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An emulsion is essentially a liquid preparation containing a mixture of oil and water that is rendered homogeneous by the addition of an emulsifying agent.
British Pharmacopoeia (BP) Definition (oral emulsions) Oral emulsions are oral liquids containing one or more active ingredients. They are stabilised oil-in-water dispersions. . either oil-inor both phases of which may contain dissolved solids.
The aqueous phase is easily flavoured. one in each phase of the emulsion. The rate of absorption is increased. It is possible to include two incompatible ingredients. Unpalatable oil-soluble drugs can be administered in oilpalatable form. .Advantages and disadvantages of emulsions as dosage forms Advantages Unpalatable oils can be administered in palatable form. The oily sensation is easily removed.
A degree of technical accuracy is needed to measure a dose. Bulky. A measuring device is needed for administration. Liable to microbial contamination which can lead to cracking. . Storage conditions may affect stability. difficult to transport and prone to container breakages.Disadvantages Preparation needs to be shaken well before use.
affected. .Extemporaneous preparation In oral emulsions prepared according to the formula and directions given for extemporaneous preparation. the quantity of emulsifying agent specified in individual monographs may be reduced to yield a preparation of suitable consistency provided that by so doing the stability of the preparation is not adversely affected.
.Stability of emulsions Emulsions can break down in the following ways: cracking creaming phase inversion.
Cracking This is the term applied when the disperse phase coalesces and forms a separate layer. Cracking can occur if the oil turns rancid during storage. Redispersion cannot be achieved by shaking and the preparation is no longer an emulsion. causing the two phases to separate. . The acid formed denatures the emulsifying agent.
forming a layer on top of the emulsion. cream on the top of a pint of milk).Creaming In creaming. . milk). the (e. but it usually remains in globules so that it can be redispersed on shaking (e.g. the oil separates out.
dose. . Creaming is less likely to occur if the viscosity of the continuous phase is increased.---Continued-----Continued--- This is undesirable as the product appearance is poor and if the product is not adequately shaken there is a risk of the patient obtaining an incorrect dose. increased.
. For stability of an emulsion. the optimum range of concentration of dispersed phase is 30 60% of the total volume.Phase inversion This is the process when an oil-in-water oil-inemulsion changes to a water-in-oil water-inemulsion or vice versa.
. As the concentration of the disperse phase approaches a theoretical maximum of 74% 74% of the total volume. occur. phase inversion is more likely to occur. the stability of the emulsion is questionable.---Continued-----Continued--- If the disperse phase exceeds this. questionable.
. Can be saved emulsion on shaking. product not homogeneous. one containing more of the disperse phase.Summary of the problems encountered by emulsions Creaming: Separation of the emulsion into two regions. Possible reasons for problem: lack of stability of the system.
Possible reasons for problem: incompatible emulsifying agent decomposition of the emulsifying agent change of storage temperature. The emulsion will not reform on shaking.----Continued-------Continued---- Cracking: The globules of the disperse phase coalesce and there is separation of the disperse phase into a separate layer. .
water-inoil-inPossible reason for problem: amount of disperse phase greater than 74%. .---Continued-----Continued--Phase inversion From oil-in-water to water-in-oil or oil-inwater-infrom water-in-oil to oil-in-water. The emulsion will not reform on shaking.