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Pharmaceutical companies often use lyophilisation (or freeze-drying) to increase the shelf life of the products, such as live virus vaccines, biologics and other injectables. By removing the water from the material and sealing the material in a glass vial, the material can be easily stored, shipped, and later reconstituted to its original form for injection. Another example from the pharmaceutical industry is in tablet or wafer production, the advantage of which is less excipient as well as a rapidly absorbed and easily administered dosage form.
Lyophilisation is also used in manufacturing of raw materials for pharmaceutical products. Active Pharmaceutical Product Ingredients (APIs) are lyophilised to achieve chemical stability under room temperature storage. Bulk freeze-drying of APIs is typically conducted using trays instead of glass vials.
Dry powders of probiotics are often produced by bulk lyophilisation of live microorganisms such as Lactic acid bacteria and Bifidobacteria.
Blood transfusions have been used successfully since the early 1900s, and blood banks have been in use since 1914. After donation, whole blood is separated into several components for processing and storage under different conditions, and one of these components is the red blood cell fraction.
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to make the recipient believe they are receiving something they are not in order to establish whether the true active agent has a noticeable remedy to the ailment it is intended to…
In a pharmaceutical freeze drying process, it is mandatory to preserve product quality. This means that for a given formulation that has to be freeze dried, the temperature has to remain below a limit value corresponding to the eutectic temperature for a product that crystallises after freezing, with the goal…
22 October 2012 | By Henning Gieseler, Associate Professor at the Division of Pharmaceutics, University of Erlangen & CEO, GILYOS GmbH and Peter Stärtzel, Pharmaceutical Scientist, GILYOS GmbH
The stochastic nature of nucleation during the freezing step of the freeze-drying process has been regarded as a demerit in a process which is considered under rigorous control. The freezing performance of a product can impact its subsequent drying behaviour and the final product quality attributes. Hence, the idea to…
10 July 2012 | By David Sek, Research Scientist, Pfizer
One of the key factors in stabilising proteins is determining the optimal pH and buffer system to provide adequate solubility and stability. Currently, three buffers, citrate, phosphate and acetate, make up the majority of buffers used in parenteral pharmaceuticals approved by the FDA, but less precedented excipients are certainly available…
13 December 2011 | By Mingshi Yang, Faculty of Pharmaceutical Sciences, University of Copenhagen
Spray drying is a widely used technical method to produce fine particles, coarse powders, agglomerates or granulates in various industries. The characteristics of the particles produced by this method can be controlled and the particle properties can be maintained as constant throughout a continuous operation. The product from this process…
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…
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…
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…
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…
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…
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…
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…
Over the last decade, the development of new drug delivery methods and devices for dry powder inhalation1, needle-free intradermal powder injection2 or sustained parenteral drug delivery3 has led to an increasing demand for powder formulations incorporating an active pharmaceutical ingredient (API)4,5.
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…
