PRESENTATION ON AEROSOL
Submitted To: Submitted By:
Dr. Pallavi Tiwari Shivani Singh
Assistant Professor M. Pharma
1styear
School of Pharmaceutical Science, CSJMU
CONTENT
Definition
Advantage
Disadvantage
Types of aerosol
Component of Aerosol
Manufacturing of Aerosol
Pharmaceutical Application of Aerosol
Evaluation parameter of Aerosol
DEFINITION
• Aerosols is defined as a system that depends on the power of a
compressed or liquefied gas to expel the medicament which inside
container.
• Aerosols are pressurized dosage forms containing one or more
medicament inside container and when valve is open its release its
medicament.
ADVANTAGE
• Avoid first pass metabolism.
• Deliver uniform dosage form.
• Targeted drug delivery system.
• Due to presence of propellant its produce cooling effect in site of action.
• It is used for medicament that are sensitive for oxygen, moisture, light or
heat sensitive drug.
• It is easy to use.
DISADVANTAGE
• It is difficult to prepare aerosols dosage form of insoluble drug.
• If long term used of propellant it is produced toxic effect.
• It is expensive dosage form.
• Some time its contaminate drugs by its trace metal that presence in container
TYPES OF AEROSOLS
1. Space spray :- this types of aerosols producing dispersion of particles
which remain in the air for prolonged periods. The particles of spray are
usually less then 50 µm in size.
2. Surface coating spray :- such aerosols used for producing a film on the
surface treated this type of aerosols is relatively coarse. The particles range
in size from 50 to 200 µm.
3. Foams :- They are formed when expansion of propellant within an
emulsion results in production of small bubbles.
COMPONENTS OF AERSOLS
• Container
• Valve
• Actuator
• Propellant
• Medicament
MANUFACTURING OF AEROSOLS
Aerosols are generally manufactured by following methods:
• Pressure filling
• Cold filling
COLD FILLING
• Step 1: Product concentrate is cooled/freezed to -30 to -40 0C
• Step 2: Cold concentrate is added to chilled container.
• Step 3: Propellant is added
• Step 4: Valve is crimped in place
• Step 5; The filled pack is passed through the water bath at 55 0C (for leak test)
PRESSURE FILLING
• Step 1: Chilled product concentrate is added to an open container
• Step 2: Valve is crimped in place
• Step 3: Propellant is added under pressure through the valve
• Step 4: The filled pack is passed through the water path (for leak test)
• Step 5: Actuator and cap placement
PHARMACEUTICAL AEROSOL APPLICATIONS
Pharmaceutical aerosols including metered-dose inhalers (MDIs) and dry powder inhalers (DPIs) are
devices that deliver a specific quantity of drug to the lungs. The particle size distribution and shape of the
delivered dose is more critical for inhalation aerosols than for most other conventional drug products
because these factors greatly influence the deposition profile in the lungs of the patient. The optimum
aerodynamic particle size distribution for most inhalation aerosols has generally been recognized as being in
the range of 1-5 µm.
Although the compendial tests for pharmaceutical aerosols are based on cascade impactors, microscopic
analysis can provide valuable information on particle size and shape distribution of the drug particles such
as:
•The presence of large particles
•Changes in morphology of the drug substance particle
•Extent of agglomeration
•Crystal growth
•Presence of foreign particulate matter
EVALUATION PARAMETERS OF PHARMACEUTICAL
AEROSOLS
A. Flammability and combustibility
1. Flash point
2. Flame extension, including flashback
B. Physiochemical characteristics
3. Density
4. Moisture content
5. Identification of propellant(s)
6. Concentrate-propellant ratio
7. Vapor pressure
C. Performance
8. Spray pattern
9. Aerosol valve discharge rate
10. Dosage with metered valves
11. Net contents
12. Foam stability
13. Particle size determination
14. Leakage
D. Biologic characteristics
E. Therapeutic activity
FLAME PROJECTION
• This test indicates the effect of an aerosol formulation on the extension of an open flame.
• Product is sprayed for 4 sec. into flame.
• Depending on the nature of formulation, the fame is extended, and exact length was measured
with ruler.
FLASH POINT
Determined by using standard Tag Open Cap Apparatus.
Step involves are
•Aerosol product is chilled to temperature of - 25 0 F and transferred to the test apparatus.
•Temperature of test liquid increased slowly, and the temperature at which the vapors ignite is
taken a flash point.
FLAME PROJECTION
• This test indicates the effect of an aerosol formulation on the extension of an open
flame.
• Product is sprayed for 4 sec. into flame.
• Depending on the nature of formulation, the fame is extended, and exact length was
measured with ruler.
DENSITY
Determined by hydrometer or a pycnometer.
Step involves are
• A pressure tube is fitted with metal fingers and hoke valve, which allow for the
introduction of liquids under pressure.
• The hydrometer is placed in to the glass pressure tube.
•Sufficient sample is introduced through the valve to cause the hydrometer to rise
half way up the length of the tube.
•The density can be read directly.
MOISTURE CONTENT
Method used -- Karl Fischer method
G. C has also been used
Identification of propellants
G.C,
I.R Spectrophotometry
Aerosol valve discharge rate
Determined by taking an aerosol known weight and discharging the contents for
given time using standard apparatus.
By reweighing the container after time limit has expired, the change in weight per time
dispensed is discharge rate,
Expressed as gram per seconds.
PARTICLE SIZE DETERMINATION
Cascade impactor
Light scatter decay method
Cascade impactor
• Operates on the projected through a series of nozzle and glass slides at high viscosity, the
large particles become impacted first on the lower velocity stages, and the smaller particles
pass on and are collected at high velocity stages.
• These particles ranging from 0.1 to 30 micron and retaining on RTI.
• Modification made to improve efficacy
METERED DOSE INHALER
To increased interest in modifying metered dose inhalers (MDIs) to minimize the
number.
Administration error and to improve the drug delivery of aerosols particles into the
drug delivery system of the nasal passageways and respiratory tract.