Stability of extemporaneously prepared voriconazole ophthalmic solution

Abstract

Voriconazole 2% (20 mg/mL) solution preserved with 0.01% benzalkonium chloride prepared as alternative antifungal eye drops was stable for 16 weeks when stored at 2-8 degrees C and 25 degrees C and for 8 weeks when stored at 40 degrees C, while voriconazole 1% solution was stable at 2-8 degrees C for up to 14 weeks.

Treatment of dematiaceous fungal keratitis in a dog

“…After reconstitution, the contents were carefully transferred into a sterile ophthalmic dropper bottle for administration. 32 Fungal keratitis is rarely reported in small animal patients, and the finding of a dematiaceous fungal organism in a patient from a nontropical and nonsubtropical region with no history of the patient having traveled outside the region is also uncommon. 29 This alteration maintains the lipophilicity of voriconazole, which allows for high corneal permeability when it is applied topically.…”

An Update on Voriconazole in Ophthalmology

“…Stability of voriconazole eye drops According to the stability study by Al-Badriyeh et al, 1% voriconazole eye drops, prepared in sterile benzalkonium chloride 0.01% solution, were stable for at least 14 weeks when stored at 2-8 0 C, while 2% voriconazole eye drops, also prepared in sterile benzalkonium chloride solution, were stable for 16 weeks at 2-8, 25, and 40 0 C. 13 This was consistent with the stability study by Dupuis et al, where 1% voriconazole eye drops, prepared in sterile water for injection, were stable for at least four weeks when stored at 4 0 C. 14 Such long-term stability data will help minimize wastage and is pivotal to facilitate the use of the eye drops in the outpatient setting.…”

Eye

“…amphotericin B, fluconazole, mitomycin, and voriconazole [123][124][125][126]. A sterile product with the active substance (i.e.…”

“…The first preparation step involves dissolution of the powder in the vial, thus resembling the reconstitution for the designated use. The sterile vehicle used may contain a preservative [123] or may be water for injections [124,125], saline or buffer solution [126]. Sometimes dilution to a larger volume is necessary before finally filling the eye drops into the container.…”

“…Sometimes dilution to a larger volume is necessary before finally filling the eye drops into the container. It depends on the outcome of a risk assessment of each individual case, if filling should include filtration [123][124][125] or not (see Table 10.19). Aseptic handling, outside a Class A environment, may be achieved by preparing in a 'nearly closed system', by filling the sterile dropper bottle by piercing the package wrapped around it, after suitable disinfection of the packaging surface (see Fig.…”