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Emulsion Stability and Testing
Emulsion Stability and Testing
The measurement of both the (or projected shelf-life of the product) References
droplet size and size distribution 1. P. Becher, Emulsions: Theory
of emulsions is a critical metric. Elevated temperature 37 oC for 6 months and 45 oC for 6 months and Practice, Reinhold Publishing
A variety of sizing techniques are Corp., New York (1957)
available (see PSI Technical Brief Refrigerator Approximately 4 oC for 3 months 2. P. Becher (Ed), Encyclopedia of
2009 Volumes 6 and 7) but, from
Emulsion Technology, Volume 1:
Figure 1, it is obvious that image
Freeze/thaw cycles (5) Approximately -10 oC to ambient Basic Theory, Marcel Dekker, New
analysis (for regular emulsions)
York (1983)
should be a prime candidate.
Cycling chamber 4 oC to 45 oC in 48 hours for 1 month 3. C. Cowell and B. Vincent, J.
Emulsion Stability Testing Colloid and Interface Science, 87
Light exposure 1 month exposure to north-facing daylight 518 (1982)
Stability testing is an integral part
of emulsion development work. A or light cabinet 4. E. Dickinson and G. Stainsby,
discussion of drug stability testing Colloids in Food, Applied Science
methods and kinetics is beyond Publishers, London (1982)
Table 2
the scope of this Technical Brief 5. E. D. Goddard and B. Vincent
and the reader is referred to the EMULSION PROPERTIES TO BE MONITORED (eds), Polymer Adsorption and
Dispersion Stability, ACS Sym-
many excellent books and review DURING STABILITY TESTING posium Series 240, America
papers on this subject8-10.
Property Test Method Chemical Society, Washington DC
The emulsion formulator is gener-
(1984)
ally concerned with understanding pH pH meter
the effects of storage and shipping 6. S. R. Reddy and H. S. Olger, J.
conditions on shelf-life which may Viscosity Rotational viscometer Colloid and Interface Science, 79
include extremes of temperatures 105 (1981)
Flow behavior Oscillatory shear viscosity with a cone/plate rheometer
and exposure to sunlight, vibration 7. M. A. J. S. van Boekel and P.
and humidity. Hence, formula- Tack/Texture Extensional and compressional deformation Walstra, Colloids and Surfaces, 3
tions are stored under standard- 99 (1981)
ized test conditions and carefully Color Visual or colorimeter
8. K. A. Connors, G. L. Amidon
examined at periodic intervals. Odor Organoleptic and J. S. Valentino, Chemical Sta-
Table 1 lists general conditions bility of Pharmaceuticals: A Hand-
commonly and historically used to Specific gravity Pycnometer book for Pharmacists, John Wiley,
evaluate emulsion stability, though New York (1986)
Separation Creaming value - visual or instrumental
regulated emulsion products must
9. W. Grimm and K. Krummen
be tested in compliance with ap- Conductivity Conductivity meter (eds), Stability Testing in the EC,
plicable ICH guidelines. Further,
Droplet size Microscopic examination (image analysis) Japan and the USA: Scientific
although freeze-thaw has been
distribution and instrumental and Regulatory Requirements,
widely used as an accelerated path
Wissenschaftliche Verlagsgesell-
to judge emulsion stability, it is Preservation Microbial challenge and/or assay schaft, Stuttgart (1993)
not truly appropriate to rely solely
on it to make those judgements. Vibration Shipping test or shaker table 10. J. Wells, Pharmaceutical Pre-
The cycling of temperature in formulation: The Physicochemical
Active Chemical or bio-assay Properties of Drug Substances,
freeze-thaw experiments affects ingredient(s)
parameters other than those that Ellis Horwood, Chichester (1988)