Abstract
Lyophilization, is an important development for medicament formulation because of its ability to safely dry heat-sensitive vaccines, antibiotics, and protein-based formulations. The lyophilization process results in long shelf lives powder formulation which can be reconstituted at the point of use. As Injectable biopharmaceuticals become a more prominent part of the overall drug market the value of lyophilized product is has increased significantly. In 1998, lyophilized pharmaceuticals accounted for 11.9% of all new Injectable or infusible drugs, but, by 2015, they made up half of all such new drug introductions (Ratti et al 2001, Bubnovich et al 2012).
Highlights
Principle: The principle involved in Lyophilization is the transition of a solid to the gas phase, without first becoming liquid phase
In order to start the removal of water, the pressure inside the freeze dryer must be below the “triple point value” for the product, whilst maintaining the temperature of the sample below its freeze point in the lyophilization process which is suitable for drying of thermo-labile materials (Nail et al, 1992)
The steps involved in lyophilization begins with preparation of sample followed by Pre-freezing, primary drying and secondary drying, to obtain the final dried product with
Summary
Principle: The principle involved in Lyophilization is the transition of a solid (ice) to the gas phase, without first becoming liquid phase. The driving force for the removal of water during Lyophilization is the concentration gradient of water vapor between the drying front and condenser (Sheena et al 2018). In order to start the removal of water, the pressure inside the freeze dryer must be below the “triple point value” for the product, whilst maintaining the temperature of the sample below its freeze point in the lyophilization process which is suitable for drying of thermo-labile materials (Nail et al, 1992). Primary drying temperature should be maintained as high as possible, but below the critical process temperature, to avoid a loss of cake structure. This critical process temperature is the collapse temperature for amorphous substance, or eutectic melt for the crystalline substance. In most of the lyophilized formulations, excipients are included to improve the functional properties and stability of the lyophilized product (Nireesha et al, 2013)
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