ภาคผนวกที่ 1

ตารางแสดงตัวอย่างรูปแบบของยา (Dosage form) ตามมาตรฐาน EDQM

No.Dosage formDefinition
1bath additiveSolid, semi-solid or liquid preparation to be added to the bath water.
2capsule, hardSolid single-dose preparation contained in a hard shell, the capacity of which can be varied. The shell is made of gelatin or other substances. It consists of two prefabricated cylindrical sections one end of which is rounded and closed, the other being open. The contents of the shell may be a solid or semi-solid preparation, which is filled into one of the sections and closed by slipping the other section over it. Hard capsules are intended for oral use.
3capsule, softSolid single-dose preparation contained in a soft shell, the capacity and shape of which can be varied. The shell is made of gelatin or other substances and may contain (a) solid active substance(s). The shell is thicker than that of hard capsules and consists of one part as soft capsules usually are formed, filled and sealed in one operation. The contents of the shell may be a semi-solid or liquid preparation. Soft capsules are intended for oral use.
4chewable tabletSolid single-dose preparation consisting of an uncoated tablet intended to be chewed before being swallowed. Chewable tablets are intended for oral administration.
5coated tabletSolid single-dose preparation consisting of a tablet coated with one or more layers of mixtures of various substances such as sugars and waxes. To the coating colouring matter, flavouring substances and active substance(s) may be added. The thickness of the coating is greater than that of a film-coated tablet. Coated tablets have a smooth surface. They are intended for oral use. When the coating dissolves or disintegrates the active substance(s) is (are) released into the gastrointestinal fluid at a rate depending essentially on its intrinsic properties (conventional release).
6collodionLiquid preparation usually containing pyroxylin in a mixture of ether and ethanol. When applied to the skin, the preparation forms a flexible film on the site of application.
7concentrate and solvent for solution for infusionSterile concentrate and sterile solvent intended for the preparation of a solution for infusion by diluting the concentrate with the solvent.
8concentrate for cutaneous solutionLiquid preparation intended to be diluted in the specified liquid to obtain a cutaneous solution.
9concentrate for gargleLiquid preparation consisting of an aqueous solution intended to be diluted in water to obtain a gargle.
10concentrate for haemodialysis solutionLiquid preparation consisting of an aqueous solution of electrolytes intended to be diluted with water of a suitable quality to obtain a solution for haemodialysis. Glucose may be included.
11concentrate for oral solutionLiquid preparation intended to be diluted in the specified liquid to obtain an oral solution.
12concentrate for solution for infusionLiquid sterile preparation consisting of an aqueous solution intended to be diluted in the specified aqueous liquid to obtain a solution for infusion. It may be added to a solution for infusion during the administration.
13concentrate for solution for injectionLiquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection.
14concentrate for solution for injection/infusionLiquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection/infusion.
15creamSemi-solid single-dose or multidose preparation of homogeneous appearance consisting of a lipophilic phase and an aqueous phase, one of which is finely dispersed in the other. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic or hydrophobic. Creams are intended for cutaneous use. In certain cases, transdermal delivery may be obtained.
16cutaneous emulsionLiquid, usually multidose preparation consisting of an emulsion intended for cutaneous use.
17cutaneous liquidLiquid, usually multidose preparation consisting of a liquid active substance per se, intended for cutaneous use.
18cutaneous pasteSemi-solid single-dose or multidose preparation containing a large proportion of finely divided solids dispersed in the basis, intended for cutaneous use.
19cutaneous patchFlexible single-dose preparation intended to be applied to the unbroken skin to obtain a local effect by penetration of the active substance(s) into the skin.
20cutaneous powderSolid, usually multidose preparation consisting of a powder intended for cutaneous use. Cutaneous spray, powder is excluded.
21cutaneous solutionLiquid, usually multidose preparation consisting of a solution of the active substance in a suitable vehicle intended for cutaneous use.
22cutaneous spray, ointmentOintment formed at the time of administration from a liquid preparation in a pressurised container with a spray valve or in a container equipped with a spray pump.
23cutaneous spray, solutionLiquid preparation, usually multidose, consisting of a solution in a pressurised container with a spray valve or in a container equipped with a spray pump, intended for cutaneous use.
24cutaneous stickSolid preparation, usually rod-shaped or conical, intended for application to the skin to obtain a local effect. Cutaneous sticks may consist of the active substance(s) alone or dissolved or dispersed in a suitable basis.
25cutaneous suspensionLiquid, usually multidose preparation consisting of a suspension of fine particles in a suitable vehicle intended for cutaneous use.
26dental gelSemi-solid, usually multidose preparation consisting of a hydrophilic gel intended for administration on teeth and gums by rubbing.
27dental pasteSemi-solid single-dose or multidose preparation consisting of solid particles finely dispersed in a suitable basis, intended for administration on or inside the tooth or on and/or around the nerves supplying the teeth. Toothpaste is excluded.
28dental solutionLiquid, usually multidose preparation consisting of a solution intended for administration on teeth and gums.
29dental suspensionLiquid, usually multidose preparation consisting of a suspension intended for administration on teeth and gums.
30dispersible tabletSolid single-dose preparation consisting of a tablet intended to be dispersed in the specified liquid before being swallowed.
31ear drops, solutionLiquid single-dose or multidose preparation consisting of an aqueous or oily solution intended for application to the external auditory meatus. Multidose containers may be dropper containers or containers provided with a dropper applicator, or the dropper may be supplied separately. Drops are not necessarily administered dropwise, but may also be administered as a small volume.
32ear drops, suspensionLiquid single-dose or multidose preparation consisting of an aqueous or oily suspension intended for application to the external auditory meatus. Multidose containers may be dropper containers or containers provided with a dropper applicator, or the dropper may be supplied separately. Drops are not necessarily administered dropwise, but may also be administered as a small volume.
33ear powderSolid, usually multidose preparation consisting of one or more powders consisting of (a) solid active substance(s) intended for application to the external auditory meatus. Ear powders are presented in containers fitted with a suitable applicator or device for insufflation.
34ear wash, solutionLiquid single-dose or multidose preparation consisting usually of an aqueous solution with a pH within physiological limits. Ear washes are intended to clean the external auditory meatus.
35ear/eye drops, solutionLiquid sterile preparation consisting of a solution intended for use as ear drops or eye drops.
36effervescent granulesSolid single-dose or multidose preparation consisting of uncoated granules generally containing acidic substances and carbonates or hydrogen carbonates that rapidly react in the presence of water to release carbon dioxide. Effervescent granules are intended to be dissolved or dispersed in water before oral use.
37effervescent powderSolid single-dose or multidose preparation consisting of one or more powders generally containing acid substances and carbonates or hydrogen carbonates that react rapidly in the presence of water to release carbon dioxide. Effervescent powders are intended to be dissolved or dispersed in water before administration.
38effervescent tabletSolid single-dose preparation consisting of an uncoated tablet generally containing acid substances and carbonates or hydrogen carbonates, which react rapidly in the presence of water to release carbon dioxide. Effervescent tablets are intended to be dissolved or dispersed in water before oral use.
39emulsion for infusionLiquid sterile preparation consisting of an oil-in-water emulsion intended to be introduced, usually in large volumes, usually into the circulating blood stream.
40emulsion for injectionLiquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by injection.
41emulsion for injection/infusionLiquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by injection or infusion.
42endotracheopulmonary instillation, powder for solutionSolid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain an endotracheopulmonary instillation solution.
43endotracheopulmonary instillation, suspensionLiquid preparation consisting of an aqueous suspension intended for instillation to the trachea and/or bronchi. Preparations for inhalation use are excluded.
44eye drops, emulsionLiquid sterile single-dose or multidose preparation consisting of an emulsion intended for ocular use. Multidose preparations are presented in containers that allow successive drops to be administered. The containers contain usually at most 10 mL of the preparation.
45eye drops, solutionLiquid sterile single-dose or multidose preparation consisting of an aqueous or oily solution intended for ocular use. Multidose preparations are presented in containers that allow successive drops to be administered. The containers contain usually at most 10 mL of the preparation.
46eye drops, suspensionLiquid sterile single-dose or multidose preparation consisting of an aqueous or oily suspension intended for ocular use. Multidose preparations are presented in containers that allow successive drops to be administered. The containers contain usually at most 10 mL of the preparation.
47eye drops, tablet and solvent for solution –
48eye gelSemi-solid sterile single-dose or multidose preparation consisting of a gel intended for ocular use. Eye gels may be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g of the preparation. Eye gels may also be presented in suitably designed single-dose containers. The containers or nozzles of tubes are of a shape that facilitates administration without contamination.
49eye lotionLiquid sterile single-dose or multidose preparation consisting of an aqueous solution intended for washing or bathing the eye.
50eye ointmentSemi-solid sterile single-dose or multidose preparation consisting of an ointment intended for ocular use. Eye ointments may be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g of the preparation. Eye ointments may also be presented in suitably designed single-dose containers. The containers or nozzles of tubes are of a shape that facilitates administration without contamination.
51film-coated tabletSolid single-dose preparation consisting of a tablet coated with a thin polymeric film that dissolves within a few minutes in the gastrointestinal fluid. Film-coated tablets are intended for oral use to release active substance(s) at a rate which is not significantly delayed compared to that of the uncoated tablet.
52gargleLiquid preparation consisting of an aqueous solution intended for gargling to obtain a local effect in the oral cavity and the throat. Gargles are not to be swallowed.
53gargle/mouthwashLiquid preparation consisting of a solution intended for use as a gargle or a mouthwash.
54gastro-resistant capsule, hardSolid single-dose, delayed-release preparation contained in a hard shell. The preparation is intended to resist the gastric fluid and to release the active substance(s) in the intestinal fluid. Hard gastro-resistant capsules are usually made by filling hard capsules with gastro-resistant granules or solid particles made gastro-resistant by coating or, in certain cases, by providing hard capsules with a gastro-resistant shell. They are intended for oral use.
55gastro-resistant granulesSolid preparation consisting of delayed-release granules intended to resist the gastric fluid and release the active substance(s) in the intestinal fluid. This deliberate modification is achieved by coating the granules with a gastro-resistant material or by embedding the solid particles in the gastro-resistant material. Gastro-resistant granules are usually single-dose preparations intended for oral use.
56gastro-resistant granules for oral suspensionSolid preparation consisting of gastro-resistant granules intended to be dispersed in the specified liquid to obtain a gastro-resistant oral suspension.
57gastro-resistant tabletSolid single-dose, delayed-release tablet intended to resist the gastric fluid and to release the active substance(s) in the intestinal fluid. These properties are achieved by coating the tablet with a gastro-resistant material or by embedding solid particles in the gastro-resistant material before compression. Gastro-resistant tablets are intended for oral administration.
58gelSemi-solid single-dose or multidose preparation consisting of a single-phase basis of liquids gelled by a suitable gelling agent, intended for cutaneous use. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic or hydrophobic.
59gel for injectionSterile single-dose preparation consisting of a hydrophilic gel intended for injection into a specific tissue or organ.
60gingival gelSemi-solid single-dose or multidose preparation consisting of a gel intended for gingival use to obtain a local effect.
61gingival solutionLiquid, usually multidose preparation consisting of a solution intended for gingival use.
62granulesSolid single-dose or multidose preparation consisting of solid, dry aggregates of powder particles that are sufficiently resistant to withstand handling. Granules are intended for oral use to release active substance(s) in the gastrointestinal fluids by a rate depending essentially on the intrinsic properties of the active substance(s) (conventional release). They may be swallowed as such and/or chewed before swallowing, and some may also be dissolved or dispersed in water or another suitable liquid before oral administration. Granules for oral solution and Granules for oral suspension are excluded.
63granules for oral solutionSolid preparation consisting of aggregated particles that may include excipients to facilitate wetting and dissolution, intended to be dissolved in the specified liquid to obtain an oral solution, which is usually prepared just before administration to the patient.
64granules for oral suspensionSolid preparation consisting of aggregated particles that may include excipients to facilitate wetting and dispersion, intended to be dispersed in the specified liquid to obtain an oral suspension, which is usually prepared just before administration to the patient.
65granules for syrupSolid preparation consisting of aggregated particles that may include excipients to facilitate wetting and dissolution and to obtain the characteristics of a syrup, intended to be dissolved in water to obtain a syrup.
66implantSolid sterile preparation of a size and shape suitable for implantation. It may be prepared by moulding or other means other than compression. Each implant is presented in a sterile container that may be provided with an administration device. Implants are intended for release over an extended period of time in order to obtain local or systemic effect. ‘Implantation tablet’, ‘Implantation chain’ and ‘Implantation matrix’ are excluded.
67implantation chainSolid sterile preparation consisting of small spheres mounted on a non-degradable thread to form a chain that allows withdrawal of the remainder of the chain after a certain period of action. Each implantation chain is presented in a sterile container. The implantation chain is intended for release over an extended period of time in order to obtain local or systemic effect.
68impregnated dressingSolid preparation consisting of a piece or strip of gauze or other suitable fabric impregnated with a liquid or semi-solid preparation intended for cutaneous use.
69inhalation powderSolid, usually multidose preparation intended for inhalation use, consisting of one or more powders of solid active substance(s) to be administered by a dry-powder inhaler containing a metering dose mechanism within the inhaler. ‘Inhalation powder, hard capsule’ and ‘Inhalation powder, pre-dispensed’ are excluded.
70inhalation powder, hard capsuleSolid single-dose preparation intended for inhalation use, consisting of one or more powders of solid active substance(s) enclosed in a hard capsule. The capsule is loaded into a dry-powder inhaler to generate an aerosol.
71inhalation powder, pre-dispensedSolid preparation intended for inhalation use, consisting of one or more powders of solid active substance(s) presented in a suitable pharmaceutical form other than a hard capsule, either in the form of a single dose or divided into multiple single doses. The preparation is loaded into a dry-powder inhaler to generate an aerosol.
72inhalation solutionLiquid, usually multidose preparation consisting of a solution intended for inhalation use. The preparation is presented in a non-pressurised container fitted with a metering dose mechanism. ‘Nebuliser solution’ and ‘Pressurised inhalation, solution’ are excluded.
73inhalation vapour, liquidLiquid preparation consisting of a liquid active substance per se, such as an essential oil or a volatile anaesthetic, intended for generation of vapour to be inhaled. The vapour may be generated by adding the liquid to hot water or by the use of a vaporising device.
74inhalation vapour, solutionLiquid preparation consisting of a solution intended for generation of vapour to be inhaled to obtain a local effect. The vapour is usually generated by adding the solution to hot water.
75intestinal gelSemi-solid preparation consisting of a gel intended for intestinal use.
76intrauterine delivery systemSolid single-dose delivery system intended for intrauterine use that releases its contents of active substance(s) over an extended period of time.
77intravesical solutionLiquid preparation consisting of an aqueous solution intended for intravesical use by means of a suitable applicator. ‘Bladder irrigation’ is excluded.
78intravitreal implant in applicatorMedicinal product consisting of an intravitreal implant presented in an applicator.
79irrigation solutionLiquid sterile preparation consisting of a large-volume aqueous solution intended for irrigation of body cavities, wounds and surfaces, for example during surgical procedures. Irrigation solutions are either solutions of active substance(s), electrolytes or osmotically active substances in water for injections, or they consist of water for injections as such.
80lozengeSolid single-dose preparation intended to be sucked to obtain, usually, a local effect in the oral cavity and the throat. Lozenges are hard preparations prepared by moulding. They usually contain flavouring and sweetening agents. Lozenges dissolve or disintegrate slowly when sucked.
81medicated chewing-gumSolid single-dose preparation consisting of a basis, mainly composed of gums, intended to be chewed but not swallowed. The active substance(s) is (are) released in saliva by chewing. Medicated chewing gum is intended for local treatment of mouth diseases or systemic delivery after absorption through the oral mucosa or from the gastrointestinal tract.
82medicated plasterFlexible single-dose preparation intended to be applied to the skin to obtain, usually, a local effect. Medicated plasters consist of an adhesive basis containing the active substance and spread as a uniform layer on an appropriate support made of natural or synthetic material. The adhesive layer is covered by a suitable protective liner, which is removed before applying the plaster to the skin. Medicated plasters are presented in a range of sizes or as larger sheets to be cut before use.
83modified-release capsule, hardSolid single-dose preparation consisting of a hard shell containing a solid or semi-solid formulation, showing a rate, a place and/or a time of release different from that of a conventional-release capsule. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Hard modified-release capsules are intended for oral use, and include prolonged-release, delayed-release and pulsatile-release preparations. The generic term ‘modified-release capsule, hard’ is used only when the more specific terms ‘gastro-resistant capsule, hard’ or ‘prolonged-release capsule, hard’ do not apply.
84modified-release tabletSolid single-dose preparation consisting of a tablet showing a rate, a place and/or a time of release different from that of a conventional-release tablet. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Modified-release tablets are intended for oral use, and include prolonged-release, delayed-release and pulsatile-release preparations. The generic term ‘modified-release tablet’ is used only when the more specific terms ‘gastro-resistant tablet’ or ‘prolonged-release tablet’ do not apply.
85mouthwashLiquid preparation consisting of an aqueous solution intended for use in contact with the oral mucosa. It is not to be swallowed. Mouthwashes may contain excipients to adjust the pH which as far as possible is neutral.
86nasal drops, powder for solutionSolid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a nasal drops solution.
87nasal drops, solutionLiquid single-dose or multidose preparation consisting of a solution intended for nasal use by means of a suitable applicator.
88nasal gelSemi-solid single-dose or multidose preparation consisting of usually a hydrophilic gel, intended for nasal use, usually to obtain a local effect. Nasal gels are usually presented in tubes fitted with a nasal applicator.
89nasal spray, powder for solutionSolid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a nasal spray solution.
90nasal spray, solutionLiquid single-dose or multidose preparation consisting of a solution in a container with or without a metering dose valve or in a container with a spray pump or equivalent device to create a spray, intended for nasal use.
91nasal spray, suspensionLiquid single-dose or multidose preparation consisting of a suspension in a container with or without a metering dose valve or in a container with a spray pump or equivalent device to create a spray, intended for nasal use.
92nebuliser solutionLiquid preparation consisting of a solution intended for inhalation use. The solution is converted into an aerosol by a continuously operating nebuliser or a metered-dose nebuliser.
93nebuliser suspensionLiquid preparation consisting of a suspension intended for inhalation use. The suspension is converted into an aerosol by a continuously operating nebuliser or a metered-dose nebuliser.
94ointmentSemi-solid single-dose or multidose preparation consisting of a single-phase basis in which solids or liquids may be dispersed. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic, hydrophobic or water-emulsifying. Ointments are intended for cutaneous use. In certain cases, transdermal delivery may be obtained.
95oral drops, emulsionLiquid, usually multidose preparation consisting of an emulsion intended for oral use. The preparation is administered in small volumes by means of a suitable measuring device such as a dropper, pipette or oral syringe capable of accurate dosing of the emulsion. The measured dose may be diluted in water or another suitable liquid before swallowing.
96oral drops, liquidLiquid, usually multidose preparation consisting of a liquid active substance per se, intended for oral use. The preparation is administered in small volumes by means of a suitable measuring device such as a dropper, pipette or oral syringe capable of accurate dosing of the liquid. The measured dose may be diluted in water or another suitable liquid before swallowing.
97oral drops, solutionLiquid, usually multidose preparation consisting of a solution intended for oral use. The preparation is administered in small volumes by means of a suitable measuring device such as a dropper, pipette or oral syringe capable of accurate dosing of the solution. The measured dose may be diluted in water or another suitable liquid before swallowing.
98oral drops, suspensionLiquid, usually multidose preparation consisting of a suspension intended for oral use. The preparation is administered in small volumes by means of a suitable measuring device such as a dropper, pipette or oral syringe capable of accurate dosing of the suspension. The measured dose may be diluted in water or another suitable liquid before swallowing.
99oral emulsionLiquid single-dose or multidose preparation consisting of an emulsion intended for oral use. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
100oral gelSemi-solid single-dose or multidose preparation intended for oral use, consisting of a gel, usually hydrophilic, to be swallowed after administration to the oral cavity.
101oral liquidLiquid single-dose or multidose preparation consisting of a liquid active substance per se, intended for oral use. Each dose from a multidose container is administered by means of a suitable device such as a measuring spoon.
102oral lyophilisateSolid single-dose preparation made by freeze-drying of a liquid or semi-solid preparation. This fast-releasing preparation is intended to be placed in the mouth where its contents are released in saliva and swallowed or, alternatively, to be dissolved in water before oral administration.
103oral pasteSemi-solid single-dose or multidose preparation intended for oral use, consisting of a paste to be swallowed after administration to the oral cavity.
104oral powderSingle-dose or multidose preparation consisting of one or more particulate solids of varying degrees of fineness. Oral powders are intended for oral administration. They are generally administered in or with water or another suitable liquid, but may also be swallowed directly.
105oral solutionLiquid single-dose or multidose preparation consisting of a solution intended for oral use. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
106oral suspensionLiquid single-dose or multidose preparation consisting of a suspension intended for oral use. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
107oral/rectal suspensionLiquid preparation consisting of a suspension intended for oral or rectal use.
108orodispersible tabletSolid single-dose preparation consisting of an uncoated tablet intended to be placed in the mouth where it disperses rapidly in saliva before being swallowed.
109oromucosal dropsLiquid, usually multidose preparation consisting of a solution, suspension or emulsion intended for oromucosal use. Oromucosal drops are administered by instillation into the oral cavity or onto a specific part of the oral cavity.
110oromucosal gelSemi-solid single-dose or multidose preparation consisting of a hydrophilic gel intended for oromucosal use. It is applied to the oral cavity or onto a specific part of the oral cavity, to obtain a local effect. Gingival gel is excluded.
111oromucosal pasteSemi-solid single-dose or multidose preparation consisting of a paste of solid particles finely dispersed in a hydrophilic basis intended for oromucosal use. Oromucosal pastes are applied to the oral cavity or onto a specific part of the oral cavity, to obtain a local effect. Gingival paste is excluded.
112oromucosal solutionLiquid single-dose or multidose preparation consisting of a solution intended for oromucosal use.
113oromucosal spray, solutionLiquid, usually multidose preparation consisting of a solution intended for oromucosal use. It is administered by spraying into the oral cavity or onto a specific part of the oral cavity or the throat. It is presented in a container with a spray pump or in a pressurised container with or without a metering valve. Sublingual sprays are excluded.
114pastilleSolid single-dose preparation intended to be sucked to obtain, usually, a local effect in the oral cavity and the throat. Pastilles are soft, flexible preparations prepared by moulding of mixtures containing natural or synthetic polymers or gums and sweeteners. They dissolve or disintegrate slowly when sucked.
115pessarySolid, single-dose preparation usually prepared by moulding, of various shapes, usually ovoid, with a volume and consistency suitable for insertion into the vagina to obtain a local effect. It contains one or more active substances dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at body temperature.
116powder and solvent for oral solutionPowder (including freeze-dried powder) and solvent intended for the preparation of an oral solution by dissolving the powder in the solvent.
117powder and solvent for oral suspensionPowder (including freeze-dried powder) and solvent intended for the preparation of an oral suspension by dispersing the powder in the solvent.
118powder and solvent for prolonged-release suspension for injectionSterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a prolonged-release suspension for injection by dispersing the powder in the solvent.
119powder and solvent for solution for infusionSterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for infusion by dissolving the powder in the solvent.
120powder and solvent for solution for injectionSterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for injection by dissolving the powder in the solvent.
121powder and solvent for solution for injection/infusionSterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for injection/infusion by dissolving the powder in the solvent.
122powder and solvent for suspension for injectionSterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a suspension for injection by dispersing the powder in the solvent.
123powder and suspension for suspension for injectionSterile powder (including freeze-dried powder) and sterile suspension, both of which contain active substance(s), intended for the preparation of a suspension for injection by dispersing the powder in the suspension.
124powder for concentrate for dispersion for infusionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain a concentrate for dispersion for infusion, which must subsequently be diluted before administration as a dispersion for infusion.
125powder for concentrate for solution for infusionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a concentrate for solution for infusion, which must subsequently be diluted before administration as a solution for infusion.
126powder for cutaneous solutionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a concentrate for solution for infusion, which must subsequently be diluted before administration as a solution for infusion.
127powder for oral solutionSolid preparation consisting of (a) solid active substance(s) which may also include excipients to facilitate dissolution in the prescribed liquid. Powders for oral solution include freeze-dried powders. The oral solution is usually prepared just before administration to the patient.
128powder for oral suspensionSolid preparation consisting of (a) solid active substance(s) which may also include excipients to facilitate dispersion in the prescribed liquid and to prevent sedimentation during storage of the oral suspension. Powders for oral suspension include freeze-dried powders. The oral suspension is usually prepared just before administration to the patient.
129powder for oral/rectal suspensionSolid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain an oral/rectal solution.
130powder for rectal solutionSolid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed in the specified liquid to obtain a rectal suspension.
131powder for solution for infusionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified aqueous liquid to obtain a solution for infusion.
132powder for solution for injectionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a solution for injection.
133powder for solution for injection/infusionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a solution for injection/infusion.
134powder for suspension for infusionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified aqueous liquid to obtain a solution for infusion
135powder for suspension for injectionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a solution for injection.
136powder for syrupSolid preparation consisting of one or more powders, including freeze-dried powders, that may include excipients to facilitate dissolution in water and to obtain the characteristics of a syrup, intended to be dissolved in water to obtain a syrup.
137pressurised inhalation, solutionLiquid, usually multidose preparation consisting of a solution intended for inhalation use. The preparation is presented in a pressurised container usually fitted with a metering dose valve.
138pressurised inhalation, suspensionLiquid, usually multidose preparation consisting of a suspension intended for inhalation use. The preparation is presented in a pressurised container fitted with a metering dose valve.
139prolonged-release capsule, hardSolid single-dose preparation consisting of a hard shell containing a solid or semi-solid formulation, showing a slower release of the active substance(s) than that of a conventional-release capsule. Prolonged release is achieved by a special formulation design and/or manufacturing method. Hard prolonged-release capsules are intended for oral use.
140prolonged-release granulesSolid preparation consisting of granules showing a slower release than that of conventional-release granules. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Prolonged-release granules are usually single-dose preparations intended for oral use.
141prolonged-release suspension for injectionLiquid sterile preparation consisting of a suspension intended for administration by injection; the active substance(s) are released over an extended period of time.
142prolonged-release tabletSolid single-dose preparation consisting of a tablet showing a slower release of the active substance(s) than that of a conventional-release tablet. Prolonged release is achieved by a special formulation design and/or manufacturing method. Prolonged-release tablets are intended for oral use.
143rectal foamLiquid preparation, usually presented in a pressurised container provided with an applicator suitable for delivery to the rectum of foam containing large volumes of gas dispersed in a liquid containing the active substance. Rectal foams are intended for a local effect.
144rectal solutionLiquid preparation consisting of a solution intended for rectal use or for diagnostic purposes. Rectal solutions are usually presented in containers with a volume in the range of 2.5 mL to 2000 mL. The container is fitted with an applicator or an applicator is provided separately.
145rectal suspensionLiquid preparation consisting of a suspension intended for rectal use or for diagnostic purposes. Rectal suspension are usually presented in containers with a volume in the range of 2.5 mL to 2000 mL. The container is fitted with an applicator or an applicator is provided separately.
146shampooLiquid or, occasionally, semi-solid, usually multidose preparation intended for application to the scalp by rubbing and subsequent washing away with water. Upon rubbing with water, shampoos usually form foam. Shampoos are solutions, suspensions or emulsions containing surface-active agents.
147solution for cardioplegiaLiquid sterile preparation consisting of an aqueous solution intended for use in inducing cardiac arrest during heart surgery. Some preparations may require mixing with other preparations prior to administration, for example to adjust the pH.
148solution for haemodialysis/ haemofiltrationLiquid sterile preparation consisting of a solution intended for use as a solution for haemodialysis or a solution for haemofiltration.
149solution for infusionLiquid sterile preparation consisting of an aqueous solution intended to be introduced, usually in large volumes, usually into the circulating blood stream.
150solution for injectionLiquid sterile single-dose or multidose preparation consisting of a solution intended for administration by injection.
151solution for injection/infusionLiquid sterile single-dose or multidose preparation consisting of a solution intended for administration by injection or infusion.
152solution for organ preservationLiquid sterile preparation consisting of an aqueous solution of electrolytes typically at a concentration close to the intracellular electrolyte composition, intended for storage, protection and/or perfusion of mammalian body organs that are in particular destined for transplantation.
153solution for peritoneal dialysisLiquid sterile preparation consisting of an aqueous solution containing electrolytes with a concentration close to the electrolytic composition of plasma and glucose in varying concentrations or other suitable osmotic agents, intended for intraperitoneal use as a dialysis solution.
154solution for sealantLiquid sterile preparation consisting of a solution intended for the preparation of a sealant.
155sublingual spray, solutionLiquid, usually multidose preparation consisting of a solution intended for sublingual use. Sublingual sprays are usually presented in pressurised containers with a metering valve.
156sublingual tabletSolid single-dose preparation consisting of an uncoated tablet intended for sublingual use. Sublingual tablets are usually prepared by compression of mixtures of powders or granulations into tablets with a shape suited for the intended use. Other technologies such as moulding may be used.
157suppositorySolid single-dose preparation of a shape, size and consistency suitable for rectal use, containing active substance(s) dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at body temperature.
158suspension and effervescent granules for oral suspensionSuspension and effervescent granules, both containing active ingredients, intended for the preparation of an oral suspension by dissolving or dispersing the granules in the suspension.
159suspension and solution for spraySuspension and solution for spray
160suspension for injectionLiquid sterile single-dose or multidose preparation consisting of a suspension intended for administration by injection.
161syrupLiquid single-dose or multidose aqueous preparation characterised by a sweet taste and a viscous consistency and usually containing aromatic or other flavouring agents, intended for oral use. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof.
162tabletSolid single-dose uncoated preparation obtained by compressing uniform volumes of particulate solids or by other means such as extrusion or moulding. Tablets include single-layer tablets resulting from a single compression of particles and multi-layer tablets consisting of concentric or parallel layers obtained by successive compressions of particles of different composition. Tablets are intended for oral use to release active substance(s) in the gastrointestinal fluids by a rate depending essentially on the intrinsic properties of active substance(s) (conventional release).
163transdermal patchFlexible single-dose preparation intended to be applied to the unbroken skin to obtain a systemic delivery over an extended period of time. Transdermal patches consist of a backing sheet supporting a reservoir or a matrix containing the active substance(s) and on the top a pressure-sensitive adhesive, which assures the adhesion of the preparation to the skin. The backing sheet is impermeable to the active substance(s) and normally impermeable to water. In reservoir systems the active substance may be dissolved or dispersed in a semi-solid basis or in a solid polymer matrix, which is separated from the skin by a rate-controlling membrane. The pressure-sensitive adhesive may, in this case, be applied to some or all parts of the membrane, or only around the border of the membrane and the backing sheet. Matrix systems contain the active substance in a solid or semi-solid matrix, the properties of which control the diffusion pattern to the skin. The matrix system may also be a solution or dispersion of the active substance in the pressure-sensitive adhesive. The releasing surface of the patch is covered by a protective liner to be removed before applying the patch to the skin.
164transdermal solutionLiquid single-dose or multidose preparation consisting of a solution intended for transdermal use. The term ‘Transdermal solution’ is used only when more-specific terms such as ‘Pour-on solution’, ‘Solution for iontophoresis’, ‘Spot-on solution’ and ‘Transdermal spray, solution’ do not apply.
165vaginal capsule, hardSolid single-dose preparation consisting of a hard capsule of a size and shape suited for vaginal use, containing a liquid or semi-solid formulation, intended for a local effect.
166vaginal capsule, softSolid single-dose preparation consisting of a soft capsule of a size and shape suited for vaginal use, containing a liquid or semi-solid formulation, intended for a local effect.
167vaginal creamSemi-solid preparation consisting of a cream usually presented in a single-dose container provided with a suitable applicator, intended for vaginal use to obtain a local effect.
168vaginal delivery systemDrug delivery system intended to be inserted in the vagina where it releases its contents over an extended period of time. Medicated sponge and medicated vaginal tampon are excluded.
169vaginal gelSemi-solid preparation consisting of a gel usually presented in a single-dose container provided with a suitable applicator, intended for vaginal use to obtain a local effect.
170vaginal tabletSolid single-dose preparation consisting of a tablet, usually uncoated or film-coated, intended for administration to the vagina to obtain a local effect. Vaginal tablets are usually of larger size and a different shape from tablets intended for oral administration.