Stability of itraconazole in an extemporaneously compounded oral liquid. 1995

P A Jacobson, and C E Johnson, and J R Walters
University of Michigan Medical Center (UMMC), College of Pharmacy, University of Michigan (UM), Ann Arbor, USA.

The stability of itraconazole in an extemporaneously compounded oral liquid formulation was studied. A suspension was prepared from the beads contained in commercially available 100-mg itraconazole capsules and sufficient Simple Syrup, NF, to make a final volume of 60 mL. The final concentration of itraconazole in the suspension was 40 mg/mL. Three identical volumes of each suspension were prepared and stored in 2-oz capped, amber glass prescription bottles and refrigerated at 4 degrees C (range, 2-6 degrees C). Immediately after preparation and at 7, 14, 21, 28, and 35 days, samples were visually inspected and assayed in duplicate by high-performance liquid chromatography; the pH of the samples was also determined. On day 35, the mean +/- S.D. percentage of initial itraconazole concentration remaining in the three suspensions was 95.3 +/- 2.2%. The color, odor, and pH of the samples did not change appreciably over the study period. Itraconazole 40 mg/mL in an oral liquid compounded from simple syrup and beads from capsules, stored in amber glass bottles, was stable for 35 days at 4 degrees C.

UI MeSH Term Description Entries
D002626 Chemistry, Pharmaceutical Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use. Medicinal Chemistry,Chemistry, Pharmaceutic,Pharmaceutic Chemistry,Pharmaceutical Chemistry,Chemistry, Medicinal
D002851 Chromatography, High Pressure Liquid Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed. Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D004356 Drug Storage The process of keeping pharmaceutical products in an appropriate location. Drug Storages,Storage, Drug,Storages, Drug
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000935 Antifungal Agents Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. Anti-Fungal Agents,Antifungal Agent,Fungicides, Therapeutic,Antibiotics, Antifungal,Therapeutic Fungicides,Agent, Antifungal,Anti Fungal Agents,Antifungal Antibiotics
D017964 Itraconazole A triazole antifungal agent that inhibits cytochrome P-450-dependent enzymes required for ERGOSTEROL synthesis. Orungal,R-51211,Sporanox,R 51211,R51211

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