Elixirs are clear, sweetened hydroalcoholic solutions intended for oral use and are usually flavored to enhance their palatability. Non-medicated elixirs are employed as vehicles, and medicated elixirs are used for the therapeutic effect of the medicinal substances they contain.
Compared with syrups, elixirs are usually less sweet and less viscous because they contain a lower proportion of sugar and consequently are less effective than syrups in masking the taste of medicinal substances. Because of their hydroalcoholic character, elixirs are better able than aqueous syrups to maintain both water-soluble and alcohol-soluble components in solution. Also, because of their stable characteristics and the ease with which they are prepared (by simple solution), from a manufacturing standpoint, elixirs are preferred to syrups.
The proportion of alcohol in elixirs varies widely because the individual components of the elixirs have different water and alcohol solubility characteristics. Each elixir requires a specific blend of alcohol and water to maintain all of the components in solution. Naturally, for elixirs containing agents with poor water solubility, the proportion of alcohol required is greater than for elixirs prepared from components having good water
In addition to alcohol and water, other solvents, such as glycerin and propylene glycol, are frequently employed in elixirs as adjunctive solvents. Although many elixirs are sweetened with sucrose or with a sucrose syrup, some use sorbitol, glycerin, and/or artificial sweeteners. Elixirs having a high alcoholic content usually use an artificial sweetener, such as saccharin, which is required only in small amounts, rather than sucrose, which is only slightly soluble in alcohol and requires greater quantities for
equivalent sweetness. All elixirs contain flavorings to increase their palatability, and most elixirs have coloring agents to enhance their appearance. Elixirs containing more than 10% to 12% of alcohol are usually self-preserving and do not require the addition of an antimicrobial agent.
A disadvantage of elixirs for children and for adults who choose to avoid alcohol is their alcoholic content. Because of their usual content of volatile oils and alcohol, elixirs should be stored in tight, light-resistant containers and protected from excessive heat.
Advantages of elixirs
• Insoluble drug compounds can be incorporated into the hydroalcoholic vehicle;
• Drug concentrates can be prepared in high-alcohol-containing elixirs
• Hydroalcoholic vehicles can be self-preserving;
• Elixirs are less viscous and contain a lower proportion of sugar.
Disadvantages of elixirs
• They cannot be administered to pediatric patients and patients on antidepressant medication;
• The concentration of active and inactive ingredients may vary if not preserved in cool places;
• Water-insoluble drug compounds may precipitate due to alcohol evaporation.
Preparation of Elixirs
Elixirs are usually prepared by simple solution with agitation and/or by admixture of two or more liquid ingredients.
Alcohol soluble and water-soluble components are generally dissolved separately in alcohol and in purified water, respectively. Then the aqueous solution is added to the alcoholic solution, rather than the reverse, to maintain the highest possible alcoholic strength at all times so that minimal separation of the alcoholsoluble components occurs. When the two solutions are completely mixed, the mixture is made to the volume with the specified solvent or vehicle.
Frequently, the final mixture will be cloudy, principally because of separation of some of the flavoring oils by the reduced alcoholic concentration. If this occurs, the elixir is usually permitted to stand for a prescribed number of hours to ensure saturation of the hydroalcoholic solvent and to permit the oil globules to coalesce so that they
may be more easily removed by filtration.
Talc, a frequent filter aid in the preparation of elixirs, absorbs the excessive amounts of oils and therefore assists in their removal from the solution. The presence
of glycerin, syrup, sorbitol, and propylene glycol in elixirs generally contributes to the solvent effect of the hydroalcoholic vehicle, assists in the dissolution of the solute, and enhances the stability of the preparation. However, the presence of these materials adds to the viscosity of the elixir and slows the rate of filtration.
Nonmedicated elixirs may be useful to the pharmacist in the extemporaneous filling of prescriptions involving
• The addition of a therapeutic agent to a pleasant-tasting vehicle and
• Dilution of an existing medicated elixir
In selecting a liquid vehicle for a drug substance, the pharmacist should be concerned with the solubility and stability of the drug substance in water and alcohol. If a hydroalcoholic vehicle is selected, the proportion of alcohol should be only slightly above the amount needed to effect and maintain the drug’s solution.
When a pharmacist is called on to dilute an existing medicated elixir, the non-medicated elixir he or she selects as the diluent should have approximately the same alcoholic concentration as the elixir being diluted. Also, the flavor and color characteristics of the diluent should not be in conflict with those of the medicated elixir, and all components should be chemically and physically compatible.
Medicated elixirs are employed for the therapeutic benefit of the medicinal agent. Most
official and commercial elixirs contain a single therapeutic agent. The main advantage of having only a single therapeutic agent is that the dosage of that single drug may be increased or decreased by simply taking more or less of the elixir, whereas when two or more therapeutic agents are present in the same preparation, it is impossible to increase or decrease the dose of one without an automatic and corresponding adjustment in the dose of the other, which may not be desired.