Liposome Characterization, Applications and Regulatory landscape in US

  • Amit Kumar B.pharm
  • Madhu Gupta
  • Simran Braya


Liposomes are lipid based drug carrier whose therapeutic performance depends on their structure. Liposomes offer several advantages over the conventional drug like target drug delivery, reduced toxicity, and extended pharmacokinetics. Characterization and Identification of critical attribute of liposomal formulation and suitable strategies for control during product development is important for quality of the liposomal drug product. This paper discusses the current status of the liposomal drug product and strategy used in regulating liposome product. Despite of lack of regulatory guidelines many liposome formulations get approved which shows the potential of liposome drug products.

Keywords: Liposomes, Phospholipid, Nanotechnology, Lamellarity, Liposomal Delivery, ANDA, FDA, CTD


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How to Cite
Kumar, A., M. Gupta, and S. Braya. “Liposome Characterization, Applications and Regulatory Landscape in US”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 2, June 2021, pp. 81-89, doi:10.22270/ijdra.v9i2.474.