lesson - 38 packaging materials science- i materials
TRANSCRIPT
Lesson - 38
Packaging Materials Science- I
Materials
-Dr Ajay Semalty
Department of Pharmaceutical Sciences,
H.N.B Garhwal University (A Central University)
Srinagar Garhwal-246174
Welcome dear learners! This week we are going to learn the packaging
Materials Science and we are here with the very first module of Packaging
material science- I (Materials).
Learning outcomes
After learning this module you will be able to understand
• Role, importance and requirements of Pharmaceutical packaging
• Basic properties of different packaging materials
Lesson Plan
We will be covering this module under the heads
• Purpose and requirements of Pharmaceutical packaging
• Types and properties of materials for packaging
• Containers
• Closures
Module 38 Packaging Materials Science I
2 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Introduction
What is the topmost factor you consider for buying a product (for a consumer
product or anything)? What do you see? The topmost feature…. Yes, It’s the
Package, the very first impression. First impression is the last impression.
And that first impression is given by packing or packaging of the product. It
indicates the quality of the product. And it ensures those three key words:
“STABILITY, SAFETY, EFFICACY”
To ensure these three factors packaging is the utmost important factor.
What is Packaging?
“Packaging is the science, art and technology of enclosing or protecting
products for distribution, storage, sale, and use.”
Pharmaceutical Packaging
Pharmaceutical packaging means the combination of components necessary to
• Contain,
• Preserve,
• Protect
• Deliver a safe, efficacious drug product,
• Such that at any time point before expiration date of the drug product,
a safe & efficacious dosage form is available.
It means during the entire shelf life the package should be able to protect
the integrity and maintain quality of the product. And that is the ultimate
aim of packaging.
Role of Packaging (IPIPC)
I have an acronym for the role of packaging (IPIPC). We always enchant IP, Indian
Pharmacopoeia. So, we can learn like this.
Module 38 Packaging Materials Science I
3 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
• Identification (green strip)
• Protection
• light
• moisture
• air/reactive gases
• microbes
• physical damage
• adulteration
• Information
• Presentation
• Convenience
Identification:
Like you always identify, even the layman identify the painkiller tablets: Oh
this is the green strip. This is identification. The package gives the
identification.
Protection
Protection from what? Packaging provides protection against light, moisture,
air/reactive gases, microbes, physical, damage and adulteration.
Information
It provides Information. When you see a package. You see what is written
there, what is the name of the product, and ancillary information uses, doses,
manufacturing date and so many features are there. Even in the FMCG
consumer goods you will find the information like calories if it is a food
product, and what are the contents like that. The information is provided by
the package.
Module 38 Packaging Materials Science I
4 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Presentation
It provides a way of presentation. Have you imagined a perfume spray in a
plastic bottle like Vaseline bottle, No! It is always in an attractive glass
package. Because the presentation does matter.
Convenience
Convenience is also an important factor. For patient, have you seen a box in
which ten or twenty tablets, for ten tablets always a strip is convenient rather
than a box/ plastic box. So convenience is also a matter. You can carry a strip
you cannot carry them lose. It provides convenience to the patients, to the
pharmacist to the doctor with respect to dispensing and use.
Types of Packaging Systems
Primary package system: Made up of those package components &
subcomponents that come into direct contact with the product, or those that
may have a direct effect on the product shelf life. E.g. ampoules, vials, strip
blister pack etc.
You take the tablet directly from the strip. The tablet is in direct contact with
that strip or the packaging. So, it is a primary packaging.
Secondary or tertiary package system: You might have seen a strip
containing ten tablets and these three strips inside a paper box. Or you might
have seen a syrup bottle in a paper box. It is secondary packaging. And what
is tertiary packaging. These paper boxes are enclosed in carton that is a
tertiary package system.
So, primary, secondary and tertiary are three major packaging system.
Module 38 Packaging Materials Science I
5 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Pharmaceutical Packaging: Requirements
I. Protect the preparation from environmental conditions/ damage or
breakage.
II. Non-reactive with the product and so does not alter the identity of the
product
III. Does not impart tastes or odors to the product
IV. Nontoxic
V. FDA approved
VI. Meet tamper-resistance requirements, wherever applicable.
VII. Adaptable to commonly employed high-speed packaging equipment.
It should be in good tune with the equipment.
Pharmaceutical Packaging: Criteria for the Selection
How you will select a package or packaging material depend on the following
factors.
Stability
Compatibility with the contents
Strength of container and the degree of protection required (very
consumer goods which were coming in glass bottles are now available
in plastic bottles e.g. many hair oil bottles etc.)
Moistureproofness
Resistance to corrosion by Acids or Alkalis
Resistance to grease
Protection against salt
Resistance to microorganisms, insects and rodents
Resistance to differences in temperature. A packaging system must be
able to withstand in the changes in temperature. Because the changes
Module 38 Packaging Materials Science I
6 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
in temperature may change the physical and chemical stability of the
chemical.
Protection against light, fire and pilferage
Odor retention and transmission: Its own odor must be retained.
Aesthetic value: It must have a good aesthetic value. And it is also a
plus point like other consumer goods. We can say that it hold true for
pharmaceutical products.
Cost (very important factor) have you seen salt in protein like
attractive pack? No, because it will just add the cost. Just see the
benefit to risk ratio with respect to cost when you are deciding the
package system.
Machine suitability of packaging and the filling method
Convenience of the packaging for the physician, pharmacist and
finally the patient (size, weight, method of opening/re-closing,
legibility of printing)
Possible Interactions b/w packaging materials and product
• Chemical leaching from components of the packaging materials to the
product. This leaching may alter the chemical composition.
• The release of visible and/or sub visible particles from container to the
product. That may cause instability.
• The absorption or adsorption of pharmaceutical components by the
packaging materials may also lead to some problems. And the
interaction may be triggered.
• Chemical reactions between product & the packaging materials
• The degradation of packaging components in contact with products
may lead to interaction and degradation of the product.
Presentation & information
• Packaging is essential source of information on medicinal product.
• Information provided may include (D&C Act 1940 & rules 1945)
Module 38 Packaging Materials Science I
7 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
• Identification no. for dispensing records.
• Name, strength & quantity
• Storage instructions.
• Direction for use.
• Name and address of dispensers/mfg.
Pharmaceutical Containers
“A container for a pharmapoeial article is intended to contain a drug
substance or drug product with which it is, or may be in direct contact. The
closure is a part of the container.” IP
It should be easy to use, protection and shelf life are the key points with
respect to choosing the container for pharmaceutical dosage forms.
Types of container (IP)
Indian Pharmacopoeia classifies the container in certain types ahich are
defined here. Please learn these definitions verbatim.
“Airtight container. A container that is impermeable to solids, liquids and
gases under ordinary conditions of handling, storage and transport. If the
container is intended to be opened on more than once, it must be so designed
that it remains airtight after re-closure.”
Module 38 Packaging Materials Science I
8 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
“Hermetically Sealed container. A container that is impervious to air or any
other gas under normal conditions of handling, shipment, storage and
distribution, e.g. sealed glass ampoule, gas cylinder etc.”
“Light-resistant container. A container that protects the contents from the
effects of actinic light (UV) by virtue of the specific properties of the material
of which it is made.”
(Alternatively, a clear and colourless or a translucent container may be made
light-resistant by means of an opaque (light-resistant) covering and/or stored
in a dark place; in such cases, the label on the container should bear a
statement that the opaque covering or storage in dark place is needed until the
contents have been used up.)
Module 38 Packaging Materials Science I
9 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Multidose container. A container that holds a quantity of the preparation
suitable for two or more doses.
Sealed container. A container closed by fusion of the material of the
container.
Single-dose container. A container that holds a quantity of the preparation
intended for total or partial use as a single administration.
Tamper-evident container: A container fitted with a device or mechanism
that reveals irreversibly whether the container has been opened.
• Tightly-closed container. A tightly-closed container protects the
contents from contamination by extraneous liquids, solids or vapours,
from loss or deterioration of the article from effervescence,
deliquescence or evaporation under normal conditions of handling,
shipment, storage and distribution. A tightly-closed container must be
capable of being tightly reclosed after use.
• Well-closed container. A well-closed container protects the contents
from extraneous solids and liquids and from loss of the article under
normal conditions of handling, shipment, storage and distribution.
Packaging materials & closures
Module 38 Packaging Materials Science I
10 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
• Glass
• Plastic
• Metals
• Paper and Board
• Rubber
• Cotton
• Adhesives and Inks
• Closures
Glass Containers:
Advantages
• Superior protective qualities
• Economical
• Readily available in a wide variety of sizes & shapes
• Essentially chemically inert, impermeable, strong and rigid
• Has regularity clearance
• Does not deteriorate with age
• Provides an excellent barrier against every element except light with a
proper closure system. Colored glass, especially amber, can give
protection against light
Disadvantages:
• Fragility
• Heavy Weight
Glass Containers: Composition of glass
Glass is mainly made up of Sand – pure silica, Soda-ash – sodium carbonate,
Limestone – calcium carbonate, Cullet – broken glass that is mixed with the
batch & acts as a fusion agent for the entire mixture.
Module 38 Packaging Materials Science I
11 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Fig. Composition of glass
The most common cations found in pharmaceutical glassware are silicone,
aluminum, boron, sodium, potassium, calcium, magnesium, zinc & barium.
The only anion of consequence is oxygen.
Module 38 Packaging Materials Science I
12 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
TYPES OF GLASS
• Type I – Borosilicate Glass
• Type II – Treated Soda-Lime Glass
• Type III – Regular Soda-Lime Glass
• Type NP – General Purpose Soda-Lime Glass
Type I: Borosilicate Glass
• Highly resistant glass
• A substantial part of the alkali & earth cations are replaced by boron
and/or aluminum & zinc.
• It is more chemically inert than the soda-lime glass (which contains either
none or an insignificant amount of these cations).
• It is used to contain strong acids & alkalies as well as all types of solvents.
• The addition of approx 6% boron to form type I glass reduces the leaching
action.
Fig. 3. Composition of borosilicate glass
Module 38 Packaging Materials Science I
13 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Type II: Treated Soda-Lime Glass
When glassware is stored for several months, especially in a damp
atmosphere or with extreme temperature variations, the wetting of the surface
by condensed moisture (condensation) results in salts being dissolved out of
the glass. This is called “blooming” or “weathering” & it gives the appearance
of fine crystals on the glass.
Type II containers are made of commercial soda-lime glass that has been de-
alkalized or treated to remove surface alkali.
The de-alkalizing process is known as “sulfur treatment” and virtually
prevents “weathering” of empty bottles.
Some manufactures expose the glass to an atmosphere containing water vapor
& acidic gases. This results in a reaction between gases & surface alkali,
which makes it resistant to attack by water. The alkali removed from the glass
appears on the surface as a sulfate bloom, which is removed when the
containers are washed before filling. Thus sulfur treatment neutralizes the
alkaline oxides on the surface & thus rendering the glass more chemically
resistant.
Type III – Regular Soda-Lime Glass
• Containers are untreated & made up of commercial soda-lime glass of
average or better-than-average chemical resistance.
Type NP – General Purpose Soda-Lime Glass
• Containers made up of soda-lime glass are supplied for non-parenteral
products, those intended for oral or topical use.
Module 38 Packaging Materials Science I
14 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Table: Package type and type of formulation for suitable glass type
Package type Type of formulation can be packed
Minimum quality of
glass that can be used
Ampoule Aqueous Injectables Of Any pH Type I
Aqueous Injectables Of pH Less Than 7
Type II
Non-Aqueous Injectables Type III
Vial Aqueous Injectables Of Any pH Type I
Aqueous Injectables Of pH Less Than 7
Type II
Non-Aqueous Injectables Type III
Dry Powders For Parenteral Use (Need To Be Reconstituted Before Use)
Type IV
Package type Type of formulation can be packed
Minimum quality
of glass that can
be used
Bottles
and
Jars
Tablets, Capsules, Oral Solids &
Other Solids For Reconstitution
Type IV
Oral Liquids (Solutions, Suspensions,
Emulsions)
Type IV
Nasal & Ear Drops Type IV
Certain Types Of External Semisolids
(Rubefacients, Local Irritants)
Type IV
Blood & Related Products Type I
Dropper Auxiliary Packaging Device With
Certain Kind Of Products
Type IV
Aerosol
container
Aerosol product ( solution,
suspension, emulsion or semisolid
type)
Type I
Module 38 Packaging Materials Science I
15 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Plastic Containers
Advantages:
• Ease of manufacturing
• Available in various types of quality
• Freedom of design to which they lend themselves
• Extremely resistant to breakage
Plastic Interactions / Limitations of Plastic Materials
• Permeation
• Leaching
• Sorption
• Chemical modification
• Alteration on the properties of plastics or product
Table: Choice of plastic container
Property Polyethylene Poly
Propylene
PVC Poly
Styrene
Acrylic
Multi-
Polymer
Nitrile
Polymer Low
Density
High
Density
Cost Low Low Low Mod Low Mod High
Typical
Uses
Cosmetics
Personal
Products
Foods
Detergents
Bleaches
Milk
Foods
Industrial
Cleansing
Powders
Drugs
Cosmetics
Drugs
Cosmetics
Syrups
Juices
Shampoos
Bath Oils
Detergent
Whisky
Wine
Floor
Waxes
Vinegar
Salad Oil
Dry
Drugs
Petroleum
Jellies
Foods
Drugs
Cosmetics
Foods
Drugs
Cosmetics
Chemicals
Aerosols
Carbonated
Beverages
Module 38 Packaging Materials Science I
16 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Metal Containers
• Aluminum & stainless steel are the metals of choice for both primary
& secondary pharmaceutical packaging.
• Form excellent tamper-evident containers.
• Metals are strong, impermeable to gases & shatterproof, so they are
ideal packaging material for pressurized containers.
Table: Choice of Metal container for dosage forms
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.
Collapsible
tubes
Ointments, creams,
gels & other
semisolids
The tubes with internal protective
coating of polymers with spike &
without spike are available.
Cans Aerosols, inhalers,
sprays etc.
Pressure resistant and internal
polymer coated aluminum containers
are available.
Films, Foils & Laminates
• Regenerated cellulose film based on viscose (chemical used for
manufacturing of rayon) & laminating two or more types of films,
cellulose coatings, foil and paper play different roles such as
supportive, barrier, heat seal & decorative.
• In the newer technology “Co-Extrusion”, a number of plastic plies are
extruded in combination to produce cheaper laminations.
Module 38 Packaging Materials Science I
17 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Closures
• Depending upon the type of container, closures may have different
shapes & sizes.
• Special design of stopper may also be required for some
pharmaceutical production processes such as lyophilization.
• Closures, which form a part of the primary packaging system, are very
important & should be therefore carefully selected. They form
essential component of the container & an integral part of the drug
preparation.
Closures: Requirements
• Resistant & compatible with the product & the product/air space.
• If closure is re-closable, it should be readily openable & effectively
resealed.
• Capable of high-speed application for automatic production by high
speed machines without loss of seal efficiency.
• Decorative & of a shape which blends in with the main container.
• Offers such additional functions: aid-pouring, metering,
administration, child resistance, tamper evidence, etc.
• Prevents exchange with the outside atmosphere to a permissible level
• Screw caps – In metal or plastic, preheated or rolled on with or
without a wadding system (i.e. wadless). Wad is a mass of soft
material used to stop hole.
Module 38 Packaging Materials Science I
18 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
• Wadless thermoplastic caps using a crab’s claw seal or a skirted bore
seal are very popular.
• Plug in – A friction push in fit
• Push over – A flanged or raised ring portion is pressed over a bead or
lip.
Functions of Closures
• Hermetic seal: Permits no exchange between the contents & the
outside of the pack, e.g. a fused glass ampoule.
• Effective microbiological seal e.g. rubber cork & metal overseal.
• Effective seal, acceptable to the product.
Module 38 Packaging Materials Science I
19 MOOC: Industrial Pharmacy-I by Dr Ajay Semalty (Course Coordinator), HNB Garhwal
University (A Central University) Srinagar (Garhwal) Uttarakhand, India
Take Away Message
• To ensure safety stability and efficacy packaging plays vital role.
• Packaging materials must be inert, nontoxic/ nonreactive to products
and compatible with packaging machines.
• Learn the verbatim definitions of Containers: air tight, hermetically
sealed, well closed etc.
• Glass, plastic, metals, paper, board, closures are used
• Selection of material: according to properties of product and material
Further Readings
• USP/ IP
• Banker GS, Rhodes CT, Modern Pharmaceutics, CRC Press.
• Aulton ME (ED), Pharmaceutics: The science of Dosage form design,
II edn, Churchill Livingstone, London, 2002.
• Qiu Y, Chang Y and Zhang GZ (Exe. Eds), Developing solid oral
dosage forms: Pharmaceutical theory and practice, Elsevier, 2009.
• Dean. Evans, Hall, Pharmaceutical Packaging technology, Taylor &
Francis, London.
References/ Credits
• USP/ IP
• Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems.
Philadelphia: Lipincott Williams and Wilkins.
• Augsburger LL, Hoag SW (Eds), Pharmaceutical Dosage Forms:
Tablets, Volume 1, III Edn, Informa healthcare, 2008
• https://www.wikihow.com/Open-a-Child-Proof-Pill-Container