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Aerosols 10.ppt
2
PHARMACEUTICAL
AEROSOLS
Presented by Group. 10
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.
Pharmaceutical aerosols:
4
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.
CLASSIFICATION OF
AEROSOLS
5
Particle size
50
Foam/Froth
6
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.
7
Suitable when drugs
degrade in GIT
Prevent Oxidation of
drugs
Maintain sterility and
easy to portable
9
10
11
HAJRA ZAFAR: 3034
12
Components of aerosols
Propellant
Container
Valve and actuator
Product concentrate container
13
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.
14
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
15
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.
16
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
17
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)
18
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
19
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.
20
Manufacturing of Pharmaceutical Aerosols
 Pressure filling method
 Cold filling method
 Compressed gas filling method
Manufacturing of AEROLOS
• Addition of
propellant
Manufacturing
of concentrate
In general Manufacturing of
aerosols takes place in two
stages
22
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
23
COLD FILLING PROCESS
24
25
26
27
28
THANKYOU

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Aerosols 10.ppt

  • 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: 4 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.
  • 6. 6 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.
  • 7. 7
  • 8. Suitable when drugs degrade in GIT Prevent Oxidation of drugs Maintain sterility and easy to portable
  • 9. 9
  • 10. 10
  • 12. 12 Components of aerosols Propellant Container Valve and actuator Product concentrate container
  • 13. 13 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.
  • 14. 14 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
  • 15. 15 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.
  • 16. 16 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
  • 17. 17 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)
  • 18. 18 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
  • 19. 19 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.
  • 20. 20 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
  • 22. 22 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
  • 24. 24
  • 25. 25
  • 26. 26
  • 27. 27