we covered all the topics related to pharmaceutical aerosol in a clear and easily understandable manner with some of the pictorials attached to it. I think it will be sufficient for both your exams as well as for you seminar purpose even i also gave presentation on this.
Hope this will be helpful for your reference purpose.
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.
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.