Related Experiment Video
Updated: Mar 8, 2026
09:51
Microfluidic Production of Lysolipid-Containing Temperature-Sensitive Liposomes
Published on: March 3, 2020
9.9K
Liposomal Drug Product Development and Quality: Current US Experience and Perspective
Mamta Kapoor1, Sau L Lee1, Katherine M Tyner2
1Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
The AAPS Journal
|February 5, 2017
Summary
Liposomal drug development faces quality challenges, particularly in identifying critical attributes and control strategies. Addressing these can streamline the creation and review of novel liposomal therapies.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Biotechnology
Background:
- Liposomes are lipid bilayer structures used to improve drug delivery by modifying pharmacokinetic profiles.
- The field of liposomal research has seen substantial growth, with numerous drug product submissions and several approved products on the US market.
Purpose of the Study:
- To identify key challenges in the development and manufacturing of liposomal drug products from a quality perspective.
- To analyze trends in liposomal drug product submissions to the agency.
Main Methods:
- A retrospective quality-focused analysis of liposomal drug product submissions, including Investigational New Drug (IND), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs).
- Examination of drug substance, administration route, and indication for liposomal products.
Main Results:
- Doxorubicin hydrochloride was the most frequent drug substance (31%), with intravenous administration (84%) and cancer indications (63%) being most common.
- Major quality challenges identified include the identification and characterization of critical quality attributes and the development of suitable control strategies.
- The majority of submissions were INDs (96%), indicating a focus on early-stage development.
Conclusions:
- Focusing on critical quality attributes and control strategies can accelerate liposomal drug product development.
- Streamlining the identification and characterization of these quality attributes can enhance the drug review process for liposomal products.
Related Concept Videos
01:24Modified-Release Drug Delivery Systems: Site-Targeted
59
Site-targeted drug delivery systems enhance therapeutic efficacy while minimizing systemic toxicity and treatment costs. Unlike conventional methods, these systems ensure precise drug delivery, improving bioavailability and reducing side effects. Targeted drug delivery is classified into three levels. First-order targeting directs drugs to the capillary beds of specific organs or tissues. Second-order targets specific cell types, such as tumor cells, using receptor-mediated interactions.
59
01:19Modified-Release Drug Delivery Systems: Rate-Programmed II
58
Rate-programmed drug delivery systems release drugs in a controlled manner to maintain therapeutic levels. Three main designs include reservoir, matrix, and hybrid systems.Reservoir systems consist of a drug core enclosed within a membrane that controls drug release. In non-swelling reservoir systems, polymers like ethyl cellulose or polymethacrylates are used. These do not hydrate in aqueous media and control release through membrane thickness, porosity, or insolubility. This type includes...
58
01:19Modified-Release Drug Delivery Systems: Overview
76
Modified-release dosage forms are designed to address the limitations of drugs with short biological half-lives. These forms maintain stable therapeutic drug concentrations over extended periods, reducing the need for frequent dosing. A consistent drug level helps minimize peak-trough fluctuations, which can reduce adverse effects, lower the risk of drug resistance, and improve overall treatment effectiveness.One common type of modified-release form is the extended-release (ER) formulation. ER...
76
01:30Modified-Release Drug Delivery Systems: Bioavailability
69
Modified-release (MR) dosage forms are designed to extend drug release over time, thereby maintaining stable plasma concentrations and reducing dosing frequency. However, their bioavailability is typically below 100% due to incomplete drug release and presystemic metabolism, and limitations in drug permeability across the gastrointestinal epithelium, all of which can restrict the fraction of the drug reaching systemic circulation. Consequently, studying the in vivo bioavailability of MR...
69
01:23Modified-Release Drug Delivery Systems: Classification
130
Modified-release drug delivery systems improve drug efficacy and minimize side effects by controlling the rate and location of drug release. These systems fall into three categories: rate-programmed, stimuli-activated, and site-targeted.Rate-programmed systems release drugs at a predetermined rate, maintaining consistent therapeutic levels and reducing fluctuations that could lead to toxicity or subtherapeutic effects. These systems use polymeric matrices, reservoir-based designs, or osmotic...
130
01:22Modified-Release Drug Delivery Systems: Rate-Programmed I
67
Rate-programmed drug delivery systems (DDS) are designed to release drugs at specific, controlled rates to maintain consistent therapeutic levels. These systems are categorized based on their release mechanisms, including dissolution-controlled DDS, diffusion-controlled DDS, and combined dissolution-diffusion-controlled DDS.In dissolution-controlled DDS, the release rate depends on the slow dissolution of the drug itself or the surrounding matrix. Drugs with inherently slow dissolution rates,...
67