M. Bury et al., APPLICATION OF A NEW METHOD BASED ON CONDUCTIVITY MEASUREMENTS TO DETERMINE THE CREAMING STABILITY OF O W EMULSIONS/, International journal of pharmaceutics, 124(2), 1995, pp. 183-194
A kinetic model, based on equations used in biological population dyna
mics, is proposed to describe the creaming profile of oil-in-water emu
lsions at the top of a storage cell. The creaming profile itself is de
termined by conductivity measurements through the emulsion at differen
t heights, and conversion of conductivities into volume fraction value
s of the dispersed phase in terms of dispersion dielectric theory. The
reliability of the proposed model was successfully verified. This met
hodology (conductivity method and kinetic model) was applied to model
emulsions, to analyze the most reliable test scheme for stability asse
ssment (room temperature storage, temperature stress test, and low cen
trifugational stress test), The conductivity method is sensitive to sm
all changes in the volume fraction of dispersed phase observed at room
temperature. The creaming profile can then be analyzed with the kinet
ic model allowing extrapolations for long-term predictions and shorten
ing the time needed for stability assessments. Additionally, an Arrhen
ius-type equation relating the creaming rate constants with the corres
ponding storage temperatures can principally be employed. With regard
to centrifugation stress testing, if under centrifugation no creaming
can be observed, it is normally correct to assume that the emulsion wi
ll be stable at normal gravitational condition. However, the reverse a
rgument does not always apply.