Analysis of thin baked-on silicone layers by FTIR and 3D-Laser scanning microscopy

S Funke, J Matilainen, H Nalenz… - European Journal of …, 2015 - Elsevier
Pre-filled syringes (PFS) and auto-injection devices with cartridges are increasingly used for
parenteral administration. To assure functionality, silicone oil is applied to the inner surface …

Silicone migration from baked-on silicone layers. Particle characterization in placebo and protein solutions

S Funke, J Matilainen, H Nalenz… - Journal of …, 2016 - Elsevier
A significant number of therapeutic proteins are marketed as pre-filled syringes or other drug/device
combination products and have been safely used in these formats for years. Silicone …

Optimization of the bake-on siliconization of cartridges. Part I: Optimization of the spray-on parameters

S Funke, J Matilainen, H Nalenz… - European Journal of …, 2016 - Elsevier
Biopharmaceutical products are increasingly commercialized as drug/device combinations
to enable self-administration. Siliconization of the inner syringe/cartridge glass barrel for …

Optimization of the bake-on siliconization of cartridges. Part II: Investigations into burn-in time and temperature

S Funke, J Matilainen, H Nalenz… - European Journal of …, 2016 - Elsevier
Combination products have become popular formats for the delivery of parenteral medications.
Bake-on siliconization of glass syringes or cartridges allows good piston break-loose and …

Physico-chemical Stability of MabThera Drug-product Solution for Subcutaneous Injection under in-use Conditions with Different Administration Materials.

C Mueller, E Dietel, SR Heynen, H Nalenz… - International Journal …, 2015 - europepmc.org
MabThera is an essential component of the standard-of-care regimens in the treatment of
non-Hodgkin lymphoma and Chronic Lymphatic Leukemia. MabThera for subcutaneous …

Prolonged In-use Stability of Reconstituted Herceptin in Commercial Intravenous Bags.

H Nalenz, E Köpf, E Dietel - International Journal of Pharmaceutical …, 2018 - europepmc.org
Herceptin is a humanized monoclonal antibody that selectively binds to the extracellular
domain of human epidermal growth factor receptor 2 (HER2). Herceptin has an important role in …

Mechanistic Study of Drying Phenomena of Highly Concentrated Protein Therapeutics—Drying Kinetics and Protein Aggregation

…, Y Ni, A Bernhard, H Nalenz - PDA Journal of …, 2022 - journal.pda.org
The fill-finish process of highly concentrated protein formulations poses several technical
challenges and, in particular, the filling process is critical to ensure filling accuracy. As highly …

[PDF][PDF] Dependence of skin drug permeation on microstructure and time dependent alterations following application of more-phasic dermatological formulations …

H Nalenz - 2006 - edoc.unibas.ch
In this work, the dependence of transdermal delivery of hydrophilic drugs on mass fraction
and microstructure of dispersed phase of multi-phase dermatological o/w formulations was …

[PDF][PDF] Investigation of the transport of lipophilic drugs in structurally diverse lipid formulations through caco-2 cell monolayer using mathematical modeling

M Schneider - 2008 - edoc.unibas.ch
Introduction: To be absorbed from the gastrointestinal tract, a drug has to be sufficiently soluble,
because, with some exceptions, passive diffusion of dissolved drug molecules from high …

[PDF][PDF] Evaluation of topical bioavailability in human stratum corneum in vivo by tape stripping using a direct sprectroscopic method

T Fässler Tassopoulos - 2006 - edoc.unibas.ch
The objective of this thesis was to develop a spectrophotometric methodology for simultaneous
determination of a sunscreening agent and relative stratum corneum tissue density in …