ISSN : 0975-9492


Open Access

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Title : Stability of Omeprazole Oral Suspensions Compounded in Humco Flavor Sweet Sugar Free Product
Authors : Pradeep Gautam, MS
Keywords : Omeprazole, Humco Flavor Products, Flavor Sweet Sugar FreeTM, Beyond-use Date, Stability of Omeprazole
Issue Date : Jun 2017
Abstract :
Omeprazole oral suspension was prepared by compounding Omeprazole powder with Humco’s Flavor Sweet Sugar FreeTM(FS-SFTM) oral vehicle, with the pH of the solution adjusted to 7.5-8.5 with 8.4% sodium bicarbonate, at two Omeprazole concentrations: 1 mg/mL and 4 mg/mL. These two strengths of Omeprazole suspensions were stored in low-actinic plastic prescription bottles at controlled room temperature (25 °C and 60% RH) and controlled cold temperature (2 – 8 °C). These formulations were evaluated over 90 days for their physical, chemical, and microbiological stability. Based on the stability data gathered over ten time-points for Omeprazole oral suspensions, both 1 mg/mL and 4 mg/mL strengths stored at controlled cold temperature were physically, chemically, and microbiologically stable for at least 90 days. Both strengths of the compounded suspensions stored at controlled room temperature were chemically stable up to 7-day time point
Page(s) : 111-117
ISSN : 0975-9492
Source : Vol. 8, No.06