Pharmaceutical aerosols are pressurized dosage forms that emit a fine dispersion of active ingredients in a gaseous or liquid medium upon actuation. They are commonly used to treat asthma and COPD by delivering drugs directly to the lungs. Aerosols consist of a propellant that expels the formulation through a metering valve. Common propellants include hydrocarbons and chlorofluorocarbons. Aerosols can be manufactured via cold or pressure filling processes. Quality control tests evaluate the containers, valves, and drug delivery performance of aerosol products.

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BY
T.Sivakumar
B.PHARMACY

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1. DEFINITION
2. COMPONENTS OF AEROSOL SYSTEMS
3. FORMULATION OF AEROSOLS
4. MANUFACTURE OF AEROSOLS
5. METERED DOSE INHALER DESIGNS
6. DRY POWDER INHALERS
7. EVALUATION OF AEROSOLS
8. QUALITY CONTROL TESTS FOR AEROSOLS

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Pharmaceutical aerosols are pressurised dosage forms
that upon actuation emit a fine dispersion of liquid or solid materials
containing one or more active ingredients in a gaseous or liquid
medium. These are also to be called as pressurised packages.
ADVANTAGES:
5. It is easy and convenient to use.
6. It is used in the treatment of asthma or COPD.
7. It provides minimum contamination.
8. It provides maximum stability.
9. Systemic side effects are reduced.

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1. Cost is high.
3. Irritation may occur upon topical administration of
aerosols.
5. It leads to inhalation toxicity.

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1. Propellants:
These are the materials which expel the
contents of the container through the valves by applying
force.
classification:
Liquefied gases:
1. Halogenated hydrocarbons
Ex: Fluorinated chlorinated
hydrocarbons
Trichloro monofluoro methane
Dichloro difluoro methane

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2. Hydrocarbon :
Ex: Propane
Butane
Isobutane
Compressed gases:
1. Soluble gases:
Ex: Carbon dioxide
Nitrous oxide
2. Insoluble gases:
Ex: Nitrogen

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various types of materials are used in the manufacture of aerosol
containers. The containers used in the formulation of aerosols should
With stand high pressure i.e.,140 to 180 psig and temperature of about
54.44 c.
Types of materials used:
1.Metal
2.Glass
Metal: Two types of metal containers are tin plated steel and aluminium
Glass: Two types of glass containers are plastic coated glass and
uncoated glass.

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3.Valves : They help in expelling the contents from the container.
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Parts of valves :
Mounting cup or Ferrule
Valve body
Stem
Gasket
Spring
Dip tube
4.Actuators : These are specially designed buttons placed on the
valve stem.
Types of actuators:
Spray actuators
Foam actuators
Solid stream actuators

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Formulation of aerosols:
1.Product concentrate.
2.Propellants.

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Manufacture of aerosols:
Procedure for the manufacturing of aerosols is carried
out in 2 stages
1.The concentrate is manufactured.
2.Then the propellants are added in the formulation.

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Different apparatus used in manufaturing are
1.The pressure filling apparatus.
2.The cold filling apparatus.
3.The compressed gas filling apparatus.

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Metered dose inhaler designs:
In this drug is dissolved or suspended in a liquid propellant
mixture presented in a pressurized canister fitted with a metering
valve.
Containers: Thin plated steel , plastic coated glass or aluminium
containers.
Propellants: Cholro fluoro carbons, hydrofluoro alkanes.
Metering valves: It permits reproducible delivery of small volumes of
product . It is used in inverted position.

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Filling metered dose inhaler canisters:
1.Cold Filling.
2.Pressure Filling.
Advantages of MDIs:
1.portability.
2.Low cost.
3.Disposability.
Disadvantages of MDTs :
1.Poor inhalation.
2.Inefficient at drug delivery.

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Dry powder inhalers:
In this drug is inhaled as cloud of fine particles. The drug is either
preloaded in a inhalation device or into hard gelatin capsules or foil
blister discs.They are propellant free and do not contain any
excipient other than carrier like lactose.
Advantages:
1. It is useful for young children.
2.It delivers larger drug doses than MDIs.
Disavantages:
1.Liberation of powders from the device.
2.Less efficient.

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1.Unit dose.
• Spinhaler.
• Rotahaler.
2.Multi dose.
• Turbhaler.
• Dischaler.

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Spinhaler:The capsule is placed in a loose-
fitting rotar is pierced through 2
needles.Inhaled air flow through the device
causes rotation of rotar resulting in the
powder being dispersed to the capsule walls
and out through the perforations into the air.
Rotahaler:The capsule is inserted into an
orifice at rear of the device and when the
two sections are rotated a fin on the inhaler
barrel pulls the two halves of the capsule
spins,dispersing its contents,which are
inhaled through the mouthpiece.

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Diskhaler:Here aluminium foil blisters are
placed in disc.Needle will pierce the blisters
as air flows the blisters causes the powder to
disperse as the patient will inhales through
the mouthpiece.
Turbohaler:Here drug is present in reservoir
from which it flows to disc.The disc is
rotated by moving the turning grip back and
forth thus drug is released which is inhaled
by patient.

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1. Moisture content.
2. Leak test.
3. Particle size determination.
4. Microbial limits.

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Evaluation of aerosols:
1.Flammability and combustion test.
1.Flash point test.
2.Flame projection test.
2.Physico chemical properties test.
1.Vapour pressure
2.Density.
3.Mositure content.
4. Propellant identification.
3.Perfomance test.
1. Valve discharge test.
2. pattern of spray.
3.Metered valve test.
4.Determination of particle size.
4. Biological test.

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Quality control tests for aerosols:
1.Container.
2.Propellants.
3.Valves, Actuators and Dip tubes.
4.Weight checking of the container.
5.Test for leakage.
6.Spray test.

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Applications:
1.Aerosols are used for oral or topical administration.
2.They exhibit systemic effect.
3.These preparations are easy to carry.
4.They are uniformly applied without touching the affected area.

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