Home' Australian Pharmacist : Australian Pharmacist February 2011 Contents Vol. 30 -- February #02
Continuing Professional Development
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.9 Self-inspections should also be
conducted at regular intervals to identify
areas for improvement and the resulting
actions should be documented.9
Patient counselling for the correct use
of eye drops is essential. APF219 and
AMH6 list useful tips and directions
for use for eye drops. Wearing soft
contact lenses is generally not
recommended while using eye drops.6
Other useful tips include advising the
patient to write the date on the bottle
when it is first opened and discarding
it within the specified time, and also
to not use the preparation if it is
discoloured or has changed in any way
since being purchased.6, 9
Key learning points
• The pharmacist should be aware of
the chemical and physical stability
of the drug substance to be
compounded as eye drops.
• The pharmacist should undertake
the preparation of the compounded
eye drops according to the
Professional Practice Standard:
Compounding sterile preparations.11
• The pharmacist should investigate
all components of commercial
products used in compounding eye
drops to ascertain whether there is
potential for excipients to adversely
affect the chemical, physical or
microbial stability of these products.
1. Al-Badriyeh D, Neoh CF, Stewart K, et al. Clinical utility
of voriconazole eye drops in ophthalmic fungal keratitis.
Clin Ophthalmol. 2010; 4:391--405.
2. Al-Badriyeh D, Leung L, Roydhouse T, et al. Prospective
open-label study of the administration of two-percent
voriconazole eye drops. Antimicrob Agents Chemother.
3. Vemulakonda GA, Hariprasad SM, Mieler WF, et al.
Aqueous and vitreous concentrations following topical
administration of 1% voriconazole in humans. Arch
Ophthalmol. 2008; 126(1):18--22.
4. Lau D, Leung L, Ferdinands M, et al. Penetration of 1%
voriconazole eye drops into human vitreous humour:
a prospective, open-label study. Clin Experiment
Ophthalmol. 2009; 37(2):197--200.
5. Senthilkumari S, Lalitha P, Prajna NV, et al. Single
and multidose ocular kinetics and stability analysis of
extemporaneous formulation of topical voriconazole in
humans. Curr Eye Res. 2010; 35(11):953--60.
6. Australian Medicines Handbook. 10th ed. Adelaide:
7. Lau D, Leung L, Fullinfaw R, et al. Chemical stability of
voriconazole 1% eye drops. J Pharm Pract Res. 2008;
8. Al-Badriyeh D, Li J, Stewart K, et al. Stability of
extemporaneously prepared voriconazole ophthalmic
solution. Am J Health Syst Pharm. 2009; 66(16):1478--83.
9. Australian Pharmaceutical Formulary and Handbook.
21st ed. Canberra: Pharmaceutical Society of Australia;
10. Allen LV, Popovich NG, Ansel HC. Ansel's
pharmaceutical dosage forms and drug delivery
systems. 8th ed. Philadelphia: Lippincott Williams &
11. Professional Practice Standards. Version 4.
Compounding Sterile Preparations. Canberra: PSA;
12. SHPA MWP. SHPA Guidelines for medicines prepared
in Australian hospital pharmacy departments. J Pharm
Pract Res. 2010; 40(2):133--43.
13. Allen LV. Voriconazole 2% Ophthalmic Solution. IJPC.
14. US Pharmacopeial Convention Inc. US Pharmacopeia
33 -- National formulary 28. Ch797 Pharmaceutical
compounding -- Sterile preparations; 2010.
15. Savolainen J, Järvinen K, Matilainen L, et al. Improved
dissolution and bioavailability of phenytoin by
and hydroxypropyl-beta-cyclodextrin (HP-beta-CD)
complexation. Int J Pharm. 1998; 165(1):69--78.
16. Savolainen J, Jarvinen K, Taipale H, et al.
Co-administration of a water-soluble polymer increases
the usefulness of cyclodextrins in solid oral dosage
forms. Pharm Res. 1998; 15(11):1696--701.
17. Savolainen J, Forsberg M, Taipale H, et al. Effects of
aqueous solubility and dissolution characteristics on
oral bioavailability of entacapone. Drug Dev Res. 2000;
18. Loftsson T, Stefansdottir O, Friðriksdóttir H,
et al. Interactions between preservatives and
2-hydroxypropyl-beta-cyclodextrin. Drug Dev Ind Pharm.
19. Van Doorne H. Interactions between cyclodextrins
and ophthalmic drugs. Eur J Pharm Biopharm. 1993;
20. PIC/S Guide for Good Manufacturing Practice for
Medicinal Products [online]. [Accessed 4 Nov 2010]. At:
21. Therapeutic Goods Administration. Australian
Regulatory Guidelines for Prescription Medicines
[online]. [Accessed 4 Nov 2010]. At: www.tga.gov.au/
1. Which of the following
statements about compounded
eye drops is FALSE?
a) Eye drops are compounded to
meet specific patient needs.
b) Eye drops extemporaneously
prepared for short-term use (24
hours) need not be sterile.
c) There is a cost-benefit associated
with the extemporaneous
preparation of voriconazole eye
d) Eye drops have the advantage of
reducing systemic adverse effects.
e) Eye drops may be compounded in
the form of aqueous/oily solutions
2. The disadvantage of using
filtration as a method of
sterilising compounded eye
a) The filter may fail due to being
incorrectly inserted into the
b) This method of sterilisation may be
used for thermosensitive drugs.
c) Sterilisation by filtration is simple
d) Pharmacists may easily use
filtration as a method of
sterilisation in everyday practice.
e) Sterilisation by filtration does not
require specialised expensive
3. Cyclodextrins are included as
excipients in pharmaceutical
formulations such as eye drops
in order to:
A score of 3 out of 4 attracts 0.75 CPD credits.
a) increase the solubility of the API
due to the ability of hydrophilic
drugs to form inclusion complexes
b) form inclusion complexes between
the cyclodextrin and the drug
resulting in improved stability of
c) improve the microbial activity of
4. What is the role of
cyclodextrin sodium in the
injection (VFEND IV)?
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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