Home' Australian Pharmacist : July 2011 Contents Vol.30–July#07
While other bases including Lipoderm
and anhydrous PLO formulations
have been used in practice,12 most
clinical studies report on methimazole
incorporated into the above PLO
base. The pharmacist, in consultation
with the veterinarian, may decide on
the use of other bases to meet the
requirements of the feline patient
or for other practical reasons. For
example, Lipoderm is considered to
be easier to apply than PLO and it may
be stored between 2–8oC without the
resultant instability that occurs when
PLO is refrigerated.
While the ‘syringe-to-syringe’ method
described in Figure 1 is useful for
adjusting the preparation to volume,
minimising loss of ingredients
(eliminating overage requirements),
and eliminating the need to transfer
the preparation to the final packaging,
the pharmacist may utilise other
methods of preparation depending
on the equipment available and
choice of packaging. It is, however,
very important to use shear mixing
when incorporating the methimazole
into the PLO base since this
results in the formation of the
micelles (bilayers, liposomes) which
incorporate the drug, enhancing
penetration in addition to ensuring
content uniformity.15 Shear mixing
is achievable using a mortar and
pestle or with electronic equipment
which provides significant shear
stress, such as an homogeniser
or an ointment mill.
Packaging, storage and expiry
Packaging the product into light-
resistant (amber) syringes will protect
the API and provide a mechanism for
accurately measuring a dose. Other
packaging types may be preferred by
the veterinarian or pet carer and the
pharmacist should contact their local
supplier for packaging options. Gloves
should also be supplied with the
packaging to prevent exposure to the
carer when applying the preparation.
Pignato et al.
in PLO to be stable for 62 days when
stored at 25°C. They also noted that
the preparation should not be stored
refrigerated since it resulted in phase
separation of the gel. Colour changes
were also noted when the product
was stored under refrigerated and
accelerated (35°C) conditions.12 The
preparation should therefore be stored
in a cool, dry place out of reach of
children and pets and an expiry date of
28 days would be appropriate.16
Compounded products are to be
labelled according to regulatory
requirements17 and should include
the approved pharmacopoeial name
(where applicable) and the name and
strength of any preservatives used. All
active ingredients and their amounts/
proportions should be included if the
preparation is not a pharmacopoeial
formulation. Ancillary labels should
be used to indicate specific storage
conditions, provide an expiry date and
indicate specific usage conditions.
Suitable labels to indicate internal or
external use, such as Label K ‘FOR
EXTERNAL USE ONLY’ should be
included. The label should also include
the species of animal, the name of
the animal’s owner and ‘FOR ANIMAL
FoR eXTeRNal use oNly
Quality control and
The pharmacist is responsible for
ensuring the quality of compounded
products and should verify that
products are prepared according to
documented procedures and meet
product specifications before release
to the patient.
should also be conducted at regular
intervals to identify areas for
improvement and the resulting actions
should be documented.
In the preparation of compounded
products, the pharmacist should be
guided by the professional standards,
the requirements of the veterinary
prescriber, the needs of the animal
concerned and the person caring
for the animal. Essential information
Directions for use
• It is important to counsel the pet
carer on appropriate methods
for preventing exposure to
methimazole, such as the use of
gloves and washing their hands after
applying the preparation to their cat.
It is also important that pet carers
are counselled to advise all those,
especially children, in contact with
their cat to avoid touching or rubbing
their cat’s ears.
• Instructions should be given on
how to open the packaging and
accurately measure a dose.
• The preparation should be applied
to the cat’s inner pinna (Figure 3) by
rubbing the gel gently while wearing
gloves, alternating ears with each
dose. Any crusted material should
be removed from the cat’s ear with
a moistened cotton ball before the
• Instructions should be given
on appropriate storage of the
product and correct disposal of the
packaging. The preparation should
not be refrigerated and should not
be used if there is visible separation
of its components in the dosing
• The pet carer should be counselled
to advise the veterinary prescriber
should they notice any side effects
in their cat including GI upset,
lethargy, excoriation of the face and
neck, bleeding or icterus.6
• The pet carer should also be made
aware of any side effects that they
may experience due to exposure
to methimazole including itching,
rash, nausea, vomiting, gastric
discomfort, headache, fever, mouth
ulcers, sore throat, severe fatigue,
arthralgia or jaundice.
effects and special precautions
would be similar to those for
carbimazole, since carbimazole is
rapidly and completely metabolised
to methimazole in the body.7, 1 8
Figure 3. Diagrammatic
representation of the application
site for methimazole
solutions through compounding
The articles in this series are independently researched and compiled by PSA commissioned authors and peer reviewed.
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