Ensuring Softgel Performance: Formulation approach, strategy and consideration for developing PEG-based softgel products
Softgels are a versatile single-unit dosage form. The successful development of PEG-based formulations requires an understanding of the manufacturing process, the potential shell/fill interactions and their impact on the product performance. The characteristics and the rational selection of shell and fill excipients are key topics of this event.
PEG is a unique excipient that offers a solution for formulating softgel hydrophilic fills and allows modulation of the fill viscosity that is in favor of good processability. However, careful evaluation is required based on the chemical attributes of the active ingredient to limit the formation of degradant products and ensure product stability during shelf life.
Key Learnings:
- Fundamentals of softgel processing, formulation design and stability issues
- Key considerations for developing PEG-based softgels
- Performance benefits of low aldehyde PEGs
- Shell formulation approaches to minimize gelatin cross-linking and further increase product shelf-life
- Formulation challenges and relevant solutions for developing PEG-based fill formulations including case studies
- Key considerations while using PEGs for developing suspension based formulation
- Use of PEGs in designing self emulsifying lipid based drug delivery system (LBDDS)