Crystallization of excipients in tablets.

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Tablets containing hygroscopic excipients like lactose or mannitol are susceptible to moisture uptake.
• High relative humidity can induce physical changes in solid dosage forms.

Purpose of the Study:

• To investigate the formation and characteristics of whisker-like crystals on tablets stored under high humidity conditions.
• To identify the composition of these observed crystalline structures.

Main Methods:

• Scanning electron microscopy (SEM) for crystal morphology observation.
• Differential scanning calorimetry (DSC) for thermal analysis.
• Thin-layer chromatography (TLC) for compositional analysis.

Main Results:

• Whisker-like crystal formation was observed on tablet surfaces.
• Crystals were identified as primarily composed of lactose or mannitol.
• Analysis confirmed the presence of hygroscopic materials in the tablet formulations.

Conclusions:

• High humidity environments can lead to significant physical changes, specifically crystal growth, in tablets containing lactose or mannitol.
• Understanding these crystal formation mechanisms is crucial for tablet stability and shelf-life prediction.
• Formulation strategies may need to account for hygroscopicity to prevent such degradation pathways.