ISSN : 0975-9492


Open Access

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Title : Stability of Captopril in an Extemporaneously Compounded Humco’s Oral Products
Authors : Pradeep Gautam, MS
Keywords : Captopril, Humco Flavor Products, Flavor SweetTM, Flavor Sweet-Sugar FreeTM, Flavor PlusTM, Beyond-use Date (BUD)
Issue Date : Jun 2017
Abstract :
Captopril oral suspensions were prepared by compounding Captopril powder with Humco’s Oral Products’ (Flavor SweetTM : Flavor PlusTM 1:1; and Flavor Sweet-Sugar FreeTM : Flavor PlusTM 1:1), at two concentrations: 0.8 mg/mL and 4 mg/mL. These bracket concentrations of all Captopril formulations 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 36 days for their physical, chemical, and microbiological stability. The chemical specification was set as 90% to 110% of initial concentration of the active. Based on the stability data gathered over 5 testing time points (day 0, 8, 13, 23, and 36) for Captopril oral suspension, both 0.8 mg/mL and 4 mg/mL strengths formulations stored at controlled cold temperature were physically, chemically, and microbiologically stable for at least 23 days. Furthermore, both strengths of the Captopril oral suspensions stored at controlled room temperature were chemically stable until the 8 day time point.
Page(s) : 105-110
ISSN : 0975-9492
Source : Vol. 8, No.06