Home' Australian Pharmacist : August 2011 Contents Vol.30–August#08
It is important to remember that
pluronic 20% gel has a temperature-
dependent viscosity, whereby it
thickens when heated, becoming
less viscous on cooling. Patients
may notice that as the preparation is
rubbed into the skin and warms up,
it may become slightly more viscous
and resistant to rubbing.
Packaging and storage
Since nifedipine undergoes
photodegradation when exposed to
light, it is important that the packaging
provides adequate protection from
light. Packaging the product into
light-resistant (amber) syringes
will protect the API and provide a
mechanism for accurately measuring
a dose. A variety of other packaging
options are available including
amber glass ointment jars or plastic
tubes combined with an appropriate
measuring device. Contact your
local supplier for packaging options.
Patients may also have a preference
for a particular packaging type. It is
important that patients are counselled
on the use, accurate measurement of
dose and appropriate disposal of the
packaging. The formulation should be
stored in a cool, dry place 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
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
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.15
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
Directions for use
• 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
• Spread a thin layer onto clean,
• Instructions on how to store the
product and to dispose of any
applicators or packaging.
• Pharmacists should consider the
precautions and adverse effects for
• Patients should also be counselled
to advise their prescriber should
they experience systemic side
effects including facial flushing,
headache, nausea, tachycardia,
dizziness, hypotension and
Patients should be encouraged to
create a favourable environment by:
• keeping hands and feet warm
by wearing warm but not tight
• avoiding tight fitting socks and
• avoiding rapid changes in
temperature, especially when
warming feet after being in the cold
(i.e. warm feet slowly);
• being strongly advised to cease
• regularly exercising to improve
circulation and consuming a
healthy diet, including avoiding
alcohol before going out in the
Key learning points
• Pharmacists, in consultation with
doctors, may decide on the use of
various bases to be used for the
topical application of nifedipine to
meet the specific requirements of
• Pharmacists should take care
in preparing nifedipine topical
products extemporaneously and
avoid exposure to light as nifedipine
degrades readily. In order to prevent
this degradation, work as quickly as
possible and switch off fluorescent
lights in the pharmacy.
• Pharmacists should counsel patients
on the appropriate storage of these
products and on their use, especially
related to potential temperature-
induced changes related to the use
of pluronic 20% gel as a base.
1. Martindale: The complete drug reference (electronic
resource). London: Pharmaceutical Press; 2010.
2. Therapeutic Guidelines: eTG Complete (electronic
resource). North Melbourne: Therapeutic Guidelines; 2010.
3. Dowd PM, Rustin MH, Lanigan S. Nifedipine in the
treatment of chilblains. Br Med J (Clin Res Ed). 1986;
4. Rustin MH, Newton JA, Smith NP, et al. The treatment
of chilblains with nifedipine: the results of a pilot
study, a double-blind placebo-controlled randomized
study and a long-term open trial. Br J Dermatol. 1989;
5. Almahameed A, Pinto DS. Pernio (chilblains). Curr Treat
Options Cardiovasc Med. 2008; 10(2):128–35.
6. Palamaras I, Kyriakis K. Calcium antagonists in
dermatology: a review of the evidence and research-
based studies. Dermatol Online J. 2005; 11(2):8.
7. Rectogesic Ointment CMI [online]. [Accessed 4 Nov
2010]. At: www.mydr.com.au/cmis/PDFs/CMI1028.pdf.
8. Australian Medicines Handbook. 10th edn. Adelaide:
Australian Medicines Handbook; 2010.
9. Meece J. Five compounds for treating diabetes-related
conditions. IJPC. 2003; 7(3):170–4 .
10. Vail J. Compounding for the complications of diabetes:
Interviews with compounding pharmacists George
B. Muller, RPh, and Jerrod Roberts, DPh. IJPC. 2007;
11. Kawabe Y, Nakamura H, Hino E, et al. Photochemical
stabilities of some dihydropyridine calcium-channel
blockers in powdered pharmaceutical tablets. J Pharm
Biomed Anal. 2008; 47(3):618–24.
12. British Pharmacopoeia 2010. Volume 1 & 2
Monographs: Medicinal and Pharmaceutical
Substances. Diethylene Glycol Monoethyl Ether.
London: British Pharmacopoeia Commission; 2010.
13. Rowe RC, Sheskey PJ, Quinn ME. Handbook of
pharmaceutical excipients. 6th edn. London:
Pharmaceutical Press; 2009.
14. Professional Practice Standards. Version 4.
Compounding. Canberra: PSA; 2010.
15. Australian Pharmaceutical Formulary and Handbook.
21st edn. Canberra: PSA; 2009.
solutions through compounding
FoR eXTeRNal use oNly
for compounding pharmacists
SATURDAY 10th – SUNDAY 11th SEPTEMBER 2011
HilT o N S YDNe Y , AUSTRAliA
Brought to you by
1300 738 306
Don’t be fooled by imitations
SPEakERS aT ThE coNfERENcE:
Lisa Ashworth (US)
International Journal of Pharmaceutical Compounding (IJPC)
Vice-Chair, 2010-2015 Pharmacy Compounding Expert Committee of the United States Pharmacopeial Convention, Inc (USP)
Member of the International Academy of Compounding Pharmacists (IACP) Foundation Board, and Literature Peer-Reviewer
Patricia Storey (US) • Angie Svoboda (US) • Dr. Fernando Cortizo (Malaysia) • Melvyn Davis
Dr. Alie Ajam • Maria Dos Santos • Kim Rumble • Dr. Jim Rowe • Jack Hammond • Matthew Bellgrove
The original Australasian Compounding Conference
A doctor’s view on compounding
Setting up a successful
Taking the PAIN out of management
(practical applications of
compounding in treating pain)
Paediatric and geriatric
The compounding market,
TGA, trends, quality control
LAST CHANCE FOR REGISTRATIONS
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.
Links Archive September 2011 July 2011 Navigation Previous Page Next Page