Aerosols formulation & Packaging

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1. AEROSOLS FORMULATIONAEROSOLS FORMULATION
&&
PACKAGINGPACKAGING
Presented By:Presented By:
Deepak Chandra JoshiDeepak Chandra Joshi
D.Pharma/B.PharmaD.Pharma/B.Pharma

2. AEROSOLSAEROSOLS
Pharmaceutical aerosols are pressurized dosage forms Pharmaceutical aerosols are pressurized dosage forms
that upon actuation emit a fine dispersion of liquid that upon actuation emit a fine dispersion of liquid
and/or solid materials containing one or more active and/or solid materials containing one or more active
ingredients in a gaseous mediumingredients in a gaseous medium..
 There are currently two main types of aerosol There are currently two main types of aerosol
generating devices. generating devices.
 1- Inhalers1- Inhalers
(a).(a). Metered Dose Inhalers (MDIMetered Dose Inhalers (MDI).).
(b). Dry Powder Inhalers (DPI(b). Dry Powder Inhalers (DPI).).
 2- Nebulizer 2- Nebulizer

3. ADVANTAGES OF AEROSOL ADVANTAGES OF AEROSOL
RATIONALE OF USE:RATIONALE OF USE:
Drug is delivered direct to the target organ (lungs).Drug is delivered direct to the target organ (lungs).
Less dose required Less dose required
Less systemic exposure Less systemic exposure
Less toxic.Less toxic.
Fast action,Fast action,
 No decomposition of drug.No decomposition of drug.

Doses generally smaller than systemic dosesDoses generally smaller than systemic doses ( (Ex: oral Ex: oral
albuterol is 2 to 4 mg; inhaled albuterol is 0.2 mg)albuterol is 2 to 4 mg; inhaled albuterol is 0.2 mg)
Systemic side effects are less frequent and severeSystemic side effects are less frequent and severe
 Onset of effect is faster than with oral dosing( eg, oral Onset of effect is faster than with oral dosing( eg, oral
albuterol is albuterol is ≤≤ 30 min; inhaled albuterol is ~ 5 min) 30 min; inhaled albuterol is ~ 5 min)
There is no decomposition or loss of drug in the There is no decomposition or loss of drug in the
gastrointestinal tractgastrointestinal tract
No danger of contamination of the product with foreign No danger of contamination of the product with foreign
materials.materials.

4. DISADVANTAGES OF AEROSOLDISADVANTAGES OF AEROSOL
Loss of Drugs: 10-20% drugs goes to lungs.Loss of Drugs: 10-20% drugs goes to lungs.
WhereWhere Does remaining Aerosol Drug GoDoes remaining Aerosol Drug Go? ?
The remaining drug is lost in the The remaining drug is lost in the devicedevice, the exhaled breath, , the exhaled breath,
the or pharynx, and the environment. the or pharynx, and the environment.
Reasons of drug loss Reasons of drug loss or dose variability or dose variability
The number and variability of device types confuses patients The number and variability of device types confuses patients
and clinicians. and clinicians.
Lack of standardized technical information on inhalers for Lack of standardized technical information on inhalers for
clinicians. clinicians.
lack of knowledge of correct or optimal use of aerosol devices lack of knowledge of correct or optimal use of aerosol devices
by patients and clinicians. by patients and clinicians.
Difficulty in coordinating hand action and inhalation with Difficulty in coordinating hand action and inhalation with
MDIs. MDIs.

5. COMPONENTS OF AEROSOLSCOMPONENTS OF AEROSOLS
AEROSOL
PROPELLENT CANTAINER
VALV
&
ACTUATOR
PRODUCT
CANCENTRATE

6. 1.PROPELLENT :-1.PROPELLENT :-
Propellants Is a liquefied gas with a vapor pressure greater Propellants Is a liquefied gas with a vapor pressure greater
than atmospheric pressure at a temperature of 105than atmospheric pressure at a temperature of 105˚˚ F (40.5 F (40.5
˚˚C).C).
In certain aerosol systems, no liquefied compressed gases, as In certain aerosol systems, no liquefied compressed gases, as
carbon dioxide, nitrogen, and nitrous oxide, are employed as carbon dioxide, nitrogen, and nitrous oxide, are employed as
the propellant.the propellant.

7. 2.CONTAINERS:-2.CONTAINERS:-
Container Material Maxi. Pressure (psig) Temp.(*F) Container Material Maxi. Pressure (psig) Temp.(*F)
Uncoated glass Uncoated glass < 18 70 < 18 70
Coated glass Coated glass < 25 70 < 25 70
Plastic Plastic < 25 70 < 25 70
Aluminum Aluminum 180 130 180 130
Stainless Steel Stainless Steel 180 130 180 130
Tin-plated steel Tin-plated steel 180 130 180 130

8. 3.VALVES:-3.VALVES:-
The function of the valve assembly is to permit expulsion of The function of the valve assembly is to permit expulsion of
the contents of the can in the desired form, at the desired rate, the contents of the can in the desired form, at the desired rate,
and in the case of metered valves, in the proper amount or and in the case of metered valves, in the proper amount or
dose.dose.
Functions:-Functions:-
It is capable of being easily opened and closed. It is capable of being easily opened and closed.
It regulate the flow of product concentrate. It regulate the flow of product concentrate.
It regulate the amount of emitted material. It regulate the amount of emitted material.
It is capable of delivering the content in the desired form (mist It is capable of delivering the content in the desired form (mist
spray, or foam). spray, or foam).
 Mist is a phenomenon of small droplets suspended in air. Mist is a phenomenon of small droplets suspended in air.
 A spray is a dynamic collection of drops dispersed in a gas. A spray is a dynamic collection of drops dispersed in a gas.
 The process of forming a spray is known atomization / The process of forming a spray is known atomization /
nebulization.nebulization.

9. TYPES OF VALVES :-TYPES OF VALVES :-
1. 1. Continuous Spray valveContinuous Spray valve is is
the most common used the most common used
valve.valve.
2. 2. Metering valvesMetering valves are used to are used to
accurately deliver a dose of accurately deliver a dose of
medication. applicable to medication. applicable to
the dispensing of potent the dispensing of potent
medication. These operate medication. These operate
on the principle of a on the principle of a
chamber whose size chamber whose size
determines the amount of determines the amount of
medication dispensed. medication dispensed.
3. 3. Foam valvesFoam valves have only one have only one
orifice that leads to a single orifice that leads to a single
expansion chamber of expansion chamber of
appropriate volume to allow appropriate volume to allow
the product concentrate to the product concentrate to
expand into a ball of foam. expand into a ball of foam.
Aerosol Valve assembly:-Aerosol Valve assembly:-
1. Actuator 1. Actuator
2. Stem2. Stem
3. Gasket3. Gasket
4. Spring4. Spring
5. Mounting cup5. Mounting cup
6. Housing6. Housing
7. Dip tube7. Dip tube

10. AEROSOL VAVLVE ASSEMBELYAEROSOL VAVLVE ASSEMBELY

11. AEROSOL SYSTEMSAEROSOL SYSTEMS
The pressure of an aerosol is critical to its performance. It can The pressure of an aerosol is critical to its performance. It can
be controlled by :-be controlled by :-
(a)(a) the typethe type and amount of propellant. and amount of propellant.
(b)(b) the naturethe nature and amount of product concentrate. and amount of product concentrate.
Space sprays generally contain a greater proportion of Space sprays generally contain a greater proportion of
propellant than do aerosols intended for surface coating.propellant than do aerosols intended for surface coating.
The aerosol system are divided into following four major The aerosol system are divided into following four major
classes as follows :- classes as follows :-
1. Solution System / 2-Phase Systems. 1. Solution System / 2-Phase Systems.
2. Water Based System / 3-Phase Systems.2. Water Based System / 3-Phase Systems.
3. Suspension or Dispersion Systems.3. Suspension or Dispersion Systems.
4. Foam System.4. Foam System.

12. AEROSOL
SYSTEMS

SOLUTION
SYSTEM
(2-PHSAE
SYSTEM)
WATER BASED
SYSTEM
(3-PHASE
SYSTEM)
SUSPENSION
OR
DISPERSION
SYSTEM
FOAM
SYSTEM
AQUOUS
STABLE
FOAM
NON
AQUOUS
STABLE
FOAM

QUICK
BREAKING
FOAM
THERMAL
FOAM

13. 1. Solution System/2-Phase Systems:-1. Solution System/2-Phase Systems:-
2-Phase2-Phase System Consist of the liquid phase, System Consist of the liquid phase,
containing the liquefied propellant and product containing the liquefied propellant and product
concentrate, and the vapor phase.concentrate, and the vapor phase.
2. Water Based System/3-Phase Systems2. Water Based System/3-Phase Systems:-:-
. . It Consist of a layer of water immiscible liquid It Consist of a layer of water immiscible liquid
propellant, a layer of highly aqueous product propellant, a layer of highly aqueous product
concentrate, and the vapor phase.concentrate, and the vapor phase.
. . The liquefied propellant usually has a greater density The liquefied propellant usually has a greater density
than the aqueous layer, it generally resides at the than the aqueous layer, it generally resides at the
bottom of the container with the aqueous phase bottom of the container with the aqueous phase
floating above it.floating above it.
. . The vapor phase within the container is replenished The vapor phase within the container is replenished
from the liquid propellant phase.from the liquid propellant phase.

14. 3.Suspension/Dispersion System:-3.Suspension/Dispersion System:-
•• It Involves dispersion of active ingredients in the It Involves dispersion of active ingredients in the
•• Propellant/mixture of propellants.Propellant/mixture of propellants.
•• Suspending agents are must be added for decreasing Suspending agents are must be added for decreasing
the rate of the rate of
•• Settling of dispersed particles.Settling of dispersed particles.

15. MANUFACTURING PROCEDURE&FILLING OPERATIONMANUFACTURING PROCEDURE&FILLING OPERATION
PRE
FORMULATION
OF
AEROSOL’S
Preparation of Product
Concentrate's
A
Addition of Propellent’s
B
MIXINING
A+B
FORMULATION /
FILLING PROCESS

16. FORMULATION
&
FILLING
PROCESS
COLD
FILLING
METHOD
PRESSURE
FILLING
METHOD
COMPRESSED
GAS FILLING
METHOD
METHOD-A METHOD-B

17. 1.Cold Filling Method:-1.Cold Filling Method:-
In this method mostly all process performed underIn this method mostly all process performed under cold cold
container at -30 to -40 *F. container at -30 to -40 *F.
Method A :-Method A :-
Step.1.Step.1.Take required amount of the product Concentrate and Take required amount of the product Concentrate and
Chilled it to temperature at -30 to -40*F .Chilled it to temperature at -30 to -40*F .
Step.2Step.2.After that above chilled product transferred into a .After that above chilled product transferred into a
container container
which is already chilled at in equal temp. at -30 to -40*F.which is already chilled at in equal temp. at -30 to -40*F.
Step.3Step.3.Finally chilled propellant is added in above chilled .Finally chilled propellant is added in above chilled
container through inlet valve.container through inlet valve.
Step.4Step.4.Finally the chilled container is tightly closed and then seal.Finally the chilled container is tightly closed and then seal
 well.well.
Step.5Step.5.Labeling the container with their required specification.Labeling the container with their required specification
-n, direction and Packed it with specific manner-n, direction and Packed it with specific manner..

18. Method B :- Method B :-
Step.1Step.1:- :- Take required amount of the product concentrate andTake required amount of the product concentrate and
then take required propellant separately at chilled then take required propellant separately at chilled
temp. -30 to -40*F.temp. -30 to -40*F.
Step.2Step.2:- Mix the both component and then transferred it into a :- Mix the both component and then transferred it into a
chilled Container at temp. -30 to -40*F.chilled Container at temp. -30 to -40*F.
Step.3Step.3:- Valves are set in place sealed tightly with container.:- Valves are set in place sealed tightly with container.
Step.4Step.4:- after that the filled container passed through water :- after that the filled container passed through water
bath. content heat to 130*F).bath. content heat to 130*F).
Step.5Step.5:- Container dried and then capped and packed well :- Container dried and then capped and packed well
after that Packed it.after that Packed it.

19. 22. . Pressure Filling MethodPressure Filling Method:-:-
Step1Step1:- the product concentrate is quantitatively placed in the :- the product concentrate is quantitatively placed in the
aerosol container through burette.aerosol container through burette.
Step.2Step.2:- the valve assembly is inserted and crimped into place:- the valve assembly is inserted and crimped into place
the liquefied gas, under pressure, is metered into the the liquefied gas, under pressure, is metered into the
valve stem from a pressure burettevalve stem from a pressure burette..
.. Step.3Step.3:- Finally pack the container and leveled it.:- Finally pack the container and leveled it.
3. Compressed gas filling method :-3. Compressed gas filling method :-
In this method the procedure of filling is as same as Pressure In this method the procedure of filling is as same as Pressure
filling method but the only difference is that in this method it filling method but the only difference is that in this method it
requires high filling pressure (150 pound/²inch gauge).requires high filling pressure (150 pound/²inch gauge).

20. Evaluation & Quality ControlEvaluation & Quality Control
QUALITY
TESTING
FLAMMABILITY
&
COMBUSTIBILITY
PHYSICO
-CHEMICAL
PROPERTIES
AEROSOL
PERFORMANCE
TEST’s
BIOLOGICAL
CHARACTERSTIC”
S
FLASH POINT
FLAM
EXTENSION
pH
DENSITY
&
WEIGHT
VISCOSITY
&
RHEOLOGY
MOISTURE
CONTENT
PRESSURE
AEROSOL
DISCHARGE
RATE
SPRAY
PATTERN &
PRTICAL SIZE
DOSAGE WITH
METERED
VALVE
NET
CONTENT
FOAM
STABILITY
LEAKAGE
PARTICLE
SIZE
THERAPUTIC
ACTIVITY
TOXICY
RATE
HEAT
OF
COMBUSTION
MISCELLANEOUS
TESTING
VOC
&
MIR
HARDNESS
TESTING
STABILITY
&
COMPATIBILITY
ACTIVE
INGREDIENT
ANALYSIS
TITRATION
GAS
CHROMATOGRA
PHY
HPLC
FTIR
MICROBIOLOGICAL
TESTING

21. EVALUATION TEST:-EVALUATION TEST:-
1.Flammability or Combustibility.1.Flammability or Combustibility.
2.Physico-Chemical Property.2.Physico-Chemical Property.
A. pHA. pH
B. ViscosityB. Viscosity
C. Moisture ContentC. Moisture Content
D. Vapor PressureD. Vapor Pressure
E. Density and weightE. Density and weight
F. Heat of Combustion F. Heat of Combustion
G. Aerosol Performance testG. Aerosol Performance test
(a). Aerosol discharge rate (a). Aerosol discharge rate
(b). Spray Pattern(b). Spray Pattern
H. Particle Size Distribution H. Particle Size Distribution
I. Net ContentI. Net Content
J. Foam StabilityJ. Foam Stability
K. Leakage TestK. Leakage Test

22. Thank You Thank You
DEEPAK CHANDRA JOSHI DEEPAK CHANDRA JOSHI
D.Pharma/B.PharmaD.Pharma/B.Pharma
Admin;- Target Pharmacy Competitive Exam Admin;- Target Pharmacy Competitive Exam
group ( Public Group )group ( Public Group )