Controlled Vocabulary of Pharmaceutical Forms, Routes of Administration and Packaging of Medicines

At one time or another everyone needs to buy medicine, don’t they?

And it is at this time that you realize that you have a medicine with a difficult name, with a complicated, similar substance, generics, reference and now you also have the same interchangeable similar.

As if that were not enough, each of these medications has a multitude of presentations and each with its own terms. This is where things really complicate, there are so many abbreviations, pharmaceutical forms, packaging, accessories, related terms that, what was meant to help, ends up causing even more headaches .

To help you, we decided to explain what all these terms mean. Check out:

Presentation

Information on medicines involves several technical characteristics, such as the pharmaceutical forms, routes of administration and packaging.

The lack of standardization of nomenclatures and concepts related to these characteristics hinders the correct classification of medicines and common understanding. Another important aspect is the abbreviation of these technical characteristics, which are widely used in official publications, but are not standardized and constitute an obstacle to communication.

This work was developed with the objective of creating controlled vocabularies (standardization of terms, concepts and abbreviations) to be used as a primary reference, mainly in the registration and post-registration of medicines, in their package inserts and labels, in information systems and other activities that require standardized information on packaging, routes of administration and pharmaceutical forms of medicines, as in the certification of Good Manufacturing Practices (hence the need to convey the drug production line in this standardization).

The standardization was carried out from the survey and systematization of the “state of the art” on pharmaceutical forms, routes of administration and packaging in terms of terminologies and concepts used by pharmacopoeias, health authorities and other national and international references. Meetings were held with several professionals in the field for the validation and review of the structure, concepts and terms, in order to arrive at the best possible classification and understanding.

In order to legitimize the work and to make the process transparent, the standardization was published in the form of Public Consultations No. 50/07, which presents the list of pharmaceutical forms and routes of administration, and No. 81/07, which presents the list of packaging . After the contributions of society and the regulated sector, standardization has reached its final format, which is flexible to accommodate new pharmaceutical forms, routes of administration and packaging that arise as a result of technological development, and can be updated periodically.

Definitions

Abbreviation for publication

Reduced form of the word up to a limit, so that there is no prejudice to the understanding in the publication of the record or in other activities that require standardized information about medicines.

Accessory

Supplement designed to dose, conduct or perform the administration of the pharmaceutical form to the patient. Marketed in the secondary packaging along with the medication and without direct contact with the pharmaceutical form.

Amber

It allows the total or partial visualization of the content and has a tone between brownish and yellowish. The amber color, being widely used, although it can be transparent or translucent, has a specific classification, due to its characteristics, which gives the packaging. It constitutes a protection barrier to luminosity.

Packaging composition

Material used in the production of a packaging component (eg: glass, plastic, aluminum).

Primary package

Packaging that maintains direct contact with the medication.

Secondary packaging

External product packaging, which is in contact with the primary packaging or intermediate packaging, and may contain one or more primary packaging.

Packing

Wrapper, container or any form of packaging, removable or not, intended to cover, package, fill, protect or maintain, specifically or not, medications.

Intermediate wrap

Optional packaging that is in contact with the primary packaging and constitutes a wrap or any other form of removable protection, and may contain one or more primary packaging, as approved by Anvisa.

Pharmaceutical form

Final state of presentation that the pharmaceutical active ingredients have after one or more pharmaceutical operations performed with the addition of appropriate excipients or without the addition of excipients, in order to facilitate its use and obtain the desired therapeutic effect, with characteristics appropriate to a particular route of administration.

Basic dosage form

General type of dosage form that groups together specific dosage forms with similar characteristics (eg capsule, tablet, suspension, solution).

Specific pharmaceutical form

Pharmaceutical form, in most cases, originates from the basic pharmaceutical form, with an indication of the form of presentation and administration and other characteristics of the formulation (eg, aerosol, for dilution, for infusion). The specific dosage forms are grouped by the basic dosage form.

Immediate release

Type of release of pharmaceutical forms that are not intentionally modified by a special formulation design and / or manufacturing method.

Prolonged release

Type of modified release of pharmaceutical forms that allows at least a reduction in the frequency of dose when compared to the drug presented in the form of immediate release. It is obtained through a special formulation design and / or manufacturing method.

Delayed release

Type of modified release of pharmaceutical forms that presents a delayed release of the active ingredient. The delayed release is achieved by means of a special formulation design and / or manufacturing method. Gastro-resistant preparations are considered delayed-release forms, as they are designed to resist gastric fluid and release the active ingredient in the intestinal fluid.

Opaque

That prevents viewing the content, covering all colors. It constitutes a protection barrier to luminosity.

Closed system

System of administration of parenteral solutions that, during all the preparation and administration, does not allow the contact of the solution with the environment.

General term

General name of the package that groups packages with similar characteristics (eg: ampoule, filled applicator, tube, blister).

Related terms

Words with similar meanings that should be used to facilitate the location of the classification.

Translucent

That allows partial visualization of the content, covering all colors except amber.

Transparent

That allows the total visualization of the content, covering all colors except amber.

Route of administration

Location of the organism through which the drug is administered.

Controlled vocabulary

Standardization of names, concepts and abbreviations.

Solid Pharmaceutical Forms

Adhesive

Concept : system designed to produce a systemic effect by the diffusion of the active principle (s) at a constant speed, for an extended period of time.
Abbreviation : ADES
For GMP certification purposes : Adhesive.

Ring

Concept : solid circular pharmaceutical form designed to release the active ingredient at a constant speed, for an extended period of time.
Abbreviation : RING
For GMP certification purposes : Ring.

bar

Concept : solid pharmaceutical form in the shape of a rectangle, containing one or more active ingredients.
Abbreviation : BAR
For GMP certification purposes : Barra.

Bat

Concept : solid pharmaceutical form containing one or more active ingredients, long and thin, often cylindrical in shape and that dissolves or melts at body temperature.
Abbreviation : BAST
For GMP certification purposes : Baton.

Capsule

General concept

Solid pharmaceutical form in which the active ingredient (s) and / or excipients are contained in a soluble hard or soft shell, of varying shapes and sizes, usually containing a single dose of the active ingredient. It is usually formed of gelatin, but it can also be of starch or other substances

Hard Capsule

Concept : capsule that consists of two prefabricated cylindrical sections (body and cover) that fit together and whose ends are rounded. It is typically filled with active ingredient (s) and excipients in solid form. It is usually formed of gelatin, but it can also be of other substances.
Abbreviation : CAP DURA
For GMP certification purposes : Capsule.

Prolonged Release Hard Capsule

Concept : capsule that consists of two prefabricated cylindrical sections (body and cover) that fit together and whose ends are rounded. It is typically filled with active ingredient (s) and excipients in solid form. It is usually formed of gelatin, but it can also be of other substances. See definition of extended release.
Abbreviation : CAP DURA LIB PROL
For GMP certification purposes : Capsule.

Delayed Release Hard Capsule

Concept : capsule that consists of two prefabricated cylindrical sections (body and cover) that fit together and whose ends are rounded. It is typically filled with active ingredient (s) and excipients in solid form. It is usually formed of gelatin, but it can also be of other substances. See definition of delayed release.
Abbreviation : CAP DURA LIB RETARD
For GMP certification purposes : Capsule.

Soft Capsule

Concept : capsule consisting of a gelatin shell, of various shapes, more malleable than that of hard capsules. It is usually filled with liquid or semi-solid contents, but it can also be filled with powders and other dry solids.
Abbreviation : CAP MOLE
For GMP certification purposes : Soft capsule.

Extended Release Soft Capsule

Concept : capsule consisting of a gelatin shell, of various shapes, more malleable than that of hard capsules. It
is usually filled with liquid or semi-solid contents, but it can also be filled with powders and other dry solids. See definition of extended release.
Abbreviation : CAP MOLE LIB PROL
For GMP certification purposes : Soft capsule.

Delayed Release Soft Capsule

Concept : capsule consisting of a gelatin wrapper, of various shapes, more malleable than that of hard capsules. It
is usually filled with liquid or semi-solid contents, but it can also be filled with powders and other dry solids. See definition of delayed release.
Abbreviation : CAP MOLE LIB RETARD
For GMP certification purposes : Soft capsule.

Compressed

General concept

Solid dosage form containing a single dose of one or more active ingredients, with or without excipients, obtained by compressing uniform volumes of particles. It can be of a wide variety of sizes and formats, have markings on the surface and be coated or not.

Compressed

Concept : uncoated tablet. The excipients used are not specifically intended to modify the release of the active ingredient (s) in digestive fluids.
Abbreviation: COM
For GMP certification purposes : Compressed.

Modified Release Tablet

Concept : pill that has a modified release. It should be classified as modified release only when the “delayed release” and “prolonged release” classifications are not adequate.
Abbreviation : COM LIB MOD
For GMP certification purposes : Compressed.

Extended Release Tablet

Concept : tablet whose excipients are specifically designed to modify the release of the active principle in digestive fluids. See definition of extended release.
Abbreviation : COM LIB PROL
For GMP certification purposes : Compressed.

Effervescent tablet

Concept : tablet containing, in addition to the active ingredients, acidic substances and carbonates or bicarbonates, which release carbon dioxide when the tablet is dissolved in water. It is intended to be dissolved or dispersed in water before administration.
Abbreviation : COM EFEV
For GMP certification purposes : Effervescent tablet.

Chewable tablet

Concept : tablet formulated so that it can be chewed, producing a pleasant aftertaste in the oral cavity.
Abbreviation : COM MAST
For GMP certification purposes : Tablet and / or Coated tablet.

Orodispersible tablet

Concept : pill that disintegrates or dissolves quickly when placed on the tongue.
Abbreviation : COM ORODISP
For GMP certification purposes : Compressed.

Mouthwash tablet

Concept : tablet that must be dissolved in water for the preparation of mouthwash, which is a liquid intended for mouthwash with action on the gums and mucous membranes of the mouth and throat. It should not be swallowed.
Abbreviation : COM COLUT
For GMP certification purposes : Compressed.

Tablet for Solution

Concept : pill intended to be dissolved in water before administration. The solution produced may be slightly cloudy due to the excipients used in the manufacture of the tablet.
Abbreviation : COM SOL
For GMP certification purposes : Compressed.

Tablet for Suspension

Concept : tablet that, when in contact with a liquid, quickly produces a homogeneous dispersion (suspension). It is intended to be dispersed before administration.
Abbreviation : COM SUS
For GMP certification purposes : Compressed.

Coated tablet

Concept : tablet that has one or more thin layers of coating, usually polymeric, designed to protect the drug from air or moisture, for drugs with an unpleasant odor and taste, to improve the appearance of the tablets or for some other property than that of change the speed or extent of release of the active ingredient.
Abbreviation : COM REV
For GMP certification purposes : Coated tablet.

Extended Release Coated Tablet

Concept : tablet that has one or more thin layers of coating, usually polymeric, designed to modify the speed or extent of release of the active ingredient (s). See definition of extended release.
Abbreviation : COM REV LIB PROL
For GMP certification purposes : Coated tablet.

Delayed Release Coated Tablet

Concept : tablet that has one or more thin layers of coating, usually polymeric, designed to modify
the speed or extent of the release of the active principle (s), presenting a delayed release of the principle (s) active). See definition of delayed release.
Abbreviation : COM REV LIB RETARD
For GMP certification purposes : Coated tablet.

Intra-uterine device

Concept : system to be inserted into the uterus to prevent effective conception from the release of the active principle at a constant speed, for an extended period of time.
Abbreviation : IUD
For BPF certification purposes : Intrauterine device.

Film

Concept : solid pharmaceutical form that consists of a thin and elongated film, containing a single dose of one or more active ingredients, with or without excipients.
Abbreviation : FIL
For GMP certification purposes : Film.

Blood cell

Concept : solid pharmaceutical form in the form of small spheres consisting of sucrose or a mixture of sucrose and lactose, impregnated with the desired potency and with alcohol above 70%.
Abbreviation : GLOB
For GMP certification purposes : Globule.

Chewing gum

Concept : solid dosage form of a single dose containing one or more active ingredients, consisting of insoluble, sweet and tasty plastic material. When chewed, it releases the active ingredient in the oral cavity. Intended for administration by mouth. It should not be swallowed.
Abbreviation : GOMA
For GMP certification purposes : Gum.

Grainy

General concept

Solid dosage form containing a single dose of one or more active ingredients, with or without excipients. It consists of solid and dry aggregates of uniform volumes of dust particles resistant to handling.

Grainy

Concept : see general concept (topic above).
Abbreviation : GRAN
For GMP certification purposes : Granules.

Effervescent granules

Concept : granules containing, in addition to the active ingredients, acidic substances and carbonates or bicarbonates, which release carbon dioxide when the granules are dissolved in water. It is intended to be dissolved or dispersed in water before administration.
Abbreviation : GRAN EFEV
For GMP certification purposes : Effervescent granules.

Granules for Solution

Concept : granules intended to be dissolved in water before administration. The produced solution can be slightly milky due to the excipients used in the manufacture of the granules.
Abbreviation : GRAN SOL
For GMP certification purposes : Granules.

Granules for Suspension

Concept : granules that, when in contact with a liquid, quickly produce a homogeneous dispersion (suspension). It is intended to be dispersed before administration.
Abbreviation : GRAN SUS
For GMP certification purposes : Granulated.

Coated Granules

Concept : granules that have one or more thin layers of coating, usually polymeric, designed to protect the drug from air or moisture, for drugs with an unpleasant odor and taste, to improve the appearance of the granules or for any other property other than that of change the speed or extent of release of the active ingredient.
Abbreviation : GRAN REV
For GMP certification purposes : Coated granules.

Extended Release Coated Granules

Concept : granules that have one or more thin layers of coating, usually polymeric, designed to modify the speed or extent of release of the active ingredients. See definition of extended release.
Abbreviation : GRAN REV LIB PROL
For GMP certification purposes : Coated granules.

Delayed Release Coated Granules

Concept : granules that have one or more thin layers of coating, usually polymeric, designed to modify the speed or extent of the release of the active ingredients, presenting a delayed release of the active ingredient. See definition of delayed release.
Abbreviation : GRAN REV LIB RETARD
For GMP certification purposes : Coated granules.

Implant

Concept : sterile solid dosage form containing one or more active ingredients and of suitable size and shape to be inserted into a body tissue in order to release the active ingredient (s) for an extended period of time. It is administered by means of an appropriate special injector or by surgical incision.
Abbreviation : IMPL
For GMP certification purposes : Implant.

Pellet

General concept

Solid pharmaceutical form that contains one or more active ingredients, usually in a sweet base and with a pleasant taste. It is used for slow dissolution or disintegration in the mouth. It can be prepared by molding or compression.

Hard Pellet

Concept : rigid tablet to be dissolved slowly.
Abbreviation : PAS DURA
For GMP certification purposes : Pellet.

Gummy Paste

Concept : flexible and soft tablet of mixtures containing synthetic or natural polymers.
Abbreviation : PAS GOM
For GMP certification purposes : Pellet.

Dust

General concept

Solid pharmaceutical form containing one or more dry active ingredients and with reduced particle size, with or without excipients.

Dust

Concept : see general concept.
Abbreviation : PO
For GMP certification purposes : Powder.

Aerosol Powder

Concept : powder packed under pressure containing a propellant gas and therapeutically active ingredients that are released after activation of an appropriate valve system.
Abbreviation : PO AER
For GMP certification purposes : Aerosol powder.

Effervescent Powder

Concept : powder containing, in addition to the active ingredient (s), acidic substances and carbonates or bicarbonates, which release carbon dioxide when the powder is dissolved in water. It is intended to be dissolved or dispersed in water before administration.
Abbreviation : PO EFEV
For GMP certification purposes : Effervescent powder.

Lyophilized Powder for Solution for Injection

Concept : sterile powder for the subsequent addition of liquid to form a solution. Prepared by lyophilization, a process that involves removing water from products by freezing at extremely low pressures.
Abbreviation : PO LIOF SOL INJ
For GMP certification purposes : Lyophilized powder.

Lyophilized Powder for Suspension for Injection

Concept : sterile powder intended for the subsequent addition of liquid to form a suspension. Prepared by lyophilization, a process that involves removing water from products by freezing at extremely low pressures.
Abbreviation : PO LIOF SUS INJ
For GMP certification purposes : Lyophilized powder.

Lyophilized Powder for Injectable Sustained-Release Suspension

Concept : sterile powder intended for the subsequent addition of liquid to form a suspension. Prepared by lyophilization, a process that involves removing water from products by freezing at extremely low pressures. See definition of extended release.
Abbreviation : PO LIOF SUS INJ LIB PROL
For GMP certification purposes : Lyophilized powder.

Mouthwash Powder

Concept : powder that must be dissolved in water before use for the preparation of mouthwash, which is a liquid intended for mouthwash with action on the gums and mucous membranes of the mouth and throat. It should not be swallowed.
Abbreviation : PO COLUT
For GMP certification purposes : Powder.

Powder for Solution

Concept : powder destined to be reconstituted to form a solution.
Abbreviation : PO SOL
For GMP certification purposes : Powder.

Powder for Solution for Injection

Concept : sterile powder for the subsequent addition of liquid to form a solution.
Abbreviation : PO SOL INJ
For GMP certification purposes : Powder (with terminal sterilization and / or aseptic preparation).

Powder for Solution for Infusion

Concept : sterile powder intended for reconstitution to form a solution for use by infusion. This solution is usually isotonic with blood and is used mainly for high volume administration.
Abbreviation : PO SOL INFUS
For GMP certification purposes : Powder (with terminal sterilization and / or aseptic preparation).

Powder for Suspension

Concept : powder destined to be reconstituted to form a suspension.
Abbreviation : PO SUS
For GMP certification purposes : Powder.

Powder for Injection Suspension

Concept : sterile powder intended for the subsequent addition of liquid to form a suspension.
Abbreviation : PO SUS INJ
For GMP certification purposes : Powder (with terminal sterilization and / or aseptic preparation).

Prolonged Release Injection Suspension Powder

Concept : sterile powder intended for the subsequent addition of liquid to form a suspension. See definition of extended release.
Abbreviation : PO SUS INJ LIB PROL
For GMP certification purposes : Powder (with terminal sterilization and / or aseptic preparation).

Erasure

Concept : dry and sectioned vegetable drug, of defined granulometry, with a diameter above 0.315 mm, intended for extemporaneous preparations such as infusions or decoctions.
Abbreviation : RAS
For GMP certification : Rasura.

Soap

Concept : solid pharmaceutical form with variable form depending on
the mold obtained, derived from the action of an alkali solution in animal or vegetable fats or oils. Intended for application on the skin surface.
Abbreviation : SAB
For GMP certification purposes : Soap.

Suppository

General concept

Solid pharmaceutical form of various sizes and shapes, adapted for insertion into the rectal, vaginal or urethral orifice of the human body, containing one or more active ingredients dissolved or dispersed on a suitable basis. Suppositories fuse, melt or dissolve at body temperature.

Suppository

Concept : see general concept.
Abbreviation : SUP
For GMP certification purposes : Suppository .

Ovum

Concept : solid dosage form of a single dose that can have several shapes, but which is usually ovoid. Contains one or more active ingredients dispersed or dissolved on an appropriate basis. Adapted for insertion into the vaginal orifice, they melt, melt or dissolve at body temperature.
Abbreviation : OVL
For GMP certification purposes : Egg.

TABLETS

Concept : solid pharmaceutical form prepared from a mass made with hydroalcoholic solution, the active ingredient (s) and lactose, or from the crushing itself moistened in hydroalcoholic solution. It is molded on tabletops and is fragile and brittle.
Abbreviation : TABLE
For GMP certification purposes : Tablet.

Liquid Pharmaceutical Forms

Emulsion

General concept

Liquid pharmaceutical form of one or more active ingredients that consists of a two-phase system involving at least two immiscible liquids and in which a liquid is dispersed in the form of small drops (internal or dispersed phase) through another liquid (external or to be continued). It is usually stabilized by one or more emulsifying agents.

Emulsion

Concept : see general concept.
Abbreviation : EMU
For GMP certification purposes : Emulsion.

Aerosol Emulsion

Concept : emulsion packaged under pressure, containing a propellant gas and therapeutically active ingredient (s) that are released after activation of an appropriate valve system.
Abbreviation : EMU AER
For GMP certification purposes : Aerosol emulsion.

Drops Emulsion

Concept : emulsion intended for administration in the form of drops.
Abbreviation : EMU GOT
For GMP certification purposes : Emulsion.

Injectable Emulsion

Concept : sterile emulsion for injection.
Abbreviation : EMU INJ
For GMP certification purposes : Small volume parenteral emulsion (with terminal sterilization or aseptic preparation).

Infusion Emulsion

Concept : sterile emulsion with water as the continuous phase, usually isotonic with blood and used mainly for administration in large volume.
Abbreviation : EMU INFUS
For GMP certification purposes : Large volume parenteral emulsion (with terminal sterilization or aseptic preparation).

Spray Emulsion

Concept : emulsion administered as a liquid finely divided by a jet of air or steam.
Abbreviation : EMU SPR
For GMP certification purposes : Emulsion.

Enamel

Concept : solution, containing one or more active ingredients, for application to the nails. It forms a film that does not come out with water.
Abbreviation : ESM
For GMP certification purposes : Enamel.

Foam

Concept : pharmaceutical form that consists of a large volume of gas dispersed in a liquid, usually containing one or more active substances. It is formed by the action of a propellant, and there may also be other excipients.
Abbreviation : ESP
For GMP certification purposes : Foam.

Liquid

General concept

Pharmaceutical form consisting of a pure chemical substance in the liquid state, which may be aqueous or oily. Note: this dosage form should not be applied to solutions, suspensions, emulsions, shampoos and liquid soaps.

Liquid

Concept : pharmaceutical form consisting of a pure chemical substance in a liquid state.
Abbreviation : LIQ
For GMP certification purposes : Net.

Oil

Concept : fatty liquid soluble in ether and insoluble in water.
Abbreviation : OLE
For GMP certification purposes : Oil.

Liquid soap

Concept : solution, containing one or more active ingredients, for application on the skin surface.
Abbreviation : SAB LIQ
For GMP certification purposes : Soap.

Solution

General concept

Clear and homogeneous liquid pharmaceutical form, which contains one or more active ingredients dissolved in a suitable solvent or in a mixture of miscible solvents.

Mouthwash

Concept : solution for mouthwash, with action on the gums and mucous membranes of the mouth and throat. It should not be swallowed.
Abbreviation : COLUT
For GMP certification purposes : Mouthwash.

Colutório Spray

Concept : solution for mouthwash, with action on the gums and mucous membranes of the mouth and throat. Presented in the form of a liquid finely divided by a jet of air or steam.
Abbreviation : COLUT SPR
For GMP certification purposes : Mouthwash.

Elixir

Concept : hydroalcoholic solution with a pleasant and sweet taste, containing dissolved active ingredient (s).
Abbreviation : ELX
For GMP certification purposes : Elixir.

Solution

Concept : see general concept.
Abbreviation : SOL
For GMP certification purposes : Solution.

Aerosol Solution

Concept : solution packaged under pressure, containing a propellant gas and therapeutically active ingredient (s) that are released after activation of an appropriate valve system.
Abbreviation : SOL AER
For GMP certification purposes : Aerosol solution.

Extended Release Solution

Concept : clear and homogeneous liquid pharmaceutical form, which contains one or more active ingredients dissolved in a suitable solvent
or in a mixture of miscible solvents. See definition of extended release.
Abbreviation : SOL LIB PROL
For GMP certification purposes : Solution.

Drops Solution

Concept : solution intended for administration in the form of drops.
Abbreviation : SOL GOT
For GMP certification purposes : Solution.

Injectable Solution

Concept : sterile solution for injection. Abbreviation: SOL INJ
For GMP certification purposes : Small volume parenteral solution (with terminal sterilization and / or aseptic preparation).

Dilution Solution

Concept : solution presented in a more concentrated form and that must be diluted before administration.
Abbreviation : SOL DIL
For GMP certification purposes : Solution.

Solution for Injectable Dilution

Concept : sterile solution presented in a concentrated form and that must be diluted to a determined volume and with an appropriate liquid before administration.
Abbreviation : SOL DIL INJ
For GMP certification purposes : Small volume parenteral solution (with terminal sterilization and / or aseptic preparation).

Mouthwash Dilution Solution

Concept : solution presented in a concentrated form and that must be diluted to a determined volume and with an appropriate liquid, intended for mouthwash with action on the gums and mucous membranes of the mouth and throat. It should not be swallowed.
Abbreviation : SOL DIL COLUT
For GMP certification purposes : Solution.

Dilution Solution for Infusion

Concept : sterile solution presented in a concentrated form and that must be diluted to a determined volume and with an appropriate liquid before being administered by infusion. This solution is usually isotonic with blood and is used mainly for high volume administration.
Abbreviation : SOL DIL INFUS
For GMP certification purposes : Small or large volume parenteral solution (with terminal sterilization and / or aseptic preparation).

Infusion Solution

Concept : sterile solution that meets all the requirements to be administered by infusion. This solution is usually isotonic with blood and is used mainly for high volume administration.
Abbreviation : SOL INFUS
For GMP certification purposes : Large volume parenteral solution (with terminal sterilization and / or aseptic preparation).

Irrigation Solution

Concept : sterile solution used to irrigate the skin and mucous membranes.
Abbreviation : SOL IRR
For GMP certification purposes : Large volume parenteral solution (with terminal sterilization and / or aseptic preparation).

Spray Solution

Concept : solution administered in the form of a liquid finely divided by a jet of air or steam.
Abbreviation : SOL SPR
For GMP certification purposes : Solution.

Suspension

General concept

Liquid dosage form containing solid particles dispersed in a liquid carrier, in which the particles are not soluble.

Suspension

Concept : see general concept.
Abbreviation : SUS
For GMP certification purposes : Suspension.

Aerosol Suspension

Concept : suspension packed under pressure, containing a propellant gas and therapeutically active ingredients that are released after activation of an appropriate valve system.
Abbreviation : SUS AER
For GMP certification purposes : Aerosol suspension.

Extended Release Suspension

Concept : liquid pharmaceutical form that contains solid particles dispersed in a liquid carrier, in which the particles are not soluble. See definition of extended release.
Abbreviation : SUS LIB PROL
For GMP certification purposes : Suspension.

Delayed Release Suspension

Concept : liquid pharmaceutical form that contains solid particles dispersed in a liquid carrier, in which the particles are not soluble. See definition of delayed release.
Abbreviation : SUS LIB RETARD
For GMP certification purposes : Suspension.

Suspension Drops

Concept : suspension intended for administration in the form of drops.
Abbreviation : SUS GOT
For GMP certification purposes : Suspension.

Injectable Suspension

Concept : sterile suspension for injection.
Abbreviation : SUS INJ
For GMP certification purposes : Small volume parenteral suspension (with terminal sterilization and / or aseptic preparation).

Extended Release Injectable Suspension

Concept : sterile suspension for injection. See definition of extended release.
Abbreviation : SUS INJ LIB PROL
For GMP certification purposes : Small volume parenteral suspension (with terminal sterilization and / or aseptic preparation).

Spray Suspension

Concept : suspension administered as a liquid finely divided by a jet of air or steam.
Abbreviation : SUS SPR
For GMP certification purposes : Suspension.

Shampoo

Concept : solution or suspension, containing one or more active ingredients, for application on the scalp surface.
Abbreviation : XAMP
For GMP certification purposes : Shampoo.

Syrup

Concept : aqueous pharmaceutical form characterized by high viscosity, which contains no less than 45% sucrose or other sugars in its composition. Syrups usually contain flavoring agents.
Abbreviation : XPE
For GMP certification purposes : Syrup.

Semi-solid dosage forms

Creme

Concept : semi-solid pharmaceutical form that consists of an emulsion, formed by a lipophilic phase and an aqueous phase. It contains one or more active ingredients dissolved or dispersed on an appropriate basis and is normally used for external application to the skin or mucous membranes.
Abbreviation : CREM
For GMP certification purposes : Cream.

Plaster

Concept : semi-solid pharmaceutical form for external application. It consists of an adhesive base containing one or more active ingredients distributed in a uniform layer on an appropriate support made of synthetic or natural material. Intended to keep the active ingredient in contact with the skin, acting as a protector or as a keratolytic agent. Abbreviation : EMPL
For GMP certification purposes : Patch.

Gel

Concept : semi-solid pharmaceutical form with one or more active ingredients, containing a gelling agent to provide firmness to a colloidal solution or dispersion (a system in which particles of colloidal size – typically between 1 nm and 1 mm – are uniformly distributed across of the liquid). A gel can contain suspended particles.
Abbreviation : GEL
For GMP certification purposes : Gel.

Ointment

General concept

Semi-solid dosage form for application to the skin or mucous membranes, which consists of a solution or dispersion of one or more active ingredients in low proportions on an appropriate basis.

Ointment

Concept : see general concept.
Abbreviation : POM
For GMP certification purposes : Ointment.

Pasta

Concept : ointment containing a large amount of dispersed solids (at least 25%).
Abbreviation : PAST
For GMP certification purposes : Pasta.

Gaseous Pharmaceutical Forms

Gas

Concept : gaseous preparation used for medicinal purposes.
Abbreviation : GAS
For GMP certification purposes : Gas.

Routes of Administration

Oral

Concept : intended for administration in the oral cavity or in a specific part of the oral cavity such as the gum, palate, tongue and teeth.
Abbreviation : BUC

Capillary

Concept : intended for application to the scalp.
Abbreviation : CAPI

Dermatological

Concept : intended for application on the surface of the skin and cutaneous attachments.
Abbreviation : DERM

Epidural

Concept : administration in the epidural space, located between the dura and the periosteum of the vertebral canal.
Abbreviation : EPI

Inhalation

Concept : administered through the nasal and oral respiratory system simultaneously for local or systemic effect.
Abbreviation : INAL

Nasal Inhalation

Concept : administered through the respiratory system, exclusively through the nasal route, for local or systemic effect.
Abbreviation : INAL NAS

Oral Inhalation

Concept : administered through the respiratory system, exclusively orally, for local or systemic effect.
Abbreviation : INAL OR

Intra-arterial

Concept : administration within an artery.
Abbreviation : IAR

Intra-articular

Concept : administered within a joint.
Abbreviation : IA

Intradermal

Concept : administration within the dermis.
Abbreviation : ID

Intramuscular

Concept : administered within a muscle.
Abbreviation : IM

Intrathecal

Concept : intended for administration within the cerebrospinal fluid or at any point on the cerebrospinal axis, including injection into the cerebral ventricles.
Abbreviation : IT

Intrauterine

Concept : intended for administration within the uterus.
Abbreviation : IU

Intravenous

Concept : administered within a vein.
Abbreviation : IV

Intravitreal

Concept : intended for application within the vitreous body of the eye.
Abbreviation : IVIT

Irrigation

Concept : intended for washing and cleaning open wounds or body cavities.
Abbreviation : IRR

Nasal

Concept : administered in the nasal cavity to obtain a local or systemic effect.
Abbreviation : NAS

Ophthalmic

Concept : intended for application to the eyeball or conjunctiva.
Abbreviation : OFT

Oral

Concept : intended for administration by mouth.
Abbreviation : OR

Otological

Concept : intended for application in the ear canal, without exerting harmful pressure on the eardrum.
Abbreviation : OTO

Rectal

Concept : intended for application to the rectum.
Abbreviation : RET

Subcutaneous

Concept : administered under the skin (hypodermic, subdermal).
Abbreviation: SC

Sublingual

Concept : intended to be placed under the tongue, where the active ingredient is absorbed directly through the oral mucosa.
Abbreviation : SUBL

Transdermal

Concept : administered by diffusion through the dermal layer of the skin into the systemic circulation.
Abbreviation : TRANSD

Urethral

Concept : intended for application in the urethra.
Abbreviation : URET

Vaginal

Concept : intended for application to the vagina.
Abbreviation : VAG

Packaging and Accessories

Ampoule

General concept

Hermetically sealed container, intended for the storage of sterile liquids for parenteral use and whose content is used in a single dose.

Translucent plastic ampoule

Abbreviation : AMP PLAS TRANSL]

Transparent plastic ampoule

Abbreviation : AMP PLAS TRANS

Amber glass ampoule

Abbreviation : AMP VD AMB

Transparent glass ampoule

Abbreviation : AMP VD TRANS

Filled applicator

General concept

Plunger device, filled with medication, for single dose administration.

Opaque filled plastic applicator

Abbreviation : APLIC PREENC PLAS OPC

Transparent plastic filled applicator

Abbreviation : APLIC PREENC PLAS TRANS

Tube

General concept

Flexible container, flattened and folded or sealed on one side, with a removable opening on the other side. Used for the packaging of semi-solid medicines.

Aluminum tube

Abbreviation : BG AL

Aluminum / opaque plastic tube

Abbreviation : BG AL PLAS OPC

Opaque plastic / aluminum tube

Abbreviation : BG PLAS AL OPC

Opaque plastic tube

Abbreviation : BG PLAS OPC

Transparent plastic tube

Abbreviation : BG PLAS TRANS

Blíster

General concept

Container consisting of a molded tray with cavities in which the pharmaceutical forms are stored, usually with a cover of laminated material sealed to the molded part, which must be opened or broken to access the contents.

Aluminum and aluminum blister

Abbreviation : BL AL AL

Blister made of aluminum and amber plastic

Abbreviation : BL AL PLAS AMB

Blister made of aluminum and opaque plastic

Abbreviation : BL AL PLAS OPC

Blister made of aluminum and translucent plastic

Abbreviation : BL AL PLAS TRANSL

Blister made of aluminum and transparent plastic

Abbreviation : BL AL PLAS TRANS

Bag

General concept

Flexible material container used to protect or contain one or more doses of a medication (eg, large volume parenterals or irrigation solution).

Clear plastic pouch

Abbreviation : BOLS PLAS TRANS

Transparent plastic bag (closed system)

Abbreviation : BOLS PLAS TRANS SIST FECH

Bottle

General concept

Container with rectangular or polygonal section, for the transport and storage of liquids.

Opaque plastic bottle

Abbreviation : BOMBO PLAS OPC

Translucent plastic bottle

Abbreviation : BOMBO PLAS TRANSL

Carpule

General concept

Container usually in tubular format, with narrow neck, flat bottom, open, with rubber plunger, to be used in an applicator pen with the possibility of multiple dosages.

Transparent glass carpule

Abbreviation : CAR VD TRANS

Cylinder

General concept

Container for the storage of compressed gas to keep a gas under pressure.

Aluminum cylinder

Abbreviation : CIL AL

Metal cylinder

Abbreviation : CIL MET

Envelope

General concept

Flexible material container formed by two sealed blades containing the medicine.

Aluminum envelope

Abbreviation : ENV AL

Aluminum / paper envelope

Abbreviation : ENV AL / PAP

Aluminum / plastic envelope

Abbreviation : ENV AL / PLAS

Envelope

Abbreviation : ENV PAP

Opaque plastic envelope

Abbreviation : ENV PLAS OPC

pencil case

General concept

Container with format and division of internal space designed to contain medicines.

Plastic case

Abbreviation : EST PLAS

Flaconete

General concept

Container for storing liquids for administration in a single dose.

Amber Plastic Flacon

Abbreviation : FLAC PLAS AMB

Opaque plastic flaconet

Abbreviation : FLAC PLAS OPC

Transparent plastic flacon

Abbreviation : FLAC PLAS TRANS

Transparent glass flacon

Abbreviation : FLAC VD TRANS

Amber glass flacon

Abbreviation : FLAC VD AMB

Opaque glass flacon

Abbreviation : FLAC VD OPC

Bottle

General concept

Container usually tubular in shape, with a narrow neck and a flat or concave bottom.

Aluminum bottle

Abbreviation : FR AL

Amber plastic bottle

Abbreviation : FR PLAS AMB

Opaque plastic jar

Abbreviation : FR PLAS OPC

Translucent plastic bottle

Abbreviation : FR PLAS TRANSL

Transparent plastic bottle

Abbreviation : FR PLAS TRANS

Amber glass bottle

Abbreviation : FR VD AMB

Opaque glass bottle

Abbreviation : FR VD OPC

Transparent glass bottle

Abbreviation : FR VD TRANS

Ampoule bottle

General concept

Container usually of tubular format, for the packaging of medicines administered by parenteral route, sealed with flexible material that must be perforated for the administration of the medicine

Transparent plastic vial

Abbreviation : FA PLAS TRANS

Transparent plastic vial (closed system)

Abbreviation : FA PLAS TRANS SIST FECH

Amber glass vial

Abbreviation : FA VD AMB

Transparent glass vial

Abbreviation : FA VD TRANS

Applicator bottle

General concept

Container usually tubular in shape, with a narrow neck, flat or concave bottom. It has a device for administering a medication to a specific location in the body (eg, potent mixes and vials used for enemas).

Amber plastic applicator bottle

Abbreviation : FR APLIC PLAS AMB

Opaque plastic applicator bottle

Abbreviation : FR APLIC PLAS OPC

Translucent plastic applicator bottle

Abbreviation : FR APLIC PLAS TRANSL

Transparent plastic applicator bottle

Abbreviation : FR APLIC PLAS TRANS

Amber glass applicator bottle

Abbreviation : FR APLIC VD AMB

Opaque glass applicator bottle

Abbreviation : FR APLIC VD OPC

Transparent glass applicator bottle

Abbreviation : FR APLIC VD TRANS

Transfer bottle

General concept

Flask with attached device that allows connection to the closed system bag.

Amber glass transfer bottle

Abbreviation : FR TRANSF VD AB

Transparent glass transfer bottle

Abbreviation : FR TRANSF VD TRANS

Drip bottle

General concept

Container usually tubular in shape, with a narrow neck and a flat or concave bottom. It has a device specifically designed for the application of a liquid in the form of a drop .

Amber plastic drip bottle

Abbreviation : FR GOT PLAS AMB

Opaque plastic drip bottle

Abbreviation : FR GOT PLAS OPC

Translucent plastic drip bottle

Abbreviation : FR GOT PLAS TRANSL

Transparent plastic drip bottle

Abbreviation : FR GOT PLAS TRANS

Amber glass drip bottle

Abbreviation : FR GOT VD AMB

Opaque glass drip bottle

Abbreviation : FR GOT VD OPC

Transparent glass drip bottle

Abbreviation : FR GOT VD TRANS

Frasco spray

General concept

Container usually tubular in shape, with a narrow neck and a flat or concave bottom. It has an atomizer or a device that expels the medicine finely divided and carried through the air. It is not used to package aerosols, since the aluminum bottle is used for packaging this pharmaceutical form.

Amber plastic spray bottle

Abbreviation : FR SPR PLAS AMB

Opaque plastic spray bottle

Abbreviation : FR SPR PLAS OPC

Translucent plastic spray bottle

Abbreviation : FR SPR PLAS TRANSL

Transparent plastic spray bottle

Abbreviation : FR SPR PLAS TRANS

Amber glass spray bottle

Abbreviation : FR SPR VD AMB

Opaque glass spray bottle

Abbreviation : FR SPR VD OPC

Transparent glass spray bottle

Abbreviation : FR SPR VD TRANS

Blade

General concept

Thin layer of flexible material.

Aluminum foil

Abbreviation : LAM AL

Paper sheet

Abbreviation : LAM PAP

Mate

General concept

Wide container with normally cylindrical shape, flat bottom and with short and wide neck. Contains solid or semi-solid medications.

Metal pot

Abbreviation : PT MET

Amber plastic pot

Abbreviation : PT PLAS AMB

Opaque plastic pot

Abbreviation : PT PLAS OPC

Translucent plastic pot

Abbreviation : PT PLAS TRANSL

Transparent plastic pot

Abbreviation : PT PLAS TRANS

Amber glass pot

Abbreviation : PT VD AMB

Opaque glass jar

Abbreviation : PT VD OPC

Transparent glass pot

Abbreviation : PT VD TRANS

Filled syringe

General concept

Cylindrical device, with cannula-shaped adapter, with or without a fixed needle and with plunger.

Syringe filled with amber plastic

Abbreviation : BE PRENC PLAS WITH

Syringe filled with clear plastic

Abbreviation : SER PREENC PLAS TRANS

Syringe filled with amber glass

Abbreviation : SER PREENC VD AMB

Syringe filled with clear glass

Abbreviation : SER PREENC VD TRANS

Strip

General concept

Flexible material container formed by two sealed blades that separate and protect each pharmaceutical form of the medicine. To access each pharmaceutical form, it must be cut or broken. Contains solid or semi-solid medications.

Aluminum Strip

Abbreviation : STR AL

Aluminum / paper strip

Abbreviation: STR AL / PAP

Aluminum / plastic strip

Abbreviation : STR AL / PLAS

Strip the papule

Abbreviation : STR PAP

Opaque plastic strip

Abbreviation : STR PLAS OPC

Tube

General concept

Container without neck, in the shape of a hollow and elongated cylinder, made of rigid material, for the storage of solid pharmaceutical forms.

Aluminium tube

Abbreviation : TB AL

Plastic tube

Abbreviation : TB PLAS

Secondary Packaging

Box

Abbreviation : CX

Cool box

Abbreviation : CX TERM

Cartridge

General concept : commercial packaging in the shape of a small box containing the primary packaging of the medicine.
Abbreviation : CT

Envelope

General concept : flexible material formed by two sealed blades.
Abbreviation : ENV

Accessories

Adapter

Concept : auxiliary device for the targeted administration of the drug, to be attached to the primary product packaging.
Abbreviation : ADAPT

Needle

Concept : hollow cylindrical fixation device for the administration of liquid pharmaceutical forms.
Abbreviation : AGU

Applicator

Concept : device for the targeted administration of a medication.
Abbreviation : APLIC

Activator

Concept : medication delivery device used in inhalers.
Abbreviation : ATIV

Pumps

Concept : device for administering pressure medication.
Abbreviation : BOMB

Inhaler chamber

Concept : device used to store the medicine after nebulization, until it is inhaled.
Abbreviation : CAM INAL

Applicator pen

Concept : device for applying medication to a specific location in the body, with or without a needle attached and with a fixed or variable dose mechanism.
Abbreviation : CAN APLIC

Measuring spoon

Concept : spoon-shaped device used for dosing and administering a medication.
Abbreviation : COL

Dropper

Concept : device intended for the application of a liquid drop by drop.
Abbreviation : CGT

Dosing cup

Concept : cup-shaped device used for dosing and administering a medication.
Abbreviation : COP

Diluent

Concept : liquid used in the reconstitution and / or dilution of a drug.
Abbreviation : DIL

Spacer

Concept : device used to conduct the medicine to be inhaled.
Abbreviation : ESPAÇ

Spatula

Concept : device designed to avoid contact with the medication during administration.
Abbreviation : ESP

Inhaler

Concept : device through which a medicine can be administered by inspiration through the nose or mouth.
Abbreviation : INAL

Tissue

Concept : device designed to clean the medication application site.
Abbreviation : LEN

Brush tool

Concept : instrument equipped with hair, bristles, threads or other filaments of any material, attached to the end of a cable.
Abbreviation : PINC

Syringe

Concept : cylindrical device, with cannula-shaped adapter, with or without a prefixed needle and plunger, for parenterally administering a dose of a medicine.
Abbreviation : SER

Dosing syringe

Concept : cylindrical device, with cannula-shaped adapter and plunger, for administering a medication.
Abbreviation : SER DOS

Dose indicator valve

Concept : device that shows the correct day of administration and the correct dose of medication, indicating that the dose has been removed.
Abbreviation : VALV

Related Terms