Stability of lisinopril in two liquid dosage forms.
BACKGROUND
Lisinopril is used in pediatric patients with hypertension. It is not commercially available as a liquid. Little is known about the stability of lisinopril in extemporaneously prepared liquid dosage forms.


OBJECTIVE
To determine the stability of lisinopril in 2 oral suspensions stored at 4 and 25 degrees C in plastic prescription bottles.


METHODS
Five bottles contained methylcellulose 1%:simple syrup NF (1:13) and the other 5 bottles had Ora Plus-Ora Sweet (1:1) at a lisinopril concentration of 1 mg/mL. Three samples were collected from each bottle at 0, 7, 14, 28, 42, 56, 70, and 91 days and analyzed by stability-indicating HPLC analytical method (n = 15).


RESULTS
At 4 degrees C, the mean +/- SD concentration of lisinopril remained >95.1 +/- 1.8% of the initial concentration in the methylcellulose formulation and 95.1 +/- 3.2% of the initial concentration in the Ora Plus-Ora Sweet formulation throughout the 91-day study period. At 25 degrees C, the mean concentration of lisinopril remained >92.4 +/- 2.2% of the initial concentration in the methylcellulose formulation for 8 weeks and 95.8 +/- 2.3% of the initial concentration in the Ora Plus-Ora Sweet formulation throughout the 91-day study period. No changes in physical appearance in any samples were seen during this period.


CONCLUSIONS
Lisinopril can be prepared in either of 2 liquid dosage forms and stored for at least 13 weeks under refrigeration and 8 weeks at room temperature.
Nahata
Milap C
MC
College of Pharmacy, Ohio State University and Children's Hospital, Columbus, 43210-1291, USA.
Morosco
Richard S
RS
D000284:Administration, Oral; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002675:Child, Preschool; D004304:Dosage Forms; D004355:Drug Stability; D006801:Humans; D007223:Infant; D017706:Lisinopril / Q000008:administration & dosage* / Q000627:therapeutic use; D013535:Suspensions
D000959:Antihypertensive Agents; D004304:Dosage Forms; D013535:Suspensions; D017706:Lisinopril