Pharmaceutical Packaging Materials
Session 10: Pharmaceutical Packaging Materials
Total Session Time: 120 minutes + 1 hour Assignment
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Packaging Materials
Resources Needed:
SESSION OVERVIEW
|Step |Time |Activity/ |Content |
| | |Method | |
|1 |05 minutes |Presentation |Introduction, Learning Tasks |
|2 |15 minutes |Presentation |Definition of a Pharmaceutical |
| | |Brainstorming |Packaging Material |
|3 |60 minutes |Presentation |Characteristics and Selection |
| | |Small group |Criteria of Pharmaceutical Packaging|
| | |discussion |Materials |
|4 | |Presentation |The Role of Pharmaceutical Packaging|
| |30minutes |Buzzing | |
|5 |05 minutes |Presentation |Key Points |
|6 |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: Definition of Pharmaceutical Packaging Material (15 minutes)
|Activity: Brainstorming (5 minutes) |
| |
|Ask students to brainstorm on the following question: |
| |
|What is a pharmaceutical packaging material? |
| |
|ALLOW few students to respond |
| |
|WRITE their responses on the flip chart/ board |
| |
|CLARIFY and SUMMARISE by using the content below |
medicinal products, excluding any outer packaging used for
transportation or shipment
to whether or not they are intended to be in direct contact with the
product
Closure liners, Stopper over seals and Container inner seals
contact with the dosage form
in direct contact with the dosage form
STEP 3: Characteristics and Selection Criteria of Pharmaceutical Packaging
Materials (60 minutes)
|Activity: Small Group Discussion ( 30 minutes) |
| |
|DIVIDE students into small manageable groups |
| |
|ASK students to discuss on the following question |
|What are the characteristics to consider when selecting the |
|pharmaceutical 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 pharmaceutical packaging materials selected must have the
following characteristics:
o The packaging materials should be suitable to the pharmaceutical
product in terms of compatibility, safety and protection
o The container closure system should be compatible with the product
components
o It should not cause unacceptable changes in the quality due to
adsorption/absorption of the API/excipients, leachable / extractable,
precipitation, pH changes or discoloration of the product or the
packaging
o Packaging materials should not leach harmful or undesirable amounts of
substances
o This is important particularly for those containers which are in
direct contact with the product, for example, unreacted monomers and
process impurities such as antioxidants in plastics
o In some cases, substances may migrate from secondary components (e g.
Ink and adhesives)
o The container closure system should protect the product from factors
that cause deterioration such as:
STEP 4: The Role of Pharmaceutical Packaging (30 minutes)
|Activity: Buzzing (5 minutes) |
| |
|ASK students to pair up and buzz on the following question for 2 |
|minutes |
| |
|What is the role of pharmaceutical packaging? |
| |
|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 |
o Being an effective barrier to light, moisture, oxygen, bacteria,
volatiles
o Protection from damage
o Identification, preparation if required (e.g. reconstitution,
dilution), use of the medicine including precautions
o Storage and shelf-life of in-use product
o Appropriate disposal of any unused medicine and the packaging itself
o For example, spoons, cups or syringes for oral dose measurement and
delivery
STEP 5: Key Points (5 minutes)
packaging of medicinal products, excluding any outer packaging used
for transportation or shipment
suitability , compatibility, safety and protection
and identify them
STEP 6: Evaluation (5 minutes)
References
Aulton, M.E.,Taylor, M.K. (2001). Pharmaceutics: The Science of dosage form
design
(2nd ed.). USA: Churchill Livingstone.
Cooper, J.W., Gunns, C., & Carter, S.J. (2008). Dispensing for
Pharmaceutical Students
(12th end). Delhi, India: CBS Publishers and Distributors.
Rawlins, E.A. (2001).Bentley’s Textbook of Pharmaceutics (8th ed.). London,
UK:
Bailliere Tindall.
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