Abstract
The objective of this study was to investigate the effect of the concentration of surfactant and oil on particle size reduction and stability of oil-in-water emulsion formulations containing polyhydroxy alcohols. Emulsions were prepared using an emulsifier system consisting of Tween 80® and Span 80® with 5%, 10%, 15% and 20% soybean oil and containing 50% w/w of either propylene glycol (PG) or glycerol (GLY) in the external phase. At each oil concentration, four emulsions were formulated with increasing surfactant concentration to provide emulsions with surfactant to oil (S/O) ratios of 0.1, 0.2, 0.3 and 0.4. Three parameters were evaluated, particle size reduction, particle size stability upon dilution, and viscosity. It was found that increase in S/O ratio resulted in substantial decrease in particle size in all cases. But there was a difference in the particle size reduction pattern between PG and GLY. Increase in oil concentration at the same S/O ratio caused particle size reduction for emulsions with PG but not for emulsions with GLY. The reduction in particle size was also greater for emulsions containing PG. Further, particle size of emulsions containing PG was found to be stable over 24 hours after dilution. However, a slight increase in particle size was observed in emulsions containing GLY. It was also found that the viscosity of emulsions increased with an increase S/O ratio as well as the concentration of the oil.
- Received November 22, 1993.
- Accepted September 16, 1994.
- Copyright © Parenteral Drug Association. All rights reserved.
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