Moisture-Induced Degradation in Pharmaceuticals: Mechanisms, Excipient Selection, and Strategies for Stability Enhancement

Background

Moisture induced degradation significantly influences the physicochemical stability of pharmaceutical formulations leading to reduced potency, and therapeutic efficacy.

Objectives

This study methodologically examines the degradation mechanisms resulting from exposure to moisture, as well as the stability of formulation under various relative humidity conditions, also, the study considers advanced stabilization methods.

Materials and Methods

Griseofulvin based formulations were stored at different temperature and relative humidity as per ICH and WHO guideline for accelerated stability, moisture sorption and microbiological studies. Karl Fischer titration, Thermogravimetric Analysis (TGA) and Near-Infrared (NIR) spectroscopy were used to determine the moisture content.

Results

The physicochemical properties of the formulations were affected by moisture and showed reduced tensile strength and rate of dissolution (p < 0.05). Microbial growth increased the disintegration time and reduced hardness. After six months of packaging tests, cyclic olefin and HDPE blisters showed a high degree of moisture protection, with less than 2.9% of moisture uptake and more than 97% of drug activity retention.

Conclusion

The findings demonstrate the significance of moisture-resistant excipients, hydrophobic coatings, and higher quality packaging in maintaining formulation stability. Future development should focus on novel packaging materials, nanocoatings and process analytical technologies for the real-time humidity control.