Audio Visual Presentation on

PHARMACEUTICAL
PACKAGING
TECHNOLOGY
Science Of Drug Packaging
Outline of presentation
Introduction
Packaging Of Various Dosage forms
Impact Of Packaging
Packaging Testing and Compatibility
Greening Of Packaging
 What is packaging ?

Packaging is defined as the collection of different

components which surround the pharmaceutical product
from the time of production until its use.
There are three types of
packaging; they are
primary, secondary and
tertiary packaging.
Function Of Packaging
Concept Of Packaging Value
Chain
 To analyze the specific activities
(packaging cost,quality) through
which firms can create a competitive
advantage is called packaging value
chain.

 The Concepts of the Value Chain Can

improve packaging and create
efficiencies.

 It gives packaging designers for

understanding their respective
contribution to packaging
development can be more effectively
understanding in practical.
Fig :Packaging value chain.
 Packaging materials of Various
Dosage Forms

Dosage Form Packaging materials

Solid Dosage Forms Blister packing

materials

Liquid Dosage Forms Glass

Plastic
Closure
Semisolid Dosage Ointment jar
Forms Collapsible tube
Aerosol Preparation Can
Valve actuator
Topical Delivery Patch
System
Packaging Science
Of Solid Dosage
Forms
 Solid oral dosage forms
 Solid dosage forms are some of the
least expensive, most popular and
convenient methods for drug
delivery.

 They can be produced in a non-

sterile area.

 Tablet and capsule are most

common solid dosage forms.
Packaging materials of Solid oral dosage
forms
The most common forms of flexible
packaging are:
 Blister package(Bubble pack):
A transparent, molded piece of plastic
often sealed to a sheet of cardboard,
used to package and display an item of
merchandise.

 Pouch : A small or medium size

container for holding or carrying
things is called pouch. Pouches made
of easily yielding materials such as
film, foil, or paper sheeting which,
when filled and sealed, acquires pliable
shape.
Blister Packaging materials
Blister materials are :
A.Tray materials :
 Materials help to Pocket formation to
receive the product in deep drawn
pockets.

 Tray materials are polypropylene

(PP)polyvinyl chloride (PVC), PVDC
(polyvinylidene chloride) etc.
 Blister packing materials
B. Lidding Material:
The lidding materials are those
which are sealed onto the support
material after the tablets or
capsules have been properly fed to
the preformed support materials.
Lidding material consists of :
 Support material: Hard
Aluminium, Soft Aluminum,
Paper Aluminum, Paper-PET-
Aluminium.
 A sealing agent : Heat-sealing
lacquer on the other side.
 Procedure for blister packaging
1.Forming film roots

2.Forming film preheating

3.Pocket formation

4.Auto feeding system

5.Aluminium foil

6.Sealing station

7.Coding embossing

8.Perforation

9.Trimming

10.Finished Product
Packaging Science Of Liquid
Dosage forms
 Liquid Dosage forms
Liquid Dosage forms are homogeneous
preparations containing one or more
active ingredients dissolved or suspended
in a suitable vehicle.

 Oral Suspensions
Parenteral Suspension
 Oral Solutions
 Oral Emulsions
 Elixirs, Linctuses,
 Oral Drops
Ophthalmic Drops

Liquid dosage forms are packed in clear or

amber glass bottle, Plastic bottle and
ampoule, vial for parenteral preparation.
Glass
 Glass
Fig: Silica,building block of glass
Glass materials
 Glass is a amorphous(non-
crystalline) solid material.

 Glasses are typically brittle,

and optically transparent
and amber type.

 Generally soda lime and

borosilicate glass are used.
Amber glass
 amber colored glass is made by
adding some additives with soda
lime or borosilicate glass.

 Clear soda lime glass ambered

by adding FeO and sulfur (in
presence of reducing agent).

 FeO and TiO2 give amber color

when add with clear
borosilicate glass
Plastic
Plastic
 The plastic material are widely
used for packing sterile as well
as non sterile liquid dosage
forms.

 Plastic bottle are made by

various type of polymer.

 Some polymers are

Polyethylene,HDPE
LLDPE,PVC,PET,LP,
 Plastic bottle may white,amber
color
Factor consider For Selection Of Plastic
There are five factors which is to be
considered during selection of plastic as a
packaging material for liquid dosage forms
·

Permeation
Leaching
Sorption
Chemical reaction
 Alteration of the solvent effect

Example : Deformation of polyethylene

containers is often caused by permeation of
gas and vapours from the environment.
 Closure And Liners
Aluminium, Plastic,Rubber
closure or stopper is used in liquid
dosage forms.

 Closure may be color or

colorless.

On the depending of the

opening method they are different
type like screw cap, pressure cap
etc.
Factors Consider Selecting Closure
Factors are :
Chemical resistance.
Appearance
Gas and vapor transmission.
Removal torque.
Heat resistance.
Shelf life.
Economical factors.
) Storage Requirements (Labeling)
Shake well before use.
Do not freeze.
 Protect from direct light.
 Packaging science of
parenteral dosage forms

Ampoule
 Ampoule
Ampoules are the most cost effective
pharmaceutical containers and are
made of Borosilicate glass.

It is essential that glass quality and

dimensional features of these
ampoules are in compliance with their
foreseen usage.

Ampoules come in many types and

sizes but mainly in two colours clear
white (transparent) and yellowish
brown (amber).
.

Packaging material for ampoule

 Ampoule are normally made by
borosilicate glass.

 Amber glass is used light sensitive

product.

 Clear glass is used for light resistant

product.

 Ampoule contain single unit dose.

 Filling of glass ampoules

Ampoules must first be rinsed out using water for
injections to remove any dust, particulate matter or
glass fragments.


Using a syringe, gently draw the volume required to
be filled plus an excess volume.


Invert the syringe to allow the air to rise towards the
needle and push up the plunger to remove all air.


Attach the membrane filter and needle to the
syringe.


Invert the ampoule over the needle and expel the
required volume of liquid into the ampoule taking
care not to splash the liquid into the neck of the
ampoule. 
  Labeling and storage

Ampoules is labeled by paper labels and

direct printing on the glass. 


The strength expressed in terms of the
amount of active ingredient in a suitable dose
volume.


Indication that a single dose preparation
should be discarded after first use .


Special labeling requirements for particular
product e.g, powders for reconstitution prior
to use, concentrated solutions requiring
dilutions prior to use.
Packaging Science Of
Parenteral Dosage
forms

Vial
 Vials
Vials are parallel side containers
with a flat or concave base with a
variety of neck finishes.

The majority of these are produced

from soda glass.

Normally uses in parenteral

preparation.

These are used as multidose

container.
 Packaging materials for vial
A. Rubber plug :
Various types of rubber plug design and
over (cap) seal may be employed.
A range of standard neck sizes are available
(13 to 20 mm).
Rubber discs or plugs can be fixed into the
over seal.
B. Aluminium overcap :

Aluminium overcaps may have a perforated

metal, plastic flip-off or peelable foil cover.

Vials have also been introduced for unit

dose packs using either an aluminium two-
piecetear off closure with a Saran coated
pulp board liner or a peel-type seal.
 Packaging materials of vial
C. Glass :
It is most commonly used in vial
(multidose container).For aqueous
solutions, neutral glass is used.

Amber glass vial are available for

light sensitive products.

Clear vials used for light-resistant

product .
 
 Vial Filling AND
Inspection
Vials contain a fixed number of dose
units, an excess volume is required to
allow the stated number of doses to be
withdrawn.

Vials are sealed using rubber closures

which are held in place by an aluminium
sealing.

Injection vials should be checked for

defects, cracks, chips, damage to the seals
and closures.

Injection solutions when examined

under suitable conditions of visibility
should be free from particles.
 STORAGE AND LABELLING
Vials are labeled by use of paper labels. 
The strength expressed in terms of the
amount of active ingredient in a suitable dose
volume.
The name and concentration of any added
substance e.g., antioxidant, anti-microbial
preservative.
Special labeling requirements for particular
product e.g., powders for reconstitution prior
to use, concentrated solutions requiring
dilutions prior to use.
The date after which the preparation is not
intended to be used (expiry date).
The conditions under which the preparation
should be stored.
 Cartridges
A glass cartridge for an injection syringe prefilled with pharmaceutical
liquid, wherein a glass barrel having an entrance end portion and the exit
end portion are formed.
 Packaging Science Of
Semi Solid Dosage forms

Ointment
 Ointment
 Ointment is a homogeneous, viscous,
semi-solid preparations means for external
application to the skin or mucous
membrane.

Semisolid preparation are ointment,

creams, paste and jellies.

Ointment apply on skin and the mucous

membrane of the eye vagina,anus, and nose.
An ointment may or may not be medicated.

Vehicle of an ointment is known as the

ointment base.The ointment base are
hydrocarbon base absorption base, water
soluble base.
 Packaging materials Of Ointment
Ointments are generally packed in
ointment jars or collapsible tubes.
Ointment jars :
 Ointment jars are made up of
colorless or amber colored
glass, plastic (PP,LDPE} and
stainless steel.
 Different shapes, types and
capacities of ointment jars
are used.
 Aluminium or plastic cap or
closure is used.
Packaging materials Of Ointment
Collapsible Tubes :

 Collapsible tubes made up of

tin or aluminium.

 They are more hygienic.

 Collapsible tubes should be

labelled to the top.
Ointment, Cream, Suppository, Paste
Packaging Science Of
Aerosol
 Aerosol
 Aerosol may be defined as a
colloidal dispersed system consisting
of very fine subdivided liquid or solid
particle surrounded by gas.

 Aerosol is two or three phase

system.

 The solid particle size less than 50

micron
 AerosOl
Major part of
aerosol
A. Can or container
B. Valve
C. Actuator or button
a. Container
On the basis of materials three
types of container are metal ,glass
and plastic container.
B. Valve : It consist of mounting cap
valve body, stem, gasket, spring, dip
tube. Fig : Aerosol construction
 Aerosol
Actuators :
The actuator allows for easy opening and closing of the valve and
is an integral part of almost every aerosol package. It also serves
to aid in producing the required type of product discharge.

Actuator Can Valve

 Aerosol manufacturing
Two stages involve :
A. Manufacture of the
concentrate.
The aerosol concentrate is
first prepared and filled into
the container.

B. Filling of the propellant.

The propellant is then filled

into the container.
 Aerosol Filling
Three methods have been
developed for filling :
 Cold filling

 Pressure filling

 Compressed gas filling

 Aerosol Filling
1.Tinplate or aluminium
is start to fill.

2.Active ingredient is
added in container
without propellant.
 Aerosol Filling
3(A).The Aerosol valve is now fitted to
the can.

3(B) .small' actuator is fitted on to the

valve before it is crimped onto the can.

4(A).The propellant is now injected

under pressure, through the valve.

4(B).The propellant may be in the

form of a liquefied gas, or a
compressed gas.
 Aerosol Filling
A large or special actuator is
fitted.

A dust cap is also fitted.

 Finally the can will be

date / batch coded, and
shrink wrapped or boxed.
Packaging Science Of Topical
Delivery System
 Topical Delivery System
Topical delivery system are self
contained discrete dosage forms
that are designed to deliver drug
via intake skin or body surface.

Three types dosage forms of

topical delivery system are
transdermal, ocular and
intrauterine.

A transdermal drug delivery

device, is an active or a passive
design, which provides an
alternative route for
administering medication.
Transdermal Drug Delivery
System

Patch
 Patch
A transdermal patch: It is a medicated adhesive patch that is placed on
the skin to deliver a specific dose of medication through the skin and
into the bloodstream.
Fig : patch
 Packaging Materials For Transdermal
Delivery Systems
Laminate materials in packaging a
transdermal drug delivery system
comprising of:

A rubber modified acrylonitrile

methyl acrylate copolymer film.

Combination with a polyester film,

where in the active drug incorporated
in the transdermal system.
 Types Of Transdermal Patches
1.Singlelayer Drug in Adhesive  3.Drug Reservoir in Adhesive

2. Multi-layer Drug in Adhesive  4.Drug Matrix in Adhesive

 Pain Relief Patch Herbal Magnetic
Patch
 
 Magnetic plaster is a patch for any
muscle or joint pain, asthma or
mammary disease. It consists of
carefully selected herb and magnetic
powder. Different herb extract are for
different disease.

It is based on the theory of magneto-

phoresis which magnetic field can
enhance medicine delivery across
skin.

Apply to clean, dry skin on the

affected painful area or recommended
acupoint
Other Drug Delivery System
Impacts Of Packaging
 
 Impacts Of Packaging
Impacts of packaging refers to the
packaging material that relates directly to
the stability and acceptability of dosage
forms.
 
For example, to optimize shelf life industrial
pharmacist must understand inter-relationship
of material properties, are important for both

FDA Regulations For Packaging

The specific FDA regulation for the drug states
that ”container,
closure, and other components of the
packaging must not be reactive, additive or
absorptive to the extent that identity,
strength, quality, or purity of the drug will
be affected”
 Impacts Of Packaging
Design : Understand customers’
exact needs and reduce
consumption.

Efficiency : Minimizes impact

on the environment.

Advance Technology :
New technology and research are
creating more impactful and
effective packaging.
 Impacts Of Packaging
Streamlined Transportation
Program : Efficient
transportation contributes to a
smaller carbon footprint. For
example :Blister packages.

Sustaining Positive Patient

Outcome :
Effective adherence packaging
has a positive impact on health
outcomes
 Factors to be consider
Following are some of the mandatory task
required to formulate an effective strategy :

 Identification of buying sectors

 supply chain of the product.

 Awareness about the latest technology

 standards to enhance the quality and sale-
ability.
 latest innovations available in packaging
industry

With the right design, practices, and

technologies, sustainability and
pharmaceutical packaging can and
should, go together hand-in-hand.
Package Testing And
Compatibility
 Package Testing
 Packaging testing involves the
measurement of a characteristic
involved with packaging.

 This includes packaging

materials, packaging
components, primary packages,
shipping containers etc.

 Testing can be a qualitative or

quantitative procedure
 Package Testing
Purpose of Packaging
Testing :

• Determine the requirements of a

specification for quality

•Provide evidence in product

liability, patents product claims, etc.

•Provide a basis for technical

communication.

•Help solve problems with current

packaging.

•Help identify potential cost savings

in packaging.
 Package Testing
 Materials Testing is done on the basis of
:

 Mechanical Properties :
Compression, Tensile strength.

 Physical Properties : Water

absorption, Moisture vapoure
Transmission rate Flammability
& Thermal conductivity

 Chemical properties : Corrosion

testing, Resistance of product
or chemical environment
 Package Testing
Leak Test : Vacuum chamber
for testing leaks in packaging
component

Moisture vapoure Transmission rate

Tester : Determine moisture
vapour
 Compatibility
Compatibility
• Compatibility Testing is
performed when the final
formulation and packaging
system have been decided.

• Compatibility test is done

within pack and product.

• Assay the effect of the pack on

the product and product on the
pack.
Greening of
Packaging
 
 Greening of
Packaging 
 Greening of packaging means the utilization Symbol of recycling
of a set of principles that recycled or reduces
the use or generation of hazardous substances
in the design, manufacture, and application of
chemical products.

For example asthma inhalers emit

greenhouse gases and many pharmaceutical
syntheses use toxic solvents by reducing the
carbon footprint, companies help the planet
and improve their image.
Greening of Packaging
 Greening of Packaging
Packaging made from recycled
materials:
Converted from waste
Scraps recovered from
manufacturing
 Made from process by products.
Returnable Packaging :
Offer packaging as a service
Design with high return ratios.
Reduce Materials Usage:
Change packaging presentation
Re-designing packaging
 Use nanotechnology
Greening Of Packaging
Use Renewable Materials :

Natural fibers/agricultural by-products


Degradable polymer

Renewable source materials

Packaging – Remove :

Integrate functions of packaging within product.

Consider after-packaging service functions

 
 
 
Life cycle Of Packaging Diagram