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Quality Control Sheet Appearance: creamy, white, thick homogenous mixture Volume: 10 mL pH: Pourability: easily pourable Redispersability: redispersable Particle size-Apperance Relationship: > 1 m, milky Physical Stability: Aggregation, Coalescence, Creaming, Microbial growth, Oxidative decomposition, Phase Inversion, Sedimentation Test Preparation A (w/o) Preparation B (o/w) Dilution Test Dissolves in oil; not dissolved in water Dissolves in water; not dissolved in oil Conductivity Test Does not light the lamp Lights up lamp Dye-Solubility Test Oil-soluble dye colors the solution; water-soluble dye forms colored aggregates Water-soluble dye colors the whole emulsion; oil-soluble dye forms colored aggregates CoCl2/Filter Paper Test CoCl2 paper stays colored blue CoCl2 paper changes from blue to pink Fluorescence Test No dotted pattern Forms dotted pattern Packaging Requirement: Preserve in well-closed containers. Label: Shake well before use Container: 15mL flint bottle Cap: Black plastic screw cap with cap liner B. Label C. Schematic Diagram D. Answers to Guide Questions 1. Official Title: non-official Category: Gastrointestinal Drug Synonyms: None Uses: - Enhances drug stability - Masking of unpleasant odor or taste of drug - Enhanced absorption of drugs & oil because of the reduced particle size of the internal phase - Absorption rate and permeation of medicaments are controlled - Suitability for topical application 2. Review of Basic Concepts: a. Dispersed Systems/ Emulsions Emulsions are dispersions in which the dispersed phase is composed of small globules of a liquid distributed throughout a vehicle in which it is immiscible. Emulsions are two-phase systems of two immiscible liquids. b. Types of Emulsions > Macromolecule emulsion the coarse pharmaceutical macroemulsions appear white and tend to separate on standing * Oil in Water (o/w) emulsion with an oleaginous internal phase and an aqueous external phase an emulsifying agent w/ hydrophilic character will promote an o/w emulsion present in casein, egg yolk, gelatin * Water in Oil (w/o) emulsion with an aqueous internal phase & an oleaginous external phase an emulsifying agent with hydrophobic character will promote w/o emulsion > Multiple emulsion dispersed phase of 3 emulsions which contain even smaller droplets which are miscible with the continuous phase; emulsions within emulsions both hydrophilic & hydrophobic emulsifiers are used & both have an effect on the yield and stability; multiple emulsions are used to separate 2 incompatible substances * Oil in Water (o/w) the aqueous phase is between the two oil phases * Water in Oil (w/o) the internal and external aqueous phases are separated by an oil phase > Microemulsion translucent or transparent, does not separate and has a droplet diameter in the nanometer size range

microemulsion is thermodynamically stable, optically transparent, isotropic mixtures of a biphasic oil-water system stabilized with surfactants Activity To Be Expected from Surfactants with Assigned HLB Numbers HLB Range Activity 0 3 antifoaming 4 6 emulsifiers (w/o) 7 9 wetting agents 8 18 emulsifiers (o/w) 10 18 solubilizers 13 15 detergents c. Basic Components of an Emulsion, with examples > Internal Phase/ Discontinuous Phase / Dispersed Phase o Ex. Water, oil > External Phase/ Continuous Phase / Dispersing Medium o Ex. Water, oil > Emulsifying Agent o (Natural) egg yolk, gelatine, casein, acacia, tragacanth, chondrus o (Synthetic) sodium lauryl sulphate, benzalkonium chloride, polyethylene glycol 400 monostearate, Span, Tween d. Uses of Ingredients * Mineral oil/water solvent * Mineral oil/ water internal phase * Span 80 / Tween 80 emulsifier * Viscosity agents * Preservatives e. RFIS 1. Heat mineral oil to 60oC. To incorporate emulsifier effectively 2. Heat water to 65oC. To incorporate emulsifier effectively 3. Maintain at 70-72oC after mixing the 2 phase. Temperature at which the 2 phases are in maximum contact with each other 4. Constant stirring. To disperse the globules evenly f. Procedure and Specifications for the ff QC tests: 1) Particle Size-Appearance relationship Droplet Size Appearance > 1 m Milky 0.1 1 m Blue-white (Tyndall effect) 0.05 0.1 m Gray, semi-transparent < 0.05 m Transparent 2) Methods of determining emulsion type > Dilution test depends on the fact that an o/w emulsion can be diluted with water and aw/o emulsion, with oil when oil is added to an o/w emulsion or water to a w/o emulsion, the additive is not incorporated into the emulsion and separation is apparent is greatly improved if the addition of water or oil is observed microscopically > Conductivity test higher conductivity is observed in an emulsion in which the continuous phase is aqueous compared to an emulsion with an oleaginous continuous phase usually, if a pair of electrodes, connected to a lamp and an electrical source, is dipped in an o/w emulsion, the lamp will light up due to passage of a current between the two electrodes if the lamp does not light, the emulsion is assumed to be the w/o type > Dye-solubility test basis: a water-soluble dye will dissolve in the aqueous phase of an emulsion while an oil-soluble dye will be taken up by the oil phase o/w emulsion: if microscopic examination shows that a water-soluble dye has been taken up the continous phase

w/o emulsion: water-soluble dye did not stain the continuous phase, but upon addition of oil-soluble dye, coloring of the continuous phase occurs > CoCl2/Filter Paper test filter paper with cobalt chloride will become blue from pink in an o/w emulsion > Flourescence test ultraviolet light thru w/o emulsion will exhibit dot patterns in o/w emulsions, the fluorescence is shown throughout the emulsion From USP 32 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-inwater 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 oilin-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 internalphase 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.