Stability of Atenolol, Clonazepam, Dexamethasone, Diclofenac Sodium, Diltiazem, Enalapril Maleate, Ketoprofen, Lamotrigine, Penicillamine-D, and Thiamine in SyrSpend SF PH4 Oral Suspensions.
The objective of this study was to evaluate the stability of 10 commonly used active pharmaceutical ingredients compounded in oral suspensions using SyrSpend SF PH4 (atenolol 1.0 and 5.0 mg/mL, clonazepam 0.2 mg/mL, dexamethasone 1.0 mg/mL, diclofenac sodium 5.0 mg/mL, diltiazem 12.0 mg/mL, enalapril maleate 1.0 mg/mL, ketoprofen 20.0 mg/mL, lamotrigine 1.0 mg/mL, penicillamine-D 50.0 mg/mL, thiamine 100 mg/m) and stored both at controlled refrigerated (2°C to 8°C) and room temperature (20°C to 25°C). Stability was assessed by means of measuring percent recovery at varying time points throughout a 90-day period. The quantification of the active pharmaceutical ingredients was performed by a stability-indicating, high-performance liquid chromatographic method. The beyond-use date of the products was found to be at least 90 days for all suspensions (except atenolol 1 mg/mL, which was stable up to 60 days), both for controlled refrigerated temperature and room temperature. This confirms that SyrSpend SF PH4 is a stable suspending vehicle for compounding with a broad range of different active pharmaceutical ingredients.
Hudson C
HC
Polonini
Sharlene
S
Loures
Luis Claudio
LC
Lima
Anderson O
AO
Ferreira
Marcos Antônio F
MA
Brandão
D001262:Atenolol / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D002998:Clonazepam / Q000737:chemistry; D003907:Dexamethasone / Q000737:chemistry; D004008:Diclofenac / Q000737:chemistry; D004110:Diltiazem / Q000737:chemistry; D004355:Drug Stability; D004656:Enalapril / Q000737:chemistry; D007660:Ketoprofen / Q000737:chemistry; D000077213:Lamotrigine; D010396:Penicillamine / Q000737:chemistry; D014677:Pharmaceutical Vehicles / Q000737:chemistry*; D013535:Suspensions; D013831:Thiamine / Q000737:chemistry; D014227:Triazines / Q000737:chemistry
D014677:Pharmaceutical Vehicles; D013535:Suspensions; D014227:Triazines; D004008:Diclofenac; D001262:Atenolol; D002998:Clonazepam; D004656:Enalapril; D003907:Dexamethasone; D007660:Ketoprofen; D004110:Diltiazem; D010396:Penicillamine; D000077213:Lamotrigine; D013831:Thiamine