PST04104 Pharmaceutical Dosage Forms

NTA Level 4 • Semester 1 • PST04104 Pharmaceutical Containers and Closures Pharmaceutical Dosage Forms • Source Session/Topic 11 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 11: Pharmaceutical Containers and Closures Total Session Time: 120 minutes + 2 hours field visit Prerequisites • Session 10:Pharmaceutical packaging materials Learning Tasks By the end of this session students are expected to be able to: • Define a pharmaceutical container and closure • List the ideal requirements of a pharmaceutical container and closure • List types of pharmaceutical containers and closures • Describe materials for making pharmaceutical containers and closures Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • Overhead projector (OHP) • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 | |Presentation |Definition of a Pharmaceutical | | |10 minutes |Brainstorming |Container and Closure | |3 |15 minutes |Presentation |Ideal Requirements of a | | | |Buzzing |Pharmaceutical Container and Closure| |4 | |Presentation |Types of Pharmaceutical Containers | | |70 minutes | |and Closures | |5 | |Presentation |Materials Used for Making | | |10 minutes |Brainstorming |Pharmaceutical Containers and | | | | |Closures | |6 |05 minutes |Presentation |Key Points | | 7 |05 minutes |Presentation |Evaluation | |8 |120 minutes|Presentation |Field Visit | 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 a Pharmaceutical Container and Closure (10 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following questions: | | | |What is a Pharmaceutical container? | |What is a pharmaceutical closure? | | | |ALLOW few students to respond | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE by using the content below | • A container for pharmaceutical use is an article which holds or is intended to contain and protect a drug and is or may be in direct contact with it • A closure is that part of a package which prevent the contents from escaping and allow no substance to enter the container • The container and its closure must not interact physically or chemically with the substance within in any way that would alter its quality • Container closure system is equivalent to a Packaging system • Packaging system is the sum of packaging components that together contain and protect the dosage form • Packaging system include primary packaging components & secondary packaging components, if the latter are intended to provide additional protection to the drug product STEP 3: Ideal Requirements of a Pharmaceutical Container and Closure (15 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What are the ideal requirements of a pharmaceutical container and | |closure? | | | | | |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 | • The container and closure ( which make up the container closure system) should: o Protect the product from factors that cause deterioration like light, microorganisms and moisture o Not shade particles into the contents o Be “pharmaceutically elegant” in appearance o Be convenient and easy to use .This can influence patient compliance o Be easy to label for product identification o Be cheap and economical o Be compatible with the dosage form o Not allow extractables or leachables ▪ Extractables are chemical substances that are obtained by exposing the packaging to a variety of solvents under exaggerated incubation conditions of time and temperature ▪ Leachables differ from extractables in that they are chemical substances that migrate under normal conditions of use from the stopper into a drug product o Be resistant to various types of sterilization i.e. it should not become brittle o Should be sterile. That is should not contain microorganism and endotoxins o Should not allow leakage of the contents o Allow stability at recommended storage temperature o Should not react chemically with inside contents i.e. active ingredient and excipients STEP 4: Types of Pharmaceutical Containers and Closures (70 minutes) • Classification of the containers depend on the materials used to make them and their shapes Classification of containers according to their materials: • There are three main types of containers according to their materials: o Glass containers o Plastic containers o Metal containers Glass containers • They are widely used for liquid and solid products o Advantages of glass: ▪ Can be easily moulded into a rigid structure of any shape and size required ▪ Available in clear or amber (light resistant) forms ▪ It can be hermetically sealed or by removal closures ▪ Impermeable to moisture and atmospheric gases ▪ Cheap and easily available ▪ Easy to label o Disadvantages ▪ It is fragile – easily broken when dropped or knocked ▪ It is heavy – high transport cost & risk charges ▪ It may release alkali to aqueous contents • Types of glass containers o Bottles o Oral and External medicines bottles ▪ Amber medicine bottles for internal use ▪ Fluted (ribbed) bottles for external use o Ear, Nasal and Eye medicine Bottles ▪ Amber Fluted (ribbed) on four sides, hexagonal in shape and fitted with a rubber teat and a glass dropper – label fixed on the plain surface o Tablets and capsules containers ▪ Amber glass fitted with screwed desired closure- good protection of tablets and capsules Plastic Containers • A collective term used to describe various polymeric