Abstract
The stability of a moisture-sensitive drug is not only determined by its own physical state, but also by the formulation in which it is present. This paper demonstrates that decomposition of amorphous vecuronium bromide in a formulation is a function of the water activity rather than of the water content in relative or stoichiometric terms. For freeze-dried formulations this means that the disadvantageous lyophilization characteristics of glass forming excipients can have definite stabilizing, other than cryoprotective, effects. With knowledge of degradation kinetics at various water levels, moisture isotherms of the formulation and the properties of package, shelf-life of a product can be estimated.
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