Professional Documents
Culture Documents
Prashant Pandey
M.Pharm (Pharmaceutics)
INTRODUCTION
Disadvantages
• Expensive
• Propellants are toxic
• Highly inflammable
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Classification of aerosols
According to administration route
– Inhalation aerosols
– Non-inhalation aerosols
– Topical aerosols
• Propellants
• Containers
• Valves and
actuators
• Product
concentrate
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Propellants
Types of propellants
(a) Liquefied gases (b) Compressed gases
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LIQUIFIED GAS
FLUORINATED HYDROCARBONS
Advantages
– Chemical inertness
– Lack of toxicity
– Non flammability & explosiveness
Disadvantages
– High cost
– It depletes the ozone layer
– Damage Global Warming Potential
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HYDROCARBONS
– Can be used for water based aerosols, topical
use
Advantages
– Inexpensive
– Excellent solvents
– It does not cause ozone depletion
Disadvantages
– Flammable
– Unknown toxicity produced
e.g. propane , butane , isobutane
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Recently HFA propellants are used instead of CFC
propellants.
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COMPRESSED GASES
- Used when the aqueous phase need not be miscible
with the propellant
- Do not have chilling effect, for topical preparation
Advantages
– Inexpensive
– Non flammable
– No environmental problems
Disadvantages
– Pressure falls during use
– Produce coarse droplet spray
– Require use of non volatile co-solvent
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Containers
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Glass Containers
• Compatible with most formulations
• Allows for greater degree of freedom in
container design resistant to corrosion, low cost.
• 25 psig pressure can be filled or 15% propellant
conc.
• Available with or without plastic coating
• Plastic coated glass containers can be filled to a
pressure of 33 psig
• Can be safely used
• Limited to use – its brittleness and breakage
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Plastic Containers
• Made with acetyl resins or poly propylene
• Can withstand high pressure
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Valves
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CONTINUOUS SPRAY VALVES
Used for topical aerosols
Valves assembles consist of following parts
Ferrule or mounting cup - Attach valve to container
Tin plated steel, Al , Brass (glass bottles), Under side of the
valve cup is coated with single or double epoxy or vinyl resins
Valve body or housing - Made up of nylon or derlin (0.013 to
0.080 inch)
Housing may or may not contain opening called VAPORTAP
This allows escape of vaporized propellant with liquid product
Fine particle, avoids clogging, inverted position, reduce flame
extension and chilling - FCIFC
Stem - Nylon or derlin , Gasket - Buna –N and neoprene
rubber
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Spring - Stainless steel , to hold gasket in place,
Dip tube - Poly ethylene or poly propylene , i.d- 0.120 –
0.125 inch,
Capillary dip tube – 0.050 inch
High viscous – 0.195 inches
METERING VALVE
• Used for all inhalations and some topical aerosols.
• Applicable to potent medication.
• It has defined volume of reservoir.
• It can be deliver desired volume of medicament by
depressing actuator.
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ACTUATORS
• It is a specially designed button which is fitted to the
valve.
• It delivers the product in a desired form.
• It discharges the product as spray, foam, solid stream.
Spray actuators
• It can be used for topical preparation, such as
antiseptics, local anesthetics and foot preparation
• It allows the stream of product concentrate and
propellant to pass through various openings and
dispense as spray
• The product is dispensed as a stream rather than
as a spray by the actuator when the propellant
conc. is low (50%or less)
• Mechanical break up actuators
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FOAM ACTUATORS
• It consist of large orifice
• Ranges from 0.070—0.0125inch
SPECIAL ACTUATORS
• These are used for a specific purpose
• It delivers the medicament to the appropriate site of
action such as throat, nose, dental and eyes etc.
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Metered Dose Inhalers
OBJECTIVES
• To minimize the number of administrations.
• To improve the drug delivery into the nasal passage
ways and respiratory air ways.
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Advantages of MDI
• It delivers specified amount of dose
• Small size and convenience
• Usually inexpensive
• Quick to use
• Multi dose capability more than 100 doses available
Disadvantages of MDI
• Difficult to deliver high doses
• Most products have low lung deposition
• Drug delivery highly dependent on good inhaler
technology
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METERING VALVE
• It delivers only a specified quantity of product
• It is most critical component of MDI
• It crimped on to the container.
• The volume of valve ranges from 25—100µl for
inhalation and up to 5ml for topical use.
• Such valve consist of two valved chambers both
are connected to actuator button
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Formulation
General formula
Active drug -10-15%
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Ethanol - 10-15
Water – 10-15
HC propellant A-46 – 55-70
Depending on water content the final product may be solution
or three
phase system.
• Hydrocarbon propellant A-70 (drier particles) while A-17
and A-31 tend to produce a wetter spray.
• These are useful for topical preparations.
Plastic coated glass containers.
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WATER BASED SYSTEM (Water based aerosols)
• Large amounts of water can be used to replace all or part of the non
aqueous solvents used in aerosols.
• Since propellant and water are not miscible, a three phase aerosol
forms (propellant, water and vapor phases).
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Testing of Pharmaceutical Aerosols
PHYSICOCHEMICAL CHARACTERISTICS
• Identification
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of propellants: GC, IR
PERFORMANCE
• Spray pattern
• Foam stability
- Rotational viscometers
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PARTICLE SIZE DETERMINATION
- Cascade Impactor: 0.1 to 30 microns
- Light scatter decay: Tyndall beam
BIOLOGICAL CHARACTERISTICS
- Therapeutic activity
- Toxicity: Topical effects – irritating, chilling effect
Inhalation effects (even intended for topical
preparations)
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Thank You
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