The Amazing Stability Powers of HP-β-CD in Infliximab Formulations

Creating stable formulations for biopharmaceuticals like infliximab is no easy task. Scientists explored using 2-hydroxypropyl-β-cyclodextrin (HP-β-CD) to keep infliximab from degrading. They made both liquid and solid formulations. For the solid version, they used a scaled-up high-speed electrospinning technique to create a product that dissolves well. The liquid formulations only had HP-β-CD at varying concentrations. They stored these formulations for six months under different conditions and checked how well infliximab stayed stable by looking at monomer recovery and fragment/aggregate analysis. The solid formulations fared better at lower temperatures (-18°C, 4°C) and lower humidity.Surprisingly, even at room temperature, the monomer loss stayed below 10% after two months. Increasing HP-β-CD in liquid formulations boosted infliximab's long-term stability and shielded it from mechanical stress. The researchers also dug into how HP-β-CD stabilizes infliximab using molecular interaction tests. They found that HP-β-CD cuts down on infliximab's self-interaction, which helps explain its anti-aggregation effect seen in stability studies. These findings highlight the promise of HP-β-CD as a stabilizer for infliximab in various formulations.