Influence of processing methods on physico-mechanical properties of Ibuprofen/HPC-SSL formulation

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Optimizing drug formulation involves understanding how processing methods affect physical and mechanical properties.
• Hydrophilic Polymer-Solvent System (HPC-SSL) is a key excipient in drug delivery systems.

Purpose of the Study:

• To investigate the impact of melt granulation (MG) and wet granulation (WG) on ibuprofen formulations.
• To compare the physical and mechanical properties of ibuprofen tablets produced by different granulation methods.

Main Methods:

• Ibuprofen and HPC-SSL blends were processed using hot melt extrusion (HME) for MG and high shear mixing for WG.
• Granules and powder blends were compressed into tablets using a Riva Piccola tablet press.
• Characterization included DSC, XRPD, SEM, particle size analysis, and compaction studies (Heckel, Kawakita, CTC).

Main Results:

• Granulation significantly improved particle density and flow properties without altering ibuprofen crystallinity.
• Melt granulation (MG) resulted in superior flow characteristics compared to other formulations.
• Both WG and MG enhanced particle size, leading to higher compressibility and densification at lower compression pressures.

Conclusions:

• Granulation techniques, particularly MG and WG, significantly enhance the physical and mechanical properties of ibuprofen formulations.
• Processing method selection is crucial for optimizing tablet properties, potentially reducing the need for excipient changes.
• This study provides insights for rational selection of processing methods in pharmaceutical manufacturing.