Pharmaceutical Development of Liposomes Using the QbD Approach

Abstract

Quality by Design (QbD) is a systematic, risk-based approach to pharmaceutical product and manufacturing development, which uses quality-improving scientific methods upstream in the research, development, and design phases, in order to assure that quality and safety are designed into product at as early stage as possible. This work focuses on the state-of-the-art applications of the QbD principles in the development of liposomes. The QbD approach has recently been proposed as a useful tool to obtain higher-quality liposomal products, as their development is a challenging task, involving intricate formulation and manufacturing processes. Thus, the current strategies to define the relationship between the critical material attributes or process parameters and product critical quality attributes and to establish the design space are overviewed. Additionally, the current characterization methodologies are described, as part of the control strategy required within the QbD paradigm.

Recombinant Human Epidermal Growth Factor/Quatsome Nanoconjugates: A Robust Topical Delivery System for Complex Wound Healing

“…These are major critical quality attributes of colloidal systems, which play an important role in determining their stability, drug loading, drug release, biodistribution, and targeting ability. [ 20 ]…”

Quality by Design Approach for the Development of Liposome Carrying Ghrelin for Intranasal Administration

“…The application of a quality management visualization tool, such as a fishbone diagram or effect diagram (Ishikawa), is always useful for the identification of the CMAs and the CPPs of the aimed liposomal product [ 32 ]. Figure 1 shows the Ishikawa diagram with CMA and CPP identified and risk analysis in the production of peptide carrier liposomes and selecting the most influential CQAs.…”

Quality-by-Design-Based Development of n-Propyl-Gallate-Loaded Hyaluronic-Acid-Coated Liposomes for Intranasal Administration

“…The Ishikawa diagram as a quality management tool was applied for evaluating the cause-and-effect relationships for screening the CQAs that influence the final product profile [ 45 ]. This cause-and-effect diagram is also significant for the selection of the QTPP and CPPs in new QbD-guided design development [ 25 , 46 ]. The identification and selection of factors having critical effects on the product is the second step of the QbD approach.…”

“…Moreover, it can enhance the targetability of the nanocarrier. In addition, the use of QbD strengthens the validation of the novel method (DPM) for the development of HA-coated liposomes [ 18 , 24 , 25 ].…”