PACKAGING

PRODUCTS
GROUP 4
BAYSA| GUERRERO| REBOLLIDO| BALTAZAR|
LURA| LUTRANIA| MORALES| SAB-IT
PACKAGING
-is the science, art and technology of enclosing or
protecting products for distribution, storage, sale,
and use

-also refers to the process of design, evaluation,

and production of packages.

PHARMACEUTICAL
PACKAGING
Packaging can be defined as the economical means of
providing presentation, protection, identification ,
information, convenience ,compliance , integrity and
stability of the product
FUNCTIONS OF PACKAGING:

a) Product Identification
b) Product Protection - Packaging protects the contents of a
product from spoilage, breakage, leakage, etc.
c) Facilitating the use of product - Packaging should be
convenience to open, handle and use for the consumers.
d) Product Promotion - Packaging is also used for promotional
and attracting the attention of the people while purchasing.

Packaging must meet the following

Requirements:

 Protect the preparation from environmental conditions.

 Non-reactive with the product and so does not alter the identity
of the product
 Does not impart tastes or odors to the product
 Nontoxic
 FDA approved
Presentation & information
 Packaging is essential source of information on
medicinal product.
 Information provided to patient may include:

 Identification no. for dispensing records.

 Name, strength & quantity
 Storage instructions.
 Direction for use.
 Name and address of dispensers
TYPES OF PACKAGING SYSTEMS
1. Primary packaging
- is the material that first envelops the product and hold it. This
usually is the smallest unit of distribution or use
Ex. Aerosol spray can, blister packs, bottle

2. Secondary packaging
- Is outside the primary packaging perhaps used to group primary
package together
Ex. Boxes, cartons

3. Tertiary packaging
- is used to bulk handling and shipping
Ex. Barrel, container, edge protector
 TYPES OF CONTAINERS

Well-closed containers
- protects the contents from loss during transportation, handling storage or
sale.

Single-dose containers
- containers used to supply only one of medicament and hold parental
products (e.g. ampoules and vials)

Multi dose containers

- allow the withdrawal of dose at various intervals without changing the
strength, quality or purity of remaining portion, used for injectables. (e.g.
vials)
Light resistant containers
- protect the medicament from harmful effects of
light. It is used to store the medicaments which are
photo sensitive.

Air-tight containers
- These are also called hermetic containers. These
containers protect the products from dust, moisture
and air. It is used for injectables and are meant for
storage of other products.

Aerosol containers
- are used to hold aerosol products. These
containers have adequate mechanical strength in
order to bear the pressure of aerosol packing.
TYPES OF PACKAGING
MATERIALS USED FOR
PHARMACEUTICAL PACKAGING

PACKAGING MATERIALS &

CLOSURES
• GLASS
• PLASTICS
• METALS
• RUBBER
GLASS
Glass is an inorganic material (mostly silicates) or
mixture of materials which when heated up and then
cooled, solidifies without crystallization.

 are classified into Type I glass(borosilicate glass),

Type II glass(treated sodalime glass), Type III
glass(regular soda-lime glass) and Type
IV(general purpose soda-lime glass) glass based
on their degree of chemical/hydrolytic resistance
to water attack

 It is used to store topical products and oral

dosage forms
Advantages glass containers:

a) Glass containers are mainly used in packaging

liquid preparations due to their rigidity and
their superior protective qualities

b) Its high transparency allows easy inspection of

its contents.

c) It offers better protection because it is relatively

impermeable to air and moisture.

d) It is chemically resistance to
most medicinal products.

e) Colored glass (amber glass and red colored

glass) can protect its content from ultraviolet
rays and certain wavelengths.
f) Glass containers can be easily sterilized using
heat.
Disadvantages glass containers:

a) Glass containers are expensive to

manufacture

b) They are fragile and relatively heavy

c) During heat sterilization, some types of

glass containers have the tendency of
shedding some part of the silica into the
formulation.
PLASTICS

Plastic containers used in pharmaceutical

industries should be such that:

 The ingredients of the formulation in contact

with the plastic package are not significantly
adsorbed on its surface or absorbed
significantly into or through the plastic
container.

 The plastic package does not have any

effect on the stability of the formulation
through the release substances (leaching of
plastic materials) in sufficient quantities into
the formulation.
They are used for many different types of
packs including:

 rigid bottles which serve as packaging

systems for solid dosage forms (tablets
and capsules)
 sterile plastic packaging systems for
human blood and blood components
 plastic packaging systems for aqueous
solutions
 bags for parenteral solutions
 infusion dry powder and metered-dose
inhalers
 squeezable bottles for eye drops, ear
drops and nasal sprays
 jars
 refillable syringes
 flexible tubes
 sachets, blister packs and strip packs
 cartridges, nebulizers, and vials etc.
Advantages of plastic containers:

a) Plastic containers are not breakable.

b) They are light in weight and resistant to leakage.
c) They are cheap to manufacture
d) They can be easily moulded or remoulded
e) They have excellent finishing
f) Plastic containers are chemically inert and resistant to corrosion
g) They are collapsible

Disadvantages of plastic containers:

a) Plastic containers have poor physical stability due to adsorption,

absorption lightness and/or interactions between the formulation
and the container
b) They have low heat resistant and poor ductility.
c) Most plastic containers are usually not as clear as glass, and,
therefore, inspection of the contents is impeded.
METALS
Metals are used for construction of
containers. The metals commonly used for
this purpose are aluminum, tin plated steel,
stainless steel, tin and lead. Aluminum &
stainless steel are the metals of choice for
both primary & secondary pharmaceutical
packaging.

Advantages:
a) They are impermeable to light, moisture
and gases.
b) They are made into rigid unbreakable
containers by impact extrusion.
c) They are light in weight compared to glass
containers.
d) Labels can printed directly on to their
surface
Disadvantages:
a) They are expensive.
b) They react with certain chemicals

3.1 Tinplate

3.2 Aluminium and various alloys

3.3 Aluminium foil, usually as laminations

for blister, strip, and sachet packaging.

3.4 Metallisation, often used as a more

economical substitute to foil but has lower
protective properties.

3.5 Stainless steel, i.e. a chromium (12–

14%) and nickel (up to 0.7%) steel widely
used for mixing vessels and manufacturing
equipment.

3.6 Other metals—tin is occasionally used

for collapsible tubes.
PACKAGE TYPE FORMULATION REMARKS

Strip, blister Tablets, capsules Polymer coated aluminum with various

thickness are available to improve the
sealability of the pack and stability of the
product.

Cans Aerosols, inhalers, sprays etc. Pressure resistant and internal polymer
coated aluminum containers are
available.

Collapsible tubes Ointments, creams, gels & other The tubes with internal protective
semisolids coating of polymers with spike & without
spike are available.
RUBBER

Rubber is used mainly for the construction of

closure meant for vials, transfusion fluid
bottles, dropping bottles and as washers in
many other types of product. Use as stoppers
for glass bottles, medicine bottles, and
pharmaceuticals

4.1BUTYL RUBBER
Advantages:
 Permeability to water vapour .
 Water absorption is very low.
 They are relatively cheaper
compared to other synthetic
rubbers.

Disadvantages:
 Slow decomposition takes place above 130
oC

 Oil and solvent resistance is not very good

4.2 NITRILE RUBBER

Advantages:
 Oil resistant due to polar nitrile group.
 Heat resistant.
Disadvantages:
Absorption of bactericide and leaching of
extractives are considerable.

4.3 CHLOROPRENE RUBBERS :

Advantages:
Oil resistant. heat stability is good.

4.4 SILICON RUBBERS:

Advantages:
 Heat resistance.
 Extremely low absorption and
permeability of water.
Excellent aging characteristic.
Disadvantages:
They are very expensive.
CLOSURE
• Provide a totally humetic seal.
• Provide an effective seal which is acceptable
to the products.
• Provide an effective microbiological seal.

Characteristics Of Closure:

• It should be resistant and compatible with the

product and the product /air space
• If closure is of re closable type, it should be
readily operable and should be re-sealed
effectively.
• It should be capable of high speed application
where necessary for automatic production
without loss of seal efficiency.
• It should be decorative and of a shape that
blends in with the main containers.
Types of closures :
Closures are available in five basic
designs
• Screw-on, threaded, or lug
• Crimp-on (crowns)
• Press-on (snap)
• Roll-on
• Friction.
Many variations of these basic types exist,
including vacuum, tamperproof, safety,
child resistant, and liner less types, and
dispenser applicators.
Special types of closure

Tamper-evident closures. Tampering

includes three aspects, namely altering,
pilfering and falsifying the pharmaceutical
product.

Child-resistant closures. Tragic accidents

involving the drug intoxication of children
has led to new legislation making it difficult
for drug packaging to be opened by young
children, while allowing adults easy access
LABEL
Label means display of printed information which is
securely affixed to the containers and primary
packaging containing the medicines. It should provide
the patient with all necessary info for appropriate use
of medicine.
-General labeling requirements
-Cautionary and advisory levels
-Special instructions for different types of products(
e,g.directions for use- eardrops, aerosols inhalations,
creams)

TYPES OF LABELS
Manufacturer label- contain drug information for the
use of medical practitioners, pharmacists, or nurses
supplied by the manufacturer, packer, or the distributor
of the drug (FDA)
 1. Legal Requirements of
Manufacturer Label
 name of preparation
 Strength and dosage form
 Quantity
 Instructions for the use
 Precautions and warnings
 Registration number
 Batch number
 Manufacturing and expiry date
 Price
 Name and address of
pharmaceutical industry
2, Dispensing Label
includes:

 Drug name and

quantity
 Patient name
 Prescription number
 Phone number
 instructions for use
 Pharmacy name and
address
TYPES OF LABELS USED

Paper Labels:
It is economical method
• The disadvantage of this material is its appearance
of being tacked on.
• Vulnerable to scuffing, wrinkling, blistering and
lifted or curled edges.

Foil Labels:
• Foils are always laminated with paper so that they
work properly in labeling machine. It is done so
because of the dead fold character of the foil.
• Heat sensitive coatings are used.
• The appearance is better than paper label

Sleeve Labels:
• Sleeve labels are used on cylindrical surfaces like
bottles etc.
• It is also pilfer evident when sealed atop the
closure of the bottle
PHARMACEUTICAL PACKAGE
INSERTS AND PAMPHLETS
describes all forms of product information (the insert,
prescribing information, and PDR or Physicians'
Desk Reference listing). As utilized by the
pharmaceutical industry, product information and
prescribing information appear to be global terms of
reference about a product's characteristics, risks,
and recommended uses. The package insert refers
specifically to the product information that is included
with the medication itself.
Sections of a package insert
1. Brand name and generic name of the
product
2. Clinical pharmacology - tells how the
medicine works in the body, how it is
absorbed and eliminated, and what its
effects are likely to be at various
concentrations. May also contain results of
various clinical trials (studies) and/or
explanations of the medication's effect on
various populations (e.g. children, women,
etc.).
3. Indications and usage - uses (indications)
for which the drug has been FDA-approved
(e.g. migraines, seizures, high blood
pressure). Physicians legally can and often
do prescribe medicines for purposes not
listed in this section (so-called "off-label
uses").
4. Contraindications - lists situations
in which the medication
should not be used, for example in
patients with other medical
conditions such as kidney
problems or allergies
5. Warnings - covers possible
serious side effects that may occur
6. Precautions - explains how to use
the medication safely including
physical impairments and drug
interactions; for example "Do not
drink alcohol while taking this
medication" or "Do not take this
medication if you are currently
taking MAOI inhibitors“
7. Adverse reactions - lists all side
effects observed in all studies of
the drug (as opposed to just the
dangerous side effects which are
separately listed in "Warnings"
section)
8. Drug abuse and dependence - provides
information regarding whether prolonged
use of the medication can cause physical
dependence (only included if applicable)

9. Over dosage - gives the results of

an overdose and provides recommended
action in such cases

10. Dosage and administration - gives

recommended dosage(s); may list more
than one for different conditions or
different patients (e.g., lower dosages
for children)
11. How supplied - explains in detail the
physical characteristics of the
medication including color, shape,
markings, etc., and storage information
(e.g., "Store between 68 and 78°F "
PAMPHLETS/LEAFLETS
Patient information leaflets (PILs)
Unless all the information is on the pack,
all medicines must include a PIL,
regardless of how patients get them.

PILs must:
 be easy to understand
 not contain personal information that
can identify an individual, including
names of staff members or digital
signatures

Warnings on labels and leaflets for

medicines:
 Labels must include warnings for safe
use of the medicine. All products that
contain paracetamol must include
statutory warnings.
 Additional warning statements must be
included on the packaging of specified
medicines.