Table 1.
Properties of hydrogels and associated evaluation parameters at each formulation stage.
Development Stage | Property | Evaluation Parameters |
---|---|---|
Pre-formulation | Solubility | • pKa |
• pH range solubility | ||
• Temperature range solubility | ||
• Dissolution | ||
Stability | • Payload at varying temperatures and pH | |
• Monomers and crosslinkers at varying temperatures and pH | ||
• Drug-polymer interaction | ||
Drug crystallinity | ||
Drug polymorphism | ||
Formulation | Mechanical properties | • Rheology |
• Compression/Extension | ||
• Crosslinking density evaluation | ||
Morphology | • Porosity | |
• Topography | ||
Swelling | ||
Drug content | ||
Drug release | • Dissolution | |
Biosafety | • In vitro and in vivo biocompatibility | |
Bioactivity | ||
Manufacturing | Stability | • Post-sterilization |
• Shelf-life | ||
• Bulk stability | ||
Administration | • Tool compatibility | |
• Pre-injection mixing |