E-DRUG: Global storage conditions for medicines (6)
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Dear Colleagues
It is true that some medicines cannot be formulated into a
product that is sufficiently stable at 30degC for a shelf
life that can cover distribution and supply. However I make
the following points:
- Remote distribution centres may not be able to store
products at 25degC so a 30degC storage condition is
definitely preferred
- Manufacturers sometimes opt for a 'Store below 25degC'
condition in order to gain a longer shelf life for
commercial purposes. In that case a viable shelf life at
30deg may be possible, although shorter.
- In some cases, more protective packaging materials can
produce a viable shelf life at 30degC, but this must be
balanced against a possible increase the cost of the
medicine
Susan Walters
Australia
"susanw" <susanw@netspeed.com.au>
E-DRUG: Global storage conditions for medicines (7)
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I am fully in agreement with Susan. Sri Lankan state sector ( I am not certain about the private sector) is finding it very difficult to store the large quantities of medicines we import below 25degC as we are resource limited. When quality issues arise the manufacturers always try to blame it on the temperature but it is possible that they were substandard when they arrived into the country.
We are trying to store samples from every batch for testing
when a quality failure is detected, in order to prove or disprove the allegation by the manufacturer. In fact we would agree for a shorter shelf life as the medicines are consumed long before it reaches the labelled shelf life.
Prof Rohini Fernandopulle
Clinical Pharmacologist
Sri Lanka
"Rohini Fernandopulle" <rohinifernandopulle@hotmail.com>
E-DRUG: Global storage conditions for medicines (8)
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Dear All,
I'll caution against the use of ambiguous terms to describe storage conditions on the labels of medicines. Terms like 'store in a cool and dry place' or 'store below 25C' imply that this product is good even if stored in the freezer at -20C or -80C! Although lower is better in a majority of medicines we all now chemical properties of some products can be altered at below freezing temperatures and instead render the medicines unstable.
My advice is to state the actual temperature range at which stability was established e.g. between 4C-30C.
Best regards.
Magnus Ajong, PhD
Pharmcokineticist
Montreal, Canada
magnusajong@yahoo.com