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Oral liquids are homogeneous liquid preparations, usually a solution, an emulsion or a suspension of one or more active ingredients in a suitable liquid base. They are prepared for oral administration as such or after dilution. They may contain other substances such as suitable dispersing, solubilizing, wetting, emulsifying, stabilizing, suspending, thickening agents and antimicrobial substances for preservation.
They may contain suitable sweetening agents, flavoring agents and approved coloring agents. If sodium saccharin or potassium saccharin is used for sweetening, its concentration in infant preparations should not exceed 5 mg per kg of body weight.
During the oral fluid manufacturing, packaging, storage and distribution process, microbial quality should be maintained and microbial counts should be within acceptance criteria. Oral fluids should not be diluted and stored after dilution unless the individual monograph directs dilution. The reconstituted oral liquid may not be physically and chemically stable for long periods of time so it should be freshly diluted or used within the time stated on the label.
1. Syrup: Syrup is a diluted oral liquid containing one or more active ingredients in solution. The base usually contains large amounts of sucrose or other sugars to which sorbitol may be added to inhibit crystallization or alter solubility, flavor, and other base properties. Sugar-free syrups may contain saccharin and other sweetening agents such as thickening agents. Syrups may contain ethanol (95%) as a preservative or as a solvent for flavoring. Antimicrobial agents may also be added to syrups to maintain the microbial quality of the preparation.
2. Oral Suspension: Oral suspension is an oral liquid containing one or more active ingredients suspended in a suitable base. Suspended solids may have different retention times but are readily redispersed by shaking. In the manufacture of oral suspensions containing suspended particles, it should be ensured that the size of the particles should be controlled for the intended use of the preparation.
3. Oral Solution: An oral solution is an oral liquid containing one or more active ingredients dissolved in a suitable base.
4. Oral drops: Oral drops are an oral liquid prepared for ingestion in small amounts with a suitable measuring device such as a dropper.
5. Oral emulsions: Oral emulsions are oral liquids containing one or more active ingredients that are unstable in the aqueous phase and stable oil-water dispersions; Either or both stages of preparation may contain dissolved solids. Both stages of preparation may be separate but are easily mixed by shaking. The preparation is completely stable to give a homogeneous dose when taken after proper shaking.
6. Mixture: Mixture is an oral liquid in which one or more active ingredients are suspended or dispersed in a suitable base. Suspended solids may separate for a period of time but are easily resuspended by shaking.
7. Linctus: Linctus is a viscous oral liquid containing one or more active ingredients dissolved in a suitable base which usually contains a high concentration of sucrose or other sugars. Linctus is usually prepared to treat cough and is taken without water.
8. Elixir: It is a clear, flavored oral liquid containing one or more active ingredients dissolved in a suitable base containing a high proportion of sucrose and may contain ethanol (95 percent) or a diluted ethanol.
