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Published Online, 12 January 2004, www.theannals.com, DOI 10.1345/aph.1D415.
 The Annals of Pharmacotherapy: Vol. 38, No. 3, pp. 396-399. DOI 10.1345/aph.1D415
© 2004 Harvey Whitney Books Company.
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PEDIATRICS

Stability of Lisinopril in Two Liquid Dosage Forms

Milap C Nahata, PharmD

Professor of Pharmacy and Division Chair, College of Pharmacy; Professor of Pediatrics and Internal Medicine, College of Medicine and Public Health, Ohio State University and Children's Hospital, Columbus, OH

Richard S Morosco

Research Associate, College of Pharmacy, Ohio State University

Reprints: Milap C Nahata PharmD, College of Pharmacy, Ohio State University, 500 W. 12th Ave., Columbus, OH 43210-1291, fax 614/292-1335

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 °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 °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 °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.

Key Words: lisinopril, pediatrics, stability

Published Online, January 12, 2004. www.theannals.com, DOI 10.1345/aph.1D415




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