Stability and uniformity of extemporaneous preparations of voriconazole in two liquid suspension vehicles at two storage temperatures

Kyvan Q. Nguyen, Michelle Hawkins, Ian T. Taylor, Valerie J. Wiebe, Lisa A Tell

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Objective-To determine the stability and distribution of voriconazole in 2 extemporaneously prepared (compounded) suspensions stored for 30 days at 2 temperatures. Sample Population-Voriconazole suspensions (40 mg/mL) compounded from commercially available 200-mg tablets suspended in 1 of 2 vehicles. One vehicle contained a commercially available suspending agent and a sweetening syrup in a 1:1 mixture (SASS). The other vehicle contained the suspending agent with deionized water in a 3:1 mixture (SADI). Procedures-Voriconazole suspensions (40 mg/mL in 40-mL volumes) were compounded on day 0 and stored at room temperature (approx 21°C) or refrigerated (approx 5°C). To evaluate distribution, room-temperature aliquots of voriconazole were measured immediately after preparation. Refrigerated aliquots were measured after 3 hours of refrigeration. To evaluate stability, aliquots from each suspension were measured at approximately 7-day intervals for up to 30 days. Voriconazole concentration, color, odor, opacity, and pH were measured, and aerobic and anaerobic bacterial cultures were performed at various points. Results-Drug distribution was uniform (coefficient of variation, < 5%) in both suspensions. On day 0, 87.8% to 93.0% of voriconazole was recovered; percentage recovery increased to between 95.1% and 100.8% by day 7. On subsequent days, up to day 30, percentage recovery was stable (> 90%) for all suspensions. The pH of each suspension did not differ significantly throughout the 30-day period. Storage temperature did not affect drug concentrations at any time, nor was bacterial growth obtained. Conclusions and Clinical Relevance-Extemporaneously prepared voriconazole in SASS and SADI resulted in suspensions that remained stable for at least 30 days. Refrigerated versus room-temperature storage of the suspensions had no effect on drug stability.

Original languageEnglish (US)
Pages (from-to)908-914
Number of pages7
JournalAmerican Journal of Veterinary Research
Volume70
Issue number7
DOIs
StatePublished - Jul 2009

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storage temperature
Suspensions
Temperature
liquids
ambient temperature
Excipients
drugs
Drug Stability
Refrigeration
Voriconazole
opacity
syrups
refrigeration
Pharmaceutical Preparations
Tablets
microbial growth
Color
odors
Water
color

ASJC Scopus subject areas

  • veterinary(all)

Cite this

Stability and uniformity of extemporaneous preparations of voriconazole in two liquid suspension vehicles at two storage temperatures. / Nguyen, Kyvan Q.; Hawkins, Michelle; Taylor, Ian T.; Wiebe, Valerie J.; Tell, Lisa A.

In: American Journal of Veterinary Research, Vol. 70, No. 7, 07.2009, p. 908-914.

Research output: Contribution to journalArticle

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title = "Stability and uniformity of extemporaneous preparations of voriconazole in two liquid suspension vehicles at two storage temperatures",
abstract = "Objective-To determine the stability and distribution of voriconazole in 2 extemporaneously prepared (compounded) suspensions stored for 30 days at 2 temperatures. Sample Population-Voriconazole suspensions (40 mg/mL) compounded from commercially available 200-mg tablets suspended in 1 of 2 vehicles. One vehicle contained a commercially available suspending agent and a sweetening syrup in a 1:1 mixture (SASS). The other vehicle contained the suspending agent with deionized water in a 3:1 mixture (SADI). Procedures-Voriconazole suspensions (40 mg/mL in 40-mL volumes) were compounded on day 0 and stored at room temperature (approx 21°C) or refrigerated (approx 5°C). To evaluate distribution, room-temperature aliquots of voriconazole were measured immediately after preparation. Refrigerated aliquots were measured after 3 hours of refrigeration. To evaluate stability, aliquots from each suspension were measured at approximately 7-day intervals for up to 30 days. Voriconazole concentration, color, odor, opacity, and pH were measured, and aerobic and anaerobic bacterial cultures were performed at various points. Results-Drug distribution was uniform (coefficient of variation, < 5{\%}) in both suspensions. On day 0, 87.8{\%} to 93.0{\%} of voriconazole was recovered; percentage recovery increased to between 95.1{\%} and 100.8{\%} by day 7. On subsequent days, up to day 30, percentage recovery was stable (> 90{\%}) for all suspensions. The pH of each suspension did not differ significantly throughout the 30-day period. Storage temperature did not affect drug concentrations at any time, nor was bacterial growth obtained. Conclusions and Clinical Relevance-Extemporaneously prepared voriconazole in SASS and SADI resulted in suspensions that remained stable for at least 30 days. Refrigerated versus room-temperature storage of the suspensions had no effect on drug stability.",
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AB - Objective-To determine the stability and distribution of voriconazole in 2 extemporaneously prepared (compounded) suspensions stored for 30 days at 2 temperatures. Sample Population-Voriconazole suspensions (40 mg/mL) compounded from commercially available 200-mg tablets suspended in 1 of 2 vehicles. One vehicle contained a commercially available suspending agent and a sweetening syrup in a 1:1 mixture (SASS). The other vehicle contained the suspending agent with deionized water in a 3:1 mixture (SADI). Procedures-Voriconazole suspensions (40 mg/mL in 40-mL volumes) were compounded on day 0 and stored at room temperature (approx 21°C) or refrigerated (approx 5°C). To evaluate distribution, room-temperature aliquots of voriconazole were measured immediately after preparation. Refrigerated aliquots were measured after 3 hours of refrigeration. To evaluate stability, aliquots from each suspension were measured at approximately 7-day intervals for up to 30 days. Voriconazole concentration, color, odor, opacity, and pH were measured, and aerobic and anaerobic bacterial cultures were performed at various points. Results-Drug distribution was uniform (coefficient of variation, < 5%) in both suspensions. On day 0, 87.8% to 93.0% of voriconazole was recovered; percentage recovery increased to between 95.1% and 100.8% by day 7. On subsequent days, up to day 30, percentage recovery was stable (> 90%) for all suspensions. The pH of each suspension did not differ significantly throughout the 30-day period. Storage temperature did not affect drug concentrations at any time, nor was bacterial growth obtained. Conclusions and Clinical Relevance-Extemporaneously prepared voriconazole in SASS and SADI resulted in suspensions that remained stable for at least 30 days. Refrigerated versus room-temperature storage of the suspensions had no effect on drug stability.

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