AEROSOL SCIENCE AND TECHNOLOGY

Presented By:
Sharifa Sultana
Assistant PRofessor
Department of Pharmacy
1. Propellant
 An aerosol can contains one fluid that boils well
below room temperature called the propellant.
 The propellant is the means of getting the product
out of the can.
 Propellant includes one propellant or a mixture of
propellants.
 Mixture of propellants are used to get the desired
vapour pressure.
Cont………..

 In the more popular system, the propellant is a

liquefied gas. This means that the propellant will
take liquid form when it is highly compressed, even
if it is kept well above its boiling point.
It may be-

 Liquefiedgas or gas- mixture (part of which remains in

the vapor phase)

 Non-liquefied compressed gas or gas-mixture

Functions of Propellants
 Primary function-Produce a pressure for expelling
the product concentrates when the container valve is
opened.
 Other Functions-
1) May act as the solvent for the active
substance.
2) Can affect the physical characteristics of the
expelled product.
Classification of Propellants:
Liquified gas propellants:
 Exist as gas at room temperature and pressure but

can be easily liquefied by applying pressure or

reducing temperature. They are of two types-
 Chlorofluro hydrocarbon

 Hydrocarbons
CFC propellants:

Traditionally chlorofluorocarbons (CFC) have been used.

They possess-
 Low pulmonary toxicity
 High chemical stability
 Compatibility with packaging materials.

The three most widely used CFCs are:

 Trichloromonofluromethane(CFC11)
 Di chlorodifluromethane(CFC12)
 1,2- dichlorotrifluroethane(CFC114)

CFCs are ozone-depleting propellants and destroy the

ozone layer of the atmosphere, thus increasing
environment and health hazards.
Why CFCs are banned in manufacturing
of aerosol products?

What is its alternative in aerosol

technology?
Table. Formula and physicochemical properties of chlorofluorocarbons
(CFCs) used in MDI formulations
Number Formula Boiling point Vapour Density (g/mL
(ºC) pressure (kPa at 20 ºC)
at 20 ºC)
11 CCl3F 23.7 89 (0.89 bar) 1.49
12 CCl2F2 -29.8 568 (5.68 bar) 1.33
114 C2Cl2F4 3.6 183 (1.83 bar) 1.47
 HFC propellants:

 Hydroflurocarbons (HFC), also called

hydrofluroroalkanes (HFA),are used as alternatives
to CFCs.
 They are low ozone depleting but contribute to
global warming.
 Additionally, they have less solvent power and cause
problem in dissolving surfactants.
 The two most widely used pharmaceutical HFCs are:
 1,1,1,2-tetrafluroethane(HFC 134a,HFA 134a)
 1,1,1,2,3,3,3-heptafluropropane(HFC227,HFA
227)
Table. Formula and physicochemical properties of
hydrofluoroalkanes (HFAs) used in MDI formulations
Number Formula Boiling Vapour Density
point (ºC) pressure (g/mL at 20
(kPa at 20 ºC)
ºC)
134a C2F4H2 -26.5 660 (6.6 1.23
bar)
227 C3F7H -17.3 398 (3.98 1.41
bar)
Numbering system:

 Three digit number are assigned

 1st digit: number of C atoms-1(0 is omitted)
 2nd digit: number of H atom+1
 3rd digit: number of F atoms
 More asymmetrical isomers are designated as a, b, c etc.

CFC and HFC propellants have been banned or are in

the process of banning in most countries of the
world. They are still allowed to be used in
pharmaceutical inhalation aerosols until safe and
technically suitable non-CFC propellants are
developed and available commercially.
Hydrocarbon propellants:

Most commonly used hydrocarbon propellants are n-

butane, isobutene, and propane. They are usually
blended to obtain the desired properties. They are
mostly employed in topical products.
 Advantage of Hydrocarbon propellants:
 Dissolve ability- to dissolve a wide range of medicaments
 Stability-Chemical & physical stability
 Odor-lack of odor
 Cost-Low cost
 Toxicity-Low toxicity
 Comparison between chlorofluorohydrocarbons
propellants and Hydrocarbons propellants:
Chlorofluorohydrocarbons Hydrocarbons
Halogens atoms ( Cl, F)in the No halogen in the molecule,
molecule besides C and H only contains C and H.
Low miscibility with water Very low miscibility with
water
More dense than water Less dense than water thus
they stay above the aqueous
water.
Usually not inflammable Flammable
Ozone-depleting Not ozone-depleting
Compressed Gas propellants
 They remain highly compressed within the container

but no liquid phase of the gas exists. Example:

nitrous oxide (N2O), carbon di oxide (CO2).
Pharmaceutical Aerosol

Presented By:
Sharifa Sultana
Assistant Professor
Department of Pharmacy
Daffodil International University
 2.Container
Components of aerosol package-container
Five different materials have been used for the
construction of aerosol containers.
I. Tin-plated steel
II. Aluminum
III. Stainless steel
IV. Glass
V. Plastic
 Container materials must withstand pressure as high

as 140 to 180psi at 1300F.

Types of container
A.Metals containers

1. Tinplated steel
2.Aluminium
3. Stainless steel

B.Glass

1. Uncoated glass
2. Plastic coated glass
A.Metals containers
1. Tinplated steel-
 steel electroplated with tin

 may be coated or non coated with plastic

 Light, durable and inexpensive

2. Aluminium-
 Usually uncoated but sometimes coated

 Usually more resistant(pure water and pure ethanol may cause

corrosion)
 Seamless

3. Stainless steel-
 Usually no coating required

 Can withstand high pressure

 Expensive
B.Glass

1. Uncoated glass
2. Plastic coated glass

Choice of container material

 Required to withstand pressure of the system

 Stable in wide range of temperature

 Stable in aqueous or non aqueous system

 Unaffected by the pH of the product

 Unaffected by other formulation components etc.

 3. Valve and actuator
 Valve-Aid in the release of product from the
container in the desired form when it is opened.
 Two types of valves:

 Conventional or continuous spray valve-expel the

product as long as the valve is opened.

 Metered dose valve-predetermined quantity of the

product when the valve is opened.
 Basic parts of valve assembly :

 Ferrule or mounting cup

 Valve body or housing
 Stem
 Gasket
 Spring
 Dip tube
 Basic parts of valve assembly :

Fig: A, ferrule; B, stem; C, valve seat; D, valve body, E, mounting

gasket; F, dip tube
Ferrule or Mounting Cup
 It is used to attach the valve properly to the
container.
 Ferrules are used with glass bottles or small
aluminium tubes
 It is usually made from a softer metal such as
aluminium.
Valve Body or Housing
 Directly below the mounting cup
 the housing links the dip tube and the stem and
actuator.

 The housing is generally manufactured from nylon

 Stem
 Supports the actuator and delivers the formulation in
the proper form to the chamber of the actuator.
 The stem is made from Nylon, but metals such as
stainless steel can be utilized also.
 Gasket
 Placed tightly with the stem,
 prevents leakage of the formulation in the proper form
to the chamber of the actuator.
 Rubber are commonly used for the gasket material
 Compatible with most pharmaceutical formulations.
Spring
 The spring serves to hold the gasket in place, and when
the actuator is depressed and released,
it returns the valve to its closed position.
 Stainless steel can be used with most aerosols.
Dip Tube
 Extends from the housing down into the product; brings
the formulation from the container to the valve.
 Dip tubes are made from polyethylene or
polypropylene. Both materials are acceptable for use
although the polypropylene tube is usually more rigid.
 The inside diameter of the commonly used dip tube is
about 0.120 inch to 0.125 inch,
 Although capillary dip tubes are about 0.050 inch, and
dip tubes for highly viscous products may be as large as
0.195 inch.
Metered dose valve

It has a specially designed chamber in the valve

housing which holds a certain amount of the product
for releasing outside, thus ensuring a definite
dose.These are use in MDIs.
 4.Product concentrate
 An aerosol formulation consists of two essential
components:
 1. product concentrate
 2.propellant.

 The product concentrate consists of active ingredients, or

a mixture of active ingredients,
 and other necessary agents such as solvents,
antioxidants, and surfactants.
 Propellants can be combined with active ingredients in
many different ways, producing products with varying
characteristics.
 Depending on the formulation of aerosol system
utilized, the pharmaceutical aerosol may be
dispensed as a
1. Fine mist,
2. Wet spray,
3. Quick breaking foam,
4. Stable foam,
5. Semisolid or solid.
 The type of system selected depends on many

factors, including the following:

(1) physical, chemical, and pharmacologic properties
of active ingredients,
(2) site of application.
Differences between MDI & DPI
Pharmaceutical Aerosol

Presented By:
Sharifa Sultana
Assistant Professor
Department of Pharmacy
Daffodil International University
Pharmaceutical Aerosol

Presented By:
Sharifa Sultana
Assistant Professor
Department of Pharmacy
Daffodil International University