Accelerated Stability Assessment of Extemporaneously Compounded Amiloride Nasal Spray

Area of Science:

• Pharmacology and Pharmaceutical Sciences
• Neuroscience

Background:

• Amiloride, an FDA-approved diuretic, is being investigated for anxiety treatment due to its acid-sensing ion channel antagonism.
• Intranasal amiloride offers rapid delivery for potential anxiety disorder therapeutic outcomes.
• Compounded nasal preparations lack the pre-formulation characterization of manufactured drugs, necessitating stability assessment.

Purpose of the Study:

• To evaluate the chemical stability of extemporaneously compounded amiloride nasal spray over 6 and 12 months.
• To assess the physical stability and compatibility of amiloride nasal spray with benzyl alcohol.

Main Methods:

• Accelerated degradation studies using high heat and the Arrhenius equation.
• Stability-indicating high-performance liquid chromatography (HPLC) analysis over 12 months.
• Visual inspection, pH monitoring, and turbidity measurements for physical stability and compatibility.

Main Results:

• Amiloride demonstrated chemical stability in the nasal spray formulation over the 12-month study period.
• Extrapolation using the Arrhenius equation supports long-term chemical stability.
• Physical stability and compatibility with benzyl alcohol were confirmed.

Conclusions:

• Compounded amiloride nasal spray is chemically stable for at least 12 months.
• The findings support the potential use of compounded amiloride nasal spray for anxiety disorders.
• Further research into clinical efficacy is warranted.