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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

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Stability of Lisinopril Syrup (2 mg/mL) Extemporaneously Compounded from Tablets.

D J Rose¹, A A Webster, B A English

¹Pharmacokinetics Center, McWhorter School of Pharmacy, Samford University, Birmingham, Alabama.

International Journal of Pharmaceutical Compounding

|August 29, 2013

Summary

Extemporaneously compounded lisinopril syrup (2 mg/mL) demonstrated excellent stability over 30 days. This compounded medication maintained over 95% of its original lisinopril concentration at both refrigerated and room temperatures.

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Area of Science:

Pharmaceutical Sciences
Compounding Pharmacy
Drug Stability

Background:

Extemporaneous compounding of oral liquid dosage forms is crucial for patient-specific needs.
Lisinopril, an angiotensin-converting enzyme (ACE) inhibitor, is commonly prescribed but often requires liquid formulations for pediatric or geriatric populations.
Investigating the stability of compounded lisinopril syrup ensures therapeutic efficacy and safety.

Purpose of the Study:

To evaluate the stability of extemporaneously compounded lisinopril syrup (2 mg/mL) prepared from Zestril tablets.
To determine the shelf-life of the compounded lisinopril syrup under different storage conditions.

Main Methods:

Lisinopril syrup (2 mg/mL) was prepared by crushing Zestril tablets, dissolving in water, filtering, and diluting with syrup NF.
Compounded samples were stored in amber bottles at 5°C and 23°C for 30 days.
Lisinopril concentration was quantified using a stability-indicating high-performance liquid chromatography (HPLC) assay.
pH measurements and visual inspections (color, clarity) were also performed.

Main Results:

Lisinopril concentration remained high throughout the 30-day study period.
At 5°C, concentrations ranged from 99.42% ± 0.19% to 95.68% ± 1.5% of the initial concentration.
At 23°C, concentrations ranged from 98.83% ± 0.46% to 96.48% ± 0.62% of the initial concentration.
No significant changes in pH, color, or clarity were observed.

Conclusions:

Extemporaneously compounded lisinopril syrup (2 mg/mL) is stable for at least 30 days when stored at 5°C or 23°C.
The compounded formulation maintains its integrity and therapeutic potential within the study period.
This study supports the use of extemporaneous compounding for lisinopril oral solutions.