Pharmaceutical Packaging Materials – PST04104 Pharmaceutical Dosage Forms
NTA Level 4 • Semester 1 • PST04104 Pharmaceutical Packaging Materials Pharmaceutical Dosage Forms • Source Session/Topic 10 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 10: Pharmaceutical Packaging Materials Total Session Time: 120 minutes + 1 hour Assignment Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Define a Pharmaceutical Packaging Material • Explain Characteristics and Selection Criteria of Pharmaceutical Packaging Materials • Explain the Role of Pharmaceutical Packaging Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Overhead projector (OHP) • Computer 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 | • Packaging material is any material employed in the packaging of medicinal products, excluding any outer packaging used for transportation or shipment • Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product • Packaging component is any single part of a container closure system • Typical components are Containers , Container liners, Closures, Closure liners, Stopper over seals and Container inner seals • Primary packaging component is the one that is or may be in direct contact with the dosage form • Secondary packaging component is the one that is not and will not be 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: • Suitability o The packaging materials should be suitable to the pharmaceutical product in terms of compatibility, safety and protection • Compatibility 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 • Safety 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) • Protection o The container closure system should protect the product from factors that cause deterioration such as: ▪ Exposure to light ▪ Exposure to reactive gases such as oxygen ▪ Absorption of water vapour ▪ Loss of solvent ▪ Microbial contamination ▪ Exposure to other contamination sources such as dirt and dust • It should be cheap, economical and easy to label 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 | • Protecting the product from the environment and vice versa o Being an effective barrier to light, moisture, oxygen, bacteria, volatiles o Protection from damage • Providing all necessary information for: 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 • Enabling accurate dosing and compliance o For example, spoons, cups or syringes for oral dose measurement and delivery • Ensuring supply-chain integrity of the medicine o E.g. Anti-counterfeiting measures STEP 5: Key Points (5 minutes) • Pharmaceutical packaging material is any material employed in the packaging of medicinal products, excluding any outer packaging used for transportation or shipment • Pharmaceutical packaging materials should be chosen basing on suitability , compatibility, safety and protection • It is important to pack pharmaceutical products in order to protect and identify them STEP 6: Evaluation (5 minutes) • What is a pharmaceutical packaging material? • What are the characteristics of pharmaceutical packaging materials? • Why is it important to pack pharmaceutical products? 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).