Thermal Stability and Kinetic Study of Fluvoxamine Stability in Binary Samples with Lactose

Area of Science:

• Pharmaceutical Sciences
• Physical Chemistry
• Materials Science

Background:

• Drug-excipient interactions can significantly impact pharmaceutical product stability and performance.
• Fluvoxamine (FLM) is a selective serotonin reuptake inhibitor, and lactose is a common pharmaceutical excipient.
• Understanding solid-state incompatibilities is crucial for formulation development.

Purpose of the Study:

• To investigate the solid-state incompatibility between fluvoxamine (FLM) and lactose.
• To characterize the kinetics of the drug-excipient interaction using thermal analysis.
• To determine the activation energy of the observed incompatibility.

Main Methods:

• Differential Scanning Calorimetry (DSC) for thermal analysis.
• Fourier-Transform Infrared (FTIR) spectroscopy for chemical interaction analysis.
• Mass Spectrometry (MS) for further characterization.
• Application of kinetic models (Friedman, Flynn-Wall-Ozawa, Kissinger-Akahira-Sunose) to non-isothermally stressed mixtures.

Main Results:

• The incompatibility between FLM and lactose, a reducing carbohydrate, was confirmed.
• Physicochemical techniques, including DSC and FTIR, provided evidence for Maillard reaction between lactose and FLM.
• Solid-state kinetic parameters and activation energy for the interaction were successfully calculated.
• DSC-based kinetic analysis demonstrated a fast and versatile method for comparing activation energies.

Conclusions:

• Fluvoxamine (FLM) exhibits incompatibility with lactose in solid-state mixtures.
• The observed incompatibility is attributed to Maillard interactions between FLM and lactose.
• Kinetic analysis using thermal methods provides valuable insights into drug-excipient interactions and formulation stability.