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Medical devices regulatory framework
Honegr, Jan ; Staša, Josef (advisor) ; Vedral, Josef (referee)
Charles University in Prague, Faculty of Law Department of Administrative law Candidate: PharmDr. Jan Honegr, Ph.D. Supervisor: JUDr. Ing. Josef Staša, CSc. Title of diploma thesis: Medical devices regulatory framework The subject of this diploma thesis is the regulatory framework for the so-called "general" medical devices with a slight overlap in the field of in-vitro medical devices. The presented work aims to describe the impact of the planned change in the regulatory framework for medical devices on economic operators in the field of production and distribution of medical devices in the Czech Republic. In this work I gradually deal with the historical development of the regulatory framework for goods in the European Communities and subsequently the European Union and the specific regulation of for medical devices. I deal in detail with the multilevel regulatory framework and the relationships between its components. I focus in more detail on the key change in the regulatory framework, which is represented by the hitherto ineffective EU Medical Devices Regulation 2017/745 and government bills to prepare the Czech legal system for the adoption of this directly effective European Union legislation. The main parts of the work are chapters 5 and 6 in which, I deal with the potential impacts of the...
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Utilisation of electromigration methods in analysis of naturally occuring compounds
Honegr, Jan ; Pospíšilová, Marie (advisor) ; Urbánek, Marek (referee)
UTILISATION OF ELECTROMIGRATION METHODS IN ANALYSIS OF NATURALLY OCCURING COMPOUNDS Jan Honegr ABSTRACT A transient isotachophoresis-capillary zone electrophoresis (tITP-CZE) method has been developed for pre-concentration and determination of nine analytes: caffeic, chlorogenic, o- coumaric, p-coumaric, ferulic and protocatechuic acid, and kaempferol, quercetin and rutin. The effects of several factors such as control of EOF, pH and concentration of the running buffer, addition of organic solvents and their concentrations, addition of cyclodextrins, the duration of injection and the λ max of UV detection were investigated to find the optimum conditions. Under these conditions, the analytes were separated within 15 min. Linearity was evaluated for concentration range 2.5-37.5µg/ml with R = 0.9924-0.9983; the detection limits (S/N 3:1) ranged from 203ng/ml to 5.556µg/ml. The relative standard deviations of the migration times (peak areas) were between 0.79 and 1.01% (1.34 and 2.13%).
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Hydrophobically laminated nanomembranes
Vlková, Veronika ; Doležal, Pavel (advisor) ; Honegr, Jan (referee)
1 ABSTRACT The diploma thesis first describes the theory biopharmaceutical classification system, it gives a detailed summary of naproxen as the drug used at further in vitro experiments for drug delivery and a brief information about nanofiber membranes in general and their use as drug carriers is also given. Experimental section is focused to in vitro release of naproxen from electrospinning nanofiber membranes with regard to the possibility of the use of lamination. At non-laminated nanofiber membranes with three different concentrations of naproxen (5%, 15% and 30% by weight) the rates of drug release of 90 % amount were very fast, always up to 10 minutes. Total releaseable amount of naproxen was always about 65% of the total drug load in the membrane. The nanofiber membranes laminated with oleoester show always much prolonged time profiles of naproxen released. This deceleration of delivery rates did not excert any negative influence on the total amounts of drug within an therapeutically interesting period of 1 hour.
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Separation and assay of indomethacin and its degradation products by micellar electrokinetic chromatography
Mitlenerová, Dagmar ; Michalíková, Klára (advisor) ; Honegr, Jan (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Analytical Chemistry Candidate: Dagmar Mitlenerová Supervisor: PharmDr. Klára Petrů, Ph.D. Consultant: doc. RNDr. Miroslav Polášek, CSc. Title of Diploma Thesis: Micellar electrokinetic chromatography for the separation and assay of indomethacin and its degradations products A new method of micellar electrokinetic chromatography (MEKC) for analysis of indomethacin and its degradation products, 4-chlorbenzoic acid (4CHBA) and 5-methoxy- 2methy-3indolylacetic acid (MMIAA), was developed and optimized. The separation was carried out in uncoated fused silica capillary (with i.d. 75 µm, total length 33 cm and effective length 24,5 cm) with applied voltage 15 kV and temperature of capillary 25ř C. Wave length for UV detection was 224 nm and 234 nm. The optimized background electrolyte contained: 10mM phosphate buffer, 60mM SDS (pH 7,0) and 10% (v/v) of methanol. Internal standard was 1-naftylacetic acid. Large volume sample stacking method was used for sensitivity enhancement. The mixture of standards was injected hydrodynamically at 100 mBar for 10 s (24% of capillary total length). Voltage -7,5 kV was applied for stacking of the analytes. Polarity was switched to +15 kV (time of switching 1,5 min), when 95% of original...
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Development of Methods for Sensitivity Enhancement in Capillary Zone Electrophoresis of Natural Polyphenolic Compounds with Use of Online Elektromigration Preconcentration Techniques
Honegr, Jan ; Pospíšilová, Marie (advisor) ; Fischer, Jan (referee) ; Dohnal, Jiří (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Analytical Chemistry Candidate Mgr. Jan Honegr Supervisor Doc. RNDr. Marie Pospíšilová, CSc. Title of Doctoral Thesis Development of methods for sensitivity enhancement in capillary zone electrophoresis of natural polyphenolic compounds with use of online electromigration preconcentration techniques The thesis presented is dealing with the development of capillary zone electrophoresis (CZE) with UV detection for the sensitivity enhancement in the analysis of polyphenolic substances of natural origin. Basic principles of capillary electrophoresis, different online preconcentration techniques (including stacking) and corresponding instrumentation are discussed in the theoretical part. Moreover a survey of properties of polyphenolic compounds and of herbal drugs containing such substances is presented in this section. The experimental part is focused on the development and validation of three new analytical procedures with online electrophoretic preconcentration for the assay of polyphenols in plant extracts. The analytes under study were ferulic, chlorogenic, caffeic, p-coumaric, rosmarinic, carnosolic, cinnamic, protocatechuic, vanillic and syringic acid and a group of flavonoids involving quercitrin, quercetin,...
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Hydrophobically laminated nanomembranes
Vlková, Veronika ; Doležal, Pavel (advisor) ; Honegr, Jan (referee)
1 ABSTRACT The diploma thesis first describes the theory biopharmaceutical classification system, it gives a detailed summary of naproxen as the drug used at further in vitro experiments for drug delivery and a brief information about nanofiber membranes in general and their use as drug carriers is also given. Experimental section is focused to in vitro release of naproxen from electrospinning nanofiber membranes with regard to the possibility of the use of lamination. At non-laminated nanofiber membranes with three different concentrations of naproxen (5%, 15% and 30% by weight) the rates of drug release of 90 % amount were very fast, always up to 10 minutes. Total releaseable amount of naproxen was always about 65% of the total drug load in the membrane. The nanofiber membranes laminated with oleoester show always much prolonged time profiles of naproxen released. This deceleration of delivery rates did not excert any negative influence on the total amounts of drug within an therapeutically interesting period of 1 hour.
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Utilisation of electromigration methods in analysis of naturally occuring compounds
Honegr, Jan ; Pospíšilová, Marie (advisor) ; Urbánek, Marek (referee)
UTILISATION OF ELECTROMIGRATION METHODS IN ANALYSIS OF NATURALLY OCCURING COMPOUNDS Jan Honegr ABSTRACT A transient isotachophoresis-capillary zone electrophoresis (tITP-CZE) method has been developed for pre-concentration and determination of nine analytes: caffeic, chlorogenic, o- coumaric, p-coumaric, ferulic and protocatechuic acid, and kaempferol, quercetin and rutin. The effects of several factors such as control of EOF, pH and concentration of the running buffer, addition of organic solvents and their concentrations, addition of cyclodextrins, the duration of injection and the λ max of UV detection were investigated to find the optimum conditions. Under these conditions, the analytes were separated within 15 min. Linearity was evaluated for concentration range 2.5-37.5µg/ml with R = 0.9924-0.9983; the detection limits (S/N 3:1) ranged from 203ng/ml to 5.556µg/ml. The relative standard deviations of the migration times (peak areas) were between 0.79 and 1.01% (1.34 and 2.13%).
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