Abstract
Labrafil M2125-CS is a non-ionic surfactant component widely used for improving the solubilization of poor water-soluble drugs and as component of lipid-based nanosystem formulation. The aim of this research work was to evaluate in depth the stability of lipid-based nanosystems when exposed at several experimental conditions, such as temperature- and pH-variations, and during a specific storage process—lyophilization. Dynamic light scattering was the main analysis carried out during this research work for investigating eventual physico-chemical variations of nanosystem properties after different storage phases. We demonstrated that many of prepared formulations were able to maintain almost unchanged mean size and polydispersity index values, resisting acid and basic pH or high and low temperature, as well as the freeze-drying process. Finally, the results showed that there are no univocal experimental conditions suitable for the storage of all formulation types, but each sample requires customized conditions.
Highlights
The drug delivery systems’ approach was developed in order to obtain therapeutic effect and overcome all the limitations of drug administration in free form, such as sideeffects due to nonspecific action, number of administrations, instability of active compounds in physiological conditions, etc. [1,2].In these attempts, several lipid-based colloidal systems, including a heterogeneous set of nanoformulations, have been realized to obtain a controlled delivery of drugs with different physicochemical features [3]
The evaluation of the physicochemical features of the nanosystems is a crucial factor to investigate since the mean size and the polydispersity index are fundamental aspects as they strongly influence the biopharmaceutical fate of the formulations
Was combined with PL-90G® in different molar ratios, according to the procedure described in Section 2.2 for the realization of an innovative system
Summary
[1,2] In these attempts, several lipid-based colloidal systems, including a heterogeneous set of nanoformulations, have been realized to obtain a controlled delivery of drugs with different physicochemical features [3]. Considering that one of the main disadvantages in the translation of nanoformulations into clinical practice is its high costs [4] derived from expensive preparation methods and components, and detailed manufacture and quality control, the importance of stability evaluation through the investigation of several factors play an important role, determining preparation process, storage conditions and applications. A deeper investigation into physicochemical parameters, considering the influence of external factors such as temperatures and pH, could prevent instability phenomena such as flocculation, sedimentation, or coagulation [6]. Lyophilization is a widely employed storage method in several fields, as well as a pharmaceutical one, with the advantage to prevent degradation and guarantee optimal starting conditions after sample resuspension
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