp1. Once the product temperature in this area of interest exceeds the critical formulation temperature (typically denoted as "collapse temperature", Tc) during primary drying, a stepwise loss of the cake structure…

Dr Heiko Schiffter
Dr Heiko Schiffter
article

The determination of structural changes of biopharmaceuticals during Freeze-Drying using Fourier Transform Infrared Spectroscopyb

20 March 2009 | By ,

Peptides and proteins are powerful active therapeutic ingredients used in a wide variety of serious conditions and illnesses such as diabetes, arthritis or cancer. The application of these so-called biopharmaceuticals has been rapidly increasing since the middle of the 1990s, facilitated by improvements in modern recombinant DNA technology and biotechnological…

Lyophilisation freeze drying machine
Lyophilisation freeze drying machine
article

Application of DSC and MDSC in the development of freeze dried pharmaceuticals

3 December 2008 | By Jakob Beirowski, Pharmacist and Dr. Henning Gieseler, Assistant Professor, Division of Pharmaceutics, University of Erlangen-Nuremberg

Freeze drying of pharmaceuticals requires an adequate formulation design to prevent low-temperature, freezing and drying stresses. The goal is to achieve a final product with long storage stability and elegant appearance. To meet these specifications the product temperature must be controlled below the critical formulation temperature during the freeze drying…

article

A significant comparison between collapse and glass transition temperatures

29 September 2008 | By Eva Meister and Dr. Henning Gieseler, Division of Pharmaceutics, University of Erlangen-Nuremberg

Rational freeze-drying process design is based on a representative and accurate measurement of the critical formulation temperature. To avoid product shrinkage or collapse, it is indispensable to control the product temperature just below this key temperature during primary drying. Over the last decades, DSC was routinely used to determine the…

Lyophilisation freeze drying machine
Lyophilisation freeze drying machine
article

Lyophilization: cycle robustness and process tolerances, transfer and scale up

19 June 2008 | By Serguei Tchessalov and Nicholas Warne, Wyeth BioPharma, Andover

During the past 10-15 years, close attention has been paid to the development of optimal lyophilization cycles for different types of pharmaceuticals1-4. Recent advances in process control, such as the Smart Freeze-DryerTM technology or similar approaches, [5-7] make cycle development a routine procedure. The attention of many researchers has shifted…

article

Personalised medicine: are we ready for the revolution?

19 March 2008 | By

The impact of biomarker technology and biomarker strategies in pharmaceutical development is still in its infancy; but the impact is already proving significant. Biomarker strategy forms the basis for personalised medicine, the industry/regulatory focus centres on improving the success rate and reducing the high attrition rate often encountered in early…

Dr Henning Gieseler
Dr Henning Gieseler
article

PAT for freeze drying: cycle optimisation in the laboratory

25 January 2007 | By Dr. Henning Gieseler, PhD., Department of Pharmaceutics, University of Erlangen-Nuremberg

Freeze drying is generally known to be a time consuming and therefore expensive process. In order to lower costs during manufacturing, the effective cycle time must be reduced. This goal can be achieved by optimising a freeze drying cycle in the laboratory – in particular the primary drying phase. Applying…

smith figure 1
smith figure 1
article

Maintaining vaccine security

20 July 2006 | By Howard Smith, Technical and Commercial Manager, Cambridge Biostability

Ninety per cent of the world’s medical research funding is being spent on just ten per cent of the world’s health problems, mostly those afflicting the residents of wealthy countries.

Linkam launches a new platform to replicate large scale freeze drying systems
Linkam launches a new platform to replicate large scale freeze drying systems
article

Lyophilization: An ever-evolving technology

23 May 2006 | By Prof. Louis Rey, Scientific Advisor and Head, Laboratory of Experimental Freeze-Drying AERIAL – CRT, and Dalal Aoude-Werner, Head of Project, AERIAL – CRT

Almost 60 years have elapsed since freeze-drying/lyophilization was introduced on an industrial scale. Developed initially for the rapid delivery of human blood plasma on the World’s battle fields, lyophilization gained its credentials with the massive production of penicillin under the guidance of the late Nobel Laureate Sir Ernst Boris Chain.

wiggenhorn figure 2
wiggenhorn figure 2
article

The current state of PAT in freeze drying

11 November 2005 | By Michael Wiggenhorn, Gerhard Winter, Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-University and Ingo Presser, Boehringer Ingelheim

Freeze drying is a widely used method to stabilise protein pharmaceuticals. The stability of proteins and the biological activity can be influenced by several factors, which may lead to conformational changes and to denaturation, aggregation or absorption to surfaces1.