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Table 1 Short dictionary of drug formulation terminology

From: Drugs for neglected tropical diseases: availability of age-appropriate oral formulations for young children

Term

Definition

Active pharmaceutical ingredient (API)

Any drug or drug substance used in a finished pharmaceutical product, whose use is to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition

Capsule sizes [8]

0: External diameter = 7.64 mm; length = 21.7 mm

1: External diameter = 6.91 mm; length = 19.4 mm

2: External diameter = 6.35 mm; length = 18.0 mm

3: External diameter = 5.82 mm; length = 15.9 mm

4: External diameter = 5.32 mm; length = 14.3 mm

Drug/drug substance

Any substance that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition

Drug product/finished pharmaceutical product

A product that contains one or more APIs. Products can exist in many forms including tablets, capsules, liquids, creams and patches. They can also be administered in different ways, e.g. orally, as an injections into the vein, muscle or subcutaneous tissue or applied directly to the skin

Excipient

Substances other than the API that have been appropriately evaluated for safety and are intentionally included in a drug product/finished pharmaceutical product to serve different needs, e.g. stabilisation, enhancing solubility, filler

Solid oral dosage form

Refers to tablets or capsules or other solid dosage forms (made from powder)

These can be sub-divided into those intended for immediate release and those intended to modify the release of the API

Tablets

Refers to:

• Uncoated or coated (film-coated or sugar-coated) tablets that are intended to be swallowed whole

• Unscored and scored*

• Tablets that are intended to be chewed before being swallowed

• Tablets that are intended to be dispersed or dissolved in water or another suitable liquid before being swallowed

• Tablets that are intended to be crushed before being swallowed

The term ‘tablet’ without qualification means an immediate-release tablet; any type of modified release version would have appropriate wording included in a qualifying description

*Scored tablets may be divided for ease of swallowing, provided that dose is a whole number of tablets

Tablets (qualified)

Refers to a specific type of tablet:

• Chewable—tablets that are intended to be chewed before being swallowed

• Dispersible—tablets that are intended to be dispersed in water or another suitable liquid before being swallowed

• Soluble—tablets that are intended to be dissolved in water or another suitable liquid before being swallowed

• Crushable—tablets that are intended to be crushed before being swallowed

• Scored—tablets bearing a break mark or marks where subdivision is intended to provide doses of less than one tablet

• Orodispersible—tablets that are intended to disperse within the mouth, without the need for additional water, before being swallowed. These are also referred to as ‘melts’ as they ‘melt’ onto the tongue in the saliva

• Sublingual—tablets that are intended to be placed beneath the tongue

Modified release tablets (qualified)

Refers to a specific type of modified release tablet including delayed-release tablets (gastro-resistant/enteric-coated tablets) and sustained-release tablets (extended-/prolonged-release tablets)

• SR, CR, XR or ER is short for sustained, controlled or extended release, respectively, meaning that the tablet is formulated so that the API is released slowly over time

• MR is short for modified-release, meaning that the tablet is formulated so that the API release is not instant but can be triggered by gastrointestinal conditions. It can also mean that the API is released slowly over time

• Gastro-resistant or enteric-coated tablets are those where a coating is applied to prevent disintegration in the stomach so that the API will only be released once the tablet reaches the small intestine

Capsule

Refers to hard or soft capsules

The term ‘capsule’ without qualification is never intended to allow any type of modified-release capsule

Capsules (qualified)

The term ‘capsule’ with qualification refers to gastro-resistant (such capsules may sometimes be described as enteric coated or as delayed release), prolonged release or another modified release form

Granules

Preparations that are issued to patient as granules to be swallowed without further preparation, to be chewed or to be taken in or with water or another suitable liquid

Granules can be presented within capsules or sachets that are opened to extract the dose

The term ‘granules’ without further qualification is never intended to allow any type of modified-release granules

Oral powder

Preparations that are issued to patient as powder (usually as single-dose) to be taken in or with water or another suitable liquid

Powders can be provided within capsules or sachets that are opened to extract the dose

Oral liquid

Liquid preparations intended to be swallowed, i.e. oral solutions, suspensions, emulsions and oral drops, including those constituted from powders or granules, but not those preparations intended for oromucosal administration, e.g. gargles and mouthwashes

Oral liquids presented as powders or granules may offer benefits in the form of better stability and lower transport costs. If more than one type of oral liquid is available on the same market (e.g. solution, suspension, granules for reconstitution), they may be interchanged and, in such cases, should be bioequivalent. It is preferable that oral liquids do not contain sugar and that solutions for children do not contain alcohol

Oral disintegrating/dissolving films or strips

Oral disintegrating/dissolving films or strips are defined as drug delivery systems that rapidly release API within the oral cavity by dissolving within the saliva present. The drug may then be absorbed directly from the mucosal surfaces of the oral cavity as well as swallowed and absorbed from the gastrointestinal tract

  1. Source: [9, 10]