INTERNATIONAL JOURNAL OF ADVANCE RESEARCH
IN MULTIDISCIPLINARY

One of the biggest formulation issues that arises while developing oral medicinal formulations is poor water solubility. A significant percentage of recently discovered drug candidates have low aqueous solubility, which can lead to poor gastrointestinal absorption, variable bioavailability, sluggish dissolution, and diminished therapeutic efficacy. An appealing lipid-based nanocarrier for enhancing the solubility and distribution properties of medications that are poorly soluble in water is solid lipid nanoparticles (SLNs). They are beneficial for pharmaceutical applications due to their tiny particle size, high specific surface area, capacity to integrate lipophilic compounds, regulated drug-release potential, and generally good biocompatibility.

A methodical approach to the formulation and optimisation of SLNs for weakly water-soluble pharmaceuticals is covered in this study, with a focus on Quality by Design (QbD) concepts. The Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs), risk assessment, experimental design, statistical optimisation, formulation characterisation, and design space establishment are all part of the suggested development strategy. The type and concentration of solid lipid, surfactant concentration, drug-to-lipid ratio, aqueous-to-lipid phase ratio, homogenisation conditions, sonication time, and processing temperature are all significant formulation variables. Major quality parameters include particle size, polydispersity index, zeta potential, entrapment efficiency, drug loading, morphology, crystallinity, in vitro drug release, and stability.

In addition to reducing trial-and-error experimentation, a QbD-based optimisation technique can improve comprehension of the connection between formulation variables and product performance. Thus, the method can aid in the creation of scalable and repeatable SLN formulations for medications that are poorly soluble in water. Additionally included are the regulatory aspects of therapeutic products utilising nanomaterials, such as manufacturing uniformity, stability, management of essential qualities, and characterisation.