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PHARMACEUTICAL AEROSOLS
BY
A.HIMA BINDU
16DU1R0001
B. PHARMACYSt. Ann’s college of pharmacy,
chirala.
CONTENTS
• INTRODUCTION
• HISTORY
• ADVANTAGES AND DISADVANTAGES
• COMPONENTS OF AEROSOL
• FORMULATION OF AEROSOLS
• TYPES OF AEROSOL SYSTEMS
• MANUFACTURING OF AEROSOLS
• PACKING, LABELLING AND STORAGE
• REFERENCES
INTRODUCTION
Pharmaceutical aerosols are defined as " Colloidal systems consisting of
very finely subdivided liquid or solid particles dispersed in and surrounded by gas ".
Pressurized packs.
Particle size : >50µm.
Aerosol products can be developed as
o NASAL INHALERS.
o DRY POWDER INHALER.
o NEBULIZER/ ATOMIZER.
o METERED DOSE AEROSOL INHALERS.
HISTORY
• In1941 - Americans Lyle Goodhue and William Sullivan, invented the modern
spray can.
• In 1942- First Aerosol was developed (Insecticide).
• In 1950- Pharmaceutical Aerosol for topical administration was developed.
• In 1955- Aerosols for the local activity in the respiratory tract was developed
(Epinephrine).
ADVANTAGES
Rapid onset of action.
Avoidance of manual contact with the medicament.
Immediate local application.
No contamination of the product.
DISADVANTAGES
High cost and expensive.
Highly flammable.
Toxic.
CFC can cause ozone layer depletion.
COMPONENTS OF AEROSOL
•PROPELLANTS.
•CONTAINERS.
•VALVE AND ACTUATOR.
•PRODUCT CONCENTRATE.
PROPELLANTS
• Generally propellant is regarded as the heart of the aerosol package.
• It provide driving force to expel the product from the container.
• TYPES OF PROPELLANTS
a) Liquefied gases propellants:
FLUORINATED HYDROCARBONS:
Eg. CFC, HCFC
HYDROCARBONS
b) Compressed gases propellants:
Eg. Ar, CO2.
LIQUEFIED GAS PROPELLANT
• Liquefied propellants are gases that exist as liquids under
pressure.
• Because the aerosol is under pressure propellant exists mainly as
a liquid, but it will also be in the head space as a gas.
• The product is used up as the valve is opened, some of the liquid
propellant turns to gas and keeps the head space full of gas.
• In this way the pressure in the can remains essentially constant
and the spray performance is maintained throughout the life of
the aerosol.
COMPRESSED GAS PROPELLANT
• It occupies the headspace above the liquid out of the
can.
• When the aerosol valve is opened the gas pushes the
liquid out of the can.
• The amount of gas in the head space remains the same
but it has more space, and as a result the pressure will
drop during the life of the can. Spray performance is
maintained however by careful choice of the aerosol
valve and the actuator.
CONTAINERS
• They must be able to withstand pressure as high as 140 to 180 psig at 130ºF.
METAL CONTAINER
TIN PLATE STEEL CONTAINER:
contains electroplated sheet.
ALUMINIUM CONTAINER:
great resistance against corrosion.
light weight.
STAINLESS STEEL CONTAINER:
Limited for smaller size.
Can withstand pressure.
Strong and resistant to moisture.
GLASS CONTAINER
• Preferred because of its aesthetic value and absence of incompatibilities.
• Limited to the products having low pressure and low % of propellant.
• Used for topical and MDI aerosol.
• Types:
i. Uncoated glass container
 less cost
 high clarity
ii. Plastic coated glass container
 prevents the glass from shattering during breakage.
VALVE:
• Capable of delivering the contents in the desired form such a spray, foam, solid
stream etc.
• TYPES OFVALVE
i. Continuous spray
ii. Metered valve
• VALVE ASSEMBLY
ACTUATORS
• These are specially designed buttons which helps in the delivering the drug in the
desired form i.e; wet stream, foam or solid stream.
• TYPES OF ACTUATORS:
i. Spray actuator
ii. Foam actuator
iii. Solid steam actuator
iv. Special actuator
FORMULATION OF AEROSOLS
• The formulation consists of 2 essential components:
i. PRODUCT CONCENTRATE
o It includes mixture of active ingredient and other necessary agents (solvents,
surfactants etc.).
ii. PROPELLANT
o Single or blend of propellants and solvents are used to achieve the desired
solubility.
o It should be selected to give the desired vapour pressure, solubility and particle
size.
TYPES OF AEROSOL SYSTEMS
1. SOLUTION SYSTEM/ TWO PHASE SYSTEM
• Simplest system.
• Contains liquid phase and solid phase.
• Creates homogenous system due to dissolved or dispersed propellants and
solvents.
• On activation of valve, pressure of vapour phase causes liquid phase to rise in dip
tube and expelled from the container.
2.THREE PHASE SYSTEMS
a. A layer of water immiscible liquid propellant.
b. A layer of highly aqueous product concentrate.
c. A vapour phase.
• Mostly used when formulation requires the presence of a liquid phase that
is propellant immiscible.
• When aerosol valve is actuated , the pressure of the vapour phase causes
the liquid phase to rise in the dip tube and gets expelled.
MANUFACTURING OF AEROSOL
• Aerosols should be maintained with the protective caps in place to prevent
accidental activation of the valve assembly/ contamination by dust and other
foreign materials.
• Medicinal aerosol that are to be dispersed only upon prescription.
• An aerosol required to be labelled “flammable”.
• Exposed to temperature above 49ºc may burst an aerosol container.
• Generally recommended for storage between 15ºc and 30ºc.
REFERENCES
• “The Theory & Practice Of Industrial Pharmacy” by Leon Lachman,
H.A., LIEBERMAN.
• Sciarra, JJ., Stoller, L., 1998.The science and technology of aerosol
packaging. A Wiley-interscience publication, NewYork, 247-255.
• Remington’s “The Science & Practise of Pharmacy” 21st Edition,
Volume-1.
Pharmaceutical Aerosols
Pharmaceutical Aerosols

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Pharmaceutical Aerosols

  • 1. PHARMACEUTICAL AEROSOLS BY A.HIMA BINDU 16DU1R0001 B. PHARMACYSt. Ann’s college of pharmacy, chirala.
  • 2. CONTENTS • INTRODUCTION • HISTORY • ADVANTAGES AND DISADVANTAGES • COMPONENTS OF AEROSOL • FORMULATION OF AEROSOLS • TYPES OF AEROSOL SYSTEMS • MANUFACTURING OF AEROSOLS • PACKING, LABELLING AND STORAGE • REFERENCES
  • 3. INTRODUCTION Pharmaceutical aerosols are defined as " Colloidal systems consisting of very finely subdivided liquid or solid particles dispersed in and surrounded by gas ". Pressurized packs. Particle size : >50µm. Aerosol products can be developed as o NASAL INHALERS. o DRY POWDER INHALER. o NEBULIZER/ ATOMIZER. o METERED DOSE AEROSOL INHALERS.
  • 4. HISTORY • In1941 - Americans Lyle Goodhue and William Sullivan, invented the modern spray can. • In 1942- First Aerosol was developed (Insecticide). • In 1950- Pharmaceutical Aerosol for topical administration was developed. • In 1955- Aerosols for the local activity in the respiratory tract was developed (Epinephrine).
  • 5. ADVANTAGES Rapid onset of action. Avoidance of manual contact with the medicament. Immediate local application. No contamination of the product. DISADVANTAGES High cost and expensive. Highly flammable. Toxic. CFC can cause ozone layer depletion.
  • 7. PROPELLANTS • Generally propellant is regarded as the heart of the aerosol package. • It provide driving force to expel the product from the container. • TYPES OF PROPELLANTS a) Liquefied gases propellants: FLUORINATED HYDROCARBONS: Eg. CFC, HCFC HYDROCARBONS b) Compressed gases propellants: Eg. Ar, CO2.
  • 8. LIQUEFIED GAS PROPELLANT • Liquefied propellants are gases that exist as liquids under pressure. • Because the aerosol is under pressure propellant exists mainly as a liquid, but it will also be in the head space as a gas. • The product is used up as the valve is opened, some of the liquid propellant turns to gas and keeps the head space full of gas. • In this way the pressure in the can remains essentially constant and the spray performance is maintained throughout the life of the aerosol.
  • 9. COMPRESSED GAS PROPELLANT • It occupies the headspace above the liquid out of the can. • When the aerosol valve is opened the gas pushes the liquid out of the can. • The amount of gas in the head space remains the same but it has more space, and as a result the pressure will drop during the life of the can. Spray performance is maintained however by careful choice of the aerosol valve and the actuator.
  • 10. CONTAINERS • They must be able to withstand pressure as high as 140 to 180 psig at 130ºF. METAL CONTAINER TIN PLATE STEEL CONTAINER: contains electroplated sheet. ALUMINIUM CONTAINER: great resistance against corrosion. light weight. STAINLESS STEEL CONTAINER: Limited for smaller size. Can withstand pressure. Strong and resistant to moisture.
  • 11. GLASS CONTAINER • Preferred because of its aesthetic value and absence of incompatibilities. • Limited to the products having low pressure and low % of propellant. • Used for topical and MDI aerosol. • Types: i. Uncoated glass container  less cost  high clarity ii. Plastic coated glass container  prevents the glass from shattering during breakage.
  • 12. VALVE: • Capable of delivering the contents in the desired form such a spray, foam, solid stream etc. • TYPES OFVALVE i. Continuous spray ii. Metered valve • VALVE ASSEMBLY
  • 13. ACTUATORS • These are specially designed buttons which helps in the delivering the drug in the desired form i.e; wet stream, foam or solid stream. • TYPES OF ACTUATORS: i. Spray actuator ii. Foam actuator iii. Solid steam actuator iv. Special actuator
  • 14. FORMULATION OF AEROSOLS • The formulation consists of 2 essential components: i. PRODUCT CONCENTRATE o It includes mixture of active ingredient and other necessary agents (solvents, surfactants etc.). ii. PROPELLANT o Single or blend of propellants and solvents are used to achieve the desired solubility. o It should be selected to give the desired vapour pressure, solubility and particle size.
  • 15. TYPES OF AEROSOL SYSTEMS 1. SOLUTION SYSTEM/ TWO PHASE SYSTEM • Simplest system. • Contains liquid phase and solid phase. • Creates homogenous system due to dissolved or dispersed propellants and solvents. • On activation of valve, pressure of vapour phase causes liquid phase to rise in dip tube and expelled from the container.
  • 16. 2.THREE PHASE SYSTEMS a. A layer of water immiscible liquid propellant. b. A layer of highly aqueous product concentrate. c. A vapour phase. • Mostly used when formulation requires the presence of a liquid phase that is propellant immiscible. • When aerosol valve is actuated , the pressure of the vapour phase causes the liquid phase to rise in the dip tube and gets expelled.
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  • 22. • Aerosols should be maintained with the protective caps in place to prevent accidental activation of the valve assembly/ contamination by dust and other foreign materials. • Medicinal aerosol that are to be dispersed only upon prescription. • An aerosol required to be labelled “flammable”. • Exposed to temperature above 49ºc may burst an aerosol container. • Generally recommended for storage between 15ºc and 30ºc.
  • 23. REFERENCES • “The Theory & Practice Of Industrial Pharmacy” by Leon Lachman, H.A., LIEBERMAN. • Sciarra, JJ., Stoller, L., 1998.The science and technology of aerosol packaging. A Wiley-interscience publication, NewYork, 247-255. • Remington’s “The Science & Practise of Pharmacy” 21st Edition, Volume-1.