Freeze-Drying/Lyophilization Of Pharmaceutical & Biological by Louis Rey, Joan C. May

By Louis Rey, Joan C. May

Thoroughly acquainting the reader with freeze-drying fundamentals-including water homes severe to the method and mechanisms and technique of protein stabilization-Freeze-Drying/Lyophilization of Pharmaceutical and organic items, moment version carves sensible guidance from the very most up-to-date theoretical learn, applied sciences, and commercial procedures-ensuring the easiest execution of steps from closure practise and regulatory keep watch over of goods to gear sterilization and procedure validation.

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The proportion of cubic ice increases with decreasing temperature. This is in sharp contrast to bulk water, which always nucleates into hexagonal ice. Results relative to a 25% hydrated Vycor sample indicates that, at room temperature, interfacial water has a structure similar to that of bulk Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved. supercooled water at a temperature of about 0 C which corresponds to a shift of about 30 K [50]. The structure of interfacial water is characterized by an increase of the long-range correlations, which corresponds to the building of the H-bond network as it appears in low-density amorphous ice [51].

These diffraction techniques allow access to the intermolecular pair correlation function g(r) [31] of a system that is the probability density of finding another atom lying in another molecule at a distance r from any atom. In x-ray measurements g(r) is the pair correlation function of the molecular centers, to a good approximation equal to the oxygen–oxygen correlation function. In neutron measurements g(r) is the weighed sum of the three partial functions relative, respectively, to the oxygen–oxygen pairs, oxygen–deuterium pairs, and deuterium–deuterium pairs.

Figure 20 shows the principle of the method we developed jointly with J. Mosnier (deceased). The selected vial or ampoule is placed in a thermostatic metallic block where temperature can be maintained constant Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved. Figure 20 Operating principle of the device made to measure the equilibrium water vapor pressure inside a sealed vial. Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved. from À10 C to þ60 C. On one side of the block a metallic ‘‘finger’’ having at its end a tiny polished stainless steel cylindrical mirror (2 Â 6 mm) is pushed toward the outside wall of the glass vessel and the connection is made optically and thermally tight thanks to a trace of silicon grease.

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