U.S. PHARMACOPEIA

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EMULSIONS
Emulsions are two-phase systems in which one liquid is dispersed throughout another liquid in the form of small droplets. Where oil is the dispersed phase and an aqueous solution is the continuous phase, the system is designated as an oil-in-water emulsion. Conversely, where water or an aqueous solution is the dispersed phase and oil or oleaginous material is the continuous phase, the system is designated as a water-in-oil emulsion. Emulsions are stabilized by emulsifying agents that prevent coalescence, the merging of small droplets into larger droplets and, ultimately, into a single separated phase. Emulsifying agents (surfactants) do this by concentrating in the interface between the droplet and external phase and by providing a physical barrier around the particle to coalescence. Surfactants also reduce the interfacial tension between the phases, thus increasing the ease of emulsification upon mixing.
Natural, semisynthetic, and synthetic hydrophilic polymers may be used in conjunction with surfactants in oil-in-water emulsions as they accumulate at interfaces and also increase the viscosity of the aqueous phase, thereby decreasing the rate of formation of aggregates of droplets. Aggregation is generally accompanied by a relatively rapid separation of an emulsion into a droplet-rich and droplet-poor phase. Normally the density of an oil is lower than that of water, in which case the oil droplets and droplet aggregates rise, a process referred to as creaming. The greater the rate of aggregation, the greater the droplet size and the greater the rate of creaming. The water droplets in a water-in-oil emulsion generally sediment because of their greater density.
The consistency of emulsions varies widely, ranging from easily pourable liquids to semisolid creams. Generally oil-in-water creams are prepared at high temperature, where they are fluid, and cooled to room temperature, whereupon they solidify as a result of solidification of the internal phase. When this is the case, a high internal-phase volume to external-phase volume ratio is not necessary for semisolid character, and, for example, stearic acid creams or vanishing creams are semisolid with as little as 15% internal phase. Any semisolid character with water-in-oil emulsions generally is attributable to a semisolid external phase.
All emulsions require an antimicrobial agent because the aqueous phase is favorable to the growth of microorganisms. The presence of a preservative is particularly critical in oil-in-water emulsions where contamination of the external phase occurs readily. Since fungi and yeasts are found with greater frequency than bacteria, fungistatic as well as bacteriostatic properties are desirable. Bacteria have been shown to degrade nonionic and anionic emulsifying agents, glycerin, and many natural stabilizers such as tragacanth and guar gum.
Complications arise in preserving emulsion systems, as a result of partitioning of the antimicrobial agent out of the aqueous phase where it is most needed, or of complexation with emulsion ingredients that reduce effectiveness. Therefore, the effectiveness of the preservative system should always be tested in the final product. Preservatives commonly used in emulsions include methyl-, ethyl-, propyl-, and butyl-parabens, benzoic acid, and quaternary ammonium compounds.
See also Creams and Ointments.