Abstract

Abstract

Pharmaceutical compounding provides individualized oral dosage forms for patients who cannot use commercially available medicines; however, formulation-specific stability data are required to establish appropriate beyond-use dates (BUDs). This study evaluated the physical, chemical, and microbiological stability of oral suspensions containing acyclovir 40 mg/mL (200 mg/5 mL), aprepitant 20 mg/mL, glibenclamide (glyburide) 0.2 mg/mL, or mebendazole 10 mg/mL compounded with SyrSpend® SF PH4. The formulations were stored at room temperature (15–30 °C) and under refrigeration (2–8 °C) and evaluated at 0, 7, 14, 30, 60, and 90 days. Chemical stability was assessed in six replicates at each time point using validated high-performance liquid chromatography methods, with an acceptance criterion of 90.0%–110.0% of the nominal concentration. Physical appearance, pH, and microbiological quality were also monitored throughout the study. No changes in color, odor, phase separation, precipitation, or apparent viscosity were observed during the supported stability periods, and pH values did not deviate from their initial values by more than 0.5 pH unit. Acyclovir 40 mg/mL (200 mg/5 mL), aprepitant 20 mg/mL, and mebendazole 10 mg/mL remained physically, chemically, and microbiologically stable for 90 days under both storage conditions. Glibenclamide (glyburide) 0.2 mg/mL supported a BUD of 90 days at room temperature and 60 days under refrigeration. These findings provide scientifically supported BUDs for four compounded oral suspensions. Under the conditions studied, SyrSpend® SF PH4 was a suitable vehicle for preparing these individualized oral formulations when appropriate commercially available dosage forms are unavailable.

Related Keywords

• Schettino Kegele Carolina
• Taylor Sarah
• Polonini Hudson
• Beyond-use Date
• Compounded Oral Suspension
• Stability-indicating HPLC
• Antimicrobial Effectiveness Testing
• SyrSpend® SF PH4

Related Categories

• PEER-REVIEWED
• STABILITIES, COMPATIBILITIES
• DOSAGE FORMS/DRUG CARRIERS