Regulatory, Safety and Future Directions of Biodegradable Polymer-Based Therapies
Corresponding author: [email protected]
Abstract
Biodegradable polymer-based nanocarriers have an extensive preclinical literature and an expanding base of mechanistic understanding, yet a comparatively thin line of approved products. This chapter examines that gap, arguing that the barriers lie less in polymer chemistry or pharmacology than in the toxicological testing framework, in manufacturing processes that struggle in the transition from flask to GMP plant, and in regulatory systems still adapting to nanoscale drug delivery. It covers polymer degradation products in tissue, the protein-corona problem and limits of ISO 10993, manufacturing scale-up, a comparison of FDA, EMA and CDSCO frameworks, case studies of approved and terminated programmes, and emerging tools including AI-assisted formulation design, PBPK modelling and organ-on-chip systems.
Author Affiliations
- 1 Anandi Pharmacy College, Kalambe tarf Kale, Kolhapur, Maharashtra, India.