PHARMACEUTICAL AEROSOLS

Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
PHARMACEUTICAL
AEROSOLS
A Seminar as a part of curricular requirement for
I year M.Pharm II semester
Raghavendra Institute of Pharmaceutical Education and Research(RIPER)-
Autonomous
JNT University Anantapur
Master of Pharmacy
in
Pharmaceutics
Presented by
UDIT NARAYAN SINGH (20L81S307)
Under the guidance of
Dr. C H Pavan Kumar
Head of the Department
Department of Pharmaceutics

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
I got a hike
of extra
80,000
I got just of
20,000
Almost 71% of total profit incurred by CIPLA Ltd. is from “AEROSOL” products.

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Contents
Background
What are “Aerosols”
Advantages & Disadvantages of aerosols
Desired characteristics
Components of aerosol
Types of aerosol system
Formulation of aerosols
Manufacturing of aerosols
Evaluation of aerosols
References
3

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Background
1942
Beginning of aerosol industry
1950s
Application of aerosol technology
to pharmaceuticals
1955
Aerosols for local activity in
respiratory tract were developed
Aerosols were invented by Erik Rotheim in 1926

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
What is
this
Aerosol ?

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Definition
AEROSOLS
Depend upon the power of a liquified or
compressed gas
To dispense the active ingredient(s) in the form of a finely
dispersed mist
Pharmaceutical product

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Dose removal without contamination of the bulk
• Enhanced stability for substances affected by oxygen and/or moisture
• Sterility is maintained
• Minimum or no irritation due to application
• Dose lowering in case of steroid therapy
• Circumvention of first pass effect
• Application of medication in a thin layer
• Tamperproof system.
Advantages of using Aerosols

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Costly
• Difficult disposal of container due to flammable propellants
• Allergic in some cases
• Explosive
• Some formulations are difficult to formulate as aerosols
• In some cases propellants may cause toxic reactions.
Disadvantages of using Aerosols

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Less explosive.
• Uniform and constant dose delivery.
• Non allergic.
• Economic/Low cost.
• Easy to handle.
• Non Breakable.
• Eco-friendly
Desired characteristics

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Propellant
• Container
• Valve
• Actuator
• Product concentrate
Components of Aerosol

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
PROPELLANTS
“Heart of Aerosol”
Determine characteristics of the
product
Types
Provide force to
expel the
product in
desired form
Act as solvent
and diluent
Liquified gas Hydrocarbon Compressed gases

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Widely used propellant
• Relatively inert, nontoxic and non flammable
• Immediately separate into a liquid and a vapor phase
• Maintain a constant pressure within the container
• Contains are maintained in fine mist or foam form
• Examples – Chlorofluorocarbons (CFCs)
Hydrochlorofluorocarbons (HCFCs)
Hydrofluorocarbons (HFCs)
• FCs are widely used in inhalational and oral aerosols.
Liquified gases

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Flammable
• Less toxic
• Less dense
• More Soluble
• Chemically more stable
• More economic
• Examples – Butane
Propane
• Earlier restricted to use with foams and water based aerosols
• Development of “Vapor tap” and “Aquasol valve” extended their use.
Hydrocarbons

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Have little expansion power
• Fairly wet spray is produced
• Foam is less stable as compared to liquified gases
• Do not have a chilling effect
• Used mostly in topical pharmaceutical aerosol products
• Examples – Nitrogen
Nitrous oxide
Carbon dioxide
Compressed Gases

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• All propellants are designated by three digits
• When the first digit is zero, the propellant is designated by last two digits
• Example – Propellant 011 is Propellant 11
• The first digit is one fewer than the number of carbon atoms in the compound
• First digit – Zero indicates methane derivative
• First digit – One indicates Ethane derivative
• First digit – Two indicates Propane derivative
• The second digit is one more than the number of hydrogen atoms in the compound
• For cyclic compounds a “C” is used before the number
Common rules of nomenclature

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Containers
Must withstand pressure as high as 140 to 180 psig at 130 degree F
Two types
Glass
Metals
Tinplated
Aluminium
Stainless steel
Uncoated Plastic coated

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Tin plated steel containers
Consist of a sheet of steel plate, the sheet is coated with tin by electrolytic method
Divided into three parts
Top
Attached to body by
shouldering
Bottom Body
Coated Sheet
If required
Coated with –
Organic material usually
oleoresin, phenolic, vinyl or
epoxy coating

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Aluminium Containers
Used for inhalational and topical aerosols
Manufactured by impact extrusion process
Added resistance can be obtained by coating with organic coat
Light in weight, Less fragile, reduced incompatibility instances, greater resistance to corrosion
Pure water and ethanol cause corrosion
Phenolic Vinyl Epoxy Polyamide resins

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Stainless Steel Containers
Used for “Inhalational” aerosols
Advantages –
Extremely strong
Resistant to many
materials
No need for internal
coating
Disadvantages –
Costly
Higher molding force
needed

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Glass containers
Preferred because of its aesthetic value and absence of incompatibilities
Used for topical and MDI aerosols
Uncoated –
Less cost, High clarity
Limited to products having lower pressure (33 psig) and lower percentage of propellant
Two types
Plastic coated –
Higher protection from
shattering

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Valves
Two types
Delivers the drug in desired form
Delivers proper amount of medication
Metering valve
Continuous spray valve
Used for topical preparations
Used to dispense potent
medication

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Components of “Valve”
Gasket
Body /
Housing
Dip tube
Ferrule or
Mounting cup
Spring
Stem
Attaches
valve to
container,
Made of tin
plated steel,
Al, Brass.
Under side is
coated with
epoxy or
vinyl resins.
Made of
Nylon or
Derlin,
Contains a
opening at
attachment
point of Dip
tube (0.013
to 0.080
inch).
Made of
Nylon or
Derlin,
Sometimes
brass and
stainless
steel
(Orifice –
0.013 to
0.030
inch)
Made of
Buna-N
and
neoprene
rubber
Made of
stainless
steel,
Used to
hold gasket
in place
Made of
Poly
ethylene or
poly
propylene,
Inner
diameter –
0.120 to
0.125 inch

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
METERED DOSE VALVE
Operates on the principle of dispensing medication based on the size of a
“chamber”
Used for dispensing
“potent medication”
Approx. 50 to 150 mg +/- 10% of liquid materials can be dispensed
at one time with such valve

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
METERED VALVE

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
ACTUATORS
Four types
Especially designed buttons which helps in delivering drug in desired form i.e., spray, foam,
solid stream, wet stream
Foam actuators
Spray actuators Special actuators
Solid stream actuators
Dispenses in the
form of spray,
Used for topical
preparations
e.g., antiseptics
Required to dispense
semi solid products
e.g., ointments
Used to deliver
medicament to
appropriate site
e.g., throat, nose,
dental, eyes, etc.
Consists of a
large orifice
ranging from
0.070 to 0.125
inch

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
What…!
AEROSOLS also have
systems, was the
syllabus too less
before…

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
TYPES OF AEROSOL SYSTEM
Solution system
Foam system
Suspension or
dispersion system
Water based
system
Non aqueous stable Aqueous stable
Thermal
Quick breaking
Intranasal system

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Also referred as “Two phase system”
• Consists of vapor and liquid phase
• If active ingredient is soluble in propellant no other solvent is needed
• Vapor pressure of system is reduced by addition of less volatile solvents such as –
Ethanol, Acetone, Propylene glycol, Glycerin
• Amount of propellant may vary from 5% ( for foams) to 95% ( for inhalations)
• General formula Weight %
Active drug to 10-15
Propellant 12/11 (50:50) to 100
Solution system

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Depending on water content, final product may be solution or three phase system
• Solution aerosols produce a fine to coarse spray
• Hydrocarbon propellant A-70 produces drier particles
• Hydrocarbon propellant A-17 and A-31 tend to produce a wetter spray
• Useful for topical preparations
• Packaged in plastic coated glass containers
Contd.

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
SOLUTION SYSTEM

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Large amounts of water can be used to replace all or part of non aqueous solvent
• Spray or foam is produced
• For spray production formulation must consist of dispersion of API and other solvents in
emulsion system with propellant as external phase
• Since propellant and water are not miscible, a three phase aerosol forms (propellant, water
and vapor phases).
• Ethanol can be used as cosolvent to solubilize propellant in water. It also reduces surface
tension aiding in the production of smaller particles .
• 0.5 to 2% of surfactant is used to produce a homogenous dispersion.
Water based system

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Surfactants with low water solubility and high solubility in non polar solvents will be most
useful e.g., Long chain fatty acid esters of polyhydric compounds including glycol, glycerol
and sorbitan esters of oleic, stearic, palmitic and lauric acids
• Propellant concentration varies from about 25 to 60%
• Aquasol system (Aquasol valve) – dispensing fine mist or spray of active ingredient dissolved
in water
• No chilling effect, since only active ingredient and water are dispensed, propellant is in vapor
state
• Difference between aquasol system and three phase system is aquasol dispenses fairly dry
spray with very small particles, non flammability of the product .
Contd.

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• It involves dispersion of active ingredient in the propellant or mixture of propellants.
• To decrease the rate of settling of dispersed particles, surfactants or suspending agents can
be added.
• Primarily used for inhalation aerosols.
• Example:
Formulation Weight%
Epinephrine bitartrate(1-5 Microns) 0.50
Sorbitan trioleate 0.50
Propellant -114 + Propellant -12 99
• Epinephrine bitartrate has minimum solubility in propellant system but soluble in fluids in
the lungs.
Suspension system

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
FOAM SYSTEM
Total propellant
content – 3-5%w/w
or
8-10%v/v
Aqueous stable
foam
Non-aqueous
stable foam
Quick breaking
foam
Thermal foam
Glycols such as
Polyethylene glycol
are used
Emulsifying agent
used is Propylene
glycol
monostearate
Propellant is in
external phase
Used to produce
warm foam for
shaving
Higher propellant
cause stiff and dry
foam,
Low conc. cause
wet foam
Propellant – HC &
CG
Product is emitted
as foam when
dispensed
Surfactant soluble
in both alcohol and
water, used for
topical medication
Corrosion problems
with hair colors and
dyes
Expensive,
Inconvenient to use,
Less effectiveness

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
FOAM SYSTEM

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Physical stability of aerosol
dispersion can be increased by
Control of moisture
content(<300ppm)
Reducing rate of
agglomeration
Use of dispersing
agents
Density of propellant
and suspensoid
equalized
Avoiding high
temperatures
Aqueous stable
Use of Isopropyl myristate
and mineral oil
HLB less than 10
Conc.- 0.01-1%
Particle size less than
5 micron

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Formulation
&
Manufacture
(AEROSOLS)

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
FORMULATION OF AEROSOLS
Can be dispensed as-
Fine mist, Wet spray, Quick breaking foam, Stable foam, Semi solid
Product concentrate Propellant
API or mixture of API and
other necessary
ingredients –
Solvents, Anti oxidants,
Surfactants for proper
HLB
Single or blend of
propellants is used based
on desired vapor
pressure, solubility and
particle size
Selection is
based on –
Physical,
Chemical,
Pharmacological
properties of
drug
&
Site of
application

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
MANUFACTURE OF AEROSOLS
Pressure filling
apparatus
Compressed gas filling
apparatus
Cold filling apparatus
Disadvantages –
Certain metering
valves can only be
handled by cold
filling,
Process is slower
than cold filling
Advantage –
Solutions, suspensions,
emulsions can be filled,
Contamination by
moisture is less,
High production speed,
Loss of propellant is
less
Advantage –
Easy process
Disadvantages –
Aqueous products,
emulsions, and
those adversely
effected by cold
temperature
cannot be used

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
VARIOUS UNITS USED IN AEROSOL FILLING LINE
Unscrambler
Purger, Vaccum crimper,
Pressure filler are
replaced with single unit
filling by “under the cap
method”
Purger
Water bath
Valve placer
Air cleaner
Valve crimper
Propellant filler
Concentrate filler
Labeler, Coder and Packaging table

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• It consists of a pressure burette capable of metering small volumes of liquefied gas into the
aerosol container under pressure
• Propellant is added through an inlet valve located at the bottom or top of the pressure
burette
• The propellant is allowed to flow with its own vapor pressure in the container through
aerosol valve the trapped air escapes out from the upper valve
• Propellant stops flowing when the pressure of burette and container becomes equal
• Excess of the propellant is replaced into the container by help of positive pressure exerted by
nitrogen from another container
• This type of device cannot be used for filling inhalation aerosols which have metered valves.
Pressure filling apparatus

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• This method involves filling of the concentrate into the container at the room temperature
• Then the valve is placed in the container and crimped
• Through the opening of the valve the propellant are added or it can be added “under the
cap”
• Since the opening of the valve are smaller in size ranging from 0.018-0.030 inches, it limits
the production and the process becomes slow
• But with the use of rotary filling machines and newer filling heads where the propellants are
filled through valve stem, the production rate is increased
• The trapped air in the container and air present in head space is removed before filling the
propellant to protect the products from getting adversely affected.
Procedure

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
PRESSURE FILLING APPARATUS PRESSURE BURETTE

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• It consist of an insulated box fitted with copper tubings and the tubings are coiled to increase
the area exposed to cooling
• The insulated box should be filled with dry ice or acetone prior to use
• The apparatus can be operated with or without metered valves
• Hydrocarbon propellant cannot be filled into aerosol containers using this apparatus because
large amount of propellant escapes out and vaporizes
• This may lead to formation of an explosive mixture
• Fluorocarbon vapors do not form any explosive or flammable mixture though their vapors
are heavier than air.
Cold filling apparatus

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Non aqueous products and products which can withstand low temperatures of - 40°F are
used in this method
• The product concentrate is chilled to a temperature of - 40°F and filled into already chilled
container
• Then the chilled propellant is added completely in 1 or 2 stages, depending on the amount
• Another method is to chill both the product concentrate and propellant in a separate
pressure vessel to - 40 °F and then filling them into the container
• The valve is placed and crimped on to the container
• Then test for leakage and strength of container is carried out by passing container into a
heated water bath, where the contents of the container are heated to 130°F. After this, the
containers are air dried , capped and labeled.
Procedure

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
COLD FILLING APPARATUS

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Compressed gases have high pressure hence a pressure reducing valve is required.
• The apparatus consists of delivery gauge
• A flexible hose pipe which can withstand 150 pounds per square inch gauge pressure is
attached to the delivery gauge along with the filling head
• A flow indicator is also present in specialized equipments.
Compressed gas filling apparatus

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• The product concentrate is filled into the container
• Valve is placed and crimped on the container
• With the help of vacuum pump the air is removed from the container
• Filling head is put in the opening of the valve and the valve is depressed and the gas is
allowed to flow in to container
• The gas stops flowing if the delivery pressure and the pressure within the container become
equal
• Carbon dioxide and nitrous oxide is used if more amount of gas is required
• High solubility of the gas in the product can be achieved by shaking the container manually
or with the help of mechanical shakers.
Procedure

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Is your
product’s
quality upto the
mark..?

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
EVALUATION OF AEROSOLS
Quality control Tests involved
Propellants,
Valve
acceptance,
Actuator,
Dip tubes,
Weight
checking,
Leak testing,
Spray testing
Performance –
Aerosol valve
discharge,
Spray pattern,
Dosage with
metered valve,
Net content,
Foam stability,
Particle size,
Leakage
Flammability
and
combustibility –
Flash point,
Flame extension
Biological
characteristics
Physicochemical
–
Vapor pressure,
Density,
Moisture content,
Identification of
propellant,
Concentrate
propellant ratio

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
PROPELLANTS
Vapor pressure and density compared with specification sheet
Purity and acceptability Identification
Moisture,
Halogen,
Non-volatile
residue
determination
Gas
chromatography,
IR spectroscopy

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
VALVES, ACTUATORS AND DIP TUBES
Objective is to minimize
variation in valve delivery
Sampling is done as in military standards
“MIL-STD-105D”
25 Valves are placed on containers
Actuator 0.02 inch orifice is placed
Weight difference upon fullest actuation for 2 sec is measured
Test repeated for 25 samples

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Valve
acceptance
54 microliter or less - +/- 15%
55-200 microliter - +/- 10%
If 3 are outside limit, another 25 valves are tested – If more than 1 fail - Rejected
Out of 50 individual deliveries
If 4 or more are outside the limits – valves are rejected
If 2 deliveries from one valve are outside limit, another 25 valves are tested – If
more than 1 fail - Rejected

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
CONTAINERS
Containers are examined for defects in lining
Quality control aspects includes degree of conductivity of electric
current as measure of exposed metals
Glass containers are examined for flaws
WEIGHT CHECKING
Done by periodic weighing of containers in two stages –
Before filling (tared weight)
After filling (increased weight is checked)

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
LEAK TESTING
Checking crimping of valve and detect any defects (Crimp’s dimension)
SPRAY TESTING
Most pharmaceutical aerosols are 100% spray tested
Final testing is done by passing filled containers through water bath
This checks for defects in valves and spray patterns

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
FLAMMABILITY & COMBUSTIBILITY
Apparatus –
Tag Open Cup Apparatus
Flash point
Product is chilled at -25 degree
centigrade and test liquid
temperature is allowed to rise
Temperature at which vapor
ignites is “Flash point”
Product is sprayed for 4 sec
into a flame
Flame projection
Exact extension in the length of
the flame is measured

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
PHYSICOCHEMICAL
Pressure gauge,
Can puncturing
device
Vapor Pressure Density Moisture
Propellant
identification
Hydrometer,
Pycnometer
Karl Fischer
method,
Gas
chromatography
Gas
chromatography,
IR spectroscopy

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
PERFORMANCE
Contents of the aerosol product
of known weight is discharged
Aerosol valve discharge rate
Impingement of spray on piece
of paper treated with “Dye-Talc
mixture”
Spray pattern
Change in weight per time
dispensed gives the discharge
rate (g/sec)
Particles that strike the paper
cause the dye to go into
solution
Particles get adsorbed on the
paper giving a record for
comparison purpose

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
DOSAGE WITH METERED
VALVES
Reproducibility of dosage can be determined by -
NET CONTENTS
Tared cans weighed and filled in lines and reweighed for difference
Assay techniques
Accurate weighing of filled container followed by dispensing of several dose and
subsequent weighing
Destructive technique – weighing full container and then dispensing as much
content as possible. Contents are weighed to get net content values

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
FOAM STABILITY
Methods
Visual
examination
Time for
given mass
to penetrate
the foam
Time for
given rod
that is
inserted
into foam to
fall
Rotational
viscometer

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
PARTICLE SIZE
DETERMINATION
Cascade Impactor Light Scattering Decay
Stream of
particles
projected through
a series of nozzles
and glass slides at
high velocity
As aerosol settles
under turbulent
conditions, the
change in light
intensity of a
Tyndall beam is
measured
Larger particles are impacted first on lower velocity and
smaller particles are collected later at higher velocity
PARTICLE SIZE
DETERMINATION

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
CASCADE IMPACTOR

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Stage 0 Nozzle diameter 96 2.55 +/- 0.025
DESCRIPTION NUMBER DIMENSION (microm.)

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Therapeutic activity
BIOLOGICAL TESTING
Toxicity
Determination
of therapeutic
activity is
dependent on
the particle
size
Activity is
determined by
applying the
formulation
and
calculating
amount
absorbed
Exposing test
animals to
vapors
sprayed from
aerosol
formulation
under testing
Irritation and
chilling
effects are
determined
Inhalational Topical Inhalational Topical

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
ED Test
mandatory
as per IP

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
DEPOSITION OF EMITTED DOSE
Measure of drug deposition during inhalation
Test determines the fine particles characteristics of the aerosol clouds generated
Sometimes referred as “Mass Balance”
Total mass of active substance is NLT 75% and NMT 125%

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
• Khar K R, Vyas S P, Ahmad J F, Jain K G. Lachman/Leiberman’s The Theory and Practice of
Industrial Pharmacy. Delhi; India: CBS Publishers & Distributors; 2017
• Felton L. Remington Essentials of Pharmaceutics. New Mexico; USA: Pharmaceutical Press;
2013
References

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR

PHARMACEUTICAL AEROSOLS

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to PHARMACEUTICAL AEROSOLS

Similar to PHARMACEUTICAL AEROSOLS (20)

More from Raghavendra institute of pharmaceutical education and research .

More from Raghavendra institute of pharmaceutical education and research . (20)

Recently uploaded

Recently uploaded (20)

PHARMACEUTICAL AEROSOLS