Sucrose Octaacetate Chemical Kinetics and Shelf Lives at Various Formulation pHs

Area of Science:

• Pharmaceutical Sciences
• Chemical Kinetics
• Drug Formulation

Background:

• Developing pediatric-friendly dosage forms is crucial globally.
• Sucrose octaacetate (SOA) is a recommended surrogate for bitter active pharmaceutical ingredients.
• Rigorous chemical kinetic and stability studies for SOA are lacking.

Purpose of the Study:

• To conduct chemical kinetic and stability studies on Sucrose octaacetate (SOA).
• To determine optimal formulation conditions for SOA shelf life.
• To provide data for developing stable SOA formulations.

Main Methods:

• Utilized a recently reported SOA stability-indicating method.
• Performed chemical kinetic studies including reaction order and activation energies.
• Generated pH-rate profiles at 4°C and 25°C.

Main Results:

• Estimated SOA shelf lives varied significantly with pH and temperature.
• At 25°C, shelf lives ranged from 25.3 days (pH 4.00) to 114 days (pH 5.20).
• At 4°C, shelf lives extended to 5.26 years (pH 5.20), with an optimum at pH 5.40.

Conclusions:

• SOA can be formulated at pH 4-6 for short-term use (e.g., taste studies) at 25°C.
• For long-term applications (e.g., clinical trials), formulate SOA at pH 5.40 and refrigerate at 4°C.
• The study provides essential data for stable SOA formulation and shelf-life estimation.