WP 5: Intradermal 3D drug device administration

LEADER: UL (prof. J.C. Simon)

PARTNERS: UL & IPF & SU & StU

OBJECTIVES:

• Validation of biocompatibility of the drug delivery systems with the skin.

• Testing of the drug delivery into and through the skin.

DELIVERABLES

07.2023 D 5.1

Biocompatibility tests using in vitro 2D culture models. Identification of a preparation that does not activate immune cells (macrophages, dendritic cells, T cells)

01.2024 D 5.2

Biocompatibility tests using ex vivo organ culture models. Identification of a preparation that does not lead to local toxicities upon transdermal injections

01.2024 D 5.3

Adjusted polymer matrix/nanoparticle formulation according to in vitro and ex vivo biocompatibility tests. (IPF)

04.2024 M 5.1

3D device formulation does not lead to local toxicities and immune reactions upon transdermal injections confirmed

04.2024 D 5.5

Pharmacokinetics using ex vivo organ culture models. Identification of a preparation with a high local drug delivery rate.

04.2024 D 5.6

Adjusted chemical composition, particle morphology and drug loading of lipid nanoparticles for optimal short term rug delivery rate . (SU)

07.2024 D 5.4

Biocompatibility tests using in vivo organ murine models. Will only be performed with one optimal preparation (D 5.1-5.3) to exclude allergic immune responses to the materials which can only be tested in a living organism. Identification of a preparation that does not lead to delayed-type-hypersensitivity or foreign body reactions.

07.2024 D 5.7

Adjusted chemical composition, particle morphology and drug loading for optimal transmission blocking drug delivery rate. (StU)

07.2024 D 5.8

Pharmacokinetics using in vivo organ murine models. Pharmacokinetics such as drug release, plasma levels etc. can only be tested in a living organism. Studies will only be performed with one optimal preparation (D5.5 -5.7). Identification of a preparation that leads to a sustained intradermal drug depot, continuous drug release into the circulation and relevant plasma levels.

07.2024 M 5.2

3D4D2 device with sustained intradermal drug depot, continuous drug release into the circulation and relevant plasma levels confirmed