Packaging of Tablets and Capsules – PST06103 Pharmaceutical Production

NTA Level 6 • Semester 1 • PST06103

Packaging of Tablets and Capsules

Pharmaceutical Production • Source Session/Topic 20
Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability.

Session 20: Packaging of Tablets and Capsules

Total Session Time: 120 minutes

Pre-requisites

• None

Learning Tasks

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

• Define packaging
• List Materials used in Tablet of Packaging
• Explain Types of Packaging Materials for Tablets and Capsules
• Describe Procedures for Packaging of Tablets and Capsules

Resources Needed:

• Flip charts, marker pens, and masking tape
• Black/white board and chalk/whiteboard markers
• LCD projector and computer

SESSION OVERVIEW

|Step |Time |Activity/ |Content |

| | |Method | |

|1 |05 minutes |Presentation |Introduction, Learning Tasks |

|2 |25 minutes |Presentation |Introduction to Packaging |

|3 |25 Minutes |Brainstorming |Characteristics of Packaging |

| | |Presentation |Materials |

|4 |40 Minutes |Presentation |Types of Packaging Materials |

|5 |15 minutes |Brainstorming |Selection of Packaging Materials |

| | |Presentation | |

|6 |05 minutes |Presentation |Key Points |

|7 |05 minutes |Presentation |Evaluation |

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: Introduction to Packaging Materials (25 minutes)

• Packaging is the science, art and technology of enclosing or protecting

a product and providing information about the product for distribution,

storage, sale and use

• Pharmaceutical packaging is defined as the economical means of providing

presentation, protection, identification, information, convenience,

compliance, integrity and stability of the product

• Packaging for pharmaceutical uses may be glass (type I, type II, type III

and type IV), plastic (thermosetting type, thermoplastic type), rubber,

paper/cardboards or metals (aluminium, tin plated steel, stainless steel,

tin and lead)

• Importance of Packaging

o Provision of physical protection to products

o Facilitates use of the product by patient

o Provide dose control

o Identifies the product

o Helps in transmission of information (lebelling)

o Provides integrity of the product

o Provide security to the product

o Packaging promotes the product

▪ Packaging is a bridge between production and marketing

STEP 3: Characteristics of Packaging Materials (25 minutes)

|Activity: Brainstorming (5 minutes) |

| |

|ASK students to brainstorm on the following question: |

| |

|Mention the characteristics of packaging materials? |

| |

|ALLOW few students to respond |

| |

|WRITE their responses on the flip chart/ board |

| |

|CLARIFY and SUMMARISE by using the content below |

• They should protect the product from environmental condition
• Should be nonreactive with the product
• Should not impart taste or odour to the product
• Should be nontoxic
• Should be adoptable to commonly high speed packaging equipment
• Should meet applicable tamper resistance requirements

Requirements of a pharmaceutical packaging are;

o Should allow easy of dispensing

o Should be child resistant but senior friendly

o Should be hemetically sealed

o Modularized machinery

STEP 4: Types of Packaging (40 minutes)

• Packaging materials are grouped into three general classes; primary,

secondary and tertiary packaging materials

• Primary Packaging

o Primary packaging is the material that envelops the product and holds

it

▪ Primary packaging are in direct contact with the product
▪ Provides the smallest unit of distribution or use
▪ Examples of primary packaging include aerosol spray can, blister

pack and bottles

o Blister Packaging

▪ It is a primary packaging materials used for small consumer goods
▪ Blister packs are commonly used for unit dose packaging for

tablets and capsules

▪ The principal components of pharmaceutical blister packages;
• The forming film (blister)

o It is a pocket inside which the product fits

o This pocket or cavity in the forming film is used to receive

the tablet or the capsule

o Forming film accounts for approximately 80-85% of the blister

pack

o Receives the product in deep drawn pockets

o Backing or Lidding material

▪ It is sticked over the back of the blister and makes up 15-20%

of the package

▪ Provides the base or main structural component upon which the

final blister package is built

▪ The lidding material is sealed onto the support material
• After the tablets have been properly fed to the preformed

support materials, the lidding material is sealed onto the

support material

• Temperature for sealing ranges from 140C to 300 C
▪ Materials used for backing/lidding are;
• Paper
• Paper-aluminium combination
• Aluminium foil
▪ The backing or lidding material can be push-through type,

peelable type (used to provide child resistant packing), pee-push,

tear-open and child resistant options

• Formation of a blister pack

o Thermosoftening

▪ Involves heat softening a sheet of thermoplastic resin and then

vacuum drawing the softened sheet of plastic onto a mould

▪ After cooling the sheet is released from the mould

o Filling

▪ The sheet then proceeds to the filling station for filling

o Sealing

▪ Sealing is then accomplished by lidding it with a heat sealable

backing material

o Advantages of blister packaging;

➢ Ensures product integrity

➢ Ensures product protection

➢ Provides tamper evident packaging

➢ Reduces the possibility of accidental misuse

➢ Enhances patient compliance

o Strip Package

▪ A strip package is formed by feeding two webs of a heat sealable

flexible film through a heated crimping rollers

▪ Strip packaging is used for capsules and tablets
▪ Materials used include;
• Foil laminations (for moisture sensitive products)
• Paper
• Polyethylene
• Cellophane (transparent plastic film formed from processed

cellulose)

▪ Steps involved in the formation of a strip package;
▪ The product is fed into the pocket formed between two heat

sealable flexible films

▪ Sealing is accomplished by heat crimping rollers
▪ The strip is then cut into desired number of packets in

length

o Alu-alu Packaging

▪ Alu-alu packaging means aluminium is used both at the upper and

lower side of the pack

▪ Alu-alu packaging is similar to that of blister packing
▪ But differ from blister packaging in that the forming film is

formed from aluminium foil instead of a plastic material

o Bottle Packaging

▪ Bottles are commonly used for liquid pharmaceuticals as well as

for tablets and capsules

▪ Bottle packaging involves packaging of pharmaceuticals in glass

or plastic bottles

▪ Materials used include;

For the bottle

• Polyethylene
• Polypropylene screw-cap
• Polystyrene
▪ For the mouth seal-Aluminium foil
• Secondary Packaging

o Secondary packaging are used around the primary packaging –are used to

group primary packages together

o Examples of secondary packaging include boxes, cartons

o Primary packaging is not in direct contact with the product

o Secondary packaging include;

➢ Labels and leaflets

➢ Wrapping materials

➢ Bags and sacks

➢ Collapsible and rigid cartons and boxes

➢ Moulded pulpboard containers

➢ Paper liners, linings and laminations

➢ Paper

Used as a flexible wrapper for products or as a closure material

for jars

Most are used with a liner applied either as a laminate or as a

coating

• Tertiary Packaging

o They are used for bulk handling, warehouse storage and transport

o Examples of tertiary packaging include barrel, container, edge

protector

STEP 5: Selection of Packaging Materials (15 minutes)

|Activity: Brainstorming (5 minutes) |

| |

|Ask students to brainstorm on the following question: |

| |

|What are the factors to consider when selection a packaging materials |

|for tablets and capsules? |

| |

|ALLOW few students to respond |

| |

|WRITE their responses on the flip chart/ board |

| |

|CLARIFY and SUMMARISE by using the content below |

• Choice of packaging materials depends on;

➢ The degree of protection required

➢ Compatibility with the dosage form

➢ Customer convenience e.g. size, weight of dosage form

➢ Filling method

➢ Sterilization method to be employed

➢ Cost

STEP 9: Key Points (5 minutes)

• Pharmaceutical packaging is defined as the economical means of providing

presentation, protection, identification, information, convenience,

compliance, integrity and stability of the product

• Requirements of a pharmaceutical packaging include easy of dispensing,

child resistant but senior friendly and hemetically sealed

• Packaging materials are grouped into three general classes; primary,

secondary and tertiary packaging materials

• Primary packaging include blister packaging, strip packaging, alu-alu

packaging and bottle packaging

• Secondary packaging does not directly contact the product e.g. boxes

STEP 10: Evaluation (5 minutes)

• What is packaging?
• What is the importance of packaging?
• List the types of packaging for tablets and capsules

References

Aulton M.E & Kevin M.G, (Eds): (2013) Pharmaceutics: The design and

manufacture of medicines, (4th ed.) Churchill Livingstone

Hugo and Russell (2011), Pharmaceutical Microbiology (8th ed.), Willey-

Blackwel publications

Gennaro, R. A, et.al (Eds) (1995) Remington: The Science and Practice of

Pharmacy, Volume I & II, (19th ed.): Mack Publishing Company, Easton,

Pennsylvania 18042

Liebsch, B et al. (1988): Tanzania Pharmaceutical Handbook, Dar es Salaam

University Press.

Lund, W. Editor (1994). The Pharmaceutical Codex, Principles and Practice

of Pharmaceutics (12th ed.): The Pharmaceutical Press, London

Polderman, J., (1990) Introduction to Pharmaceutical Production: Novib, The

Hague

Rawlins E.A, Editor: (1977) Bentley’s Textbook of Pharmaceutics, (8th ed.)

Baillie're Tindall. London Kamm, G. and Kohler, B. Editors: (1995)

Manual for Decentralized Infusion Production, Infusion Unit Project

Tanzania

Schmidt, O. (ed) (2000) Pharmaceutical Quality systems, Interpharm Press,

Colorado.

Shayne C., et al. (2008), Pharmaceutical Manufacturing Handbook: Production

and processes, John Wiley & Sons

Watson, D. G (1999) Pharmaceutical Analysis: A Textbook for Pharmacy

Students and Pharmaceutical Chemists: Churchill Livingstone,

Edinburgh.

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