By Steven W. Baertschi, Karen M. Alsante, Robert A. Reed
The second one version of Pharmaceutical pressure checking out: Predicting Drug Degradation presents a pragmatic and clinical consultant to designing, executing and analyzing rigidity checking out reports for drug substance and drug product. this can be the single advisor on hand to take on this topic in-depth. The second variation expands insurance from chemical balance into the actual features of pressure trying out, and comprises the concept that of ?€?Quality by way of Design?€™ into the strain trying out build / framework. it's been revised and multiplied to incorporate chapters on huge molecules, reminiscent of proteins and antibodies, and it outlines the alterations in rigidity checking out that experience emerged lately. Key good points comprise: A popular Editorial group and contributions from all significant drug businesses, reflecting a wealth of expertise. 10 new chapters, together with rigidity checking out and its dating to the overview of power genotoxic degradants, mixture drug remedies, proteins, oligonucleotides, actual alterations and substitute dosage kinds resembling liposomal formulations up to date methodologies for predicting drug balance and degradation pathways most sensible perform versions to keep on with An multiplied commonly asked Questions part. this can be a necessary reference ebook for Pharmaceutical Scientists and people operating in caliber insurance and Drug improvement (analytical sciences, formulations, chemical approach, venture management).
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Additional resources for Pharmaceutical Stress Testing: Predicting Drug Degradation, 2nd Edition (Drugs and the Pharmaceutical Sciences)
As discussed in the section “Thermolytic Degradation,” elevated temperatures up to 70°C should accelerate the hydrolytic degradation processes in a meaningful way. Higher temperatures can be used, but the risk of non-Arrhenius behavior increases significantly when temperature is increased further. As discussed earlier in the chapter, MacFaul et al. observed Arrhenius behavior for 166 compounds acid/base solution studies at temperatures up to 90°C, but the degradation profiles sometimes changed at the higher temperatures, illustrating the risk.
8). This example serves to illustrate how the identification of a just a single degradation product (elemental sulfur in this case) can guide the analytical approaches used for a particular compound (chemistry-guided approach). Another example of using the chemistry-guided approach is illustrated with the β-difluoronucleoside, gemcitabine hydrochloride (2’-deoxy-2’,2’-difluorocytidine, Fig. 9) (116). Gemcitabine hydrochloride is currently marketed as a lyophilized powder; however, there was an interest in developing a solution formulation.
However, the references to stressing at 80°C and 85°C suggest that such high temperatures are optional and may lead to different decomposition pathways for some compounds. MacFaul et al. described the use of stress-testing temperatures as high as 90°C in solution, with no significant deviations from Arrhenius kinetics; interestingly, in a number of cases the degradation profile at higher temperatures was significantly different than at lower temperatures (yet the degradation still followed Arrhenius kinetics) (46).
Pharmaceutical Stress Testing: Predicting Drug Degradation, 2nd Edition (Drugs and the Pharmaceutical Sciences) by Steven W. Baertschi, Karen M. Alsante, Robert A. Reed