Storage and Stability of Drugs (Students)

Storage and Stability of Drugs
by
Tan Mui Ling
Look-alike drug names

{
Ethambutol 1,000 mg was

prescribed for an HIV patient with
tuberculosis.
However, the patient received one
dose of the antiarrhythmic
Ethmozine (moricizine) 1,000 mg
before the error was discovered.
ismp 6 Oct, 1999
Look-alike drug names & strengths

{
Similar names and strengths

contributed to a pharmacist
misreading an order for ZYVOX
(linezolid) 600 mg BID as
ZOVIRAX (acyclovir) 600 mg BID.
Look-alike drugs
{
A pharmacy technician was preparing two

doses of pamidronate 90 mg for IV
infusion.
She reached into the product's storage
bin and picked up two vials, one of
pamidronate 90 mg and another of
etomidate 40 mg (2 mg/mL, 20 mL) that
looked nearly identical. Both products
were distributed by Bedford Laboratories
and packaged in grey and white vials and
cartons.
Look-alike drugs
Infection linked to multi-dose vial

Problem
An outbreak of Staphylococcus aureus
injections has been associated with
multiple-dose vials of lignocaine
used during injections into joints.
{ Recommendation
Use prefilled lignocaine syringes or
single-dose vials.
{
ismp apr-jun 2003
Check your inhaler before use

{
After using his albuterol inhaler, an

asthmatic man began to cough
uncontrollably.
Instead of the medicine making it easier
for him to breathe, he felt like something
was stuck in his breathing passages.
An x-ray at a clinic confirmed that there
was a coin in his windpipe a dime that
had to be removed through a tube
inserted down his throat
The man later told the doctor that he kept
the inhaler in his pocket without the dust
cap on along with money and coins.
Check your inhaler before use

{
{
{
{
This allowed a dime to become lodged in

the opening of the inhaler and be inhaled
along with the medicine.
People who use inhalers should always
keep the dust cap in place between uses.
They should check the mouthpiece before
use.
Even a little dust or lint can cause
problems if pushed into the windpipe or
lungs when using the inhaler.
ismp sep/oct 2005
Prevent accidental vitamin

overdoses
{
{
{
How much time does a 2-year-old child

need to gobble up to 95 vitamin E
capsules?
About 10 minutes, according to a recent
caller to a poison control centre.
Shortly after that, the little boy
complained that his stomach hurt, and he
vomited.
However, that was all that happened and
he was fine later.
Prevent accidental vitamin

overdoses
{
The bottle in this case did not have

a safety cap, and the boy easily
opened it.
Remember that all medications,
including vitamins and herbal
products, should be stored out of
reach of children, EVEN if the
bottles have child-resistant caps
10
Storage Guidelines for proper storage

of medicine
{
{
Keep out of the reach of ___________

Keep medicines in their ____________
containers.
Store away from ______ and direct
______ .
In planning and choosing accommodation
for storing drug formulations, it is
important that a _____, adequately
ventilated, shady and _______ room is
chosen.
11

of medicine
{
Do not store capsules or tablets in

the bathroom, near the kitchen sink,
or in other _________ places.
Heat or ___________ may cause the
medicine to break down.
Drugs are stored so that packed
medications received _____ are also
the _______ to be issued, using firstin first-out rule.
12

of medicine
{
{
{
Store medications for external use separate

from those for _____________ use.
Also do not leave the cotton plug in a
medicine container that has been _______,
since it may draw moisture into the
container.
Keep liquid medicines from __________ .
Do not store medicines in the _________
unless directed to do so.
13

of medicine
{
Do not leave your medicines in an

automobile for _______ periods of time.
Do not keep outdated medicine or
medicine that is no longer _________ .
Dont keep tubes of ointments or creams
next to your tube of ________. They feel
a lot alike when you grab quickly, but a
mistake could be serious.
14
Importance of proper storage

{
Medications last only as long as their

__________ conditions are favourable.
Drugs can lose their potency long before
their expiration date if exposed to
_______ , heat, ________ or humidity.
Most countrys Food and Drug
Administrations require pharmaceutical
manufacturers to provide _______ ____
on all their products.
15

{
{
{
These dates range from 12 to ___ months

from the date they are manufactured.
Expiration dates are basically _________.
Medications may __________ before the
expiration date if improperly ________
or they may last well beyond their
expiration date, as some studies have
shown.
16

{
Some drugs, like paediatric liquid

antibiotics, insulin and certain
injections will expire more ______
than medications in other form,
such as tablets.
For reconstituted injections, follow
the discard dates according to
package insert. They range from
discard ____________ to 30 days.
17
General advice on safe medication use

{
Store medications where children cant

see or reach them, for example, in a
_______ box or cabinet.
Turn on the _________ to take your
medications.
Keep medications for people separate
from pets medications or household
chemicals. Mix-ups are common and can
be ______________.
18
Stability of medications
{
No pharmaceutical product is
________ indefinitely and certainly
the majority of products are stable
only for a _________ time.
19
Results of pharmaceutical product

instability
{
Loss of ________ drug (e.g.

aspirin) through hydrolyis.
Loss of __________ e.g.
evaporation of alcohol from
alcoholic mixtures, evaporation of
________ from aqueous mixtures.
Loss of _________ uniformity e.g.
impaction of suspensions.
20
Results of pharmaceutical product

instability
{
Reduction in __________ e.g.

ageing of tablets resulting in a
change in dissolution profile.
Loss of pharmaceutical _________
e.g. fading of coloured solutions and
tablets.
Production of potentially ______
materials e.g. breakdown products
from drug degradation.
21
Degradation of pharmaceutical
products
Classified as being due to:
{ chemical mechanisms
{ physical mechanisms
{ biological mechanisms
22
Chemical Degradation
(a) Solvolysis
{ Involves the _________ of the drug
or excipients through reaction with
the solvents present in the
formulations.
{ As water is the most common
solvent in pharmaceutical products,
the degradation will be ________.
23
(b) Oxidation
{ Oxidation is an extremely common cause
of ______ and _________ degradation.
{ Occurs in both water-soluble and oilsoluble drugs as well as in _____ and
________ oils.
{ A substance is said to be ________if it
gains electronegative atoms or radicals or
loses electropositive atoms or radicals.
24
(c) Photolysis
{ Degradation of drugs or excipient
molecules can be brought about by ____,
either _______light or ___________.
{ Such reactions are termed photolysis and
light-sensitive drugs are known as
___________.
{ Photolytic reactions include the darkening
of morphine and codeine, the _______ of
tartrazine dye.
25
(d) Polymerization
{ Involves the ___________ of two or more
identical molecules to form a much larger
and complex molecule.
{ Degradation of pharmaceutical products
by polymerisation is not very common
and such reactions may occur after the
initial degradation of the drug.
{ An example is production of a strawcoloured solution after the autoclaving of
________ injection.
26
Physical Degradation
(a) Polymorphism
{ Polymorphs are different _______
forms of the same compound.
{ For example, theobroma oil used
in the preparation of suppositories
has ___ polymorphs. The form
has a melting point at ______,
while the form has a melting
point of 30oC.
27
(b) Vaporization
{ Many drugs and excipients may be _____
from pharmaceutical products at ambient
temperatures through vaporisation.
{ These drugs and excipients possess a
sufficiently high vapour pressure that
they are _______ at room temperature.
{ Examples of such drugs are glyceryl
trinitrate (GTN), alcohols, camphor.
{ These drugs may be lost from the product
because of loose-fitting _________ .
28
(c) Water loss
{ Evaporation of water from ________
preparation will cause change of
concentration of the drug with the
possibility of crystallization occurring if
the solubility of the drug in the solvent is
exceeded.
{ ________ loss to the atmosphere can be
prevented by storing the pharmaceutical
product in a well-closed container.
29
(d) Absorption of water
{ Water will be ___________ from the
atmosphere by some drugs and
pharmaceutical products.
{ For example, some drugs are
deliquescent (calcium chloride and
potassium citrate) whereas others are
hygroscopic (glycerol)
{ Effervescent powders and tablets will
deteriorate if __________ in a
_________ atmosphere.
30
Factors Influencing Degradation

(a) Temperature
{ An increase in _____________ generally
increases the ______ of reactions.
{ Thus the degradation of pharmaceutical
products is generally increased with an
__________ in temperature.
{ One method of preventing or reducing
degradation is to store the
pharmaceutical product at _______
temperature e.g. Insulin injection are
normally stored between 2oC and 8oC.
31

(b) Solvent
{ Drugs may be placed in a variety of
_________ in order to produce a
suitable dosage form.
{ However, the different solvents
used may influence the _________
of the drugs.
32

{
The most commonly used solvent is

_______ and unfortunately many
drugs hydrolyse in water.
The hydrolysis rate can be catalysed
by the presence of _________ or
alkalis which supply hydrogen ions
or hydroxyl ions to the solution.
33

(c) Moisture (atmospheric)
{ ________ or _____ can adversely affect
the stability of dry drug formulations,
such as tablets and capsules.
{ For example, gelatin capsules become
soft and swell in the presence of
moisture.
{ The presence of _______ may encourage
the growth of micro-organisms.
34

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Storage and Stability of Drugs (Students)

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Storage and Stability of Drugs

Look-alike drug names

Ethambutol 1,000 mg was