About Oral Liquids ( artical help you for your interview preparation for production and QA department in pharmaceutical industry and also in QC department )

The source of the content is Indian pharmacopoeia 2007    

Oral Liquids 

Oral Liquids are homogeneous liquid preparations, usually consisting of a solution, an emulsion or a suspension of one or more medicaments in a suitable vehicle. They are intended for oral administration either undiluted or after dilution. They may contain auxiliary substances such as suitable dispersing, emulsifying, suspending, wetting, solubilising, thickening, stabilising agents and antimicrobial preservatives. They may also contain suitable sweetening, flavouring and permitted colouring agents. if saccharin, including its sodium and potassium salts, is used as a sweetening agent, its concentration in preparations meant for paediatric use should be restricted so as to limit its intake to 5 mg per kg of body weight.

Oral Liquids other than Oral Emulsions may be supplied as liquids or prepared just before use by dissolving or dispersing granules or powder in the liquid stated on the label. The granules or powder comply with the requirements stated under 

Oral Powders.

During manufacture, packaging, storage and distribution of oral liquids, suitable means shall be taken to ensure their microbial quality; acceptance criteria for microbial quality are given in Chapter 5.9.(IP) Oral Liquids should not be diluted and stored; where, however, the individual monograph directs dilution, the diluted Oral Liquid should be freshly prepared irrespective of the nature of the diluent. Diluted Oral Liquids may be less stable physically and chemically than the corresponding undiluted

preparation and should be used within the period stated on the label. Oral Liquids are variously known as Elixirs, Linctuses Mixtures, Oral Drops, Oral Emulsions, Oral Solutions, Oral Suspensions

and Syrups. These terms are defined below.

Elixirs.

Elixirs are clear, flavored Oral Liquids containing one or more active ingredients dissolved in a vehicle that usually contains a high proportion of Sucrose or a suitable polyhydric alcohol or alcohols and may also contain Ethanol (95 per cent) or a dilute Ethanol.

Linctuses.

Linctuses are viscous Oral Liquids containing one or more active ingredients dissolved in a vehicle that usually contains a high proportion of sucrose, other sugars or a suitable polyhydric alcohol or alcohols. Linctuses are intended for use in the treatment or relief of cough, and are sipped and swallowed slowly without the addition of water.

Mixtures.

Mixtures are Oral Liquids containing one or more active ingredients dissolved, suspended or dispersed in a suitable vehicle. Suspended solids may separate slowly on keeping but are easily redispersed on shaking.

Oral Drops.
Oral Drops are Oral Liquids that are intended to be administered in small volumes with the aid of a suitable measuring device such as a dropper.

Oral Emulsions. 

Oral Emulsions are Oral Liquids containing one or more active ingredients and are stabilised oil-in-water dispersions, either or both phases of which may contain dissolved solids. Solids may also be suspended in Oral

Emulsions.
Emulsions may exhibit phase separation but are easily reformed on shaking. The preparation remains
sufficiently stable to permit a homogeneous dose to be withdrawn.

Oral Solutions.

Oral Solutions are Oral Liquids containing one or more active ingredients dissolved in a suitable vehicle. Oral Suspensions. Oral Suspensions are Oral Liquids containing one or more active ingredients suspended in a suitable vehicle. Suspended solids may slowly separate on keeping but are easily redispersed. In the manufacture of oral suspensions containing dispersed particles, measures shall be taken to ensure a suitable and controlled particle size with regard to the intended use of the

product.

Syrups. 

Syrups are viscous Oral Liquids that may contain one or more active ingredients in solution. The vehicle usually contains large amounts of Sucrose or other sugars to which certain polyhydric alcohols may be added to inhibit crystallisation or to modify solubilisation, taste and other vehicle properties. Sugarless syrups may contain sweetening agents and thickening agents. Syrups may contain Ethanol (95%) as a preservative or as a solvent to incorporate flavouring agents. Antimicrobial agents may also be added to Syrups.

Containers.

Oral Liquids may be supplied in multiple dose or single dose containers. Oral Emulsions and Oral Suspensions should be packed in bottles sufficiently wide-mouthed to facilitate the flow of the contents. They are administered either in volumes such as 5 ml, or multiples of 5 ml, or in small volumes (drops). Each dose of a multiple dose Oral Liquid is administered by means of a suitable measuring device which is usually provided with the container.

Tests

Uniformity of content.

Unless otherwise specified, single dose liquids in suspension form or powders or granules presented

in single dose containers and that contain less than 10 mg or less than 10 per cent of active ingredient comply with the following test. For Oral Liquids containing more than one active ingredient, carry out the test for each active ingredient that corresponds to the above conditions. Empty each

container as completely as possible and carry out the test on the individual contents of active ingredients. The test for Uniformity of content should be carried out only after the content of active ingredient(s) in a pooled sample of the preparation has been shown to be within the accepted limits of the stated content. Determine the content of active ingredient(s) of each of 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of

equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 to 115 per cent of the average value. The preparation fails to comply with the test if more than one individual value is outside the limits 85 to 115 per cent of the average value or if any one individual value is outside the limits 75 to 125 per cent of the average value. If one individual value is outside the limits 85 to 115 per cent but within the limits 75 to 125 per cent of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than 3 individual values are outside the limits 85 to 115 per cent and not more than one is outside the limits 75 to 125 per cent of the average value. Uniformity of weight/volume. Unless otherwise specified, Oral Liquids comply with the test for contents of packaged dosage forms . Storage. Store Oral Liquids or powders and granules for the preparation of Oral Liquids in well-closed containers at temperatures not exceeding 30º c Labeling. For Oral Liquids that are supplied as drops, the label states the number of drops per g of preparation if the dose is stated in drops or the number of drops per ml of preparation if the dose is stated in volume. For oral liquids supplied as granules or powder to be constituted before use, the label states

 (1) that the contents are meant for preparation of an Oral Liquid;

 (2) the directions for preparing the Oral liquid including the nature and quantity of the liquid to be            used;

 (3) the conditions under which the constituted solution should be stored;

 (4) the period during which the constituted Oral Liquid may be expected to remain satisfactory for            use when prepared and stored in accordance with the manufacturer’s recommendations; 

(5) the strength in terms of the active ingredient(s) in a suitable dose-volume of the constituted                 preparation.

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