This document discusses propellants used in aerosols and the quality assurance of components and formulations. It defines aerosols as products that use compressed or liquefied gases to expel contents from a container. Pharmaceutical aerosols contain active ingredients dissolved, suspended or emulsified in a propellant or solvent-propellant mixture for topical, body cavity, or oral administration. The key components of aerosols are the propellant, container, valve, actuator, and product concentrate. Propellants must have a vapor pressure greater than atmospheric pressure at 40°C to function. Quality control of aerosols involves testing the propellants, valves, actuators, dip tubes, weight, and spray performance as well as leak

1. Propellants used in aerosols andPropellants used in aerosols and
quality assurance ofquality assurance of
components and formulationcomponents and formulation
Presented By: Salim Mulla.
M.Pharm- II sem.
ALARD COLLEGE OF PHARMACY

2. Aerosols
Aerosol are the products that depend on the power of a
compressed or liquefied gas to expel the contents from
the container.
Pharmaceutical Aerosols:
Aerosol products containing therapeutically active ingredients
dissolved, suspended or emulsified in a propellant or a mixture
of solvent and propellant and intended for topical, into the
body cavities (ear, rectum and vagina) or intended for oral
administration.

3. Aerosol
: Components of aerosols :
Propellant
Container
Valve and actuator
Product concentrate

4. 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 a mixture of
liquefied gases, it can also serve as the solvent or vehicle for
the product concentrate.
PROPELLANT:

6. Formulation :
Contains two essential components:
• Product concentrate : contains ingredients or mixture of
active ingredients and other such as solvents, antioxidants
and surfactants.
• Propellant : Propellant May be single or blend of various
propellants
The type of the system
selected depends on many
factors such as
 Physical, chemical and
pharmacological properties
of active ingredients
 Site of application.

7. Formulation:
Type of systems are
1. Solution system
2. Suspension or Dispersion system.
3. Water based system.
4. Foam system.

8. Quality Assurance of components and
formulation:
Quality control of pharmaceutical aerosols:
•Propellants valves, actuator and dip tubes.
•Testing procedure.
•Valve acceptance containers.
•Weight checking.
•Leak testing.
•Spray testing.

9. Conclusion:
• At present there is much interest in developing MDIs for
conditions including Asthma, COPD, Chronic Bronchitis and
other respiratory diseases etc.
• Many of compounds have been developed using
biotechnology process and their delivery to the respiratory
system via MDI is an extremely challenging undertaking.
• As chloroflurocarbon (CFC) propellants cause ozone
depletion, they are being replaced with acceptable
Hydroflurocarbon (HFC) propellants.

10. Reference:
• “The Theory & Practice Of Industrial Pharmacy” by Leon
Lachman , H.A.Lieberman.
• Remington’s “The Science & Practice Of Pharmacy” 21st
Edition, Volume-I.

11. THANK YOU