Here we bring the topics overview. Below the overview there are annotations and names of academic supervisor(s), their university/department and project assignments to research area(s) from five key domains in The Parc: Solid state chemistry, Preformulation and solid state analysis, Drug design and process, Biopharmacy and Preclinical in vivo testing. For more information on a specific Ph.D. project, you can contact us at info@theparc.eu or you can contact the academic supervisor directly (find email below each project description).
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PhD topics overview
1/ Controlling of drug crystal properties during crystallization
2/ Particle informatics
3/ In silico crystal structure predictions for pharmaceutical ingredients
4/ Efficient screening of solvents and excipients for active ingredients using first-principles-based methods: COSMO-SAC and Monte Carlo approaches
5/ Kinetic, thermodynamic and structural aspects of forming solid dispersions of high-melting drugs
6/ Monitoring and prediction of tablet disintegration behavior using texture analysis
7/ Modelling of fluid flow during processing of colloidal suspensions
8/ Utilization of inter-and intra-molecular interactions in modelling of drug-polymer systems
9/ Development of membrane model systems to predict permeability of drugs
10/ Study of the skin barrier formation and the possibilities of its restoration at the molecular level
11/ Development of advanced formulations for topical drug delivery
12/ Optimization of HME process and formulation of amorphous solid solutions
13/ Co-processed active pharmaceutical ingredients for direct compression
14/ Advanced manufacturing concepts for flexible dose combinations
15/ High-throughput robotic design of powder formulations
16/ Scale-up of wet nanomilling and nanocrystal formulation processes
17/ Reduction of materials consumption in pharmaceutical manufacturing processes
18/ Model based design and optimization of wet granulation processes
19/ Hydrogel Depot Systems for Sustained and Controlled Drug Delivery
20/ Testing of inhaled drugs in preclinical models of pneumonia and pulmonary fibrosis
21/ Development of methodology and application of Real World Evidence (RWE) in clinical practice and pharmaceutical research.
22/ Surface Energy Heterogeneity of Particulate Matter
23/ Sameness evaluation – Development and Application of Methods for Demonstrating the Equivalence of Active Ingredients in Generic Drugs
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1/ Controlling of drug crystals properties during crystallization
Active Pharmaceutical Ingredients (APIs) are commonly small molecules that are used in the form of particles prepared by the crystallization process. Properties of prepared crystals (i.e., physico-chemical but also formulation properties) are strongly dependent on the used drug solid form, their size, and crystal morphology. The process of spherical crystallization results in the formation of crystals assembled into spherical particles. The goal of this project is to investigate the possibility of using this procedure for the preparation of crystalline drug particles of various polymorphs and multicomponent solid forms (i.e., cocrystals) or even conglomerates containing multiple drugs in a single spherical particle. In addition, the process will be optimized to be operated in a continuous mode. Furthermore, the students will also be involved in the automation of the whole process consisting of the mixing of crystalizing streams containing a drug (drugs) and excipients but as the operation of the stirring unit where spherical crystallization is taking place using process analytical technology (characterization of particle size, shape, and composition). Obtained particles will be characterized by several analytical methods (i.e., SEM, XRD, DSC, NMR, measurement of the dissolution rate of a single particle) and their properties will be compared to those measured for crystalline particles of drugs prepared by classical cooling crystallization.
Supervisor prof. Ing. Miroslav Šoóš, Ph.D. (Miroslav.Soos@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Solid state chemistry
2/ Particle informatics
Drug substances are typically produced in the form of crystals. However, the properties of these crystals can vary dramatically when considering various polymorphs or multicomponent drug solid forms (i.e., salts or cocrystals). The goal of this project is to characterize the surface properties of the drug crystals utilizing the crystal structure. As a part of the project, the student will be involved in the preparation of drug solid forms of interest and their characterization using single-crystal XRD, followed by the solution of the crystal structure. The obtained information will be used to predict properties of the crystal surface in terms of molecules present on the surface, hydrophobicity/hydrophilicity of the surface, intermolecular interactions between molecules located on the crystal surface and to correlate these data with the properties of produced crystals (e.g., stability under elevated temperature or humidity, solubility or dissolution). Furthermore, we would extend the information about the crystal structure to the prediction of crystal-crystal interaction and their relation to the crystal flowability or prediction of bulk properties of crystals (e.g., hardness) and its relation to powder tabletability.
Supervisor prof. Ing. Miroslav Šoóš, Ph.D. (Miroslav.Soos@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Solid state chemistry/Preformulation and solid state analyses
3/ In silico crystal structure predictions for pharmaceutical ingredients
Active pharmaceutical ingredients tend to from various polymorphic crystal structures, which differ in their structure, physico-chemical properties, and thus potentially also in their pharmaceutical activity and bioavailability. Computational chemistry offers tools to predict crystal structures in silico only from the knowledge of the molecular formula. Vastness of such in silico generated polymorph landscape can tell whether there would be a single dominant stable polymorph, or rather a more complex interplay of multiple polymorphs could occur for a particular compound. Quantum-chemistry methods enable to rank the predicted candidate polymorph structures of a pharmaceutical ingredient in terms of their relative energy at various conditions (temperature, solvent, etc.) and also to predict kinetic barriers stabilizing any potential meta-stable polymorphs. Such in silico modelling performed at the initial stage of the pharmaceutical research can guide later crystal engineering efforts to reach the most beneficial drug formulation in terms of its stability for storage and transport and subsequent solubility and bioavailability. This computational project aims at assessing the applicability and reliability of diverse theoretical methods for polymorph ranking within the workflow of crystal structure prediction. Aspects of conformational polymorphism, local disorder of crystal structures, incorporation of ab initio methods into genetic algorithms, impact of a solvent on the polymorph ranking, and the high-throughput feasibility of the predictions will be addressed. The ultimate goal will be the ability to predict and identify in silico a meta-stable polymorph (more soluble by definition) that would be kinetically stabilized by high energy barriers for spurious recrystallization.
Supervisor doc. Ing. Ctirad Červinka, Ph.D. (Ctirad.Cervinka@vscht.cz)
University University of Chemistry and Technology, Department of Physical Chemistry
Parc area Solid state chemistry
4/ Efficient screening of solvents and excipients for active ingredients using first-principles-based methods: COSMO-SAC and Monte Carlo approaches
In drug formulation development, a critical challenge is identifying optimal excipients and solvents that enhance the solubility, stability, and bioavailability of active pharmaceutical ingredients (APIs). Computational approaches can significantly accelerate this process by predicting key thermodynamic and interactional properties, thereby narrowing down the list of potential candidates before experimental testing. Advanced modeling techniques, such as the quantum-mechanically-aided COSMO-SAC model and molecular simulation approaches, offer an efficient way to screen and rank excipients. This project aims to develop, test, and apply COSMO-SAC, PC-SAFT-SEPP, and Monte Carlo simulations for solvent and excipient screening in selected APIs and formulations. While these methods are rooted in first-principles electronic structure calculations, they are designed to efficiently model phase behavior and molecular interactions. A key objective is the development of an integrated computational workflow that automates the screening process, requiring minimal input (e.g., SMILES codes) to generate ranked lists of excipients and solvents. Additionally, the project will contribute to a deeper understanding of how molecular structure and interactions dictate macroscopic phase behavior, which is often a critical factor in the efficiency of pharmaceutical formulations.
Supervisor Ing. Martin Klajmon, Ph.D. (Martin.Klajmon@vscht.cz)
University University of Chemistry and Technology, Department of Physical Chemistry
Parc area Solid state chemistry
5/ Kinetic, thermodynamic and structural aspects of forming solid dispersions of high-melting drugs
High melting point drugs present a challenge in the formulation of amorphous solid dispersions, e.g. solid solutions with polymers, because the chemical stability of both the drug and the polymer makes it impossible to safely reach the eutectic melt formation temperature. Thus, solid dispersions are essentially formed by dissolving solid drug in the polymer melt, which creates both residence time and mixing requirements in the molten state, as well as requirements for compatibility of drugs and coformers to prevent undesired crystallization of the drug in the finished product. Therefore, this work will focus on the evaluation of compatibility of drugs and coformers by computational and experimental methods, stability of dispersions as a function of their composition and kinetics of drug dissolution in polymer melt. This main axis will be complemented by the study of the application properties of the formulations prepared with the possible support of an industrial partner. The work assumes a significant contribution to supervision from FHNW Basel.
Supervisor prof. Ing. Petr Zámostný, Ph.D. (Petr.Zamostny@vscht.cz)
University University of Chemistry and Technology, Department of Organic Technology
Parc area Preformulation and solid state analysis/Drug design and process
6/ Monitoring and prediction of tablet disintegration behavior using texture analysis
The disintegration kinetics of tablets is a determining step for their overall dissolution behavior, as it determines the size and specific surface area of the fragments produced during their disintegration. This kinetics depends on the rate of penetration of the disintegration medium into the tablet microstructure, both into the pores and swelling components of the tablet, and the ability of the internal dissolution and swelling processes to disrupt the tablet cohesion. The aim of this work is to study the kinetics of water absorption into the tablet as a function of its composition and microstructure by means of textural analysis and microscopic measurements, to study the resistance of the tablet to erosive effects as a function of the amount of absorbed liquid as well as the size of the fragments formed as a result of these processes. The knowledge obtained should then be used to develop a fully or partially predictive model capable of predicting disintegration behavior based on the microstructure of the tablet and the physical properties of its components.
Supervisor prof. Ing. Petr Zámostný, Ph.D. (Petr.Zamostny@vscht.cz)
University University of Chemistry and Technology, Department of Organic Technology
Parc area Preformulation and solid state analysis
7/ Modelling of fluid flow during processing of colloidal suspensions
Colloidal stability of suspensions (polymeric nanoparticles or proteins) is related to environmental parameters such as ionic strength, amount of surface-active agents, or level of shear rate. Furthermore, the presence of another phase of liquid or gas can negatively affect the stability of suspended particles. The flow field will be characterized by computational fluid dynamic (CFD) simulations of single and multiphase flow in stirred vessels with various impeller shapes typically used for aggregation of polymer nanoparticle suspensions or precipitation of proteins. The student will be involved in the buildup of computational mesh and simulation of flow (single phase or multiphase) using various approaches (Euler-Euler and Euler-Lagrange). Mesh independent results of fluid flow characteristics (i.e., maximal hydrodynamic stress, duration of high-stress exposure, mixing time) will be correlated with experimental data of aggregation/gelation time. For selected cases, the modelling of the aggregation process of suspended particles will also be implemented in the CFD.
Supervisor prof. Ing. Miroslav Šoóš, Ph.D. (Miroslav.Soos@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Preformulation and solid state analysis
8/ Utilization of inter-and intra-molecular interactions in modelling of drug-polymer systems
Interparticle interactions play a significant role during the process of micelle formation, stabilization of nanoparticles during antisolvent precipitation, stabilization of drug molecules in supersaturated solution during drug dissolution, or even in the process of selection of suitable polymers to prepare amorphous solid dispersion. In this thesis, we would like to utilize quantum mechanics and all-atom molecular dynamic simulations to tackle the above-mentioned challenges. The first studied system will contain a selection of suitable polymers to prepare an amorphous solid solution (ASS) with the selected drug while maximizing the long-term stability of ASS. In addition, we plan to study the interaction of selected polymers with a drug in a water environment to maximize drug solubility and prevent drug precipitation from supersaturated solution. The second studied system will consist of surfactant molecules (both synthetic and natural) in a water environment where we plan to study the impact of concentration of surfactant molecules, length of hydrophobic and hydrophilic chains, presence of ionic strength or temperature variation on the formation of micelles/surfactant molecule coils. Particular attention will be considered when drugs are added to this system, where the goal will be to understand the solubilization of drug molecules in the surfactant micelles. Obtained results will be compared with available experimental data containing the solubility of the drug in a polymer, time evolution of drug concentration in the supersaturated solution stabilized with polymer, or permeation measurement of drug molecules in the presence of surfactants and polymers.
Simulations will start from quantum-chemical calculations of the COSMO-RS type to enable the first and relatively quick qualitative estimation of Hansen's solubility parameters and can thus serve in the initial screening of suitable polymers. In the next step, molecular dynamic simulations will be used to simulate the polymer-drug affinity in a real system arrangement (ideally including basic experimental knowledge).
Supervisor prof. Ing. Miroslav Šoóš, Ph.D. (Miroslav.Soos@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Biopharmacy
9/ Development of membrane model systems to predict permeability of drugs
The basic step in the absorption of drugs into the body is their permeation across the cell membrane. However, it is difficult to study this phenomenon in complex organ systems. The aim of this thesis will be to establish artificial lipid membrane models that will be used for in vitro study of drug permeation. Different types of lipid systems mimicking the structure of biological membranes of selected tissues (intestinal lumen, sublingual, dermal tissue, etc.) will be developed. Membranes will be characterized in detail at the molecular level using biophysical methods (SAXS, FTIR, Raman spectroscopy, AFM and others). Furthermore, permeation kinetics will be studied on the membranes for a series of active compounds with different physicochemical properties. The data obtained will be correlated with more complex in vitro cellular models and ex vivo models. The main output of the project will be valid model systems that have the potential to predict the permeation behaviour of drugs in more complex biological environments.
Supervisor doc. Dr. Jarmila Zbytovská (Jarmila.Zbytovska@vscht.cz)
University University of Chemistry and Technology, Department of Organic Technology
Parc area Biopharmacy
10/ Study of the skin barrier formation and the possibilities of its restoration at the molecular level
The molecular mechanisms of the formation of the intercellular lipid matrix, which is crucial for skin barrier function, are still not well understood. This work will aim at unravelling these processes using biophysical techniques on model membranes (SAXS, FTIR, Raman spectroscopy, AFM, etc.), and membrane permeability will also be studied in this context. Based on these findings, the conditions for the design of topical lipid formulations capable of restoring the disrupted (diseased) skin lipid barrier will be defined. The main outcome of this project will be a stable nanostructured formulation targeting skin barrier restoration.
Supervisor doc. Dr. Jarmila Zbytovská (Jarmila.Zbytovska@vscht.cz)
University University of Chemistry and Technology, Department of Organic Technology
Parc area Drug design and process
11/ Development of advanced formulations for topical drug delivery
Newly developed drugs often show problematic physicochemical profiles resulting in very low bioavailability whether oral or topical. The aim of this work will be to search for new formulation techniques to improve the bioavailability of selected compounds. Special attention will be paid to nanoparticle systems. The bioavailability to different tissue types (e.g. skin tissue or others) will be evaluated for the developed formulations. The main output of the project will be a comparison of the efficiency of nanostructured carriers and formulations based on other enhancement techniques.
Supervisor doc. Dr. Jarmila Zbytovská (Jarmila.Zbytovska@vscht.cz)
University University of Chemistry and Technology, Department of Organic Technology
Parc area Drug design and process
12/ Optimization of HME process and formulation of amorphous solid solutions
Amorphous solid solutions (ASSs) are used to improve the dissolution rate of poorly soluble drugs. Despite their metastable nature, which commonly leads to a higher dissolution rate, the selection of suitable polymers and the optimization of the ASSs production process is a rather complicated task. To reduce the time and material requirements, in the proposed project, we plan to start with the screening of suitable polymers leading to solubility enhancement of the selected drug. In the next step, we will perform rheological characterization of the mixtures of promising polymers and selected drugs. This will consist of polymer-drug powder rheology and polymer-drug melt rheology measurement, resulting in the identification of critical process parameters of hot-melt extrusion (HME), i.e., powder flowability in the feeder, maximum feeding rate of the powder mixture into the extruder, minimum melting temperature of the polymer-drug mixture, maximum drug loading in the polymer-drug melt, viscosity of the polymer-drug melt and possible conditions for drug or polymer degradation. Since rheological measurement is fully automated and requires only a fraction of the material than HME itself, the proposed method will allow a significant reduction of time and material requirements for the optimization of HME. Obtained data will be used to construct dimensionless characteristics of the HME process suitable for easy setup of the process parameters and process scale-up. While HME is commonly used for the production of ASSs in the form of filaments, which are consequently milled into particles to be used in the final drug product, in the proposed project, we plan to extend the formulation of ASSs in the form of films or spherules. Taking advantage of HME as a continuous process, in the following step, we would extend this capability towards film formation or production of spherical particles. On-line Raman spectroscopy will be used to control the quality of the final product. This will be combined with off-line characterization (i.e., XRD, DSC, NMR, IDR measurement) to ensure the production of stable ASSs with enhanced drug dissolution rate.
Supervisor prof. Ing. Miroslav Šoóš, Ph.D. (Miroslav.Soos@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Drug design and process
13/ Co-processed active pharmaceutical ingredients for direct compression
Active pharmaceutical ingredients (APIs) in high-dose tablet formulations (e.g. metformin, ibuprofen) would benefit from as little dilution by excipients as possible to keep the tablet weight down, while maintaining processability (bulk density, flow behaviour, compressibility, etc.). Co-processing is a rapidly emerging approach that aims to combine the API with a small amount of excipient while achieving large differences in processability, usually by the modification of surface properties, particle size and morphology. The aim of this project is to explore co-processing concepts for several chosen APIs based on both dry and wet routes, and to demonstrate that co-processed APIs can be manufactured in a scalable, reproducible and cost-effective manner. The ultimate aim is to utilise co-processes APIs in direct compression, i.e. the manufacturing of high-dose tablets without any granulation step.
Supervisor prof. Ing. František Štěpánek, Ph.D. (Frantisek.Stepanek@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Drug design and process
14/ Advanced manufacturing concepts for flexible dose combinations
Fixed dose combinations (FDC) are drug products containing two or more active pharmaceutical ingredients whose combined therapeutic effect has been proven to be superior to that of individual components. Numerous clinical studies show significantly improved life expectancy of patients using FDC compared to their individual counterparts, especially in the cardiovascular area. For large therapeutic areas, it is common to develop FDCs e.g. in the form of bi-layer tablets for the most prescribed combinations of drugs and their strengths. However, smaller, or more marginal patient cohorts are not served by this approach. The aim of this project is to develop and implement novel manufacturing concepts based on the post-mixing of mass-produced single-component subunits, and thus achieve flexibility for small batch manufacturing of FDC products with a broader range of dosage strength combinations and/or interchangeable active ingredients, while achieving the speed of production comparable to classical tableting.
Supervisor prof. Ing. František Štěpánek, Ph.D. (Frantisek.Stepanek@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Drug design and process
15/ High-throughput robotic design of powder formulations
Mixing rules for the prediction of physico-chemical properties of fluids from pure components are relatively well-established in the scientific literature, but still lacking in the case of multicomponent powder blends. The knowledge of powder properties such as bulk density, flowability, compressibility, permeability, wetting or dispersibility in water is crucial for rational design of formulation in the pharmaceutical industry. The aim of this project is to implement an automated robotic platform for programmable high-throughput robotic platform for the combinatorial preparation and testing or powder mixtures, and then to devise predictive models (possible using machine learning approaches) for the estimation of mixture properties from pure component properties. The project will suit an individual with interest in powder mechanics, robotics, and computer programming.
Supervisor prof. Ing. František Štěpánek, Ph.D. (Frantisek.Stepanek@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Drug design and process
16/ Scale-up of wet nanomilling and nanocrystal formulation processes
Dried nanocrystalline suspensions of poorly soluble active pharmaceutical ingredients (APIs) have been shown to be superior to amorphous solid dispersions in terms of dissolution rate enhancement, stability, excipient dilution, and manufacturing simplicity. The formation of aqueous nanosuspension can be achieved in wet stirred media mills that can be operated in a batch mode during process development and then scaled up to flow-through arrangement either in recirculation or single-pass mode. The suspension can then be easily dried to obtain granular material suitable for direct capsule filling or direct tableting. The aim of this project is to develop and validate a robust scale-up methodology for the manufacturing of nanocrystal suspensions by flow-through wet milling at the highest possible concentration, subsequent spray during or fluid-bed drying, and processing into a final dosage form (tablets, capsules). For a chosen API, the entire process from raw API to finished products will be demonstrates and the product pharmaceutical performance (stability, in vitro dissolution, in vivo bioavailability) will be evaluated.
Supervisor prof. Ing. František Štěpánek, Ph.D. (Frantisek.Stepanek@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Drug design and process
17/ Reduction of materials consumption in pharmaceutical manufacturing processes
Many pharmaceutical tablets contain a large volume of excipients without any obvious technological or clinical benefit. Often the excipient volume is simply a consequence of a lack of (or no need for) formulation optimization during the development of the original drug product. However, for large-volume medicines after original patent expiry, there are numerous reasons for trying to reduce the volume of excipients in tablets. These include economic (cost of materials, production time), environmental (size of packaging, carbon footprint of production and distribution), quality (excipients are often the source of reactive impurities that result in degradation) and clinical (large tablets are more difficult to swallow). Therefore, the aim of this project is to identify pharmaceutical products with the most significant potential for excipient reduction, to reformulate such products while maintaining bioequivalence, and to demonstrate manufacturing and/or patient benefits. General methodology for excipient reduction based on the material properties (e.g. flowability, adhesion) will be developed. The project will be conducted in cooperation with an industrial partner and will involve real-world case studies.
Supervisor prof. Ing. František Štěpánek, Ph.D. (Frantisek.Stepanek@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Drug design and process
18/ Model based design and optimization of wet granulation processes
Wet granulation is a key step in pharmaceutical manufacturing, responsible for transforming fine powders into granules with improved flow properties, uniformity, and compressibility. In order to produce high-quality solid dosage forms, the challenge to develop robust frameworks for better control over critical quality attributes (CQAs) of granules is increasing. The aim of this research aims to address the limitations of empirical methods by leveraging mechanistic modeling and computational tools to model, simulate, and optimize high shear granulation and fluid bed granulation processes. In this research, mechanistic modeling will serve as the foundation for understanding granulation kinetics, including particle growth and breakage, binder addition and distribution, and drying kinetics. In order to facilitate a systematic approach to process optimization by enabling accurate representation of the underlying physico-chemical processes. The research will involve constructing models to simulate various operating conditions and understand their impact on granule properties, such as size, porosity, and moisture content. Experimental validation will play a pivotal role in refining this approach, using data sets from industrial granulation processes from laboratory to production scale. The validated models will then be applied to optimize granulation processes. By integrating this workflow, this research aims to address the challenges of scale-up, reducing variability and improving efficiency in process control of granulation. Therefore, the research will also have a core objective to advance the mechanistic understanding of granulation while also contributing to the adoption of model-based process development in the pharmaceutical industry, ensuring more efficient and reliable manufacturing aligned with Quality by Design (QbD) principles.
Supervisor prof. Ing. Petr Zámostný, Ph.D. (Petr.Zamostny@vscht.cz)
University University of Chemistry and Technology, Department of Organic Technology
Parc area Drug design and process
19/ Hydrogel Depot Systems for Sustained and Controlled Drug Delivery
The proposed PhD project focuses on the development of hydrogel-based depot systems for the controlled and sustained release of therapeutic agents, with a particular emphasis on subcutaneous formulations utilizing liposomes. The research will explore how to formulate these depots for both biopharmaceutics (peptides) and small-molecule drugs, aiming to identify the key factors governing sustained release based on the physicochemical properties of the encapsulated molecule. The student will optimize hydrogel composition, crosslinking strategies, and liposomal carrier integration to enhance stability, drug encapsulation efficiency, and release kinetics. A key focus will be on understanding how the interplay between hydrogel structure, liposomal properties, and drug characteristics influences release behavior and depot performance. The project will also involve physicochemical and biochemical characterization, including biocompatibility, mechanical properties, and degradation behavior. Through this research, the student will gain hands-on experience in hydrogel synthesis, liposome preparation, drug release studies, and biochemical assays, along with expertise in advanced characterization techniques such as rheology, microscopy, and spectroscopy. Additionally, the student will develop skills in scientific writing, project management, and interdisciplinary collaboration, preparing them for a career in biomedical research and drug delivery innovation.
Supervisor Ing. Denisa Lizoňová, Ph.D. (Denisa.Lizonova@vscht.cz)
University University of Chemistry and Technology, Department of Chemical Engineering
Parc area Drug design and process
20/ Testing of inhaled drugs in preclinical models of pneumonia and pulmonary fibrosis
The aim of the study will be in vivo testing of pharmacokinetics of selected drugs administered by inhalation nebulization to healthy rats and rats with induced disease (pneumonia, pulmonary fibrosis). The effect of disease on the pharmacokinetics of the drugs administered in this way will be monitored using drug concentrations in serum and bronchoalveolar lavage. The study will also include in vitro testing of the particle size distribution of the inhaled product on the Next Generation Impactor, as well as monitoring of selected biomarkers relevant for the assessment of the pathological state of the disease using molecular biology methods (rt-PCR, Western blot, ELISA).
Supervisor doc. PharmDr. Martin Šíma, Ph.D. (martin.sima@lf1.cuni.cz)
University Charles University, First Faculty of Medicine, Institute of Pharmacology
Parc area Preclinical in-vivo testing
21/ Development of methodology and application of Real World Evidence (RWE) in clinical practice and pharmaceutical research
The study will focus on the development and implementation of the RWE methodology, which integrates data from real-world clinical practice to optimize healthcare decision-making and to support innovation in pharmaceutical research. The project includes:
- Analysis of available data sources (electronic health records, patient registries, data from insurance companies).
- Development of analytical methods for processing large datasets.
- Identification of appropriate clinical and epidemiological questions that can be addressed by RWE.
- Presentation of results with emphasis on the population impact of pharmacological treatment innovations.
Supervisor prof. MUDr. Ondřej Slanař, Ph.D. (ondrej.slanar@lf1.cuni.cz)
University Charles University, First Faculty of Medicine, Institute of Pharmacology
Parc area Preclinical in-vivo testing
22/ Surface Energy Heterogeneity of Particulate Matter
The surface properties of particulate materials play a crucial role in key processes within drug production and application. Variations in surface energy significantly influence interfacial interactions such as wetting, cohesion, and adhesion, which in turn affect critical pharmaceutical processes like granulation, coating, and dissolution. However, real-world particulate systems rarely exhibit uniform or perfectly smooth surfaces. Instead, they demonstrate heterogeneities in surface energy distribution, which can impact material behaviour, including flowability, mixing, wettability, and physical or chemical stability. This project aims to systematically investigate the heterogeneity of surface energy in particulate matter and its implications for pharmaceutical formulation and processing.
The research will employ a combination of experimental and computational methods to characterize surface energy variations and their impact on material behaviour. Studies will focus on how processing conditions influence surface heterogeneity and, consequently, key performance attributes such as dissolution and bioavailability. Computational approaches will complement experimental data, helping to model and predict the effects of surface heterogeneity. The expected outcomes of this research include a deeper understanding of particulate interactions, improved strategies for surface modifications (e.g., coating, granulation), and insights into how drug formulations interact with biological fluids. These findings have the potential to enhance drug efficacy and stability, ultimately contributing to the development of more effective pharmaceutical products.
Supervisor Ing. Jan Patera, Ph.D. (Jan.Patera@vscht.cz)
University University of Chemistry and Technology, Department of Organic Technology
Parc area Preformulation and solid state analysis
23/ Sameness evaluation – Development and Application of Methods for Demonstrating the Equivalence of Active Ingredients in Generic Drugs
This dissertation focuses on the development and application of advanced analytical methods to establish proof of the sameness of active ingredients, particularly peptides, proteins and nucleotides, in generic pharmaceuticals and complex mixtures. The aim of the research is to optimise characterisation techniques, including chemical, physical and biological analyses, using orthogonal approaches. Emphasis will be placed on compliance with FDA and EMA regulatory requirements for pharmaceutical equivalence and bioequivalence.
Supervisor prof. Dr. Ing. Michaela Rumlova(Michaela.Rumlova@vscht.cz)
University University of Chemistry and Technology, Department of Biotechnology
Parc area Preformulation and solid state analysis
March 5. 2025