Compaction Properties of Particulate Proteins in Binary Powder Mixtures with Common Excipients

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Biotechnology

Background:

• Oral delivery of protein and peptide pharmaceuticals is gaining traction with new products available.
• Understanding the mechanical properties of protein compacts is crucial for successful oral dosage form development.

Purpose of the Study:

• To investigate the compaction behavior of model proteins (lysozyme, bovine serum albumin) in binary mixtures with common pharmaceutical excipients.
• To determine the influence of protein content, excipient type, and compaction pressure on the mechanical properties of the resulting compacts.

Main Methods:

• Binary mixtures of lysozyme or bovine serum albumin with microcrystalline cellulose, spray-dried lactose monohydrate, or calcium hydrogen phosphate dihydrate were prepared.
• These mixtures were compacted at different pressures, and the tensile strength of the resulting compacts was measured.

Main Results:

• Binary blends with lysozyme and brittle excipients showed increased tensile strength compared to pure materials, attributed to enhanced particle bonding.
• Bovine serum albumin, with larger particle size, decreased tensile strength in all compacts.
• The relationship between protein content and tensile strength was non-linear for both proteins.

Conclusions:

• The particulate properties of protein powders significantly impact the mechanical integrity of oral compacts.
• Principles used for small-molecule tablet design can be applied to protein-based oral dosage forms.
• Careful selection of excipients and consideration of protein characteristics are key for designing robust protein-based tablets.