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Establishing quality profiles for 3D printed tablets loaded with different poorly water-soluble substances

Terrmin

HT23

Beskrivning

Aim
To investigate the emulsion gel used for 3D printing as a drug delivery system for different poorly water-soluble substances and investigate the impact of the different substances on the quality of the gel and 3D printed tablets.

Background
Oral dosage forms are typically developed for the adult population and therefore not always age- or dose-appropriate for the pediatric population. Consequently, physical alterations or manipulations of the oral dosage forms might be needed in order to be administered to the children, for example by crushing or dispensing the dosage form in liquids (1). For certain groups of drugs, such as poorly water-soluble compounds, the manipulations might affect the solubility, bioavailability and stability of the drug (2,3). By combining lipid-based formulations (LBF) with 3D printing, personalized oral dosage forms, loaded with poorly water-soluble substances, can be developed for the sick children. Recently, tablets from emulsion gels consisting of LBF and cellulose-based polymers have successfully been 3D-printed with fenofibrate as model substance (4). Currently, an optimized emulsion gel is being developed with regards to viscoelastic properties of the gel, mass uniformity and disintegration time of the printed tablets. In theory, the emulsion gel can be loaded with different poorly water-soluble compounds without compromising the quality. However, this have yet not been explored.

Methods
• Preparation of LBF, emulsion and emulsion gels
o Determination of thermodynamic solubility of poorly water-soluble substances in LBF – HPLC
o Formulation of emulsion gel according to already established protocols
• Characterization of emulsion gel and printed tablets
o Rheology – viscosity, viscoelasticity
o Mass uniformity
o Disintegration time
o Drug content uniformity – HPLC
o Solid state characterization – XRD, Raman
o Stability of 3D printed tablets
The characterization will be carried out in triplicates for each compound investigated.

My task
The task of the student is to investigate two poorly water-soluble substances in need for personalization for the patients at the pediatric oncology and neurology ward, Uppsala University Hospital. After determination of the thermodynamic LBF solubility at room temperature for the substances, emulsion gels will be prepared and subsequently, tablets will be 3D printed. The student will utilize available protocols for the majority of the methods, while some will be developed together with the supervisors.
Expected results:
• Obtain quality profiles for the gels, loaded with different substances, and for the 3D printed tablets.
• Contribute with useful knowledge to the development of on-demand production lines of personalized 3D printed dosage forms.

Huvudområde

Läkemedelsutveckling

Ämne

Läkemedelsformulering och Molekylär galenisk farmaci

Typ

Laborativ studie

Företag

Uppsala universitet

Ort/Plats

Uppsala

Handledarens namn

Christel Bergström

Handledarens e-post

christel.bergstrom@farmaci.uu.se

Institution

Institutionen för farmaci

Program

Masterprogram i läkemedelsutveckling

Kurs

Degree project in Drug Discovery and Development 45 c - 3FK044

Omfattning/hp

45hp