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