Our research is encompassed in the following research themes.
Pre-formulation and formulation
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Physico-chemical characterization: evaluation of polymorphs, pKa, logP, solubility in water and physiologic media
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Amorphicity: detection and quantification of amorphous material content concerning suitability and stability of API and dosage forms
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Solubilization of poorly soluble compounds (solid dispersions, surfactants, hydrotropic substances)
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High throughput permeability screening with parallel artificial membrane permeability assay (PAMPA)
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BCS classification: determination of aqueous solubility, drug permeability mechanism and presystemic gut wall metabolism in Sweetana Grass side-by-side diffusion chambers with isolated intestinal tissue or Caco-2 monolayers
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Evaluation of pharmaceutical excipients potential to influence intestinal drug absorption
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Prediction of drug-drug and drug-food interactions during intestinal absorption and pre-systemic metabolism (isolated intestinal tissue, precision-cut liver slices and HepG2 cell cultures)
Drug stability
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Compatibility: early assessment of (in)compatibility between API and excipients for shorter development timelines of experimental and finished dosage forms
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Water sorption: water content sorbed by API or excipients enabling anticipation of possible instability or wetting problems
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Chemical and physical stability: intrinsic stability characterization for scientifically based dosage form design, and confirmatory stability testing of API and finished products
Drug dissolution
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USP Apparatus I, II and IV, Custom designed biorelevant flow-through dissolution model
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Physiological model of drug dissolution: dissolution experiments at conditions close to physiological (pH, volumes, flows, ionic strength)
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Mathematical models of gastric emptying and gastrointestinal transit
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In vitro – in vivo correlation
Analytical support
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Development of selective and sensitive assays for determination of drugs, metabolites, degradation products and endogenous compounds in various matrices
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Validation of analytical methods according to FDA and ICH recommendations
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State-of-the-art instrumentation and automation equipment for sample analyses including 2 LC/MS/MS, several HPLCs with DAD, FD, RI and ECD, micro DSC, automated SPE stations, etc.
Drug metabolism
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In vitro models of increasing complexity: recombinant enzymes, subcellular fractions, cell lines (Caco-2, Hep-G2), tissue slices (liver, intestine), side-by-side diffusion chambers
Bioavailability/bioequivalence and Pharmacokinetic/pharmacodynamic studies
Assistance through all stages of drug development (fundamental research, preclinical, clinical and post-marketing studies)
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Study design and protocol development
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Study monitoring and coordination with clinical sites
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Bioanalytical services
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Biostatistics
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Final report and preparation of documentation for regulatory submission
Therapeutic drug monitoring and Personalized therapy
We collaborate with hospital services in TDM for drugs with a narrow therapeutic range and dose individualisation according to genetic polymorphisms and other factors
Pharmacometrics
Application of pharmacokinetic, pharmacodynamic, pharmacokinetic/pharmacodynamic and disease progression models for optimising drug development, and therapeutic strategies, thereby increasing the safety and efficacy of pharmaceuticals in clinical settings
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Pharmacokinetic and Pharmacodynamic data analysis
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Population analysis using nonlinear mixed effects modelling
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Target mediated drug disposition
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Modelling and simulation
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Clinical trials simulation
Do you need scientific answers to direct your compounds and therapeutic strategies a step further in the development process?