NTA Level 4 • Semester 1 • PST04101

Medicines Packaging Materials

Dispensing • Source Session/Topic 9

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Session 9: Medicines Packaging Materials

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Define Packaging Material for Medicines to be Dispensed

• Explain Importance of Packaging Materials for Medicines to be Dispensed

• List Different types of Packaging Material for Medicines to be Dispensed

• Describe Features of Suitable Packaging Materials

• Select and Use Suitable Packaging Material for Medicines to be Dispensed

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board, chalk and whiteboard markers

• Samples of Packaging Materials

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Packaging Material for Medicine to be Dispensed (5

minutes)

• All medicinal products need to be protected and consequently need to be

packaged in containers that conform to prescribed standards particularly

with respect to the exclusion of moisture and light and the prevention of

leaching of extractable substances into the contents and of chemical

interaction with the contents

• Packaging material: Any material, including printed material, employed in

the packaging of a pharmaceutical product, excluding any outer packaging

used for transportation or shipment

o Primary packaging materials are those that are in direct contact

with the product

• Packaging may be defined as the collection of different components (e.g.

bottle, vial, closure, cap, ampoule, blister) which surround the

pharmaceutical product from the time of production until its use

• Prepackaging: Is the process by which the pharmacy professional transfers

a medication manually from a manufacturer's original commercial container

to another type of container in advance (before clients come to medicine

retail out lets)

STEP 3: Importance of packaging materials for medicines (10 minutes)

|Activity: Buzzing (5 minutes) |

| |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

| |

|What are the importances of packaging materials for medicine? |

| |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

| |

|WRITE their response on the flip chart/board |

| |

|CLARIFY and SUMMARIZE by using the content below |

• Importance of medicine packaging material

▪ Containment: This requires the packaging:

▪ not to leak, nor allow diffusion and permeation of the product;

▪ to be strong enough to hold the contents when subjected to normal

handling

▪ Not to be altered by the ingredients of the formulation in its

final dosage form

▪ Protection: The packaging must protect the product against all

adverse external influences that may affect its quality or potency,

such as:

▪ Light

▪ Moisture

▪ Oxygen

▪ Biological contamination

▪ Mechanical damage

▪ The compatibility: Of the packaging with the active pharmaceutical

ingredients is very important in maintaining the integrity of the

product

▪ Stability: it is necessary to know the possible interactions between

the container and the contents

▪ The packaging itself should not interact with it so as to

introduce unacceptable changes

▪ Importance of closures is to prevent moisture to reach moisture-

sensitive medicines and also prevent loss of moisture from creams and

other water-containing medicines such as ointments and pastes

STEP 4: Types of Packaging Material for Medicine to be Dispensed (15

minutes)

|Activity: Brainstorming (5 minutes) |

| |

|Ask students to brainstorm on the following question: |

| |

|What are the types of Packaging materials for medicines? |

| |

|ALLOW few students to respond |

| |

|WRITE their responses on the flip chart/ board |

| |

|CLARIFY and SUMMARISE by using the content below |

The following are different types of packaging materials for medicines;

• Ampoule: A container sealed by fusion and to be opened exclusively by

breaking. The contents are intended for use on one occasion only

• Bag: A container consisting of surfaces, whether or not with a flat

bottom, made of flexible material, closed at the bottom and at the sides

by sealing; the top may be closed by fusion of the material, depending on

the intended use

• Blister: A multi-dose container consisting of two layers, of which one is

shaped to contain the individual doses

o Strips are excluded

• Bottle: A container with a more or less pronounced neck and usually a

flat bottom.

o They can be glass or plastic

• Cartridge: A container, usually cylindrical, suitable for liquid or solid

pharmaceutical dosage forms; generally for use in a specially designed

apparatus (e.g. a prefilled syringe)

• Injection needle: A hollow needle with a locking device intended for the

administration of liquid pharmaceutical dosage forms

• Injection syringe: A cylindrical device with a cannula-like nozzle, with

or without a fixed needle and a movable piston, used for the

administration, usually parenteral, of an accurately measured quantity of

a liquid pharmaceutical form

o The syringe may be prefilled, and can be for single-dose or multi-

dose use

• Pressurized container: A container suitable for compressed, liquefied or

dissolved gas fitted with a device that, after its actuation, produces a

controlled spontaneous release of the contents at atmospheric pressure

and room temperature

• Single-dose container: A container for single doses of solid, semi-solid

or liquid preparations

• Strip: A multi-dose container consisting of two layers, usually provided

with perforations, suitable for containing single doses of solid or semi-

solid preparations. Blisters are excluded

• Tube: A container for multi-dose semi-solid pharmaceutical forms

consisting of collapsible material and its contents are released via a

nozzle by squeezing the package

• Vial: A small container for parenteral medicinal products, with a stopper

and over seal and the contents are removed after piercing the stopper

o Both single-dose and multi-dose types exist

STEP 4: Features of Suitable Packaging Materials (35 minutes)

|Activity: Small Group Discussion (15 minutes) |

| |

|DIVIDE students into small manageable groups |

| |

|ASK students to discuss on the following question |

| |

|What are the desirable features of Packaging materials? |

| |

|ALLOW students to discuss for 15 minutes |

| |

|ALLOW few groups to present and the rest to add points not mentioned |

| |

|CLARIFY and SUMMARIZE by using the contents below |

The following are desirable features for packaging materials:

• The container should protect the contents from physical and mechanical

hazards such as:

o Variation due to transportation

o Compression due to pressure applied during stacking or storage

o Shock due to impact, drops or rapid deceleration

o Puncture due to penetration from sharp objects or during handling

operations

o Abrasion

• The container’s material should not interact with the product and vice

versa.

o Interactions include migration, absorption, adsorption or extraction

whereby ingredients either from the product or container are lost or

gained. There are numerous possibilities of interactions between

(primary) packaging materials and pharmaceutical products, such as:

▪ the release of chemicals from components of the packaging

materials

▪ the release of visible and/or sub visible particles

▪ the absorption or adsorption of pharmaceutical components by the

packaging materials

▪ Chemical reactions between the pharmaceutical product and the

packaging materials

• The degradation of packaging components in contact with the

pharmaceutical products

• Container should protect the contents from atmospheric gases

o Oxygen supports the growth of micro-organisms, as well as being

involved in oxidation processes

o Carbon dioxide may cause pH shifts or a chemical reaction if absorbed

by a liquid formulation

• The container must be capable of withstanding extremes of temperature and

humidity.

o Protect the contents from both water loss and gain

▪ Moisture gain may cause chemical reactions, encourage microbial

growth or cause physical changes, e.g. softening of gelatin

capsules

▪ Moisture loss from a product may cause creams to contract and

develop a rubbery feel, and solutions to concentrate

o Protect the contents from loss of volatile materials

o The loss of excipients such as alcohol and chloroform will concentrate

the product or reduce its preservative content

• Protect the contents from light

o Many drugs are photosensitive and degraded in the presence of light

• Protect the contents from airborne particulate contamination

o contamination can be microbiological (bacteria, moulds or yeasts) or

can be solid matter such as dirt, dust, hair, fibres

• Protect the product from animal contaminations, e.g. rodents and insects

• The container should not shed particles into the contents. E.g. spicules

from glass bottles and metal flakes from metal ointment tubes

• The container should have a ‘pharmaceutically elegant’ appearance.

• Should be easy to label and thus to identify the product correctly.

• The container should be convenient and easy to use

o The container should be cheap and economical

STEP 6: Select and use suitable packaging material for medicines (35

minutes)

|Activity: Small Group Discussion ( 15 minutes) |

| |

|DIVIDE students into small manageable groups |

| |

|ASK students to discuss on the following question |

|Which packaging materials are suitable for packing of the following |

|medicine? |

|Tablets and capsules? |

|Liquids? |

|Ointment and creams? |

| |

|ALLOW students to discuss for 15 minutes |

| |

|ALLOW few groups to present and the rest to add points not mentioned |

| |

|CLARIFY and SUMMARIZE by using the contents below |

• The selection of packaging for medicines depends on:

o Nature of the medicine

o Type of patient

o Dosage form

o Method of administering the medicine

o Required shelf-life

o Use

The following are the types of packaging materials for medicines:

← Glass materials: Traditional packaging material widely used for both

liquid and solid dosage forms

o Advantages:

▪ It can be moulded to a rigid construction in a variety of shapes

and sizes

▪ It is available in clear or amber (light-resistant) forms

▪ It can be sealed hermetically or by removable closures

▪ It is impermeable to moisture and atmospheric gases

▪ It is cheap and readily available

▪ It is easily labelled

o Disadvantages:

▪ It is fragile – easily breaking when dropped or knocked

▪ It is heavy, which means transportation costs are high

▪ It may release alkali to aqueous contents

• Plastic containers: Plastic is a collective term used for a variety of

polymeric materials used for containers and closures

▪ Advantages:

▪ Flexible nature

▪ Less brittle than glass

▪ Lightweight –therefore transportation costs are cheaper than

glass

▪ Can be molded into a multiple of shapes and sizes

▪ Suitable for both container and closure

▪ Readily available

▪ Disadvantages:

▪ Few will withstand heat without softening or distorting

▪ Permeability to water vapour and atmospheric gases

▪ May interact with certain chemicals to cause softening or

distortion

▪ May sorb substances, particularly preservatives, from solution

▪ Leaching out of plasticizers and stabilizers into solutions

▪ Relatively expensive

• Metal Containers: Metals used as pharmaceutical packaging materials

include aluminum, tin and tin-coated lead

▪ Advantages:

▪ Lightness

▪ Robustness

▪ Impermeable to light, moisture and gases

▪ Can be made into rigid, unbreakable containers or into

collapsible tubes or foil

▪ Labels can be printed directly onto their surface

▪ Disadvantages:

▪ Their chemical and electrochemical activity

▪ They may shed metal particles into the pharmaceutical product

▪ Expensive

▪ Not generally available for extemporaneous dispensing

• Unit dose packaging: Unit dose packaging has become increasingly common

▪ Advantages:

▪ Hygienic

▪ Tamper evident

▪ Lightweight

▪ Child resistant

▪ Protects solid dosage forms from moisture and abrasion

▪ Available as calendar packs to aid patient compliance

▪ Wastage is reduced

▪ Accurate volume can be administered

▪ Disadvantages:

▪ Expensive

▪ Patients may experience difficulty in use

▪ Machinery is required which may be suitable for industrial or

hospital use only.

▪ Types of unit dose packaging for oral medicines include strip

packaging, blister packaging, oral liquid containers and dispensers

STEP 7: Key Points (5 minutes)

• The materials used for repackaging include: glass bottles, plastic

bottles, collapsible tubes, paper envelops, plastic envelops. original

containers may contain large amount of medicines, therefore repackaging

of medicines into another container may be necessary in order to dispense

medicines for patients.

• The function of a container for a medical preparation is to maintain; the

quality, safety, and stability of its contents

• Medicines must be suitably contained, protected and labeled from the time

of manufacture until they are used by the patient

• The container must maintain the quality, safety and stability of the

medicine

STEP 8: Evaluation (10 minutes)

• What is packaging, packaging material, repacking?

• What are the features of a suitable packaging material?

• What types of containers are used for medicine packaging?

• What are the factors contribute to the choice of packaging material?

• What are the importances of medicine packaging material?

• What are the advantages and disadvantages of different type of

containers?

References

Cooper, J. W., Gunn, C., & Carter, S. J. (2008). Cooper and Gunn's

dispensing for pharmaceutical students (12th ed.). New Delhi, India:

CBS.

FMHACA of Ethiopia (2012). Manual for Medicine Good Dispensing practices.

(2nd ed.). Ethiopia

Senya ,S. S., Mwasha, C.Y., Muyinga, A. M., Amiri,R. I., Mauga, E.A.K.

(2011) Tanzania Pharmaceutical Handbook ( 2nd ed. ) Dar eS Salaam,

Tanzania: School of Pharmaceutical Sciences

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