Home' Australian Pharmacist : Australian Pharmacist November 2016 Contents Australian Pharmacist November 2016 I ©Pharmaceutical Society of Australia Ltd.
CONTINUING PROFESSIONAL DEVELOPMENT
SOLUTIONS THROUGH COMPOUNDING
Box 2. Formula and method of preparation
Omeprazole (2 mg/mL) oral suspension 100 mL
Sodium carboxymethylcellulose (medium viscosity)
Steviol glycosides 95%
Artificial grape flavour
Artificial marshmallow flavour
Sodium hydroxide 10% (w/v) aqueous solution
to adjust pH
Sodium bicarbonate 9% (w/v) solution
to 100 mL
1. In a glass mortar, triturate omeprazole, sodium carboxymethylcellulose, steviol
glycosides 95% and acesulfame potassium to a fine powder.
2. Add 10 mL glycerol to step 1 to make a smooth paste.
3. Add 70 mL of sodium bicarbonate 9% (w/v) stock solution to a beaker with a
4. Add the step 2 mixture to the beaker with mixing. Rinse the step 2 mortar with
the remaining glycerol. Use a rubber spatula to thoroughly scrape the sides of
the mortar during this process.
5. Add flavours to step 4 with mixing.
6. Bring step 5 to the final volume with sodium bicarbonate 9% (w/v) stock solution
with mixing. Cover the beaker with aluminium foil and continue to mix until a
homogenous mixture is obtained.
7. Check the pH with a pH meter (it should be >8). If necessary, add sodium
hydroxide 10% (w/v) aqueous solution dropwise, with mixing and adjust pH to
8.0–8.5. Recheck the pH after adding each drop.
8. Transfer to a child-resistant, amber prescription bottle and label.
Sodium bicarbonate 9% (w/v) solution
has been added to provide a suspension
with a pH that will maintain the stability
of the API. Sodium hydroxide 10% (w/v)
aqueous solution is used to adjust the
The pH of the final preparation should
be determined using a suitable pH
meter and adjusted if it is <83; contact
your local supplier for options regarding
pH pens. A sodium hydroxide 10%
(w/v) aqueous solution can be used for
this purpose and should be added one
drop at a time. It is important to mix the
suspension very well and check the pH
after the addition of each drop.
Formula and method
A formula and method of preparation
for omeprazole oral suspension is
shown in Box 2, supplied from the PCCA
Packaging, storage and labelling
Since the formula should be protected
15 plastic amber prescription
bottles with child-resistant caps are
recommended. Contact your local
supplier for packaging options. It is
important that patients and carers
are counselled on the correct use,
storage and appropriate disposal of the
packaging. The preparation should be
stored out of reach of children and pets.
Compounded products are to be
labelled according to regulatory
19 and should include
the approved pharmacopoeial name
(where applicable) and the name and
strength of any preservatives used.
All APIs and their amounts/proportions
should be included if a pharmacopoeial
formulation is not used.
Ancillary labels should specify storage
conditions, provide an expiry date and
indicate specific usage conditions.
Cautionary advisory labels (CALs) J, 5,6
and 23 can be used.3
Ask your doctor or pharmacist
before using any other medicine
medicines or health products.
Do not freeze
This product has been
compounded by the pharmacist.
beFore eaCh use
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. Reviews of processes
and procedures should be conducted
regularly in order to identify areas for
improvement, and the resulting actions
should be documented.
In the preparation of compounded
products, the pharmacist is guided
by the professional standards,
prescriber and the needs of the carer
and patient. Patient counselling and
education may be adapted from
consumer medicines information (CMI)
available for commercial products.
The following essential information
should be included.
Patient advice and counselling
Common (>1%) adverse effects
include headache, nausea, vomiting,
diarrhoea, abdominal pain,
constipation, and flatulence. Patients/
carers should advise their doctor
in the case of symptoms such as
black stools or vomit that looks like
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