FUNDAMENTAL OF RT 1
Aerosol Generators and Aerosol Drug Therapy
The Characteristics of Therapeutic Aerosoles
Aerosol
- Is a suspension of solid or liquid particles in gas.
In the clinical setting, medical aerosols are
generated with nebulizers and inhalers devices.
- The effective use of medical aerosols requires an
understanding of the characteristic of aerosols and
their effect on drug delivery to the desired site of
action.
Key concept include:
a. Aerosol output
b. Particle size
c. Deposition
• Aerosol Output - It is define as the mass of fluid or drug
contained in a nebulizer.
• Particle Size - It depends on the substance being
nebulized and the method used to generate the aerosol.
The two most common laboratory methods used to
measure aerosol particle size are:
1. Cascade Impaction - collect aerosols of different
size ranges on a series of stages or plates.
2. Laser Diffraction - a computer is used to estimate
the range and frequency of droplet volumes
crossing the laser beam.
• Deposition - when aerosols particles leave suspension in
gas, they deposit on surface.
Key mechanism of aerosol deposition include:
1. Inertial Impaction - occurs when suspended
particles in motion collide with and are deposited
on a surface.
2. Sedimentation - occurs when aerosols particles
settle out of suspension and are deposited to
gravity. The greater the mass of particle, the faster
it settles.
3. Diffusion - It is the deposition of small particles,
mainly in the respiratory region where most
aerosol particles reach by diffusion.
Quantifying Aerosol Delivery
• One approach used to quantify aerosol deposition (in
vivo) involves scintigraphy, in which a drug is "tagged"
with a radioactive substance, aerosolized and inhaled.
• A scanner measures the distribution and intensity of
radiation across the device and the patient's head and
thorax.
Hazards of Aerosol Therapy
• The primary hazard of aerosol drug therapy is an adverse
reaction to the medication being administered.
• Care providers and bystanders risk these hazards as a
result of exposure to second hand aerosol drugs.
Infection
• Aerosol generators can contribute to nosocomial
infections by the airborne route.
• Offending organisms are primarily gram-negative bacili,
in particular, Pseudomonas aeruginosa and Legionella
pneumophila.
• Guidelines from the U.S. Centers Disease Control and
Prevention (CDC) state that nebulizers should be
sterilized between patients, frequently replaced with
disinfected or sterile units.
Airway Reactivity
• Cold air and high density aerosols can cause reactive
bronchospasm and increased airway resistance, especially
in patients with preexisting respiratory disease.
• Medications such as acetylcysteine, antibiotics,
steroids, cromolyn sodium, ribavirin and distilled
water have been associated with increased airway
resistance and wheezing during aerosol therapy.
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• Monitoring for reactive bronchospasm: auscultation, nebulizers), filtering exhalation to contain aerosol, and
patients’ breathing pattern, overall appearance and using environmental controls.
communication.

Aerosol Drug Delivery Systems

Pulmonary and Systemic Effects
• Effective aerosol therapy requires a device that quickly
• Preliminary assessment should balance the need versus delivers sufficient drug to the desired site of action with
the risk of aerosol therapy, especially among patients with minimal waste and at a low cost
high risk of having severe diseases.
Inhalation Therapy Type:
• For patients unable to clear their own secretions,
1. Pressurized Metered Dose Inhaler (MDI)
suctioning or other airway clearance, techniques may be
2. Dry Powder Inhaler (DPI)
indicated as an adjunct to aerosol therapy.
3. Nebulizers
• Appropriate airway clearance techniques should
accompany any aerosol therapy designed to help
Metered Dose Inhaler (MDI)
mobilized secretions.
• MDI (metered dose inhaler) is a device that used to
deliver a specific amount of medication to the lungs.
Drug Concentration
• Metered dose inhalers were first developed in 1955 by
• During nebulization, the evaporating, heating, baffling
Riker Laboratories.
and recycling of drug solutions undergoing jet or
ultrasonic nebulization increase solute concentrations. • Metered Dose Inhaler (MDI) has a pressurized container
of medication that fits into a mouthpiece, a dose of
• This increase in concentration usually is time-dependent;
medication is released into lungs by pushing the container
the greatest effect occurs when nebulization of
into the mouthpiece.
medications occurs over extended periods, as in
continuous aerosol drug delivery. Propellants:

1. Chlorofluorocarbons (CFCs)
Eye Irritation • Used to be the most commonly used propellants
• Banned due to adverse effect on ozone layer
• Aerosol administration via a face mask may deposit drug
2. Hydrofluoroalkanes (HFA)
in the eyes and cause eye irritation.
• More effective
• In very rare cases, anticholinergic medications have been • Produces an aerosol with a smaller particle size
suspected to worsen preexisting eye conditions, such as which improves deposition in the small airways
forms of glaucoma. and provides greater efficacy

Secondhand Exposure to Aerosol Drugs

• Repeated secondhand exposure to bronchodilators is

associated with increased risk of occupation asthma.

• Implementation of an occupational health and safety

policy could include using systems that introduce less
aerosol to the atmosphere (pressurized meter dose
inhalers, dry power inhalers, and breath-actuated
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Components of MDI

1. Canister - is produced in aluminium or stainless

steel, where the formulation resides.
2. Actuator - the complete made canister is fitted
into a plastic container this is called actuator,
which allows the patient to operate the device and
directs the aerosol into the patient lungs.
3. Metering valve - it allows a metered quantity of
the formulation.
4. Actuator seat - it holds metering valve and
actuator nozzle.
5. Actuator nozzle - it helps to spread the
component into the mouth.
Dose Counters

• A serious limitation of pMDIs is the lack of a "counter"

to indicate the number of doses remaining in the canister.

• After the number of label doses have been administered,

the pMDI may seem to give another 20 to 60 doses, which
may deliver little or no medications as the doses "tail-off."

• Tail-off effect refers to variability in the amount of drug

dispensed toward the end of the life of the canister.

• The result of tail-off is swings from normal to almost no

dose emitted from one breath to the next with no reliable
indicator to the user.

• Without a dose counter, there is no viable method to

Breath-Actuated Pressurized Metered Dose Inhaler determine remaining drug in a pMDI other than manually
keeping a log of every dose taken.
• Incorporates a trigger that is activated during inhalation.

• The Aerocount Autohaler is a flow-triggered pMDI.

• To use the Autohaler, the patient cocks a lever on the top

of the unit, which sets in motion a downward spring force.

• Using the closed-mouth technique, the patient draws

through the mouthpiece.

• When the patient's flow rate exceeds 30 L/min, a vane

releases the spring, which forces the canister down and
triggers the pMDI.

• A possible limitation of the device is that it can be breath

actuated only. Patients experiencing an acute exacerbation
of bronchospasm may be unable to generate sufficient
flows to trigger the Autohaler.
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Optimal Technique for Use of a Pressurized Metered
Dose Inhaler
1. Warm the pMDI canister to hand or body
temperature, and shake it vigorously.
2. Before first use of a new pMDI and when the
pMDI has not been used for several days, prime
the pMDI by pointing it into the air (away from
people) and actuating.
3. Assemble the apparatus and uncap the
mouthpiece, ensuring there are no loose objects in
the device.
4. Open mouth technique*: Open your mouth wide,
keeping tongue down. Hold the pMDI with the
canister oriented downward and the outlet aimed
at your mouth. Position the pMDI approximately
4 cm (two fingerbreadths) away from your mouth.
5. Closed mouth technique: Place mouthpiece
between lips, with tongue out of the path of the
outlet.
6. Breathe out normally.
7. As you slowly begin to breathe in (<0.5 L/sec),
actuate the pMDI.
8. Continue inspiration to total lung capacity.
9. Hold your breath for up to 10 seconds. Then relax
and breathe normally.
10. Wait 1 minute between puffs.
11. Disassemble the apparatus, and recap the
mouthpiece.
Inhalation therapy
Advantages of MDIs
• Compact, portable, convenient Multi-dose delivery
capable
• Lower risk of bacterial contamination
• Suitable for an emergency situation
Disadvantages of MDIs
• Needs correct actuation and inhalation
coordination - can be difficult in children and
elderly patients
• Cold freon effect
• High pharyngeal drug deposition
• Remaining dose is difficult to determine
Determining Dose Left in Pressurized Metered Dose
Inhaler
With dose counters
The user should:
1. Determine how many puffs of drug the pMDI has
when full.
2. Learn to read the counter display because each
dose counter has a different way of displaying
doses left in the canister.
3. Check the counter display to track the pMDI
actuations remaining in the canister.
4. Reorder the pMDI when there are a few days of
drug remaining.
5. Dispose of the pMDI properly, after the last dose
is dispensed.
Without dose counters
The user should:
1. Read the label to determine how many puffs of
drug the pMDI has when full.
2. Calculate how long the pMDI will last by dividing
the total number of puffs in the PMDI by the total
puffs used per day. If the pMDI is used more often
than planned, it will run out sooner.
3. Identify the date that the medication will run out,
and mark it on the canister or on a calendar.
4. For drugs that are prescribed to be taken as
needed, track the number of puffs of drug
administered on a daily log sheet and subtract
them from the remaining puffs to determine the
amount of medication left in the pMDI.
5. Keep the daily log sheet in a convenient place,
such as taped to the bathroom mirror.
6. Refill the pMDI prescription when there are a few
days of use remaining in the pMDI.
7. Dispose of the pMDI properly when the last dose
is dispensed.
Spacer
• Spacers are clear plastic tubes with a mouthpiece or
mask on one end and a hole for your inhaler at the other.
A valve in the spacer mouthpiece opens as you breathe in
and closes as you breathe out. A spacer makes your MDI
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(metered dose inhaler) easy to use and more effective for the powder into respirable particles depends on the
people of all ages. creation of turbulent flow in the inhaler.

Advantages of using a spacer • Turbulent flow is a function of the ability of the patient
to inhale the powder with a sufficiently high inspiratory
1. Many adults and children are unable to use their
flow rate.
metered dose inhaler effectively. The spacer
reduces the need for perfect technique. There are numerous DPIs on the market, which can be
2. Spacers are designed to deliver up to twice the divided into three categories based on the design of their
medication of an inhaler alone. 50% more dose containers:
medicine enters the lungs when a spacer is used.
1. Unit-dose DPI,
3. A spacer can help when you are short of breath
2. Multiple unit-dose DPI,
and an inhaler by itself is difficult to use. A
3. Multiple dose drug reservoir DPI.
spacer is a smaller, convenient alternative to a
nebuliser.
4. Studies on adults and children show spacers work
just as well as nebulisers in acute asthma. Spacers
with masks can help very young children inhale
their medicine.

Optimal Technique for Use of a Metered Dose Inhaler

with a Valved Holding Chamber

1. Warm the pMDI to hand or body temperature. Unit-dose DPI

2. Assemble the apparatus, ensuring there are no
objects or coins in the chamber that could be
aspirated or obstruct outflow.
3. Hold the canister vertically, and shake it - Aerolizer
vigorously. Prime if necessary.
4. Place the pMDI in the holding chamber inlet,
position chamber outlet in the mouth (or place the
mask over nose and mouth), and encourage the
patient to breathe through the mouth. Visually
inspect for proper valve function. - HandiHaler
5. With normal breathing, actuate the pMDI once
and have the patient breathe through the device for
three to seven breaths (three breaths for adults and
seven breaths for infants).* Multiple unit-dose DPIs
6. Allow 30 to 60 seconds between actuations.

Dry-powder inhaler

• Breath-actuated dosing system - Diskhaler

• The patient creates the aerosol by drawing air though a

dose of finely milled drug powder with sufficient force to
disperse and suspend the powder in the air. Dispersion of
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Nebulizers

Three categories of nebulizers:

- Twisthaler
1. Pneumatic Jet Nebulizers
2. Ultrasonic Nebulizers
3. Vibrating Mesh Nebulizers

Pneumatic Jet Nebulizers

• It is a gas-powered jet nebulizers have been for clinical

use for longer than 100 years.
- Flexhaler
• Most modern jet nebulizers are powered by high pressure
air or oxygen (O2) provided by a portable compressor,
compressed gas cylinder, or 50-psi wall outlet.

Factors Affecting Nebulizer Performanc:

Nebulizer Design
- Diskus
• Baffle
• Fill Volume
• Residual drug volume
• Nebulizer Position
• Reservoir and Extentions
• Vents, valves and gas entrainment
Factors Affecting Dry Powder Inhaler • Tolerance in manufacturing within lots
Intrinsic Resistance and Inspiratory Flow Rate

• Optimal performance for each DPI design occurs Gas Source: Wall, Cyclinder and Compressor
at a specific inspiratory flow rate. • Pressure
Exposure to Humidity and Moisture • Flow through nebulizer
• Gas density
• The emitted dose of DPI decreases in a humid • Humidity
environment, likely because of powder clumping. • Temperature
The longer the exposure and the greater the level
of absolute humidity, the lower the dose emitted.
Characteristics of Drug Formulation

Patient's Inspiratory Flow Ability • Viscosity

• Surface Tension
• High peak inspiratory flow rates are required to dispense • Homogeneity
the drug powder from most current DPI designs and result
in a pharyngeal dose comparable to the dose received from
a pMDI without an add-on device.
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Nebulizers are also described according to their reservoir
size:
1. Small Volume Nebulizers (SVNs) most
commonly used for medical aerosol therapy
which holds 5 to 20 ml of medication.
2. Large Volume Nebulizers, also known as jet
nebulizers, hold up to 200 ml and may be used
for either bland aerosol therapy or continuous
drug administration.
Four categories of jet svns:
1. SVNs with reservoir - most common SVN.
2. Continuous SVNs w/ Collection Bag - bag
reservoir hold the aerosol generated during
exhalation and allow the small particles to remain
in suspension for inhalation with the next breath,
while larger particles rain out.
3. Breath-enhanced nebulizer - generate aerosol
continuously, using a system of vents and one way
valves to minimize aerosol waste.
4. Breath-actuated nebulizer - synchronize aerosol
generation with inspiration,reducing waste of
aerosol during exhalation and increasing dose up
to threefold more than continuous and breath-
enhance nebulizers.
Optimal Technique for Using a Small Volume
Nebulizer
1. Assess the patient for need (clinical signs and
symptoms, breath sounds, peak flow, %FEV1)
2. Select mask or mouthpiece delivery (nose clips
may be needed with mouthpiece).
3. Use conserving system (thumb port, breath
actuator or reservoir) if indicated.
4. Place drug in the nebulizer. If using a multidose
vial, add saline to approved dose volume (per drug
label).
5. Set gas flow to nebulizer at 6 to 10 L/min (per
manufacturer label).
6. Coach patient to breathe slowly through the
mouth at normal VT.
7. Continue treatment until nebulizer begins to
sputter. 8. Rinse the nebulizer with sterile water
and air dry, or discard, between treatments.
8. Monitor patient for adverse response.
9. Assess outcome (change in peak flow, %FEV1).
Large Volume Jet Nebulizers
• It is also used to deliver aerosolized drugs to the lungs
and are particularly useful when traditional dosing
strategies are ineffective in the management of severe
bronchospasm.
Hand-Bulb Atomizers & Nasal Spray Pumps
• Use to administer sympathomimetic, anticholinergic,
antiinflammatory, and anesthetic aerosols to the upper
airway, including nasal passages, pharynx, and larynx.
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• It is used to manage upper airway inflammation and Vibrating mesh nebulizer

rhinitis, to provide local anesthesia, and to achieve
systemic effects.
Ultrasonic Nebulizers
• A piezoelectric crystal to generate an aerosol. The crystal
transducer converts an electrical signal into high
frequency (1.2-2.4MHz) acoustic vibrations.
• USNS are capable of higher aerosols outputs (0.2 to
1.0ml/min) and higher aerosol densities than conventional
jet nebulizers.
2 types of vibrating mesh nebulizer:
1. Active mesh nebulizer - use piezo element that
contracts and expands on application of an electric
current and vibrates a precisely drilled mesh in
contact with the medication in order to generate
aerosol.
2. Passive mesh nebulizer - use a transducer horn
that includes passive vibrations in the perforated
plate with 6000 tapered holes to produce aerosol.
New Generation Nebulizers
• Low velocity (soft-mist) aerosol, partner particles size
distribution and system that minimize residual volume of
medication left in the nebulizer substantially improve
aerosol device efficiency.
• New nebulizer designs for liquids are available for
delivery of liquids.

Smart Nebulizers

- the Ineb is a breath-actuated passive VM

nebulizer with adaptive aerosol delivery that
monitors pressure changes and inspiratory time
for the patient's first three consecutive breaths.

Large Volume Ultrasonic Nebulizers

- Incorporate air blowers to carry the mist to the

patient. Low flow through the USN is associated
with smaller particles and higher mist density.

Small Volume Ultrasonic Nebulizers

- It has been promoted for administration of wide

variety of formulations ranging from
bronchodilator to anti-inflammatory agents and
antibiotics.
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Selecting an Aerosol Drug Delivery System

Factors Associated With Reduced Aerosol Drug

Special Medication Delivery Issues for Infants and Deposition in the Lung
Children
• Mechanical ventilation
• Artificial airways
• Reduced airway caliber (e.g., infants and
children)
• Severe airway obstruction
• High gas flows
• Low minute volumes
• Poor patient compliance or technique
• Limitation of specific delivery device

Frequency of Assessment of Bronchodilator Therapy

For patient with an acute disorder who is in unstable

condition:

• Whenever possible, perform a full assessment

and obtain a pretreatment baseline.
• Assess and document all appropriate variables
before and after each treatment (breath sounds,
vital signs, side effects during therapy, and
PEFR or FEV1).
• The frequency with which physical
examination and PEFR or FEV1 are repeated
should be based on the acuteness of the disorder
and the severity of the patient's condition.
• SpO2 should be monitored continuously, if
possible.
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• Assessment should continue as dosages are
changed to optimize patient response (e.g., if an
asthmatic patient achieves 70% to 90% of
predicted or "personal best" or becomes
symptom-free).
For Stable Patient:
• In the hospital, PEFR should be measured
initially before and after each bronchodilator
administration. Thereafter, twice-daily
determinations may be adequate.
• In the home, PEFR ideally should be measured
three or four times a day: on rising, at noon,
between 4 PM and 7 PM, and at bedtime.
• For a stable COPD patient at home, measuring
PEFR twice a day may be adequate.
• Patients with asthma should adjust the
frequency of PEFR measurement according to
the severity of symptoms.
• PEFR levels before and after bronchodilator
use, medication dose, date and time, and
dyspnea scoreshould be documented.
• The patient should be reevaluated periodically
for response to therapy.
Optimal Technique for Aerosolized Drug Delivery to
Mechanically Ventilated Patients
1. Review order, identify the patient, gather
equipment, and assess the need for
bronchodilators.
2. Clear the airways as needed, by suctioning the
patient as needed.
3. If using a circuit with heat and moisture exchanger
(HME), remove HME from between the aerosol
generator and the patient.
4. If using heated humidifier, do not turn off or
disconnect before or during treatment.
5. Assemble equipment (tubing, nebulizer, circuit
adapter).
6. Fill the nebulizer with recommended volume and
medication per physician order and label.
7. Place adapter in the inspiratory limb, 6 inches
from the "wye," and connect aerosol generator.
8. Turn off or minimize bias flow during treatment.
9. Connect the nebulizer to a gas or power source, as
appropriate.
10. ----
a. For jet nebulizer (including SVN): Use gas
source on ventilator to synchronize
nebulization with inspiration, if available;
otherwise, set gas flow 2 to 10 L/min as
recommended on nebulizer label, and adjust
ventilator volume or pressure limit and alarms
to compensate for added flow and volume.
b. For USN and VM nebulizer: Attach power
source and cable from controller.
c. For pMDI: Shake canister and connect to
spacer or adapter; actuate at beginning of
inspiration.
11. Observe aerosol cloud for adequate aerosol
generation during nebulization.
12. After appropriate dose is administered, remove
aerosol generator from the ventilator circuit.
13. Reconnect HME, as appropriate.
14. Return ventilator settings and alarms to previous
values.
15. Ensure there is no leak in the ventilator circuit.
16. Rinse the nebulizer with sterile or distilled water,
shake off excess water, and allow to air dry.
17. Store aerosol device in a clean, dry place.
18. Monitor heart rate, SpO2, blood pressure, and
patient-ventilator synchronization.
19. Monitor the patient for adverse response.
20. Assess the airway, and suction as needed;
document findings.