Oral Liquid Formulations
The oral liquids are homogenous liquid preparations, which contain an emulsion, solution or suspension of one or more active ingredients that are suitable as liquid base. These preparations are administered either as is or after dilution.
The preparations contain other substances such as sweetening agents, flavouring and allowable colouring agents. For paediatric preparation, concentration of sweetening such as sodium or potassium saccharin should not be more than 5mg/kg of the body weight.
The oral liquid should not be diluted or stored after the dilution unless the monograph directs for dilution. The diluted oral liquid might become unstable after a long period physically or chemically; as such, it should be diluted freshly or used as stated on the label.
Difference between ampule and vial? Ampule- simple dose unit. Vial- Multiple dose unit.
Classes of oral liquid dosage forms include:
- Syrup: a viscous oral liquid that contains one or more active ingredients in solution. The base generally contains large amounts of sucrose, other sugars, or sweetening agents. Syrups may contain ethanol (95%) as a preservative or as a solvent for flavours. Antimicrobial agents may also be added to syrups to maintain the microbial quality of preparation.
- Oral Suspension: an oral liquid that contains one or more active ingredients suspended in a suitable base.
- Oral Solution: an oral liquid that contains one or more active ingredients dissolved in a suitable base.
- Oral Drop: an oral liquid that is prepared to take in small quantity with the help of a suitable measuring device such as a dropper.
- Oral Emulsion: an oral liquid that contains one or more active ingredients that are unstable in the water phase and is stabilized oil-in-water dispersions; either or both phases of the preparation may contain dissolved solids.
- Mixtures: an oral liquid containing one or more active ingredients suspended or dispersed in a suitable base.
- Linctus: a viscous oral liquid that contains one or more active ingredients dissolved in a suitable base that generally contains a higher concentration of sucrose or other sugars.
- Elixir: a clear, flavoured oral liquid containing one or more active ingredients dissolved in a suitable base that contains a high proportion of sucrose and may also contain ethanol (95%) or a diluted ethanol.
Dry Powder for Suspension: Dry powder for suspension are preparations of finely powdered drug intended for suspension in liquid vehicles. They are generally reconstituted with recommended volume of purified water. A dry mixer of an Antibiotic e.g. Ampicillin, when mixed with one or more suitable buffers, preservatives, stabilizers, sweetening agent and suspending agents suitable for reconstitution are called dry powder for suspension.
Powders are usually prepared by uniformly mixing drugs with or without diluents, binders, disintegrators or other suitable excipients by a suitable method to produce a pulverized or finally granulated form. If necessary coloring agents, aromatic agents, flavoring agents etc may be added.
Monophasic liquid forms are essentially homogenous solutions of active ingredient dissolved in water or non-aqueous solvent (e.g., alcohol, glycerine or ether). The most common monophasic forms are:
- Spirit/Essence. This class of dosage forms are alcoholic or hydro-alcoholic solutions of volatile substances. The substance may be solid liquid or gas but when in solution form can be used as flavouring agent or for the therapeutic value of the aromatic solute.
- Elixir. Elixirs are clear sweetened or flavoured liquid, which contains active ingredients dissolved in suitable base. Elixirs often contain a high percentage of sucrose, and may contain 95% ethanol or diluted ethanol. They are less viscous and sweet than syrups. They are more able to maintain water or alcohol soluble materials in solution than syrups are more stable and easily prepared by simple solution. Conversely, they are less able to mask the taste of medicated substances than syrups.
- Fluid extracts. Fluid extracts are solutions of drugs or therapeutic or nutritional materials usually made by solvent extraction from plant material. Examples are extracts of celery or oats.
- Mouth wash, Gargles. These liquids are usually aqueous or water-alcohol solutions that are mildly medicated to help address problems with teeth and gums, or with antiseptic to help heal throats.
Biphasic liquid forms are encountered when dissolution of the active ingredient(s) do not dissolve in common solvents. The most commonly encountered are suspensions, emulsions or mixtures.
- Oral Suspension. The oral suspension is a liquid form that contains active ingredients suspended in a suitable base. Over time, the solid particles may separate but shaking will re-disperse on shaking.
- Oral Emulsion. This oral liquid contains active ingredients that are unstable in the water phase and but can be stabilized in an oil-in-water dispersions. Either or both of the phases may contain dissolved solids. Both liquid phases may separate but can be mixed by shaking. The preparation is fully stable and can provide a homogenous dose after proper shaking.
- Mixtures. The oral liquid contains one or more active ingredients that are either suspended or dispersed in suitable base. As with the suspensions or emulsions, the suspended solids may separate but are easily re-suspended on shaking.
- Linctus. This viscous oral liquid contains active ingredients that are dissolved in a suitable base and contains high concentration of sugar. This treatment is used for cough treatment and can be taken without water.
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