AEROSOL PACKAGING AND ITS COMPONENT, MANUFACTURING AND EVALUATION.

1. PRESENTEDBY,
UTPALKUMARSAHA
B.PHARM3rd YEAR
GUIDED BY MR. SUJITDAS.

2.  DEFINITION
 PROPELLANTS
 CONTAINERS
 VALVES
 TYPES OF AEROSOL SYSTEM
 MANUFACTURE OF AEROSOLS
 QUALITY CONTROL TESTS

3. “Aerosol is a pressurized dosage forms
containing one or more therapeutic
active ingredient which upon
actuation emit a fine dispersion of
liquid and/or solid materials in a
gaseous medium”.

4. ADVANTAGES DISADVANTAGES
• Easily withdrawn of drugs.
• Easy and convenient to
apply.
• First onset of action.
• No microorganism can
enter.
• A specific amount of drugs
or dose can be removed.
• Avoid the first pass
metabolism.
• Release of contents in
controlled and Uniformly.
• Costly
• Difficult disposal of
empty aerosol
containers.
• Allergic in some
cases.
• Explosive
• Some formulation is
difficult.
• Sometimes
propellants may cause
toxic reactions.

5.  PROPELLENT
 CONTAINER
 VALVE AND ACTUATOR
 PRODUCT
CONCENTRATE

6. It is responsible for developing the power
pressure within the container and also expel
the product when the valve is opened and in
the atomization or foam production of the
product.
TYPES OF PROPELLANTS:
a) Liquefied gases.
b) Compressed gases.

7.  It disperse the active ingredient
into a fine mist.
 The pressure within the container
remain constant.
 It is relatively inert and nontoxic.

8. Types of Liquefied gases:
1. Chlorofluorohydrocarbons (CFCs)
Trichloromonfluoromethane (Prop 11)
Dichlorodifluoromethane (Prop 12)
Dichlorotetrafluoroethane (Prop 14)
2. Hydrocarbon
Propane, Butane, Isobutane
3. Hydrochlorofluorocarbon and
Hydrofluorocarbon
Monochlorodifluoroethane,Difluoromethane

9. (1)Chlorofluorohydrocarbons (CFCs)
• Propellant of choice for oral and
inhalation.
Advantages
– Chemical inertness
– Lack of toxicity
– Non flammability.
Disadvantages
– High cost
– It depletes the ozone layer
– Damage global warming potential

10. (2) Hydrocarbon
• Can be used for water based aerosols and topical
use.
Advantages
– Inexpensive
– Excellent solvents
– It does not cause ozone depletion
Disadvantages
– Inflammable
– Unknown toxicity produced
e.g. propane , butane , isobutane

11. (3)Hydrochlorofluorocarbon and
Hydrofluorocarbon
• They may not contain chlorine and have one or
more hydrogen atom.
• These compounds break down in the
atmosphere at faster rate than CFCs- lower
ozone destroying effect.
Advantages
• Low inhalation toxicity
• High chemical stability
• High purity
• Not ozone depleting
Disadvantages
• Poor solvent
• High cost

12. • Used when the aqueous phase need not be miscible with
the propellant.
• Do not have chilling effect, for topical preparation.
Advantages
– Inexpensive
– Non flammable
– No environmental problems
Disadvantages
– Pressure falls during use
– Produce coarse droplet spray
e.g. CO2, N2O, N2

13.  They must be stand at pressure as high as 140 to 180 psig
(pounds per sq. inch gauge) at 1300 F.
 A. Metals
 1. Tinplated steel
 (a) Side-seam (three pieces)
 (b) Two-piece or drawn
 (c) Tin free steel
 2. Aluminium
 (a) Two-piece
 (b) One-piece (extruded or drawn)
 3. Stainless steel
 B. Glass
 1. Uncoated glass
 2. Plastic coated glass

14. Tinplated steel :
- Used in topical pharmaceutical aerosols
- Coating decreases the compatibility problems
- Light
- Inexpensive
Aluminum:
- Used for inhalation and topical aerosols.
- Metal containers may be further coated with
organic coating, e.g. oleoresin, phenolic, vinyl
or epoxy coating for additional protection.

15. Glass containers:
 These containers are preferred
because of its esthetic value and
absence of incompatibilities.
 These containers are limited to the
products having a lower pressure
and lower percentage of the
propellant.
 Glass is basically stronger than the
metallic containers.

16. Two types of glass aerosol containers
i) Uncoated glass container:
 Decreased cost and high clarity and contents
can be viewed at all times.
ii) Plastic coated glass containers:
 These are protected by plastic coating that
prevents the glass from shattering in the event
of breakage.
 Pressures up to 33 psig can be used.
 Mainly used for some topical and metered dose
inhaler aerosols.

17. Valves
 To delivered the drug in desired form.
 To give proper amount of medication.
 Not differ from valve to valve of
medication in pharmaceutical
preparation.
Types of valves:
 - Continuous spray valve
 - High speed production technique.
 - Metering valves

22. ACTUATOR
 To ensure that aerosol product is delivered in the
proper and desired form. These are specially
designed buttons which helps in delivering the drug in
desired form i.e., spray, wet stream, foam or solid
stream
 Different types of actuators
 Spray actuators
 Foam actuators
 Solid steam actuators
 Special actuators

23. SPRAY ACTUATORS:
• It can be used for topical preparation, such as
antiseptics, local anesthetics and spray on
bandages etc.
• It allows the steam of product concentration
and propellant to pass through various openings
and dispense as spray.
FOAM ACTUATORS:
• It consist of large orifice which ranges from
0.070-0.125 inch.
SOLID STREAM ACTUATORS:
• These actuator are required for dispensing semi
solid products such as ointments.

24. SPECIAL ACTUATORS:
• These actuator are used for a specific purpose.
• It delivers the medicament to the appropriate
site of action such as throat, nose, dental and
eyes.