Professional Documents
Culture Documents
Section1:
Definition
Pharmaceutical Aerosols
PHARMACEUTICAL AEROSOLS are pressurized
dosage forms containing one or more active ingredients
which upon actuation emit a fine dispersion of liquid
and/or solid materials in a gaseous medium.
They depend upon the function of the container, its
valve assembly, and an added component--the
propellant--for the physical delivery of the medication
in proper form.
Aerosol Systems
TWO-PHASE SYSTEMS
This system is comprised of the liquid phase,
containing the liquefied propellant and product
concentrate, and the vapor phase.
THREE-PHASE SYSTEMS
This system is comprised of a layer of waterimmiscible liquid propellant, a layer of highly
aqueous product concentrate, and the vapor phase.
Emulsion or
suspension
2 the propellant
When the propellant is a liquefied gas or a mixture
of liquefied gases, it frequently serves the dual role
of propellant and solvent or vehicle for the product
concentrate.
In certain aerosol systems, no liquefied compressed
gases, as carbon dioxide, nitrogen, and nitrous
oxide, are employed as the propellant.
Chlorofluorocarbons
(CFCs).
The most used propellant in aerosol products
However these propellants are being phased out and
will be prohibited due to scientific recognition that
they reduce the amount of ozone in the stratosphere,
which results in an increase in the amount of
ultraviolet radiation reaching the earth, an increase
in the incidence of skin cancer, and other adverse
environmental effects.
How to determine
vapor
pressure
of a
Example
1:What is the
a vapor
pressure
of a 60:40
mixture of propane and isobutane. Information on two
certain mixture?
propellants is as follows:
Property
propane
isobutane
Molecular formula
C3H8
C4H10
Molecular weight
44.1
58.1
Boiling point( )
-43.7
10.9
Vapor pressure(psig@70 )
110
30.4
0.50
0.56
Flash point( )
-156
-117
n propane
n isobu tan e
60
1.36
44.1
40
0.69
58.1
Ppropane
n propane
n propane n isobu tan e
P propane
1.36
Pisobu tan e
n isobu tan e
Pisobu tan e
n propane n isobu tan e
0.69
PT=72.98+10.23=83.21psi at 70
Pressurized containers
Various materials have been used in the
manufacture of aerosol containers, including
(1)glass, uncoated or plastic coated;
(2)metal, including tin-plated steel, aluminum, and
stainless steel;
(3)plastics
Valve assembly
The function of the valve assembly is to permit the
expulsion of the contents of the can in the desired
form, at the desired rate, and, in the case of metered
valves, in the proper amount or dose.
Among the materials used in the manufacture of the
various valve parts are plastic, rubber, aluminum,
and stainless steel.
Filling Operations
COLD FILLING
PRESSURE
FILLING
COLD FILLING
both the product concentrate and the propellant
must be cooled to temperatures of -30to -40
the chilled product concentrate is quantitatively
metered into an equally cold aerosol container
the liquefied gas is added, the heavy vapors of the
cold liquid propellant generally displace the air
present in the container
PRESSURE FILLING
the product concentrate is quantitatively placed in
the aerosol container
the valve assembly is inserted and crimped into
place
the liquefied gas, under pressure, is metered into
the valve stem from a pressure burette
Section 2: Sprays
Sprays may be defined as aqueous or oleaginous
solutions in the form of coarse droplets or as finely
divided solids to be applied topically, most usually to
the nasal-pharyngeal tract or to the skin.
For example: medicinal atomizers, which are
employed for the issuance of a medicated solution to
the patient in the form of fine droplets
Section 3: Inhalations
Glossary
Aerosols; sprays; inhalations;
Pressurized container, valve assembly;
propellant;
Two-phase systems; three-phase systems;
Ingredient; solvent or vehicle ;
Chlorofluorocarbons (CFCs);
Metered dose inhalers ;
Cold filling ; pressure filling
Problems:
1 What is aerosols, sprays and inhalations?
2 Please briefly describe the influencing factors of
aerosols absorption.
3 Please briefly describe the advantages and
disadvantages of aerosols.
4 Which are the constituents of aerosols?
5 Please briefly describe the quality request of aerosols.
6 What is the function of propellants?