Escolar Documentos
Profissional Documentos
Cultura Documentos
of Drug Administration
Dosage Form
"A dosage form is the way of identifying the drug
in its physical form. In determining dosage form,
FDA examines such factors as
(1) physical appearance of the drug product,
(2) physical form of the drug product prior to
dispensing to the patient,
(3) the way the product is administered,
(4) frequency of dosing, and
(5) how pharmacists and other health professionals
might recognize and handle the product."
http://www.fda.gov/CDER/dsm/index.htm
Physical form
1. Solid
2. Semisolid
3. liquid
TABLET (TAB)
A solid dosage form
containing medicinal
substances with or without
suitable diluents.
Example: paracetamol
aspirin
CAPSULE (CAP)
A solid oral dosage form consisting
of a shell and a filling. The shell is
composed of a single sealed
enclosure, or two halves that fit
together and which are sometimes
sealed with a band. Capsule shells
may be made from gelatin, starch,
or cellulose, or other suitable
materials, may be soft or hard, and
are filled with solid or liquid
ingredients that can be poured or
squeezed.
Example: omeprazole, cefexime
SOLUTION
A clear, homogeneous
liquid dosage form that
contains one or more
chemical substances
dissolved in a solvent or
mixture of mutually
miscible solvents.
Example: iron sulfate
solution
Making a saline water solution by
dissolving table salt (NaCl) in water
SUSPENSION
A liquid dosage form
that contains solid
particles dispersed
in a liquid vehicle.
Example: antacid,
metronidazole
Flour suspended in water
SYRUP
An oral solution containing
high
concentrations
of
sucrose or other sugars; the
term has also been used to
include any other liquid
dosage form prepared in a
sweet and viscid vehicle,
including oral suspensions.
Example:
zinc
syrup,
chlorpheniramine
ELIXIR
A clear, pleasantly flavored,
sweetened hydroalcoholic
liquid containing dissolved
medicinal agents; it is
intended for oral use.
Example: diphenhydramine
, chlorpheniramine
CREAM
An emulsion, semisolid dosage
form, usually containing > 20%
water and volatiles and/or <
50% hydrocarbons, waxes, or
polyols as the vehicle. This
dosage form is generally for
external application to the skin
or mucous membranes.
Example: ketoconazole,
miconazole, hydrocortisone
OINTMENT
A semisolid dosage form,
usually containing <20%
water and volatiles and
>50% hydrocarbons,
waxes, or polyols as the
vehicle. This dosage
form is generally for
external application to
the skin or mucous
membranes.
Example: betamethasone
EMULSION
A dosage form consisting of a two-phase
system comprised of at least two immiscible
liquids, one of which is dispersed as droplets
(internal or dispersed phase) within the other
liquid (external or continuous phase), generally
stabilized with one or more emulsifying
agents. (Note: Emulsion is used as a dosage
form term unless a more specific term is
applicable, e.g. cream, lotion, ointment.)
Example: cyclosporine opthalmic emulsion,
ethylene glycol topical emulsion
GEL
A semisolid dosage form that contains a
gelling agent to provide stiffness to a
solution or a colloidal dispersion. A gel
may contain suspended particles.
Example: diclofenac gel
(Voltaren Gel is used to treat joint pain
in the hands, wrists, elbows, knees,
ankles, or feet caused by osteoarthritis.)
TINCTURE
An alcoholic or
hydroalcoholic solution
prepared from vegetable
materials or from
chemical substances.
Example: tincture of
iodine is an topical
antiseptic
LOTION
An emulsion, liquid dosage form.
This dosage form is generally for
external application to the skin.
Example: calamine lotion
(Calamine and zinc oxide lotion is
commonly used to relieve pain
anditching caused by sunburns,
rashes, and insect bites.)
AEROSOL (AER)
A product that is packaged under
pressure
and
contains
therapeutically active ingredients
that are released upon activation
of an appropriate valve system; it
is intended for topical application
to the skin as well as local
application into the nose (nasal
aerosols),
mouth
(lingual
aerosols), or lungs (inhalation)
Example: salbutamol
SUPPOSITORY
A solid body of various
weights
and
shapes,
adapted for introduction
into the rectal orifice of the
human body; they usually
melt, soften, or dissolve at
body temperature.
Example:
paracetamol,
glycerin
INJECTION
A sterile preparation intended for
parenteral use.
Routes of Drug
Administration
Important
Info
Routes of Drug
Administration
The possible routes of drug entry
into the body may be divided
into two classes:
Enteral
Parenteral
Topical
Enteral Routes
Enteral - drug placed directly in the GI
tract:
Oral
Advantages
Convenient - can be selfadministered, pain free, easy to take
Absorption - takes place along the
whole length of the GI tract
Cheap - compared to most other
parenteral routes
Oral
Disadvantages
Sometimes inefficient - only part
of the drug may be absorbed
First-pass effect - drugs absorbed
orally are initially transported to
the liver via the portal vein
irritation to gastric mucosa nausea and vomiting
Oral
Disadvantages cont.
destruction of drugs by gastric
acid and digestive juices
effect too slow for emergencies
unpleasant taste of some drugs
unable to use in unconscious
patient
Parenteral Routes
Intravascular (IV, IA)- placing a
drug directly into the blood stream
Intramuscular (IM) - drug injected
into skeletal muscle
Subcutaneous - Absorption of
drugs from the subcutaneous tissues
Inhalation - Absorption through the
lungs
Routes of Drug
Administration
Topical
Mucosal membranes (eye drops, antiseptic, nasal,
etc.)
Skin
a. Dermal - rubbing of oil or ointment (local
action)
b. Transdermal - absorption of drug through skin
(systemic action)