Stability of indomethacin solubilized system.

Area of Science:

• Pharmaceutical Sciences
• Drug Formulation
• Physical Chemistry

Background:

• Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) with potential stability challenges in liquid formulations.
• Surfactants such as Tween 80 and Brij 99 are often used to solubilize poorly soluble drugs like indomethacin.
• Optimizing formulation stability is crucial for ensuring drug efficacy and shelf-life.

Purpose of the Study:

• To evaluate the physical and chemical stability of indomethacin in various liquid dosage forms.
• To investigate the stabilizing effects of sucrose and alcohol on indomethacin formulations.
• To assess the impact of surfactants (Tween 80, Brij 99) on indomethacin stability.

Main Methods:

• Indomethacin solutions, syrups, and elixirs were prepared using Tween 80 and Brij 99 as solubilizing agents.
• Stability testing involved assessing physical (e.g., appearance, clarity) and chemical (e.g., degradation products) parameters.
• Formulations were analyzed with and without the addition of sucrose and alcohol.

Main Results:

• Indomethacin solutions, syrups, and elixirs solubilized by Tween 80 and Brij 99 exhibited varying degrees of stability.
• The addition of sucrose was found to markedly stabilize the indomethacin solution.
• Alcohol also demonstrated a significant stabilizing effect on the indomethacin formulations.

Conclusions:

• Sucrose and alcohol are effective stabilizers for indomethacin liquid formulations.
• These excipients can significantly improve the physical and chemical stability of indomethacin, extending its shelf-life.
• The findings support the use of sucrose and alcohol in developing stable indomethacin syrups and elixirs.