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AEROSOL
INTRODUCTION
An Aerosol or Pressurized package is defined as
“a system that depends on power of compressed or
liquefied gas to expel the content from the container.”
Aerosol products consist of the following parts:
1. Propellant
2. Container
3. Valve &
Actuator
4. Product
concentrate
3. ADVANTAGES OF AEROSOLS
The drug sensitive to the effect of oxygen or moisture is
protected and stability is enhanced
The drug can be directly applied to the affected areas
Administration of drug by aerosol is a rapid process
It protects the drug from gastrointestinal tract degradation
3. ADVANTAGES OF AEROSOLS
Hepatic first pass metabolism is avoided
Aerosols are used for both systemic and local application
Easy to apply
A sterile dose of drug is dispensed and also the contamination of
drug is prevented
PROPELLANTS
FOR ORAL AND
INHALATION
TRICHLORO
MONOFLUORO
METHANE
[PROPELLANT
11]
DICHLORO
DIFLUORO
METHANE
[PROPELLANT
11]
DICHLORO
TETRAFLUORO
ETHANE
[PROPELLANT
114]
DIFLUORO
ETHANE
[PROPELLANT
152a]
TOPICAL
PROPANE
A-108
BUTANE
A-17
ISOBUTANE
A-31
NITROGEN
GAS
CARBON
DIOXIDE
GAS
NITROUS
OXIDE GAS
Propellants generates proper expelling pressure within the container
product concentrate of an aerosol in which the active drug combined
with suitable excipients can be delivered in three forms of liquid form
a solution, suspension, an emulsion or in a form similar to semisolid.
There are containers in which the product concentrate is filled.
CONTAINERS
1. METAL
TINPLATED
STEEL
ALUMINIUM
STAINLESS
STEEL
2. GLASS
UNCOATED
GLASS
PLASTIC
COATED
GLASS
• WITHSTAND THE PRESSURE OF 140 TO 180 PSIG AT 130 DEGREE F
The valve is a part of the package through which the
product concentrate is expelled in the desired form and rate
The actuator is an integral part of every aerosol package
that allow easy opening and closing of the valve
which is usually designed in an appropriate way to give the
desired form of discharge LIKE
fine mist, liquid stream spray, coarse spray, etc.
Actuator:
It is the push knob which the
user presses to activate or
deactivate the assembly of the
valve system.
The physical form of the emitted
product concentrate is
determined by the combination
of the type and amount of
propellant used along with the
proper actuator design and
dimensions.
ACTUATOR TYPE
SPRAY
ACTUATOR
FOAM
ACTUATOR
SOLID
STREAM
ACTUATOR
SPECIAL
ACTUATOR
Stem:
Provides necessary
support for the
actuator and delivers
the contents in the
desired form to the
chamber of the
actuator.
GASKET:
Serves to prevent leakage of the
product concentrate when
the valve is in the deactivated
position, placed tightly with the
stem.
SPRING
It is that part of the device that allows the
actuator draw backup on releasing pressure,
returning the valve assembly to the closed
position in this way.
Besides that, it seals the gasket in place to
prevent the outflow of the formulation.
MOUNTING CUP
It is normally mounted at the top of the aerosol container serves to hold
the valve in place and feature a crimped closure at the opening of the
container.
The undersigned side of the mounting cup is exposed to the formulation,
which imposes the same consideration as the inner part of the container
with respect to meeting the criteria of compatibility.
If necessary, it may be coated to prevent an undesired interaction.
HOUSING
Positioned directly below the mounting cup and
provides the association between the dip tube part
and the valve stem along with the actuator.
With the stem collaboration, housing orifice helps
to control the delivery rate and determine the form
in which the content of the product is emitted.
DIP TUBE
It is the part of the valve assembly that extends
downstream into the product concentrate aids to
transport the contents from the container to the
valve
The inner integral dimensions of the dip tube and
housing for a particular product are determined
according to the viscosity of the product and its
intended delivery rate
TYPES OF SYSTEMS
SOLUTION SYSTEM
WATER
BASED
SYSTEM
SUSPENSION AND
DISPERSION
SYSTEM
FOAM
SYSTEM
FOAM SYSTEM
QUICK
BREAKIN
G FOAM
NON AQ. STABLE
FOAM
THERMA
L
FOAMS
FORMULATION OF AEROSOL
API ONE OR
MORE
PRODUCT
CONCENTRATE
PROPELLANT
SINGLE OR
COMBINATION
SOLVENTS
ANTIOXIDANTS
SURFACTANTS
SUSPENDING
AGENTS
EMULSIFYING
AGENTS
QUALITY CONTROL FOR PHARMACEUTICAL
AEROSOL
1. Propellants
vapour pressure is determined using pressure gauge.
Variation indicates presence of air in the headspace.
• Gas chromatography is used to determined the identity
of the propellant and its combination
• Purity of the propellant is checked for moisture, halogen
& non volatile residual determinations
2. VALVES, ACTUATOR & DIP TUBE
TESTING PROCEDURE
Take 25 valves and placed on suitable containers
The containers are filled with specific test solutions
A button actuator with 0.02 inch orifice is attached to
the valves
The filled containers are placed in a suitable
atmosphere at a temperature of 25 ± 10 C
LIMITS
54 MICROLITRE OR LESS - + 15%
55 TO 200 MICROLITRE - + 10%
When the products have attained the temperature of
25 ±10C, the filled containers are actuated to fullest
extent for 2 seconds.
This procedure is repeated for a total of 2 delivered
from each 25 test units
Valve Delivery per actuation in µL = Individual delivery
weight in mg / Specific gravity of test solution
5. Out of 50 deliveries:
If 4 or more deliveries are outside limits, then valves are
rejected.
 If 3 individual deliveries are outside limits, another 25 valves
are tested.
Lot is rejected if more than 1 delivery is outside specification.
If 2 deliveries from 1 valve are beyond limits: another 25 valves
are tested.
CONTAINERS
• Containers are examined for defects in linings
• Quality control aspects include degree of conductivity of
electric current as measure of exposed metals
• Glass containers examined for flaws
• The dimension of neck and other must be checked & weight
should be determined.
4. WEIGHT CHECKING
It is done by periodically adding empty tared containers to filling
lines which after filling with product concentrate are removed and
reweighed.
Same procedure is used for checking weight of the propellant.
5. LEAK TEST
It is done by measuring the crimp’s valve
dimension and comparing
Final testing of valve enclosure is done by
passing filled containers through the water bath
6. SPRAY TESTING
It is done to clear up dip tube of pure
propellant and concentrate
to check any defects in the valve and the
spray pattern
7. EVALUATION TEST FOR PHARMACEUTICAL
AEROSOL
1. Flame Projection
The aerosol product is sprayed to an open flame for
about 4 second and the extension of the flame is
measured with the help of a ruler
2. FLASH POINT
Tag Open Cup apparatus is the standard test apparatus.
The aerosol product is chilled to a temperature of about -250F and
transferred to the test apparatus
The temperature of the test liquid is increased slowly and the
temperature at which the vapours ignite is taken as the flash point
DENSITY MEASUREMENT
HYDROMETER PYCNOMETER
MOISTURE MEASUREMENT
KARL
FISCHER
GC
PARTICLE SIZE MEASUREMENT
CASCADE
IMPACTO
LIGHT
SCATTER
DECAY
PERFORMANCE TESTS
1. Spray Patterns
The method involves the impingement of sprays on a
piece of paper that has been treated with dye-talc mixture
It gives a record of the spray pattern
2. AEROSOL VALVE DISCHARGE RATE
An aerosol product of known weight is taken and its
contents are discharged using standard apparatus for a
given period of time
The container is reweighed
Then the change in weight per time dispensed is the
discharge rate
The discharge rate can also be
expressed as grams per second
3. DOSAGE WITH METERED VALVES
The discharge rate can also be expressed as grams
per second
The doses are dispensed into the solvents or onto
a material that absorbs the active ingredients
The assay of the solution gives the amount of
active ingredients present
4. NET CONTENTS
The tared cans are placed onto the filling line are weighed, the difference
in weight is equal to the net contents.
The other method is a Destructive method and consists of weighing a
full container and then dispensing the contents.
The contents are then weighed.
The difference in weight gives the amount of contents present in the
container.
5. FOAM STABILITY
The life of a foam ranges from a few seconds (for quick breaking
foam) to one hour or more depending on the formulation.
The methods which are used to determine the foam stability
includes visual evaluation, time for a given mass to penetrate the
foam, time for a given rod that is inserted into the foam to fall and
rotational viscometer.
6. PARTICLE SIZE DETERMINATION
Cascade
impactor
light scattering
decay
methods
are used for
particle size
determination
Biological
Testing
Therapeu
tic
activity
Toxicity
1. Therapeutic Activity
For Inhalation Aerosols The determination of therapeutic activity is
dependent on the particle size
For Topical Aerosols
Therapeutic activity of aerosol products are determined by applying the
therapeutically active ingredients topically to the test areas and the amount
of therapeutically active substances absorbed is determined.
2. Toxicity study:
For Topical Aerosols
The topically administered aerosols are checked for chilling effect or
irritation in the skin
When aerosol are topically applied, thermistor probe attached to the
recording thermometer are used to determine the change in skin
temperature for a given period of time.
For Inhalation Aerosols: Inhalation toxicity study is done by exposing test
animals to vapours sprayed from the aerosol container.

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AEROSOL.pptx

  • 2. INTRODUCTION An Aerosol or Pressurized package is defined as “a system that depends on power of compressed or liquefied gas to expel the content from the container.” Aerosol products consist of the following parts:
  • 3. 1. Propellant 2. Container 3. Valve & Actuator 4. Product concentrate
  • 4.
  • 5. 3. ADVANTAGES OF AEROSOLS The drug sensitive to the effect of oxygen or moisture is protected and stability is enhanced The drug can be directly applied to the affected areas Administration of drug by aerosol is a rapid process It protects the drug from gastrointestinal tract degradation
  • 6. 3. ADVANTAGES OF AEROSOLS Hepatic first pass metabolism is avoided Aerosols are used for both systemic and local application Easy to apply A sterile dose of drug is dispensed and also the contamination of drug is prevented
  • 9. Propellants generates proper expelling pressure within the container product concentrate of an aerosol in which the active drug combined with suitable excipients can be delivered in three forms of liquid form a solution, suspension, an emulsion or in a form similar to semisolid. There are containers in which the product concentrate is filled.
  • 12. • WITHSTAND THE PRESSURE OF 140 TO 180 PSIG AT 130 DEGREE F
  • 13. The valve is a part of the package through which the product concentrate is expelled in the desired form and rate The actuator is an integral part of every aerosol package that allow easy opening and closing of the valve which is usually designed in an appropriate way to give the desired form of discharge LIKE fine mist, liquid stream spray, coarse spray, etc.
  • 14. Actuator: It is the push knob which the user presses to activate or deactivate the assembly of the valve system. The physical form of the emitted product concentrate is determined by the combination of the type and amount of propellant used along with the proper actuator design and dimensions.
  • 16. Stem: Provides necessary support for the actuator and delivers the contents in the desired form to the chamber of the actuator.
  • 17. GASKET: Serves to prevent leakage of the product concentrate when the valve is in the deactivated position, placed tightly with the stem.
  • 18. SPRING It is that part of the device that allows the actuator draw backup on releasing pressure, returning the valve assembly to the closed position in this way. Besides that, it seals the gasket in place to prevent the outflow of the formulation.
  • 19. MOUNTING CUP It is normally mounted at the top of the aerosol container serves to hold the valve in place and feature a crimped closure at the opening of the container. The undersigned side of the mounting cup is exposed to the formulation, which imposes the same consideration as the inner part of the container with respect to meeting the criteria of compatibility. If necessary, it may be coated to prevent an undesired interaction.
  • 20. HOUSING Positioned directly below the mounting cup and provides the association between the dip tube part and the valve stem along with the actuator. With the stem collaboration, housing orifice helps to control the delivery rate and determine the form in which the content of the product is emitted.
  • 21. DIP TUBE It is the part of the valve assembly that extends downstream into the product concentrate aids to transport the contents from the container to the valve The inner integral dimensions of the dip tube and housing for a particular product are determined according to the viscosity of the product and its intended delivery rate
  • 22.
  • 23. TYPES OF SYSTEMS SOLUTION SYSTEM WATER BASED SYSTEM SUSPENSION AND DISPERSION SYSTEM FOAM SYSTEM
  • 24. FOAM SYSTEM QUICK BREAKIN G FOAM NON AQ. STABLE FOAM THERMA L FOAMS
  • 25. FORMULATION OF AEROSOL API ONE OR MORE PRODUCT CONCENTRATE PROPELLANT SINGLE OR COMBINATION SOLVENTS ANTIOXIDANTS SURFACTANTS SUSPENDING AGENTS EMULSIFYING AGENTS
  • 26. QUALITY CONTROL FOR PHARMACEUTICAL AEROSOL
  • 27. 1. Propellants vapour pressure is determined using pressure gauge. Variation indicates presence of air in the headspace. • Gas chromatography is used to determined the identity of the propellant and its combination • Purity of the propellant is checked for moisture, halogen & non volatile residual determinations
  • 28. 2. VALVES, ACTUATOR & DIP TUBE TESTING PROCEDURE
  • 29. Take 25 valves and placed on suitable containers The containers are filled with specific test solutions A button actuator with 0.02 inch orifice is attached to the valves The filled containers are placed in a suitable atmosphere at a temperature of 25 ± 10 C
  • 30. LIMITS 54 MICROLITRE OR LESS - + 15% 55 TO 200 MICROLITRE - + 10%
  • 31. When the products have attained the temperature of 25 ±10C, the filled containers are actuated to fullest extent for 2 seconds. This procedure is repeated for a total of 2 delivered from each 25 test units Valve Delivery per actuation in µL = Individual delivery weight in mg / Specific gravity of test solution
  • 32. 5. Out of 50 deliveries: If 4 or more deliveries are outside limits, then valves are rejected.  If 3 individual deliveries are outside limits, another 25 valves are tested. Lot is rejected if more than 1 delivery is outside specification. If 2 deliveries from 1 valve are beyond limits: another 25 valves are tested.
  • 33. CONTAINERS • Containers are examined for defects in linings • Quality control aspects include degree of conductivity of electric current as measure of exposed metals • Glass containers examined for flaws • The dimension of neck and other must be checked & weight should be determined.
  • 34. 4. WEIGHT CHECKING It is done by periodically adding empty tared containers to filling lines which after filling with product concentrate are removed and reweighed. Same procedure is used for checking weight of the propellant.
  • 35. 5. LEAK TEST It is done by measuring the crimp’s valve dimension and comparing Final testing of valve enclosure is done by passing filled containers through the water bath
  • 36. 6. SPRAY TESTING It is done to clear up dip tube of pure propellant and concentrate to check any defects in the valve and the spray pattern
  • 37. 7. EVALUATION TEST FOR PHARMACEUTICAL AEROSOL 1. Flame Projection The aerosol product is sprayed to an open flame for about 4 second and the extension of the flame is measured with the help of a ruler
  • 38. 2. FLASH POINT Tag Open Cup apparatus is the standard test apparatus. The aerosol product is chilled to a temperature of about -250F and transferred to the test apparatus The temperature of the test liquid is increased slowly and the temperature at which the vapours ignite is taken as the flash point
  • 42. PERFORMANCE TESTS 1. Spray Patterns The method involves the impingement of sprays on a piece of paper that has been treated with dye-talc mixture It gives a record of the spray pattern
  • 43. 2. AEROSOL VALVE DISCHARGE RATE An aerosol product of known weight is taken and its contents are discharged using standard apparatus for a given period of time The container is reweighed Then the change in weight per time dispensed is the discharge rate
  • 44. The discharge rate can also be expressed as grams per second
  • 45. 3. DOSAGE WITH METERED VALVES The discharge rate can also be expressed as grams per second The doses are dispensed into the solvents or onto a material that absorbs the active ingredients The assay of the solution gives the amount of active ingredients present
  • 46. 4. NET CONTENTS The tared cans are placed onto the filling line are weighed, the difference in weight is equal to the net contents. The other method is a Destructive method and consists of weighing a full container and then dispensing the contents. The contents are then weighed. The difference in weight gives the amount of contents present in the container.
  • 47. 5. FOAM STABILITY The life of a foam ranges from a few seconds (for quick breaking foam) to one hour or more depending on the formulation. The methods which are used to determine the foam stability includes visual evaluation, time for a given mass to penetrate the foam, time for a given rod that is inserted into the foam to fall and rotational viscometer.
  • 48. 6. PARTICLE SIZE DETERMINATION Cascade impactor light scattering decay methods are used for particle size determination
  • 50. 1. Therapeutic Activity For Inhalation Aerosols The determination of therapeutic activity is dependent on the particle size For Topical Aerosols Therapeutic activity of aerosol products are determined by applying the therapeutically active ingredients topically to the test areas and the amount of therapeutically active substances absorbed is determined.
  • 51. 2. Toxicity study: For Topical Aerosols The topically administered aerosols are checked for chilling effect or irritation in the skin When aerosol are topically applied, thermistor probe attached to the recording thermometer are used to determine the change in skin temperature for a given period of time. For Inhalation Aerosols: Inhalation toxicity study is done by exposing test animals to vapours sprayed from the aerosol container.