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<1154> Liposome Drug Products

Type of Posting: General Chapter Prospectus
Posting Date: 24-Jun-22
Expert Committee: General Chapters—Dosage Forms
Proposed New Title: <1154> Liposome Drug Products
Input Deadline: 24-Jul-22

Suggested audience: Suppliers and manufactures of drug substance and drug products, contract manufacturing organizations, drug testing organizations, drug products-related regulatory agencies, and QA/QC specialists

Estimated proposal PF: Pharmacopeial Forum 48(6) [Nov.-Dec. 2022]

Description of scope and application: Liposome drug products are commonly used nanotechnology-based formulations. They contain a significant amount of intentionally produced spherical vesicles in the nanometer size range (between 1 and 1000 nm) with at least one lipid bilayer. Chapter <1153> Drug Products Containing Nanomaterials defines liposomes as lipid vesicles composed of one or more lipid bilayers enclosing a single or multiple aqueous compartments. Some liposome preparations occur in the dried state. Liposomes have been employed to formulate both water-soluble and water-insoluble drug substances. Due to their hydrophilic nature, water-soluble drug substances can be incorporated into the internal aqueous compartment(s) of liposomes and water-insoluble drug substances and due to their lipophilic nature can be incorporated into the hydrophobic regions of the lipid bilayer. Liposomes can be used to deliver drug substances via different administration routes including the inhalation, mucosal, topical, oral, or parenteral route of administration. For each administration route, the requirements of the respective chapters apply. This chapter focuses on the product quality tests that are generally necessary for liposomal preparations as well as selected specific requirements for liposomes not mentioned by other chapters. Please note that for the purposes of this chapter, the term “drug substance” and “active ingredient” can be used interchangeably.

Contact: Kahkashan Zaidi, Senior Principal Scientist (