Stability of Omeprazole Oral Suspensions Compounded in Humco Flavor Sweet Sugar Free Product



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Stability of Omeprazole Oral Suspensions
Compounded in Humco Flavor Sweet
Sugar Free Product
Pradeep Gautam, MS Address correspondence to Pradeep Gautam, HUMCO Research and Development Laboratory, 201 W. 5
th
St. Suite 1250, Austin, TX 78701. Tel. 512-474-7400, Email pgautam@humco.com

ABSTRACT:
Omeprazole oral suspension was prepared by compounding Omeprazole powder with Humco’s Flavor Sweet Sugar Free
TM
(FS-SF
TM
) 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 today time point.
KEYWORDS:
Omeprazole, Humco Flavor Products, Flavor Sweet Sugar Free
TM
, Beyond-use Date, Stability of Omeprazole


Introduction:
Experimental:
Table 1: high and low concentrations of omeprazole in humco flavor sweet-sftm ingredient (s)
Test method specification testing
Controlled room temperature (25 c, 60% rh)
Stability of omeprazole formulations over 90 days study period
Storage condition
Conclusions:



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