
Jens CeulemansJanssen Research & Development, LLC | JANSSEN
Jens Ceulemans
Doctor of Philosophy
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21
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Publications (21)
Τhe in vitro biorelevant gastrointestinal transfer (BioGIT) system is a useful screening tool for assessing the impact of dose and/or formulation on early exposure after administration of immediate release or enabling drug products with a glass of water in the fasted state. The objective of this study was to investigate potential limitations. BioGI...
The objective of the present study was to confirm the usefulness of BioGIT data in the evaluation of the impact of dose and/or formulation on early exposure after oral administration of immediate release or enabling products of low solubility active pharmaceutical ingredients (APIs) with a glass of water in the fasted state. BioGIT experiments were...
The first aim of this study was to evaluate the usefulness of optimized human fecal material in simulating sulforeductase activity in the lower intestine by assessing bacterial degradation of sulindac and sulfinpyrazone, two sulforeductase substrates. The second aim was to evaluate the usefulness of drug degradation half-life generated in simulated...
The absorption of oral drugs is frequently plagued by significant variability with potentially serious therapeutic consequences. The source of variability can be traced back to interindividual variability in physiology, differences in special populations (age- and disease-dependent), drug and formulation properties, or food-drug interactions. Clini...
Although oral drug delivery is the preferred administration route and has been used for centuries, modern drug discovery and development pipelines challenge conventional formulation approaches and highlight the insufficient mechanistic understanding of processes critical to oral drug absorption. This review presents the opinion of UNGAP scientists...
Introduction
: In the development of bio-enabling formulations, innovative in vivo predictive tools to understand and predict the in vivo performance of such formulations are needed. Etravirine, a non-nucleoside reverse transcriptase inhibitor, is currently marketed as an amorphous solid dispersion (Intelence® tablets). The aims of this study were...
This study investigates 3 amorphous technologies to improve the dissolution rate and oral bioavailability of flubendazole (FLU). The selected approaches are (1) a standard spray-dried dispersion with hydroxypropylmethylcellulose (HPMC) E5 or polyvinylpyrrolidone-vinyl acetate 64, both with Vitamin E d-α-tocopheryl polyethylene glycol succinate; (2)...
Various powder mixtures were used to administer insulin via the nasal route: a co-spray dried mixture of Amioca starch and Carbopol 974 P (1/3), drum dried waxy maize starch and Carbopol 974 P (9/1), maltodextrin DE38/Carbopol 974 P (9/1) and pure drum dried waxy maize starch. Oscillatory rheology is performed to study and compare the viscosity, el...
The optimisation of the in vitro interaction between several poly(acrylic acid) derivatives (Carbopol 1342P NF, Carbopol 974P and Carbopol 980 NF) and mucin was performed by an analysis technique combining oscillatory shear rheology and experimental design in order to improve the formulation of carbomer viscous eye drops.First, standard oscillation...
The development of an ocular dosage form containing xanthan gum and capable of interacting with mucin in the precorneal area is a challenge. The polymer concentration that can be applied is restricted because of the limited patient acceptability of highly viscous preparations. The precorneal mucin concentration is low and the high ionic strength of...
In the present study, the use of an in vitro technique applying oscillatory shear rheology to determine the interaction between a dry polymer powder and mucin is investigated. The polymers examined are Carbopol 974P, Noveon AA1 and a polymer mixture containing Carbopol 974P and Drum Dried Waxy Maize Starch. The degree of interaction is assessed by...
The present study investigates the use of a polymer mixture containing Carbopol 974P and drum dried waxy maize starch to obtain prolonged drug release to the anterior eye segment. Two dosage forms with this composition are compared: a hydrated polymer dispersion and a minitablet. A model fluorescent tracer is used to study the ocular release and di...
Artificial tear formulations are commonly employed in the treatment of dry eyes. In this article an overview is given of the preparations commercially available in Belgium. The rheological behaviour, the mucoadhesive and surface-active properties of the different viscolysers are illustrated. The preservatives used in this kind of formulations and t...
In measuring consistency and spreadability of highly viscous topical preparations, different techniques can be applied. The aim of this study is to compare the use of penetrometry, extensometry and shear rheology to measure consistency and spreadability of Unguentum Simplex, Basis Non-Ionicus and Carbopolgel. The basic differences between the techn...
Five commercial preparations are characterised physically using creep and continuous flow shear rheometry after they were classified as low or high stress-resistant by penetrometry and extensometry. Several rheological procedures are tested. The difference between the procedures is determined by the course of the stress as a function of time. Evalu...
Ophthalmic drugs are commonly administered topically as eyedrops. The bioavailability however is usually not more than 1 - 3 %. By the protective mechanisms of the eye, such as lacrymation, reflex blinking and drainage, the drops instilled are removed quickly from the eye surface. To maintain a therapeutic concentration at the site of action, drops...
ZYTIGA® (abiraterone acetate, AA) is approved in more than 40 countries, including the United States, European Union and Canada, for treatment of patients with advanced metastatic castration resistant prostate cancer (mCRPC) who have progressed after prior docetaxel-based chemotherapy and is under investigation in Chemotherapy naïve patients with m...