Analytical Method Development for Complex Drug Delivery Systems: Nanoparticles, Liposomes, and Nanosponges

Kiran Kumar Byram; Chirag Patel; Sagar Patel; Shravan Kumar Muthyam

doi:10.37022/wjcmpr.v8i2.389

Authors

Kiran Kumar Byram Department of Chemistry, Acharya Nagarjuna University, NH 16, Nagarjuna Nagar, Guntur, Andhra Pradesh 522510
Chirag Patel Senior Scientist II, Department of AR&D, Amneal Pharmaceuticals, 49 Colonial Drive, Piscataway, New Jersey 08854
Sagar Patel Research Scientist, Department of AR&D, Amneal Pharmaceuticals, 49 Colonial Drive, Piscataway, New Jersey 08854
Shravan Kumar Muthyam Lead Scientist, Quality Control, New England Avenue, Piscataway, NJ, 08854.

Abstract

Nanotechnology-based drug delivery systems (NDDS), including nanoparticles, liposomes, and nanosponges, have significantly transformed modern pharmaceutical research by addressing the limitations of conventional drug delivery approaches. These systems enhance drug solubility, stability, bioavailability, and targeted delivery, thereby improving therapeutic outcomes. However, their complex structure and multi-component nature necessitate the development of robust and reliable analytical methods for effective characterisation. This review focuses on analytical method development strategies for NDDS, emphasising critical quality attributes such as particle size, zeta potential, drug loading, morphology, drug release, and stability. Various analytical techniques, including physicochemical, spectroscopic, chromatographic, thermal, and advanced imaging methods, are discussed for comprehensive characterisation. The review also highlights challenges associated with analytical method development, including system complexity, separation difficulties, stability issues, and reproducibility concerns. A comparative analysis of nanoparticles, liposomes, and nanosponges is presented to illustrate their distinct properties and analytical requirements. Furthermore, regulatory considerations and validation parameters based on ICH guidelines are addressed. Finally, emerging trends such as real-time monitoring tools and personalised nanomedicine are explored, providing insights into future advancements in analytical methodologies for complex drug delivery systems.

Keywords:

Nanoparticles, Liposomes, Nanosponges, Analytical method development, Drug delivery systems, Characterisation, HPLC, NDDS

DOI

https://doi.org/10.37022/wjcmpr.v8i2.389

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