Aerosols Material 2021

22-10-2021
AEROSOLS
By
Dr. GSN Koteswara Rao
Vice Principal & Professor
K L College of Pharmacy
K L Deemed to be University
drgsnkrao@gmail.com
Dr. GSN Koteswara Rao (Eswar)
Pharmaceutical Definition
Aerosols
Propellants
Containers
Valves
Types of aerosol systems
Formulation and manufacture of aerosols
Quality control tests and

Evaluation of aerosols
stability studies
Dr. GSN Koteswara Rao (Eswar), KLU 1

22-10-2021
Pain relief
DEFINITION OF AEROSOLS
• “Pressurized dosage forms containing one or more active

ingredients which upon actuation emit a fine dispersion of liquid
and/or solid materials in a gaseous medium typically smaller than
50 µm”
• Meant for oral, topical, rectal, vaginal or systemic administration
• Dispersed/discontinuous Phase is Solid / Liquid and
• Continuous phase is Gas / Propellants
• Ingredients: Propellant + Product concentrate
• Particles of 2 to 5 μm in size reach bronchioles.
• Particles less than 2 μm in size reach alveoli.

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Fine Steady
mist stream
Coarse Coarse
Wet Dry
spray spray
Stable Fast
breaking
foam foam
Types of product output from aerosol

Types of aerosols
SPACE SPRAYS
• Aerosols used to provide air borne mist (<50 m)
More
• E.g., Room disinfectant, room deodorizers, space insecticides propellant
• 85% propellant. = Spray
SURFACE SPRAYS
• Aerosols intended to carry active ingredient to surface.
• E.g., Dermatological aerosols, cosmetic sprays
• 30-70% propellant
FOAM AEROSOLS Less
propellant
• Vaginal & Rectal foams etc.
= Foam
• 10-20% propellant

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Advantages of aerosols
No contamination due to positive pressure
Hermetic sealing: No oxidation, No hydrolysis, No photolysis
Uniform application as thin layer without touching effected area
Different forms of product outcome based on formulation
Control over the dose with special valves
Dosing can be minimized
Immediate onset of action
Bypass first pass metabolism
Disadvantages of aerosols
Expensive
The disposal of empty containers may be difficult
Patients may be sensitive to certain propellants
Fluorocarbons cause damage to environment
Exposure to heat or flame may cause blast due to raise in pressure
Insoluble drugs may clog the path if not properly formulated
Propellants may cause toxic reactions on long term therapy


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Components of aerosols
1. Propellant
2. Product Concentrate
3. Container
4. Actuator and Valve Assembly

1. PROPELLANT
• It is a chemical substance responsible for developing the

pressure within the container and helps to expel the
product by atomization when the valve is opened up on
pressing the actuator
• Blend of propellants are also preferred to attain required
pressure. Propellant Blends 12/11, 12/114
• Vapour pressure of mixture of propellants calculated
using Dalton’s Law (total pressure is equal to sum of
individual / partial pressures of various components)
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Types of propellants
A. LIQUIFIED GAS PROPELLANTS:

FLUORINATED HYDROCARBONS (CHLOROFLUOROCARBONS):
For oral and inhalation pharmaceutical aerosols
• Tri-chloro mono-fluoro methane (propellant 11)
• Di-chloro di-fluoro methane (propellant 12)
• Di-chloro tetra-fluoro ethane (propellant 114) B. COMPRESSED GAS PROPELLANTS:
HYDROCARBONS:
Topical pharmaceutical aerosols
Topical pharmaceutical aerosols
• Nitrogen
• Propane
• Butane • Carbon dioxide
• Isobutane • Nitrous dioxide
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Numerical designation or Nomenclature

Example: Propellant 1 1 4
• Digit at the extreme right refers to number of fluorine
atoms in molecule
• Second digit from right is one greater than the number of
actual hydrogen’s in molecule
• Third digit from right is one less than the actual number of
‘C’ atoms in molecule
• Capital ‘C’ before a number indicates the cyclic nature of a
compound.
• Small letter following a number indicate decreasing
symmetry of isometric compounds, with “b” indicating less
symmetry than “a” & so forth. The number of chlorine
atoms in a molecule may be determined by subtracting the
total number of hydrogen & fluorine atoms from the total
number of atoms which may be the carbon chain.
Therefore, Propellant 114 = Di-chloro tetra-fluoro ethane
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Chlorofluorocarbon (CFC) Propellants
• Advantages: Chemical inertness, Non

toxic, Non flammable and Non
explosive.
• Hence used in aerosol products for
several years.
• Disadvantage: Causing depletion of
ozone layer.
• Used in low amount in the treatment
of asthma and chronic obstructive
pulmonary disease (COPD).
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Hydrocarbon Propellants
• Advantages: Environmental acceptance, low toxicity and non reactivity

• Hydrocarbons are used in the preparation of water based aerosols as they are
not susceptible to hydrolysis due to the absence of chlorine.
• Since they are immiscible with water, they remain on the top of water. They
provide the force to push the contents out of the container.
• Disadvantages: Flammability and explosiveness, which can be reduced by
using as a blend and vapor tap.
Propane Butane Isobutane
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Advantages: Low toxicity, high stability, high purity,

inexpensive, environment friendly
Compressed
gas These propellants dispenses product in the form of
fine mist, foam, wet spray or semisolid.
Propellants
Disadvantages: Requires non-volatile co-solvent,
Pressure drops on use, Foams are not as stable as
produced by the liquefied gas propellants, Produces
coarse spray
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Difference between Liquefied Propellant

and Compressed Gas Propellant
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2. PRODUCT CONCENTRATE/FORMULATION
The product
concentrate is the The Active drug  Propellant  to
mixture of active for therapeutic expel the contents
ingredient with the activity from the container
required adjuncts
Solvents  to
prepare a stable and
Antioxidants  to
Surfactants  to efficacious product
prevent degradation
Increase miscibility and to retard the
of product
evaporation of the
propellant.
Suspending agents
 to prepare stable
suspensions
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PRINCIPLE OR MECHANISM OF
AEROSOL WORKING
• An equilibrium is quickly established between

the liquified propellant phase and vapor
phase and occupies the upper portion of the
aerosol container.
• So, the vapour phase exerts pressure in all
directions, against the walls of the container,
the valve assembly and the surface of the
liquid phase, which is composed of the
liquified gas and the product concentrate.
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AEROSOL WORKING
• Upon actuation of the valve assembly, the

pressure exerted by the gaseous propellant
forces the contents of the package out
through the dip tube into the opening of the
valve and releases into the atmosphere.
• As the propellant meets the air, it expands
and evaporates because of the drop in
pressure, leaving the product concentrate as
airborne liquid droplets, fine mist, a coarse,
wet, or dry spray; a steady stream; or stable
or fast-breaking foam depending upon the
formulation type at applied area.
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AEROSOL WORKING
• As the liquid phase is removed from the container,

equilibrium between the liquefied propellant and
vapour propellant is reestablished.
• Thus even during expulsion of the product from
the aerosol package, the pressure within remains
virtually constant, and the product may be
continuously released at an even rate and with
the same propulsion.
• However, when the liquid reservoir is depleted,
the pressure may not be maintained, and the gas
may be expelled from the container with
diminishing pressure until it is exhausted
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3. CONTAINER
• They must withstand pressures as high as 140 to 180 psig (pounds per sq. inch
gauge) at 1300 F (54.40 C).
• The containers are generally made up of metal or glass or plastic.
• Metals are strong but expensive, corrosive hence limited to small sizes
• Brittleness restricts the use of glass. If the pressure is less than 25 psig and
propellant content is less than 15% then glass can be used.
• Glass should be coated with epoxy and vinyl resins as linings. Epoxy resins can
be used as they are resistant to steam. Vinyl resins get damaged by steam.
• A vinyl coating on which the epoxy coating is given is most suitable for
products having less pH.
• Plastics have permeability issues and chances of drug interactions and
preferred at less than 25 psig pressure
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Choice of the material depends on- Pressure of the system, whether product is
aqueous or not, pH of the product and physicochemical properties of
preparation.
Different types of materials for aerosol containers are:
METALS
• Tin plated steel (Side-seam or
Three, Two piece or Tin-free
steel)
• Aluminum (can give seamless
container by extrusion method)
• Stainless steel
GLASS
• Uncoated glass
• Plastic coated glass
PLASTICS
SOUDRONIC WELDING MACHINE
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4. ACTUATOR AND
VALVE ASSEMBLY
• Actuator: Button, the user presses to
activate the valve assembly for emission
of product.
• Physical form (mist, coarse spray, solid
stream, foam) of expulsion depends on the
design of inner chamber and emission
orifice size of actuator.
• Made of plastic.
• Different types of actuators available
a) Spray actuators
b) Foam actuators
c) Solid stream actuators
d) Special/ Mist actuators
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a) Spray actuators:
• These are capable of dispersing the stream of product concentrate and
propellant into relatively small particles by allowing the stream to pass
through or swirl various openings 0.016 to 0.040 inches.
• These actuators used for topical use such as spray-on bandages, antiseptics,
local anesthetics and foot preparations.
b) Foam actuators:
• It consists of relatively large orifices ranges from 0.070 to 0.125 inches.
c) Solid stream actuators:
• Similar to foam type of actuators. Used for semisolid products like ointments.
d) Special/ Mist actuators:
• These are designed for special purpose, to deliver the contents of
medicaments at site of action like throat, eye or vaginal tract.
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VALVE ASSEMBLY and its components:

• Actuator
• Mounting cup/Valve cup
• Stem
• Gasket
• Spring
• Housing
• Dip tube
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VALVE ASSEMBLY:
• Actuator
• Mounting cup/Valve cup
• Stem
• Gasket
• Spring
• Housing
• Dip tube
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Mounting Cup or Ferrule:

• The Mounting cup or Ferrule is generally made
up of aluminum which serves to place the
valve in its position, and attached to the
aerosol container.
• As the underside of the mounting cup/ Ferrule
is exposed to the contents of the container, so
it is to be compatible with the contents so as
to prevent any interaction.
• It may be coated with an inert material such
as vinyl coating as it prevents any interaction
with the contents also corrosion of aluminum
is prevented.
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Stem:
• The actuator is supported by the stem and the
formulation is delivered in the proper form to
the chamber of the actuator by the stem. It is
made up of Nylon, Delrin, Brass and Stainless
steel.
Gasket:
• The stem and valve are placed tightly in their
place by the gasket and the leakage of the
formulation is prevented by gasket. It is made
up of Buna N and Neoprene rubber.
Spring:
• The gasket is held in its place by the spring
and also helps to keep the valve in closed
position when the pressure is released upon
actuation of the formulation.
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Housing or Valve body:

• The Housing or Valve body located directly below the Mounting cup or Ferrule is
made up of Nylon or Delrin work to connect the dip tube and the stem and
actuator. The rate of delivery of product and the desired form in which the
product is to be emitted is determined by its orifice.
• Size is 0.013 to 0.080 inches.
Dip Tube:
• The dip tube is made up of polyethylene or polypropylene extends from the
housing or valve body down into the product concentrate works to bring the
formulation from the container to the valve.
• The inner diameter of the dip tube increases with an increase in the viscosity of
the formulation.
• For less viscous solutions, the inner diameter ranges from 0.12 inch to 0.125
inch. While for viscous solution, inner diameter is as large as 0.195 inch.
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• The actuator, stem, housing,

and dip tube are generally
made of plastic
• the mounting cup and spring of
metal
• the gasket of rubber
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FORMULATION & MANUFACTURING OF AEROSOLS
• Step-1: Preparation of product concentrate by using

Types of
active agent and and other additives like vehicles,
aerosol Antioxidants, surfactants, suspending agents etc.
systems
• Step-2: Preparation of propellant blend or arranging a
propellant
Filling & • Step-3: Filling into the aerosol container and crimping
Sealing the valve assembly for sealing
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TYPES OF AEROSOL SYSTEMS
• Solution system / Two Phase system

• Water based system / Three Phase system
• Suspension / Dispersion system
• Foam system / Emulsion systems
• Aqueous stable foams
• Non-Aqueous stable foams
• Quick Breaking foams
• Thermal foams
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Solution system / Two Phase system

• Phase-1: Liquid phase (product concentrate and liquefied propellant and)
• Phase-2: Vapour phase (propellant)
• Product concentrate is miscible with liquid propellant.
• Propellant 12/11 (30:70, 50:50), Propellant 12/114(45:55) (or) propellant
12/114 (55:45) can be used for oral inhalation.
• The amount of propellant may vary from 5% (foams) to 95% (Inhalation
products).
• Lowering of vapour pressure also produce through the addition of less volatile
solvents such as ethyl alcohol, propylene glycol, ethyl acetate glycerin and
acetone.
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Water based system / Three Phase system

• Aqueous product concentrate + Water-immiscible liquid propellant + vapour
phase.
• Product concentrate is immiscible with the propellant.
• This system emits the contents as spray or foam. Emulsion based, in which
propellant acts as external phase.
• Ethanol used as a cosolvent to solubilize propellant in the water.
• Surfactants are used for the preparation of homogeneous dispersion.
• The surfactants composition ranges between 0.5 to 2.0 and propellant
composition in range from 25 to 60%.
• Aquasol valve (water + alcohol solvent mixture) is used for dispersing of a
fine mist or spray of active ingredient.
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Suspension / Dispersion system

• In this system, the drug particles are suspended in the propellant or the blend
of propellants.
• Surfactants, suspending agents and lubricants at 0.01 – 1% are added to reduce
the settling rate.
• Agglomeration may result in clogging of valve, inaccuracy in dose and damage
to the liner of metal container, particularly at elevated temperatures.
• Oleic acid as dispersing agent for steroid & prevents or reduces particle
growth or agglomeration. It acts as valve lubricant & prevents metered valve
from “sticking” in open position.
• Surfactants & lubricants are added to avoid/control clogging: isopropyl
myristate & mineral oil
• Nonionic surfactants are best, HLB < 10 like sorbitan trioleate.
• Sorbitan nanolaurate, sorbitan monoleate, sorbitan resquiloeate. (0.01-1%)
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Foam system / Emulsion systems

• Emulsion and foam aerosols consist of Active ingredient + Aqueous or Non
aqueous vehicle + Surfactant + and propellant (Hydrocarbon or compressed
gases).
• Here the propellant which is present in the liquid acts as internal phase.
• These aerosols dispensed as stable aqueous or nonaqueous or quick breaking
foam aerosol.
Aqueous stable foams

• This system consists of propellant in the range of 8-10% v/v.
• As the concentration of propellant increases, it results in stiff
and drier spray. And wetter spray is produced as the
concentration of propellant decreases.
• Both Hydrocarbon and Compressed gases are used as
propellants.
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Non-Aqueous stable foams

• These nonaqueous stable foams of aerosols are formulated with the use of
different glycols like PEG and esters of glycols (propylene glycol
monostearate) as emulsifying agents.
Quick Breaking foams

• Here propellant is the external phase. When
dispensed the product will be emitted as foam which
soon collapses or merges into liquid.
• Applied to small area or larger surface topical
medication without mechanical application.
• Here cationic or anionic or non-ionic types of
surfactants are used. It should be soluble in both
alcohol and water.
This
• Dr. is pressurized
GSN Koteswara Rao (Eswar) by mixing of 90% concentrate and
10% propellant.
37
Thermal foams
• These are not used much these days. These are used when the warmness is
required.
• To produce warm foam for shaving.
• Not readily accepted by the consumer, so discontinued due to expense and
lack of effectiveness.
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Filling and Sealing
1. COLD FILLING
2. PRESSURE FILLING
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COLD FILLING
Method-1
1. The product concentrate is chilled to 2. The chilled propellant is added

a temperature of - 30 to - 400 F and through an inlet valve present under side
added to chilled aerosol container. of the valve of the aerosol container.
Method-2
1. Both the product concentrate and the 2. Then the mixture is added to the
propellant are chilled to – 300 to – 400 F. chilled aerosol container.
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COLD FILLING
• In both the methods, after the aerosol containers are filled, the valves are
set in its place and the filled aerosol containers are passed through a water
bath in which the contents of the containers are heated to 130 0F to test for
leaks and strength. Then the containers are air dried, capped and labeled.
• Disadvantage: Formation of ice crystals with aqueous systems
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PRESSURE FILLING
The product concentrate is filled to the aerosol
container through the metering pressure filling burette
at room temperature.
The valve is crimped in place.
The propellant is added through the inlet valve using a

burette.
The flow of propellant stops when the pressure of the

propellant flowing to the container from the burette
becomes equal to the pressure within the container.
The aerosol container is capped and labeled.
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PACKAGING
• An unique aspect of pharmaceutical aerosols compared to other dosage

forms is that the product is actually packaged as part of the manufacturing
process.
• Most aerosol products have a protective cap or cover that fits snugly over
the valve and mounting cup.
• This protective cap helps to prevent accidental activation of the valve
assembly or contamination by dust and other foreign materials.
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LABELLING & STORAGE
• Pressurised container
• Protect from sunlight and do not expose to
temperatures exceeding 50°C.
• Do not pierce or burn after use.
• NOT TO PUNCTURE
• Do not spray on a naked flame, onto or near fire,
or any incandescent material.
• Keep away from sources of ignition - No smoking
• FLAMMABLE or EXTREMELY FLAMMABLE together
with a FLAME SYMBOL
• KEEP OUT OF REACH OF CHILDREN
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EVALUATION OF AEROSOLS
• Aerosols are pressurized packages and many tests are necessary to

ensure proper performance of the package and safety during the use
and storage.
• There is a special department called as DOT (Department of
Transportation) to look after the safe transportation of pressurized
aerosol packages.
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Evaluation Tests / Quality Control Tests
• Testing of Containers • Performance Test

• Weight checking • Aerosol Valve Discharge Rate
• Spray Patterns
• Testing of Actuators, Valves, Dip tubes • Dose Uniformity / Dosage Testing with
• Physico - Chemical Characteristics Metered valves
• Vapour Pressure • Net Contents
• Density • Foam stability
• Moisture Content • Particle Size determination
• Identification of Propellant • Leakage Test
• Concentrate – Propellant ratio • Biological Testing
• Flammability and Combustibility • Therapeutic Activity
• Flame Projection and flash back • Toxicity
• Flash Point • Extractable substances
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Testing of Containers:
 Metal containers are examined for
defects in linings.
 Degree of conductivity of electric
current for exposed metals.
 Glass containers examined for Flaws.
Weight checking:
• Weight checking is done periodically in the filling
lines by taring principle of empty and filled containers.
• Same procedure is used for checking weight of
propellants. It ensures proper blend of the propellants.
• Revolving dynamic weight checker for aerosols.
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Testing of Actuators, Valves and Dip tubes: The limits for valve acceptance are
• Both physical and chemical examinations are
done. Delivery Limits
• Specific mixture of propellants Iso Propyl 54 µL or less ± 15%
Myristate, Dichloro Difluoro methane, Dichloro 55 µL to 200 µL ± 10%
tetrafluoro ethane, Trichloro monofluoro
methane and Alcohol are used to prepare 3
For 50 deliveries:
sets of test solutions
 If 4 or more deliveries are outside limits, then
valves are rejected.
Testing procedure:
• Take 25 valves and place on suitable containers filled with the test solutions.
• A button actuator with 0.02 inches or larger unrestricted orifice is attached
to the valves.
• In an atmosphere of 25 ± 1 0C, the filled containers are actuated to fullest
extent for 2 seconds for complete dispensing of a single delivery.
• This procedure is repeated for a total of 2 deliveries from each 25 test units,
so total 50 deliveries
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Physico-Chemical Equipments for

Characteristic measurement
• Can Punching device
Vapour pressure
• Pressure Gauge
• Hydrometer
Density
• Pycnometer
• Karl Fischer method
Moisture content
• Gas Chromatography
Identification of • Gas Chromatography
propellant/s, ratio • IR Spectrometry
Gas Chromatography Karl Fischer Apparatus
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Flame Projection and flash back:

• This test indicates the effect of an
aerosol formulation on the extension of
an open flame.
• Product is sprayed for 4 sec. into open
flame and exact length of extended
flame is measured with ruler.
Flash Point
• Determined by using “Standard Tag Open
Cup Apparatus”.
• Aerosol product is chilled to temperature of
-25 0F and transferred to the test apparatus.
• Temperature of test liquid increased slowly,
and the temperature at which the vapors of
propellant ignite is taken a flash point.
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Aerosol Valve Discharge Rate:

• It is determined by taking an aerosol known weight and discharging the
contents for given time using standard apparatus.
• By reweighing the container after time limit has expired, the change in
weight per time dispensed is discharge rate. It is expressed as gram per
seconds.
Spray Patterns:
• The method involves the impingement of sprays
on a piece of paper that has been treated with
dye - talc mixture.
• Depending on the nature of the aerosol, an oil
soluble or water soluble dye is used.
• The particles that strike the paper cause the
dye to go into solution and to be absorbed onto
the paper. It gives a record of the spray
pattern.
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Dose Uniformity / Dosage Testing with Metered valves:

• Reproducibility of dosage each time the valve is dispensed and amount of
medication actually received by the patient.
• Reproducibility has been determined by assay technique and amount of active
ingredient is determined.
• Another method involves accurate weighing of filled container followed by
dispensing of several doses, container can reweighed, and difference in weight
divided by Number of doses, gives the average dosage.
Net Contents:
• Weight method: The tared cans are placed on to the filling line and weighed,
the difference in weight is equal to the net contents.
• Destructive method: This method consists of weighing of a full container, and
dispensing the contents from the container. The net contents are then
weighed. The difference in weight also gives the net weight of the container.
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Foam stability:
The life of a foam ranges from a few seconds
(for quick breaking foam) to one hour or more
depending on the formulation and type of
foam.
The methods used to determine the foam
stability are Visual evaluation. Visual
evaluation is the time for a given mass to
penetrate the foam, time for given rod that is
inserted into the foam to fall. The use of
rotational viscometers.
Particle Size determination:

Particle size can be determined by Cascade impactor and Light scattering
decay methods.
Leakage Test:
Leak test is done by checking the crimping of the valve that must be
available to prevent defective containers. This is accomplished by measuring
the crimp’s dimension and ensuring that they meet specifications. Final
testing of valve closure is done by passing filled containers through water
bath.
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Biological Testing
The final phase of testing of aerosols involved in a comprehensive research and
development program for pharmaceutical aerosols must involve biological
testing. These are similar to tests performed for non aerosol pharmaceuticals.
Therapeutic Activity: Toxicity: Extractable substances:

For Inhalation Aerosols: For Inhalation Aerosols: Since pressurized inhalers and
Therapeutic activity depends Inhalation toxicity is studied by aerosols are normally formulated
on the particle size. exposing test animals to vapor with organic solvents as the
For Topical Aerosols: sprayed from Aerosol container. propellant or the vehicle,
Therapeutic activity of aerosol For Topical Aerosols: Irritation on leaching of extractables from the
products are determined by the skin & Chilling effects are elastomeric and plastic
applying the active ingredients checked. When aerosol is topically components into the formulation
topically to test areas and the applied, thermistor is used to is a potentially serious problem.
amount of therapeutic active determine the change in skin
ingredients absorbed is temperature for a given period of
determined. time.
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STABILITY TESTING OF AEROSOLS
Two types of stability testing:

(1) Electrochemical and
(2) Long Term Static
• Electrochemical testing for rapid screening.
• Long Term Static over several months/years.
• Elevated temperature (120°F) and room temperature stability tests should be
performed concurrently.
• Low temperature testing (~45°F) is recommended for viscous products, products
prone to crystallization and/or precipitation.
• Container quality, Valve gasket swell and hardness issues are to be estimated.
• Product stability and delivery performance are to be estimated.
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APPLICATIONS
1. Local anesthetics (e.g. Benzocaine)
2. Topical/Spray on bandages
• Proprietary burn applications
• Antibacterials (e.g. Neomycin)
• Antifungal sprays (e.g. Miconazole)
• Anti-inflammatory steroids (e.g. Dexamethasone)
3. Nasal
• Decongestants (e.g. Phenylephrine)
• Anti-inflammatory steroids (e.g. Beclomethasone)
• Moisturizers (e.g. Normal saline)
4. Oral inhalation:
• Antiallergics (e.g. Cromolyn sodium)
• Antiasthmatic (e.g. Terbutaline sulfate)
5. Systemic access: Antidiuretics (e.g. Desmopressin)
6. Antismoking (Nicotine)
7. Ocular: Contact lens cleaning solutions Dr. GSN Koteswara Rao (Eswar)
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Pharmaceutical Definition
Aerosols
Propellants
Containers
Valves
Types of aerosol systems
Formulation and manufacture of aerosols
Quality control tests and

Evaluation of aerosols
stability studies
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REFERENCES
1) The Theory and Practice of Industrial Pharmacy by Leon Lachman, Herbert A. Lieberman and Joseph L. Kanig Third
edition, Varghese Publishing House
2) Remington’s “The Science & Practice of Pharmacy”, 21st Edition, Volume-I, page no 1000-1017.
3) Pharmaceutics- The science of Dosage Form Design, edited by Michael. E. Aulton, Low price edition, page no 341-
358.
4) Pharmaceutical Dosage Forms and Drug Delivery Systems, Seventh Edition by Howard C. Ansel, Loyd V. Allen,
Nicholas G. Popovich. Page no 383-396.
5) Indian Pharmacopoeia 1996, Volume-I, page no. 24.
6) United State Pharmacopoeia
7) Introduction to pharmaceutics I & II by Ashok. K Gupta, 3rd edition, CBS publishers & Distributors 5496/1A, 11
Darya Ganj. New Delhi. India.
8) Mr.Hitesh, G. Pokar, Dr.K.R. Patel, Dr.N.M. Patel. Review article on “Pharmaceutical Aerosol”- Internationale
Pharmaceutica Sciencia April-June 2012, vol.2, Issue 2.
9) Lahkar sunita. Review article “An Overview on Pharmaceutical Aerosols”- International Research Journal of
Pharmacy, 2012, 3(9), Page 68 to 75.
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Name any two

propellants used in
topical aerosols
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If propellant concentration is
around 10%, then what is the
expected product output?
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Tag open cup apparatus is used

for which test of aerosols?
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22-10-2021
Propellant type and

concentration can be determined
by using which instrument?
69
70

22-10-2021
If liquid propellant is not miscible

with product concentrate then
total how many phases exist in
packed aerosol container?
71
72

22-10-2021
Gasket is made up of which

material?
73
74

22-10-2021
Cold welding is not suitable for

which type of product
concentrate?
75
76

22-10-2021
For how much duration, flame

projection has to be done?
77
78

Aerosols Material 2021

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Aerosols Material 2021

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22-10-2021

Dr. GSN Koteswara Rao (Eswar)

Types of aerosol systems

Formulation and manufacture of aerosols

Quality control tests and

Dr. GSN Koteswara Rao (Eswar), KLU 1

Dr. GSN Koteswara Rao (Eswar)

• “Pressurized dosage forms containing one or more active

Dr. GSN Koteswara Rao (Eswar), KLU 2

Types of product output from aerosol

Dr. GSN Koteswara Rao (Eswar), KLU 3

No contamination due to positive pressure

Hermetic sealing: No oxidation, No hydrolysis, No photolysis

Uniform application as thin layer without touching effected area

Different forms of product outcome based on formulation

Control over the dose with special valves

Dosing can be minimized

Immediate onset of action

Bypass first pass metabolism

The disposal of empty containers may be difficult

Patients may be sensitive to certain propellants

Fluorocarbons cause damage to environment

Exposure to heat or flame may cause blast due to raise in pressure

Insoluble drugs may clog the path if not properly formulated

Propellants may cause toxic reactions on long term therapy

Dr. GSN Koteswara Rao (Eswar), KLU 4

4. Actuator and Valve Assembly

• It is a chemical substance responsible for developing the

Dr. GSN Koteswara Rao (Eswar)

Dr. GSN Koteswara Rao (Eswar), KLU 5

A. LIQUIFIED GAS PROPELLANTS:

Numerical designation or Nomenclature

Dr. GSN Koteswara Rao (Eswar), KLU 6

Chlorofluorocarbon (CFC) Propellants

• Advantages: Chemical inertness, Non

• Advantages: Environmental acceptance, low toxicity and non reactivity

Propane Butane Isobutane

Dr. GSN Koteswara Rao (Eswar), KLU 7

Advantages: Low toxicity, high stability, high purity,

Dr. GSN Koteswara Rao (Eswar)

Difference between Liquefied Propellant

Dr. GSN Koteswara Rao (Eswar)

Dr. GSN Koteswara Rao (Eswar), KLU 8

• An equilibrium is quickly established between

Dr. GSN Koteswara Rao (Eswar)

Dr. GSN Koteswara Rao (Eswar), KLU 9

• Upon actuation of the valve assembly, the

• As the liquid phase is removed from the container,

Dr. GSN Koteswara Rao (Eswar), KLU 10

Dr. GSN Koteswara Rao (Eswar), KLU 11

Dr. GSN Koteswara Rao (Eswar), KLU 12

VALVE ASSEMBLY and its components:

Dr. GSN Koteswara Rao (Eswar)

Dr. GSN Koteswara Rao (Eswar)

Dr. GSN Koteswara Rao (Eswar), KLU 13

Mounting Cup or Ferrule:

Dr. GSN Koteswara Rao (Eswar)

Dr. GSN Koteswara Rao (Eswar), KLU 14

Housing or Valve body:

• The actuator, stem, housing,

Dr. GSN Koteswara Rao (Eswar)

Dr. GSN Koteswara Rao (Eswar), KLU 15

FORMULATION & MANUFACTURING OF AEROSOLS