Pharmaceutical Containers and Closures
Session 11: Pharmaceutical Containers and Closures
Total Session Time: 120 minutes + 2 hours field visit
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
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 |
intended to contain and protect a drug and is or may be in direct contact
with it
escaping and allow no substance to enter the container
with the substance within in any way that would alter its quality
and protect the dosage form
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 |
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
exposing the packaging to a variety of solvents under
exaggerated incubation conditions of time and temperature
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)
them and their shapes
Classification of containers according to their materials:
o Glass containers
o Plastic containers
o Metal containers
Glass containers
o Advantages of glass:
required
o Disadvantages
o Bottles
o Oral and External medicines bottles
o Ear, Nasal and Eye medicine Bottles
with a rubber teat and a glass dropper – label fixed on the plain
surface
o Tablets and capsules containers
tablets and capsules
Plastic Containers
containers
o Basic materials include:
o Advantages:
o Disadvantages
o Bottles:
bottles of similar shape and design as glass bottles
o Containers for tablets and capsules
shown that many of them have poor resistance to moisture and tendency
to fracture on impact
o Containers for semi-solid preparations
Metal containers
o Advantages:
o Disadvantages:
o Collapsible tubes for semi-solid preparations
to prevent attach by acids, alkalis and ethyl alcohol
o Metal containers for tablets and capsules
prevent corrosion
Metal foil -may be used for wrapping individual moulded suppositories
or pessaries
Classification of containers according to shape:
o Wide mouthed bottles are used for containing solid dosage forms like
powder, capsules, tablets
o To absorb the moisture sometimes silica-gel bags are given inside the
bottle
o For low viscosity liquids e.g. gargles, mouth washes, mixtures,
elixirs narrow mouthed bottle is used
o For high viscosity liquids or for suspensions wide-mouthed bottles are
used
paints etc. are supplied in coloured fluted bottles in order to
distinguish them from preparations meant for internal use
o Eye drops, ear drops, nasal drops etc. should be dispensed in amber
colour glass bottles fitted with a dropper
o It is a single piece of squeezable container having an in built
dropper
o Ointments, pastes, gels are packed in plastic or metal tubes
o Ampoules are made of special type of neutral glass having low melting
point so that it can be heat sealed at low temperature
o Used for storing multidose indictable preparations.
o The needle is passed through the rubber closure, the drug is drawn
out.
o The rubber plug automatically seals the hole. Thus contamination of
bacteria is checked.
o These flexible bags or packets are made of PVC, polyethylene or
polypropylene
o Polythene / glass bottle for infusion fluids
o Glass bottles with big rubber stoppers
o Gases are made liquid under high pressure
o Screw-on, threaded or lug
o Crimp-on (Crowns)
o Press-on (snap)
o Roll-on
o Friction
proof, safety, child-resistant and linerless types and dispenser
application
o When the screw-cap is placed on the neck of the container, its threads
engage with the corresponding threads moulded on the neck of the
bottle
o A liner in the cap seals the opening of the container
o Screw-caps are commonly made of metals (tinplate or aluminium) and
plastics (thermoplastics and thermosetting)
o Metal caps are usually coated on the inside with an enamel or lacquer
for resistance against corrosion
o It is similar to screw-cap in principle. It is simply an interrupted
thread on the glass Finnish, instead of continuous thread
o It requires only a quarter turn. It is used for both normal
atmospheric pressure and vacuum-pressure closing
o This type of caps are widely used in food industry
o This style of cap is commonly used as a crimped closure for beverage
bottles and remains unchanged for more than 50 years
o Crown-caps are made of metals
o Roll-on closures are obtained as thread less shell
o This shells are placed on glass bottles having threaded neck
o The shell is placed and then pressed so that a thread is automatically
formed
o Roll-on type of closures are extremely suitable for glass-containers,
since these closures allow for dimensional changes in the glass
container
o It is similar to roll-on closures except that it has a greater skirt
length
o This additional length extends below the threaded portion to form a
bank, which is fastened to the basic cap of a series of narrow metal
“bridges”
o When the pilfer-proof closure is removed, the bridges break, and the
bank remains in place on the neck of the container
o In some packaging applications a reusable cap is not desired
o Vials for ophthalmic products are good example of this type
o The aluminium roll-on closures have to be torn-off the tabs
STEP 5: Materials Used for Making Pharmaceutical Containers and
Closures (10 minutes)
|Activity: Brainstorming (5 minutes) |
| |
|Ask students to brainstorm on the following question: |
| |
|What are the characteristics of materials used to make pharmaceutical |
|containers and closures? |
|ALLOW few students to respond |
| |
|WRITE their responses on the flip chart/ board |
| |
|CLARIFY and SUMMARISE by using the content below |
characteristics of pharmaceuticals packaging materials
as discussed in characteristics of materials for pharmaceuticals
packaging in session 10.
STEP 6: Key Points (5 minutes)
intended to contain and protect a drug and is or may be in direct contact
with it
escaping and allow no substance to enter the container
STEP 7: Evaluation (5 minutes)
closures?
STEP 8: Field Visit (10 minutes)
|Activity: Field Visit (2 hours) |
| |
|PREPARE for field trip |
| |
|ORIENT the students on objectives and guide of the trip |
| |
|[pic]REFER students to Session 10 and 11 contents |
| |
|TAKE students to the site to learn about pharmaceuticals containers |
|and closures and pharmaceutical packaging materials. |
| |
|PREPARE students for feedback session |
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.
Wondifraw, Z. W. (2010). WHO workshop on assessment of interchangeable
multisource
medicines, Addis Ababa.
| |
———————–
PST 04104 Pharmaceutical Dosage Forms
NTA Level 4 Semester 1
December 2016
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