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Callahan et al. [30] divided excipients into four classes; non-hygroscopic (I), slightly hygroscopic (II), moderately hygroscopic (III) and very hygroscopic (IV). The authors determined the equilibrium moisture values for 30 common excipients and classified the excipients on this basis. Kontny [31] described how in a closed system water from excipients will re-equilibrate between the individual components of the formulation, via the vapour phase, to attain the most thermodynamically stable state.

5 Conclusions By understanding the manufacturing process and the stability of the drug substance, whether from synthetic, natural, or recombinant sources, the chemist is able to identify, control, and measure the impurities, and so the quality of the drug substance and reproducibility from production batch to batch are maintained. Disclaimer The views expressed above are the personal views of the authors. S. government. References 1. USPharmacopeia 29/National Formulary 24, 1086, Rockville, MD, 2006, p.

In contrast, the amorphous form behaves like a singlet-oxygen sensitiser. The crystalline form has an ordered close-packed structure, whereas the amorphous form does not, and singlet-oxygen has greater reactivity resulting in faster photodegradation and more photodegradants. Aman and Thoma [38] studied the processing of the photolabile drugs, nifedipine and molsidomine. 7). The influence of tablet manufacturing process was also investigated. The authors investigated direct compression (DC), aqueous wet granulation (WG) and alcoholic wet granulation (WG); in the latter cases they used polvinylpyrollidone (PVP) as the binder.

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