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Stability of lisinopril in two liquid dosage forms
Milap C Nahata1, Richard S Morosco
1College of Pharmacy, Ohio State University and Children's Hospital, Columbus, 43210-1291, USA.
The Annals of Pharmacotherapy
|January 27, 2004
Summary
Lisinopril liquid suspensions are stable for up to 13 weeks refrigerated or 8 weeks at room temperature. This study assessed the stability of extemporaneously prepared lisinopril oral suspensions.
Area of Science:
- Pharmaceutical Science
- Drug Stability
- Pediatric Formulations
Background:
- Lisinopril is prescribed for pediatric hypertension.
- Commercial liquid formulations of lisinopril are unavailable.
- Limited data exists on the stability of extemporaneously prepared lisinopril liquid dosage forms.
Purpose of the Study:
- To evaluate the stability of lisinopril in two distinct oral suspension formulations.
- To assess stability under refrigeration (4°C) and room temperature (25°C).
- To determine the shelf-life of these extemporaneous preparations in plastic bottles.
Main Methods:
- Two oral suspensions of lisinopril (1 mg/mL) were prepared: methylcellulose 1%:simple syrup NF (1:13) and Ora Plus-Ora Sweet (1:1).
- Samples were stored in plastic prescription bottles at 4°C and 25°C.
- Stability-indicating High-Performance Liquid Chromatography (HPLC) was used to analyze samples collected over 91 days.
Main Results:
- At 4°C, lisinopril concentrations remained above 95% in both formulations throughout 91 days.
- At 25°C, lisinopril concentrations remained above 92% in methylcellulose and 95% in Ora Plus-Ora Sweet formulations for 8 and 91 days, respectively.
- No physical changes were observed in any samples during the study period.
Conclusions:
- Lisinopril can be compounded into methylcellulose or Ora Plus-Ora Sweet oral suspensions.
- These liquid formulations demonstrate adequate stability for at least 13 weeks when refrigerated.
- Stability at room temperature supports storage for up to 8 weeks.