Modeling the Analysis Process of a Lipid-Based, Multi-Compartment Drug Delivery System

Abstract

Solid lipid microparticles (SLMs) are multi-compartment lipid drug carriers that can be used in various forms via many routes of administration, primarily to obtain prolonged release, protect the drug substance or mask its taste. It is practically impossible to theoretically predict the effectiveness of the incorporation and distribution of active pharmaceutical ingredients (APIs) in SLMs, and these are fundamental features that determine the key properties of the dosage form. The possibility of an effective assessment of these features by selecting or developing sensitive, universal methods, therefore, conditions further development and practical use of this carrier. Therefore, unlike the already available review papers on SLMs, the aim of this mini-review is to focus solely on the issues of API distribution in SLMs and their release. For this purpose, the most important observations and results of our own research were collected and summarized, and then an attempt was made to confront them with the available literature data. Among the methods describing the critical attributes of SLMs, instrumental methods (DSC, AFM, Raman spectroscopy and NMR), quantitative studies for assessing API distribution in SLMs (including entrapment efficiency and drug-loading parameters) as well as different release techniques (without a membrane, in a dialysis bag and in horizontal chambers, taking into account physiological factors) were characterized and compared. The aim of this review is to facilitate the understanding of the SLM properties and to assess their ability to achieve the intended effect in vivo, as well as to standardize studies of such carriers, facilitating a comparison of the results between centers.