Lesson - 38 Packaging Materials Science- I Materials

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.




• 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.




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.




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




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)




• 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.”




“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.)




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




• 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.




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.




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




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.




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




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




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.




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.




• 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.




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

https://www.wikihow.com/Open-a-Child-Proof-Pill-Container

Documents

Lesson - 38 Packaging Materials Science- I Materials