Dosage Form Homework

 Capsules:
Capsules are solid preparations with hard or soft shells of various shapes and capacities, containing a
single dose of active substance(s). They are usually intended for oral administration.

The capsule shells are made of gelatin or other substances, the consistency of which may be
adjusted by the addition of substances such as glycerol or sorbitol. Excipients such as surface-active
agents, opaque fillers, antimicrobial preservatives, sweeteners, coloring matter authorized by the
competent authority and flavoring substances may be added. The capsules may bear surface
markings.

The contents of capsules may be solid, semi-solid or liquid. They consist of one or more active
substances with or without excipients such as solvents, diluents, lubricants and disintegrating
agents. The contents do not cause deterioration of the shell. The shell, however, is attacked by the
digestive fluids and the contents are released.

Several categories of capsules may be distinguished: hard capsules, soft capsules, gastro-resistant
capsules, modified-release capsules, and cachets.

 Collodions
Collodions are Liquids for Cutaneous Application, usually containing Pyroxylin in a mixture of Ether
and Ethanol. When they are allowed to dry, a flexible film is formed at the site of application.

 Creams
Creams are formulated to provide preparations that are essentially miscible with the skin secretion.
They are intended to be applied to the skin or certain mucous membranes for protective,
therapeutic or prophylactic purposes especially where an occlusive effect is not necessary.

Creams should not normally be diluted. However, should dilution be necessary care should be taken,
in particular, to prevent microbial contamination. The appropriate diluent should be used and
heating should be avoided during mixing. Excessive dilution may affect the stability of some creams.
If diluted, creams should normally be used within two weeks of their preparation.

 Dusting powders
Dusting Powders are finely divided powders that are intended to be applied to the skin for
therapeutic, prophylactic or lubricant purposes, which should be stored in a dry place.
 Ear drops
Ear drops and ear sprays are solutions, emulsions or suspensions of one or more active substances in
liquids suitable for application to the auditory meatus without exerting harmful pressure on the
eardrum (for example, water, glycols or fatty oils). They may also be placed in the auditory meatus
by means of a tampon impregnated with the liquid.

Emulsions may show evidence of phase separation but are readily redispersed on shaking.
Suspensions may show a sediment, which is readily dispersed on shaking to give a suspension that
remains sufficiently stable to enable the correct dose to be delivered.

Ear drops are usually supplied in multidose containers of glass or suitable plastic material that are
fitted with an integral dropper or with a screw cap of suitable materials incorporating a dropper and
rubber or plastic teat. Alternatively, such a cap assembly is supplied separately. Ear sprays are
usually supplied in multidose containers fitted with an appropriate applicator. 

 Elixirs
Elixirs are clear, flavoured Oral Liquids containing one or more active ingredients dissolved in a
vehicle that usually contains a high proportion of Sucrose or a suitable polyhydric alcohol or alcohols
and may also contain Ethanol (96 %) or a Dilute Ethanol.

 Emulsions
Oral Emulsions are Oral Liquids containing one or more active ingredients. They are stabilised oil-in-
water dispersions, either or both phases of which may contain dissolved solids. Solids may also be
suspended in Oral Emulsions. When issued for use, Oral Emulsions should be supplied in wide-
mouthed bottles.

 Eye drops
Eye drops are sterile aqueous or oily solutions, emulsions or suspensions of one or more active
substances intended for instillation into the eye.

Eye drops may contain excipients, for example, to adjust the tonicity or the viscosity of the
preparation, to adjust or stabilise the pH, to increase the solubility of the active substance, or to
stabilise the preparation. These substances do not adversely affect the intended medicinal action or,
at the concentrations used, cause undue local irritation.

Aqueous preparations supplied in multidose containers contain a suitable antimicrobial preservative

in appropriate concentration except when the preparation itself has adequate antimicrobial
properties. The antimicrobial preservative chosen must be compatible with the other ingredients of
the preparation and must remain effective throughout the period of time during which eye drops are
in use. If eye drops do not contain antimicrobial preservatives they are supplied in single-dose
containers or in multidose containers preventing microbial contamination of the contents after
opening. Eye drops intended for use in surgical procedures do not contain antimicrobial
preservatives.
 Eye drops that are solutions, examined under suitable conditions of visibility, are practically clear
and practically free from particles.

Eye drops that are suspensions may show a sediment that is readily redispersed on shaking to give a
suspension which remains sufficiently stable to enable the correct dose to be delivered.

Multidose preparations are supplied in containers that allow successive drops of the preparation to
be administered. The containers contain at most 10 mL of the preparation, unless otherwise justified
and authorised.

 Gargles
Gargles are aqueous solutions intended for gargling to obtain a local effect. They are not to be
swallowed. They are supplied as ready-to-use solutions or concentrated solutions to be diluted. They
may also be prepared from powders or tablets to be dissolved in water before use. They may
contain excipients to adjust the pH which, as far as possible, is neutral.

 Granules
Granules are preparations consisting of solid, dry aggregates of powder particles sufficiently robust
to withstand handling. They are intended for oral administration. Some are swallowed as such, some
are chewed and some are dissolved or dispersed in water or another suitable liquid before being
administered.

For reasons of patient safety and to ensure the correct administration of the medicinal product, this
term may also be used where very small tablets (rather than granules) are presented in a sachet, and
where the entire contents of the sachet are intended for oral administration as a single dose.

Granules contain one or more active substances with or without excipients and, if necessary,
colouring matter authorised by the competent authority and flavouring substances.

Granules are presented as single-dose or multidose preparations. Each dose of a multidose

preparation is administered by means of a device suitable for measuring the quantity prescribed. For
single-dose granules, each dose is enclosed in an individual container, for example a sachet or a vial.

 Implants
Implants are sterile, solid preparations of a size and shape suitable for parenteral implantation and
release of the active substance(s) over an extended period of time. Each dose is provided in a sterile
container.

 Inhalations
Preparations for inhalation are liquid, semi-solid or solid preparations intended for administration as
vapours or aerosols to the lung in order to obtain a local or systemic effect. They contain one or
more active substances that may be dissolved or dispersed in a suitable vehicle.
 Preparations for inhalation may, depending on the type of preparation, contain propellants,
cosolvents, diluents, antimicrobial preservatives, carriers, solubilising and stabilising agents, etc.
These excipients do not adversely affect the functions of the mucosa of the respiratory tract or its
cilia. Suspensions and emulsions are readily dispersible on shaking and they remain sufficiently
stable to enable the correct dose to be delivered. Preparations for inhalation are supplied in
multidose or single-dose containers.

Several categories of preparations for inhalation may be distinguished:

— preparations to be converted into vapour;
— liquid preparations for nebulisation;
— pressurised metered-dose preparations for inhalation;
— non-pressurised metered-dose preparations for inhalation;
— inhalation powders.

 Injections
Injections are sterile solutions, emulsions or suspensions. They are prepared by dissolving,
emulsifying or suspending the active substance(s) and any added excipients in water, in a suitable
non-aqueous liquid, that may be non-sterile where justified, or in a mixture of these vehicles.
Solutions for injection, examined under suitable conditions of visibility, are clear and practically free
from particles

Emulsions for injection do not show any evidence of phase separation. Suspensions for injection may
show a sediment which is readily dispersed on shaking to give a suspension which remains
sufficiently stable to enable the correct dose to be withdrawn.

Multidose preparations: Multidose aqueous injections contain a suitable antimicrobial preservative

at an appropriate concentration except when the preparation itself has adequate antimicrobial
properties. When a preparation for parenteral administration is presented in a multidose container,
the precautions to be taken for its administration and more particularly for its storage between
successive withdrawals are given.

Antimicrobial preservatives: Aqueous preparations which are prepared using aseptic precautions and
which cannot be terminally sterilised may contain a suitable antimicrobial preservative in an
appropriate concentration.

 Irrigations
Preparations for irrigation are sterile, aqueous, large-volume preparations intended to be used for
irrigation of body cavities, wounds and surfaces, for example during surgical procedures.

Preparations for irrigation are either solutions prepared by dissolving one or more active substances,
electrolytes or osmotically active substances in water complying with the requirements for Water
for injections or they consist of such water alone. In the latter case, the preparation may be labelled
as ‘water for irrigation’. Irrigation solutions are usually adjusted to make the preparation isotonic
with respect to blood. Examined in suitable conditions of visibility, preparations for irrigation are
clear and practically free from particles.
 Preparations for irrigation are supplied in single-dose containers. The containers and closures
comply with the requirements for containers for preparations for parenteral administration, but the
administration port of the container is incompatible with intravenous administration equipment and
does not allow the preparation for irrigation to be administered with such equipment.

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

 Mouthwashes
Mouthwashes are aqueous solutions intended for use in contact with the mucous membrane of the
oral cavity. They are not to be swallowed. They are supplied as ready-to-use solutions or
concentrated solutions to be diluted. They may also be prepared from powders or tablets to be
dissolved in water before use. Mouthwashes may contain excipients to adjust the pH which, as far as
possible, is neutral.

 Nasal drops and sprays

Nasal drops and liquid nasal sprays are solutions, emulsions or suspensions intended for instillation
or spraying into the nasal cavities. Emulsions may show evidence of phase separation but are easily
redispersed on shaking. Suspensions may show a sediment, which is readily dispersed on shaking to
give a suspension that remains sufficiently stable to enable the correct dose to be delivered.

Nasal drops are usually supplied in multidose containers provided with a suitable applicator. Liquid
nasal sprays are supplied in containers with atomising devices or in pressurised containers fitted
with a suitable adapter and with or without a metering dose valve. The size of droplets of the spray
is such as to localise their deposition in the nasal cavity.

 Ointments
Ointments are formulated to provide preparations that are immiscible, miscible or emulsifiable with
the skin secretion. Hydrophobic ointments and water-emulsifying ointments are intended to be
applied to the skin or certain mucous membranes for emollient, protective, therapeutic or
prophylactic purposes where a degree of occlusion is desired. Hydrophilic ointments are miscible
with the skin secretion and are less emollient as a consequence.

In tropical and subtropical countries varying quantities of Arachis Oil, White Beeswax, Wool Fat,
Hard Paraffin, White Soft Paraffin, Yellow Soft Paraffin or Liquid Paraffin may be used in the
preparation of the Ointments of the Pharmacopoeia when prevailing high temperatures otherwise
 make them too soft for convenient use, but the specified proportions of the active ingredients must
be maintained.

Ointments should not normally be diluted. However, should dilution be necessary care should be
taken in the selection of diluents to avoid risk of incompatibility or instability.

 Paints
Paints are Liquids for Cutaneous Applications and are solutions or dispersions of one or more active
ingredients. They are intended for application to the skin or, in some cases, mucous membranes.

 Pessaries
Pessaries are solid, single-dose preparations. They have various shapes, usually ovoid, with a volume
and consistency suitable for insertion into the vagina. They contain 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. Excipients such as diluents, adsorbents, surface-active agents, lubricants,
antimicrobial preservatives and colouring matter authorised by the competent authority may be
added, if necessary.

 Powders
Oral powders are preparations consisting of solid, loose, dry particles of varying degrees of fineness.
They contain one or more active substances, with or without excipients and, if necessary, colouring
matter authorised by the competent authority and flavouring substances. They are generally
administered in or with water or another suitable liquid. They may also be swallowed directly. They
are presented as single-dose or multidose preparations.

Multidose oral powders require the provision of a measuring device capable of delivering the
quantity prescribed. Each dose of a single-dose powder is enclosed in an individual container, for
example a sachet or a vial.

 Syrups
Syrups are aqueous preparations characterised by a sweet taste and a viscous consistency. They may
contain sucrose at a concentration of at least 45 per cent m/m. The sweet taste can also be obtained
by using other polyols or sweetening agents. Syrups usually contain aromatic or other flavouring
agents. Each dose from a multidose container is administered by means of a device suitable for
measuring the prescribed volume. The device is usually a spoon or a cup for volumes of 5 mL.

 Tablets
Tablets are solid preparations each containing a single dose of one or more active substances. They
are obtained by compressing uniform volumes of particles or by another suitable manufacturing
 technique, such as extrusion, moulding or freeze-drying (lyophilisation). Tablets are intended for oral
administration. Some are swallowed whole, some after being chewed, some are dissolved or
dispersed in water before being administered and some are retained in the mouth where the active
substance is liberated.

The particles consist of one or more active substances with or without excipients such as diluents,
binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of
the preparation in the digestive tract, colouring matter authorised by the competent authority and
flavouring substances.

Tablets are usually straight, solid cylinders, the end surfaces of which are flat or convex and the
edges of which may be bevelled. They may have break-marks and may bear a symbol or other
markings. Tablets may be coated.

 Lozenges and pastilles

Lozenges and pastilles are solid, single-dose preparations intended to be sucked to obtain, usually, a
local effect in the oral cavity and the throat. They contain one or more active substances, usually in a
flavoured and sweetened base, and are intended to dissolve or disintegrate slowly in the mouth
when sucked.

Lozenges are hard preparations prepared by moulding. Pastilles are soft, flexible preparations
prepared by moulding of mixtures containing natural or synthetic polymers or gums and sweeteners.