Preparation
of 2% Ketoconazole Eyedrops in Batch Size
Chedsada
Noppawinyoowong B.Sc. (pharm)*,
Yosanan Yospaiboon M.D. **
* Pharmaceutical
Manufacturing Unit, Srinagarind Hospital Khon Kaen University, Khon Kaen
** Department of Ophthalmology Faculty of Medicine Khon Kaen University,
Khon Kaen
ABSTRACT
The
result of treatment for keratomycosis is often unsatisfactory. This is due
to lack of effective ophthalmic antifungal preparation commercially available.
Conventionally, 0.3% amphotericin B eyedrops made of lyophilized powder of
amphotericin B lOmg. and sterile water 3 ml. in 10 ml dropper bottle has been
used to treat this condition for serveral years.
Because of its unsatisfied
result, short shelflife and remarkable irritability 2% ketoconazole eyedrops
has been introduced to treat this infection. Initially, we followed the procedure
sugggested by Torres in 1985. After arising requests, we have developed
a new formula and method of preparation, followed by terminal pasteurization
for a batch size manufacture. The formula consists of ketoconazole powder
20 g., hydroxypropylmethylcelluose 12.5 g, boric acid 19.0g, borax 1.9 g,
henzalkonium chloride 0.2 g. and distilled water to make 1000 ml. We found
that this new-formula ketoconazole eyedrops gives a satisfactory result in
clinical use.
Thai J Ophthalmol 1990; July - Dec 4 (2):
129-133
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