By Louis Rey
Completely acquainting the reader with freeze-drying fundamentals-including water homes serious to the method and mechanisms and technique of protein stabilization-Freeze-Drying/Lyophilization of Pharmaceutical and organic items, moment version carves sensible directions from the very most modern theoretical learn, applied sciences, and business procedures-ensuring the easiest execution of steps from closure instruction and regulatory keep an eye on of goods to apparatus sterilization and strategy validation.
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Extra info for Freeze-Drying Lyophilization of Pharmaceutical and Biological Products, Second Edition, (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs)
This is why two chapters in this book relate directly to that topic (Watts and Bellissent-Funel/Teixeira). Accordingly, we will not deal with it. However, we would like to share with our readers and colleagues some ideas that evolved from recent experiments that we have carried out on the low-temperature thermoluminescence of diﬀerent systems and, in particular, on water itself (see Fig. 12). 14 Rey Figure 11 (a and b) Recombinant glycoprotein-Mol-2. 4 C, followed by a progressive melting starting around À 8 C.
Impedance, though at ﬁrst sight the system remains a compact solid. Figure 9 summarizes this evolution. The magnitude and temperature of these events are, of course, dependent on the system under investigation, as can be seen in Figure 10 which compares D2O/glycerol and H2O/glycerol mixtures. This type of behavior is not uncommon in pharmaceutical preparations. Indeed, it is often required that a thermal treatment be applied to the material in order to secure a steady and successful freeze-drying operation.
Of Sciences, Natl. Res. , 1962, pp 25–42. 12. L Rieutord. International patents, 1961. 13. M Espagnan, P Plume, G Marcellin. Dosime´trie des doses e´leve´es par Thermoluminescence des pics profonds du Fluorure de Lithium: Fli: Mg, Ti. Radioprotection 26:51–64, 1991. -C. Bellissent-Funel and J. Teixeira Laboratoire Le´on-Brillouin (CEA-CNRS), CEA Saclay, Gif-sur-Yvette, France I. INTRODUCTION The structural and dynamic properties of bulk water are now mostly well understood in some ranges of temperatures and pressures.
Freeze-Drying Lyophilization of Pharmaceutical and Biological Products, Second Edition, (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs) by Louis Rey