Prilling of API/fatty acid suspensions: Processability and characterisation

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Drug Delivery Systems

Background:

• Traditional prilling utilizes active pharmaceutical ingredient/fatty acid (API/FA) solutions.
• Expanding the application of prilling requires exploring alternative formulations like suspensions.
• Investigating API/FA suspensions is crucial for developing novel drug delivery systems.

Purpose of the Study:

• To evaluate the processability and characteristics of prills formed from API/FA suspensions.
• To determine the impact of drug load and fatty acid chain length on prill properties and drug release.
• To assess the physical and chemical stability of API/FA prills after processing and storage.

Main Methods:

• Utilized lab-scale prilling equipment to process API/FA suspensions.
• Characterized prill morphology (sphericity, surface smoothness, particle size) using imaging techniques.
• Performed in vitro drug release studies under varying conditions.
• Assessed solid-state properties using X-ray Diffraction (XRD) and Raman spectroscopy.
• Evaluated drug release stability over six months using the similarity factor (f2).

Main Results:

• API/FA suspensions were successfully processed into spherical prills without thermal degradation or sedimentation.
• Prill characteristics (size, shape) were independent of drug load and fatty acid chain length.
• Faster drug release was observed with higher drug load, increased API water solubility, and shorter fatty acid chains.
• API and FA crystallinity were maintained post-processing and during storage.
• Stable drug release profiles were confirmed for metformin hydrochloride and paracetamol prills after six months.

Conclusions:

• API/FA suspensions are a viable alternative to solutions for prilling, broadening its applicability.
• Prilling of API/FA suspensions yields stable drug products with predictable release characteristics.
• The developed prilling process offers a promising method for manufacturing stable solid dosage forms with controlled drug release.