This document provides an overview of pharmaceutical aerosols. It defines pharmaceutical aerosols as products containing therapeutically active ingredients intended for topical, oral, nasal, or other cavity administration as fine particles or mist. It describes the key components of aerosols including propellants, containers, valves, actuators, and product concentrates. It also outlines the manufacturing processes for aerosols including cold filling and pressure filling methods.

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PHARMACEUTICAL
AEROSOLS
Presented by Group. 10

3. Definition
Packaging of therapeutic active ingredients in a
pressurized system.
Aerosols depends on the power of compressed
or liquefied gas to expel the contents from
containers.

4. Pharmaceutical aerosols:
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Aerosol products containing therapeutically active ingredients
dissolved, suspended or emulsified in a propellant or a
mixture of solvent and propellant and intended for topical
application, for administration into one of the body cavities
(ear, rectum and vagina) or intended for administration
orally or nasally as fine solid particles or liquid mists through
the pulmonary airways, nasal passages or oral cavity.

5. CLASSIFICATION OF
AEROSOLS
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Particle size
50
Foam/Froth

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Advantages
• A dose can be removed with out contamination of
materials.
• The medication can be delivered directly to the
affected area in a desired form, such as spray, steam,
quick breaking foam or stable foam.
• Controlled and uniform dose is released
• Ease of convenience of application.
• The onset of action is faster because the medicament
is directly administered to the affected part.

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8. Suitable when drugs
degrade in GIT
Prevent Oxidation of
drugs
Maintain sterility and
easy to portable

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HAJRA ZAFAR: 3034

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Components of aerosols
Propellant
Container
Valve and actuator
Product concentrate container

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Propellant:
A propellant is a chemical with a vapor pressure
greater than atmospheric pressure at 40°C (105°F.
Function:
1) It is responsible for developing the vapor pressure
within the container
2) Expel the product when the valve is opened and in
the atomization or foam production of the product.
3) When the propellant is a liquefied gas or
compressed gases, it can also serve as the solvent
or vehicle for the product concentrate.

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Compressed Gas
Propellants
Inert Gases
Carbon Dioxide
Nitrous Oxide
Nitrogen
Liquefied Gas
Propellants
Hydrocarbons
Liquefied Petroleum
Gases
(Propane, Isobutane, n-
Butane) Isopentane, n-
Pentane
Fluorocarbons
1,1 Difluoroethane
(152a)
1,1,1,2 Tetrafluoroethane
(134a)
Ethers Dimethyl Ether

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Containers
They must be stand at pressure as high as 140 to 180 psig
(pounds per sq. inch gauge) at 1300 F.
1.Tinplated steel:
Consist of sheet of that has been
electroplated on both sides with tin.
2. Aluminium :
Greater resistance to corrosion
Light weight
Good for light sensitive drugs.

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3. Glass Container:
 Available with plastic or without
plastic coating
 Compatible with many additives
 No corrosion problems
 Can have various shape because of
molding
 Not for light sensitive drug
4. Stainless steel:
 Limited for smaller size
 Extremely strong and resistant to
moist materials
 Pressure stand

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Valves
To delivered the drug in desired form.
To give proper amount of medication.
Not differ from valve to valve of medication in
pharmaceutical preparation.
Types:
 Continuous spray valve:
usually used for topical
 Metering valves
Dispersing of potent medication at proper dispersion/ spray
approximately 50 to 150 mg ±10 % of liquid materials at one
time use of same valve. (minimize wastage and errors of
overdosing)

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Actuator:
These are specially designed
buttons which helps in delivering
the drug in desired form i.e., spray
, wet stream, foam or
solid stream. To ensure that
aerosol product is delivered in the
proper and desired form.
Different types of actuators
Spray actuators
Foam actuators
Solid steam actuators
Special actuators

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Formulation of pharmaceutical
aerosols
Contains two essential components
Product concentrate
Product concentrate contains ingredients or mixture of active
ingredients and other such as solvents, antioxidants and surfactants.
Propellant
May be single or blend of various propellants
 Blends of propellant used in a p’ceutical formulation to achieve
desired solubility characteristics or various surfactants are mixed to
give the proper HLB value for emulsion system.
 To give the desired vapor pressure, solubility & particle size.

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Manufacturing of Pharmaceutical Aerosols
 Pressure filling method
 Cold filling method
 Compressed gas filling method

21. Manufacturing of AEROLOS
• Addition of
propellant
Manufacturing
of concentrate
In general Manufacturing of
aerosols takes place in two
stages

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Cold Filling
FOR NON AQUEOUS
PRODUCTS OR
PRODUCTS WHICH
CAN WITHSTAND
LOW TEMP (-40F),
INCLUDES CHILING
OF PROPELLENT
AND PRODUCT
CONCENTRATE
Pressure
Filling
CARRIED OUT AT
ROOM
TEMPERATURE BY
UTILIZING
PRESSURE
EQUIPMENTS
METHODS

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COLD FILLING PROCESS

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