Title:Quality by Design Applied to Ocular Solid Lipid Nanoparticles Containing a Hydrophilic Peptide Prepared via Hot High Pressure Homogeniser
Volume: 13
Issue: 8
Author(s): Annalisa Mercuri Mercuri
Affiliation:
Keywords:
Hot High Pressure Homogeniser, Hydrophilic Peptide, Ocular drug delivery, QbD, Solid Lipid Nanoparticles.
Abstract: Background: Quality by Design (QbD) is an approach encouraged by regulatory bodies and
applied by pharmaceutical industries to improve the quality of the final product. The objective of this
paper is to describe via a QbD approach the available knowledge on the formulation and manufacturing
of solid lipid nanoparticles (SLN) for ocular applications using hot high pressure homogeniser (HPH).
Methods: The formulation of SLN for the ocular delivery of a hydrophilic peptide is discussed based on
a QbD perspective, where the knowledge is gathered from literature references.
Results: The Quality Target Product Profile (QTPP) is defined, followed by a description of the Critical
Quality Attributes (CQA) and Critical Material Attributes (CMA). After having described the manufacturing
process via hot HPH, the Critical Process Parameters (CPP) are discussed along with the possible
control strategies.
Conclusions: The QbD approach for the development of a SLN for ocular application described in this
review paper can be used as starting point for similar applications.
