Home' Australian Pharmacist : April 2011 Contents Vol. 30 -- April #04
Continuing Professional Development
appropriate disposal of the packaging.
The formulation should be stored in a
cool, dry place out of reach of children
Compounded products are to be
labelled according to regulatory
requirements14 and labels 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
L CAUTION NOT TO BE TAKEN, should
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
being released to the patient.11 Self-
inspections should also be conducted
NOT TO BE TAKEN
at regular intervals to identify areas for
improvement and the resulting actions
should be documented.11
instructions for patients
In the preparation of compounded
products, the pharmacist should be
guided by the professional standards,14
the prescriber and the needs of
the patient. Patient counselling and
education may be adapted from CMIs
available for commercially available
products. Essential information would
• wash your hands well with soap
and water before opening any
• instructions on how to open the
packaging, accurately measure
a dose, and correct use of the
• instructions on how to store the
product and to dispose of any
applicators or packaging.
Key learning points
• Pharmacists, in consultation with
doctors, may decide on the use
of various gel bases to meet the
specific requirements of the patient.
• Due to the potential for interactions
of multiple ingredients and adverse
effects in patients -- keep it simple
1. Commercially available dosage
forms containing oestrogen for
vaginal administration include:
e) a) and b).
2. The following excipient may be
included into a gel formulation
to adjust the pH to be slightly
a) propylene glycol.
c) methyl hydroxybenzoate.
e) glycerol triacetate.
3. The following property makes
gels preferable for vaginal
c) liquefies at body temperature.
d) rapidly dissolves.
4. Which of the following
statements about gels is/are
a) The pH of carbomer gels is
required to be acidic to ensure the
integrity of the gel.
b) Gels are not susceptible to
microbial contamination and
therefore need not be preserved.
c) Some gels are thermosensitive.
d) Wetting agents are rarely required.
e) c) and d).
A score of 4 out of 5 attracts 1 CPD credit.
5. You are required to weigh
incorporation into a gel base.
You can only weigh out 20 mg
accurately on the balance in
the pharmacy. If you weigh out
of an inert diluent such as
microcrystalline cellulose, how
much of the trituration do you
need to take to contain the
required amount of API?
a) 15 mg.
b) 20 mg.
c) 30 mg.
d) 40 mg.
e) 10 mg.
and limit the number of ingredients
in compounded oestrogen gels.
• Pharmacists should take care and
avoid exposure of themselves, other
staff and patients to these APIs due
to potential for absorption through
the skin and lungs.
1. Australian Medicines Handbook. 10th ed. Adelaide:
Australian Medicines Handbook; 2010.
2. Lynch C. Vaginal estrogen therapy for the treatment of
atrophic vaginitis. J Womens Health. 2009; 18(10):1595--
3. Swarbrick J, Boylan JC. Gels and Jellies. Encyclopedia
of pharmaceutical technology. 3rd ed. New York: Marcel
4. Crinone 8% CMI [online]. [Accessed 04 Nov 2010]. At:
5. Prostin E2 Vaginal Gel CMI [online]. [Accessed 04 Nov
2010]. At: www.betterhealth.vic.gov.au/bhcv2/bhcmed.
6. Zidoval Vaginal Gel [online]. [Accessed 04 Nov 2010].. At:
7. Martindale: The complete drug reference (electronic
resource). London: Pharmaceutical Press; 2010.
8. British Pharmacopoeia. Volume 1 & 2 Monographs:
Medicinal and Pharmaceutical Substances. Estriol.
London: British Pharmacopoeia Commission; 2010.
9. das Neves J, Bahia MF. Gels as vaginal drug delivery
systems. Int J Pharm. 2006; 318(1--2):1--14.
10. Justin-Temu M, Damian F, Kinget R, et al. Intravaginal
gels as drug delivery systems. J Womens Health
(Larchmt). 2004; 13(7):834--44.
11. Australian Pharmaceutical Formulary and Handbook. 21st
ed. Canberra: Pharmaceutical Society of Australia; 2009.
12. Rowe RC, Sheskey PJ, Owen SC. Handbook
of pharmaceutical excipients. 5th ed. London:
Pharmaceutical Press; 2006.
13. US Pharmacopeial Convention Inc. US Pharmacopeia 33
-- National formulary 28. USP Monographs:
14. Professional Practice Standards. Version 4.
Compounding. Pharmaceutical Society of Australia; 2010.
solutions through compounding
The articles in this series are independently researched and compiled by PSA commissioned authors and peer reviewed.
Australian Pharmacist acknowledges the unrestricted support from NxGen Wholesaling.
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