Medication Storage

Irene Brinkmann
Pharmacy Practice & Policy
 Learning Objectives
Describe the various types of packaging materials used in
pharmaceuticals
Describe the uses of the different types of packaging materials
Define the conditions under which different types of medicines should
be stored
Describe the labelling requirements for pharmaceutical products in
Namibia
Introduction
•The appropriate handling of pharmaceutical products is
essential to ensure product viability
•Product should be viable from the time of manufacture
and continue to be viable for a period after it has
reached the patient
•To ensure product viability, the following needs to be
considered:
• Packaging
• Storage
• Transport
• Labelling
Packaging
Packaging
•Purpose of packaging materials:
• Quality of the product
• Ensure its safety and stability
• Allow for product identification (e.g. color-coding drugs
with different strengths)
• Protect protection against external factors (physical,
climatic, chemical etc.)
• User friendly
•There are different types of packaging materials:
• Primary
• Secondary
• Tertiary
Types of Packaging Materials
•Primary: has direct contact with the product
• Must not react with the drug product
• Offer protection tailored to the drug
• Support the use of the product by the patient (e.g. contraceptives)
•Secondary: additional packaging
• Improves the appearance of the product
• Contains product information (can be true for primary
packaging)
• Acts as additional support and may provide evidence for
tampering (can be true for primary packaging)
•Tertiary: used for bulk handling and shipping
• Provides additional protection against external factors
Types of Materials for Packaging
Material Type Examples of use
Glass Primary Ampules, vials, bottles
Plastic Primary Ampules, vials, infusion
fluid container, dropper
bottles

Plastic Secondary Wrapper to contain 1°

packs
Board Secondary Box to contain 1° packs
Glass
•Preferred packaging material
•Advantages
• Inert
• Impervious to air & moisture
• Easy inspection of content (exception of amber glass)
• Easy to clean & sterilize
• Can be colored to improve appearance
•Disadvantages
• Fragile
• Heavy
• Expensive
• Not easily transported
Types of Glass
• Type I glass: ultra-resistant borosilicate glass
• High hydrolytic resistance
• Can withstand high temperatures (high melting point)
• Most inert of all the glass
• Expensive
• Uses: parenteral vials & ampoules
•Type II glass: Treated Soda-lime Glass
• Treated with sulfur to remove the alkali (de-alkalizing)
• De-alkalizing improves chemical & hydrolytic resistance
• Used for products sensitive to alkali
•Type III glass: Soda-lime Glass
• Has alkali, therefore less resistant to chemical and hydrolysis
• Not suitable for products sensitive to alkali
Plastic
•Versatile and has a variety of pharmaceutical uses such as;
• Containers: bottles, dispensers, ampoules etc.
• Closures: caps (screw-on, press-on, tamper-evident, child-resistant)
• Accessories: scoops, spoons, syringes, droppers, spacers)
•Advantages
• Flexible and easily molded into different shapes
• Light weight
• More affordable than glass
•Disadvantages
• Less inert than glass
• May be heat sensitive
• Additives may easily leach into the product if not handled properly
• May absorb API/additives if not handled properly
Types of Plastics
•Polyethylene (PE): light, flexible but resistant type of plastic.
• Can be produced in different densities that allow for a variety of
uses
•Polyethylene terephthalate (PET): commonly used for the
production of bottles for liquid medicines
• Resistant to the negative effects that the presence of oxygen could
have on medicines
•High-density polyethylene (HDPE): commonly used for the
packaging of solid oral dosage forms
• Suitable for moisture-sensitive products
• Polypropylene (PP): robust and resistant to heat and chemicals
• Due to flexibility and transparency, it is used for dosing accessories
such as spoons and syringes
Choice of Packaging Materials
•The use of the product & method of administration(e.g.
topical vs. oral vs. IV)
•Degree of protection required (sterile vs. non-sterile)
•Compatibility with the dosage form (solid, semi-solid vs.
liquid)
•Target population for the product (e.g. out-patients vs.
in-patients)
•Drug properties (e.g. drug sensitivity to light)
•How long the product is required to be variable
•Cost
Storage
Storage
•Medicines are required to be viable for a specified period
•Appropriate storage is essential to maintaining viability
• Patient education on appropriate storage is equally
important to ensure patient safety
•Storage conditions vary for each pharmaceutical product
• Stipulated by the manufacturer
• Refrigerated products usually require a temp between
2-8⁰ C
• Cool place refers to temperatures between 8-15⁰C
• Room temperature refers to 20-25⁰C
Examples of different types of products & its
storage
•Glyceryl Trinitrate Tablets: indicated for angina pectoris and
placed under the tongue for immediate relief
• Volatile product that is easily affected by fluctuations in temp
• This product is not repackaged and is kept in its original container
(glass)
• Storage requirements:
• Away from direct sunlight
• Store below 25⁰C (at room temperature)
• Once opened, it should be discarded after 8 weeks

•Insulin (including vials/Pens): indicated for the management of

insulin-dependent diabetes
• Product is sensitive to changes in temp. (particularly low
temperatures)
• Product should be refrigerated, however once in use it can be stored
at room temperature
• Insulin is stable for up to 28 days at room temperature
Examples of different types of products & its
storage
•Emulsions: stored in an air-tight container and protected from light,
high temperatures or freezing
•Suspensions: should be stored in a cool place but NOT in a
refrigerator.
• Very low temperatures may lead to aggregation of the suspended
particles
• Stored in a cool, dry place away from direct light
•Syrups: Stored at temperatures not exceeding 25⁰C
• Not stored in the fridge
•Suppositories (including pessaries/bougies): stored in a cool dry place
• Some suppositories may require refrigeration (e.g. Scheriproct ®)
•Vaccines: storage of vaccines is dependent on the vaccine (most are stored
between 2 and 8⁰C)
• Vaccines have what is known as a vaccine vial monitor (VVM) which is a label containing a heat-
sensitive material that is placed on the vaccine vial to register the cumulative heat exposure
over time
◦ The effects of time and temperature cause the VVM to darken gradually and irreversibly
Transport
Transport
•Transport must be efficient and comply with safety standards
to preserve the quality of the products
•Regulatory bodies may stipulate their own requirements for
the transportation of pharmaceutical products (outside of the
requirements of the manufacturer)
•Temperature Monitoring & Control
• The prescribed temperature for each pharmaceutical product
must be maintained during transportation
• This is even more important for products that require
refrigeration – cold chain supply
• Proof should be provided that temperatures were maintained
throughout the transportation of the products
Labelling
Labelling
• Appropriate labelling of pharmaceutical products is required by law (i.e. refers to labelling by manufacturer)
• The label should include the following
• Proprietary name (brand name)
• Registration Number
• Dosage form
• Non-proprietary name of each API and the quantity thereof
• Where the name of the API should be placed on the packaging (& the font size)
• Approved name and percentage of any bacteriostatic or bactericidal agent that has been added as a preservative
• Quantity of ethyl alcohol contained in medicines used for oral or parenteral administration
• Content of the medicine package expressed in the appropriate unit or volume (including excipients)
• If practicable, the indication
• If practicable, the recommended dosage
• If applicable, the instruction “Shake before use”
• In the case of a medicine intended for injection by a particular route only, the route of administration by means of
suitable words or abbreviations
• The letters “NS” followed by the appropriate schedule of the drug
• Batch number
• Manufacturing date
• Expiry date
• Manufacturer
• Storage instructions
• If applicable, for “external use only”
• The warning “Keep out of reach of children”
• For eye drops or artificial tears, the warning “Do not use for more than 30 days”
• Any specified warning specific to the drug
• The warning “contains Tartrazine”, if applicable
• The warning “contains Paracetamol”, if applicable
• If the medicine contains Aspirin, it should include the warning “should not be administered to children below the age of
16”
References
•A.J. Winfield, J.A. Rees, I. Smith (2009). Pharmaceutical Practice
fourth edition,
•K. Shafaat et el. (2013). An Overview: Storage of Pharmaceutical
Products. Retrieved from:
https://www.researchgate.net/publication/258833887_AN_OVERVIE
W_STORAGE_OF_PHARMACEUTICAL_PRODUCTS
•Medicines & Related Substances Control Act 13 of 2003 –
Regulations. Retrieved from:
https://faolex.fao.org/docs/pdf/nam175073.pdf