Question
Posted on: March 6 2013How to prepare next eye drops: Miconazole 1% oleum Arachidis up to 100g f. Eye drops
A similar formula but for Clotrimazole is in the NRF (15.22). Can the same process be followed? Miconazole (base) is soluble in most organic solvents according to the Martindale. Is Miconazole (base) sufficiently soluble in groundnut oil?
Answer
I don't think so. But in the literature it is stated that eye drops with miconazole in castor oil or nut oil may be sterilized at 150 ° C for 1 hour. In practice so 70 minutes the warming counted. The product remains stable.
I would therefore prepare 11 g of the mixture Arachisolie and miconazole and weigh this 10 g in a sterile zentropvial. The opening of the bottle is sealed with an aluminium foil and placed in a warm air oven at 150 ° C for 70 minutes. After sterilization and cooling, the vial is closed with the drip set, which was carefully stored in the packaging of the sterile vial during the sterilization.
I would therefore prepare 11 g of the mixture Arachisolie and miconazole and weigh this 10 g in a sterile zentropvial. The opening of the bottle is sealed with an aluminium foil and placed in a warm air oven at 150 ° C for 70 minutes. After sterilization and cooling, the vial is closed with the drip set, which was carefully stored in the packaging of the sterile vial during the sterilization.