ECTS: 15
Vejleder: René Holm
Background of the project
Thermally induced supersaturated lipid-based formulations offer an advantage in terms of the ability to administer highly concentrated drug solutions, however, the amount of supersaturation achievable is only a factor of two to three (Ilie et al., 2020). Paulus and coworkers (2025) have recently shown that this can be increased to a factor of six by using volatile organic solvents to solubilize the drug compound, which is subsequently added to the lipid formulations. While this approach worked very well to increase the level of supersaturation Paulus and coworkers also reported that the method led to a high amount of residual solvent as the used solvents had a high lipid solubility, hence the approach was in practice not applicable. A potential way to circumvent this issue would be to make amorphous API before the addition of the lipid, e.g. by film casting or lyophilization and thereby increasing the degree of supersaturation in lipids.
Problem formulation
Can the degree of supersaturation in lipids be increased by applying amorphous API rather than crystalline and would the system be physical stable?
Methods
The study will involve the selection and characterization of model drugs and lipid excipients, followed by the formulation and evaluation of supersaturated lipid based formulations with various classes lipids
Analytical techniques including polarized light microscopy (PLM), X-ray diffraction (XRD), and high-performance liquid chromatography (HPLC) will be employed to monitor drug crystallization and stability over time.
Guidance
There will be scheduled meetings every two weeks where the student is expected to present results, interpretations and what is subsequently planned – and from here a professional discussion is taken. In addition, there will always be the possibility of ad hoc guidance meeting.
References
Ilie AR, Griffin BT, Kolakovic R, Vertzoni M, Kuentz M, Holm R. Supersaturated lipid-based drug delivery systems - exploring impact of lipid composition type and drug properties on supersaturability and physical stability. Drug Dev Ind Pharm. 2020;46(3):356-364.
Paulus F, Stappaerts J, Bauer-Brandl A, Lauwers D, Smet L, Hermans E, Holm R. Application of Solvent Evaporation to Generate Supersaturated Lipid-Based Formulations: Investigation of Drug Load and Formulation Quality. Pharmaceutics. 2025;17(6):702.