DEVELOPMENT AND STABILITY EVALUATION OF ATORVASTATIN EXTEMPORANEOUS ORAL SUSPENSION FOR ELDERLY PATIENTS

SIRIKANYA KAEWPRADIT; YUWAKORN SIRIPITHAYA; CHUTIMA JANTARAT

doi:10.22159/ijap.2025v17i1.52519

Authors

SIRIKANYA KAEWPRADIT Drug and Cosmetics Excellence Center, Walailak University, Thasala, Nakhon Si Thammarat-80160, Thailand. School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat-80160, Thailand https://orcid.org/0000-0002-8078-7864
YUWAKORN SIRIPITHAYA The Center for Scientific and Technological Equipment, Walailak University, Nakhon Si Thammarat-80160, Thailand https://orcid.org/0009-0009-4803-561X
CHUTIMA JANTARAT Drug and Cosmetics Excellence Center, Walailak University, Thasala, Nakhon Si Thammarat-80160, Thailand. School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat-80160, Thailand 3The Center for Scientific and Technological Equipment, Walailak University, Nakhon Si Thammarat-80160, Thailand https://orcid.org/0000-0002-1056-565X

DOI:

https://doi.org/10.22159/ijap.2025v17i1.52519

Keywords:

Atorvastatin, Extemporaneous, Formulation, Suspension, Stability

Abstract

Objective: This study aims to develop an extemporaneous oral suspension formulation of atorvastatin (ATV) and evaluate its stability.

Methods: ATV extemporaneous oral suspension was developed by preparation using different suspension vehicles. The developed formulation was stored at ambient temperature (30 ± 2 °C) and refrigerated temperature (4 ± 2 °C) to evaluate its physical and chemical stability. The formulation was also exposed to 3% hydrogen peroxide (H₂O₂), 1 M hydrochloric acid (HCl), and 1 M sodium hydroxide (NaOH) to evaluate its stability under stress conditions. ATV was analyzed using High-Performance Liquid Chromatography (HPLC), which was validated prior to use.

Results: A vehicle containing 0.6% Sodium Carboxymethyl Cellulose (SCMC) was suitable for the preparation of ATV extemporaneous oral suspension. The HPLC method was found to have linearity covering the range of 10–100 mg/mL with a correlation coefficient (r) greater than 0.99. Accuracy and precision were in the range of 99–110% and below 11 %RSD, respectively. The pH and viscosity of the developed formulation stored under ambient and refrigerated temperatures did not differ over 7 days, while the re-dispersibility time of the formulation stored in refrigerator shifted to higher more slowly than the formulation stored at ambient temperature. The % ATV remaining over 7 days was 92.02–106.67% at 30 ± 2 °C and 99.64–107.58% at 4 ± 2 °C. After being subjected to stress conditions, ATV remained stable under oxidation and alkaline conditions, while it significantly degraded under acidic conditions, remaining 24.27%.

Conclusion: The developed ATV extemporaneous oral suspension using a suspension vehicle containing 0.6% SCMC was chemically stable for at least 7 days at 30 ± 2 °C and 4 ± 2 °C. However, this formulation should be preferably stored at refrigerator temperature for use within 7 days to maintain both chemical and physical stability. The formulation was not stable under acid stress conditions.

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