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CONTINUING PROFESSIONAL DEVELOPMENT
including specific examples, that should
not be crushed/modified, and the
process to ensure desired therapeutic
response is summarised in Figure 3.8
Preparation of a
compounded oral liquid
Active pharmaceutical ingredient
Pharmacists should always consider
a commercially available product
(oral liquid, transdermal patch,
dispersible tablet) or a therapeutic
alternative for patients who are unable
to swallow solid dosage forms. If neither
of these is available, they should
determine whether the medicine
is appropriate to modify, and if so,
a suitable formula with a proven stability
profile should be sought. The authors
have published two reviews on stability
data for 125 extemporaneous oral
liquids prepared from commercially
available dosage forms.9, 10
Excipients and calculations
In addition to chemical stability,
physical stability, microbial stability
and palatability, excipient suitability
(e.g. sugar-free for patients with
diabetes) and interactions with
packaging materials need to be
considered in the preparation of a
suitable extemporaneous oral liquid.9
Dose calculations are also critical
(e.g. taking into account the weight
of tablet excipients when calculating
the weight of the API), and careful
consideration of the strength of the
oral liquid (e.g. 1 mg/mL as opposed to
decimal amounts per mL) will facilitate
clinical care and reduce dosing errors.9
Commercially available vehicles for
preparing oral liquids are a convenient
resource for pharmacists, as they
contain effective preservatives and are
buffered to a slightly acidic pH (pH~4.2)
to reduce the degradation of APIs by
oxidation.7 These vehicles, which are
referred to in APF23,8 include vehicle
for oral solution USP-NF (i.e. Ora-Sweet)
and vehicle for oral suspension USP-NF
(i.e. Ora-Plus), and have been previously
described.11 Ora-Plus is effective as a
suspending agent when diluted up to
50%, and contains an antifoaming agent
to allow for vigorous shaking. Ora-Sweet
contains glycerin and sorbitol to prevent
'cap-lock', a problem associated with
many types of syrups due to sugar
crystallisation. It will retain its flavouring
properties when diluted up to 50% with
water or suspending agents, and is
also available as a sugar-free version
Formula and method
A general formula and method for the
preparation of an oral suspension is
shown in Figure 4.
Packaging, storage and labelling
Plastic amber prescription bottles with
child-resistant caps are recommended.
A suitable measuring device should also
be provided. Contact your local supplier
for packaging options. It is important
that patients and carers are counselled
on correct use and storage of the
product, and appropriate disposal of the
packaging. The mixture should be stored
out of reach of children and pets.
Compounded products are to be
labelled according to regulatory
requirements14 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 the preparation
is not a pharmacopoeial formulation.
Ancillary labels should specify storage
conditions, provide an expiry date
(28 days) and indicate specific usage
conditions. Label J should be used,
together with any other cautionary
advisory labels (CALs) required for
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.8
SOLUTIONS THROUGH COMPOUNDING
Oral suspension 1 mg/mL
API (tablets or capsules)
Vehicle for oral solution USP-NF** and
Vehicle for oral suspension USP-NF (1:1) to final volume (mL)
1. Place the required number of tablets (or the contents of the required number of
capsules) into a mortar and crush to a fine powder.
2. Add a small amount of the vehicle to wet the powder and mix to a uniform paste.
3. Continue adding most of the vehicle using the method of doubling (geometric
dilution) and mix thoroughly to form a smooth mixture.
4. Transfer to a tared, amber prescription bottle with a child-resistant cap.
5. Rinse the mortar with the remaining vehicle and make up to the final volume.
6. Shake well and label.
*Calculate the number of tablets/capsules needed to create a 1 mg/mL suspension.
**For a sugar-free preparation, use vehicle for oral solution sugar-free USP-NF.
Figure 4. Preparation of an oral suspension13
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