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Papers by Marzena Jamrógiewicz

Research paper thumbnail of Problematyka lotnych związków organicznych w farmacji

Research paper thumbnail of Direct Human Contact with Siloxanes (Silicones) – Safety or Risk Part 1. Characteristics of Siloxanes (Silicones)

Siloxanes are commonly known as silicones. They belong to the organosilicon compounds and are exc... more Siloxanes are commonly known as silicones. They belong to the organosilicon compounds and are exclusively obtained by synthesis. Their chemical structure determines a range of physicochemical properties which were recognized as unique. Due to the susceptibility to chemical modifications, ability to create short, long or complex polymer particles, siloxanes found an application in many areas of human life. Siloxanes differ in particle size, molecular weight, shape and chemical groups. As a result, this determines the different physico-chemical properties, that directly affect the safety or the risk of their use. The areas that can be a source of danger to human health will be commented in this paper.

Research paper thumbnail of Determination of API content in a pilot-scale blending by near-infrared spectroscopy as a first step method to process line implementation

Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufact... more Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufacturing control of a medicinal product powder mixture containing active pharmaceutical ingredient (API). Aiming at initiating a Process Analytical Technology (PAT) activity, the first step was a stationary mode at-line evaluation. In this, the content of pharmaceutical active compound in the powder mixtures intended to the direct tabletting was estimated based on recorded NIR spectra. Five formulations containing different quantities of API were prepared and analyzed also by a reference method--UV-Vis spectroscopy. A chemometric model was developed for calculation of the API amount in the mixtures. The Principal Component Regression (PCR) and Partial Least Squares (PLS) algorithms were used to obtain a model useful in further implementation for the PAT recommendations, into in-line blending control.

Research paper thumbnail of Consequences of New Approach to Chemical Stability Tests to Active Pharmaceutical Ingredients

There is a great need of broaden look on stability tests of active pharmaceutical ingredients (AP... more There is a great need of broaden look on stability tests of active pharmaceutical ingredients (APIs) in comparison with current requirements contained in pharmacopeia. By usage of many modern analytical methods the conception of monitoring the changes of APIs during initial stage of their exposure to harmful factors has been developed. New knowledge must be acquired in terms of identification of each degradation products, especially volatile ones. Further research as toxicology prediction during in silico studies of determined and identified degradation products is necessary. In silico methods are known as computational toxicology or computer-assisted technologies which are used for predicting toxicology of pharmaceutical substances such as impurities or degradation products. This is a specialized software and databases intended to calculate probability of genotoxicity or mutagenicity of these substances through a chemical structure-based screening process and algorithm specific to ...

Research paper thumbnail of Spectroscopic evaluation on pseudopolymorphs of sodium naproxen

Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Research paper thumbnail of Short term monitor of photodegradation processes in ranitidine hydrochloride observed by FTIR and ATR-FTIR

Journal of Food and Drug Analysis

The effects of degradation of ranitidine hydrochloride exposed to UVB radiation (l = 310 nm) and ... more The effects of degradation of ranitidine hydrochloride exposed to UVB radiation (l = 310 nm) and oxygen in a weathering chamber were studied by Fourier Transform Infrared spectroscopy (FTIR) and Attenuated Total Reflectance Fourier Transform Infrared spectroscopy (ATR-FTIR). ATR-FTIR profile indicated that the degradation was spatially heterogeneous. Significant amounts of photoproducts were detected only in a directly irradiated layer. Major damage/change was reflected in the appearance of broad, extended group of signals near the wavenumber 3600-3200 cm-1 or/and 3500-3400 cm-1. We examined whether FTIR-ATR technique is a great tool to observe the simplest and the first changes on the surface of a substance in powder.

Research paper thumbnail of Experimental and predicted physicochemical properties of monopropanolamine-based deep eutectic solvents

Journal of Molecular Liquids

Research paper thumbnail of Definitions and analytical procedures concerning pharmaceutical compound stability and the shelf-life of the drug product

Research paper thumbnail of Sacharides and their derivatives as pharmaceutical additives

Research paper thumbnail of Light-sensitive medicinal compounds – the actual review of studies and strategies in proceedings

Research paper thumbnail of Studies on the influence of β-cyclodextrin derivatives on the physical stability of famotidine

Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Research paper thumbnail of Recent breakthroughs in the stability testing of pharmaceutical compounds

TrAC Trends in Analytical Chemistry

Research paper thumbnail of Physical and Mechanical Evaluation of Silicone-Based Double-Layer Adhesive Patch Intended for Keloids and Scar Treatment Therapy

Polymers

Growing interest in silicone elastomers for pharmaceutical purposes is due to both their benefici... more Growing interest in silicone elastomers for pharmaceutical purposes is due to both their beneficial material effect for scar treatment and their potential as drug carriers. Regarding their morphological structure, silicone polymers possess unique properties, which enable a wide range of applicability possibilities. The present study focused on developing a double-layer adhesive silicone film (DLASil) by evaluating its physical and mechanical properties, morphology, and stability. DLASil suitability for treatment of scars and keloids was evaluated by measurement of tensile strength, elasticity modulus, and elongation. The results indicated that mechanical and physical properties of the developed product were satisfying.

Research paper thumbnail of Consequences of New Approach of Chemical Stability Tests of Active Pharmaceutical Ingredients (APIs)

Frontiers in Pharmacology

There is a great need of broaden look on stability tests of active pharmaceutical ingredients (AP... more There is a great need of broaden look on stability tests of active pharmaceutical ingredients (APIs) in comparison with current requirements contained in pharmacopeia. By usage of many modern analytical methods the conception of monitoring the changes of APIs during initial stage of their exposure to harmful factors has been developed. New knowledge must be acquired in terms of identification of each degradation products, especially volatile ones. Further research as toxicology prediction during in silico studies of determined and identified degradation products is necessary. In silico methods are known as computational toxicology or computer-assisted technologies which are used for predicting toxicology of pharmaceutical substances such as impurities or degradation products. This is a specialized software and databases intended to calculate probability of genotoxicity or mutagenicity of these substances through a chemical structure-based screening process and algorithm specific to a given software program. Applying of new analytical approach is proposed as the usage of PAT tools, XRD, HS-SPME GC-MS/MS, LC-MS/MS for stability testing. Described improvements should be taken into account in case of each drug existing already in the market as well as being implemented as new one.

Research paper thumbnail of Direct Human Contact with Siloxanes (Silicones) – Safety or Risk Part 1. Characteristics of Siloxanes (Silicones)

Frontiers in Pharmacology

Siloxanes are commonly known as silicones. They belong to the organosilicon compounds and are exc... more Siloxanes are commonly known as silicones. They belong to the organosilicon compounds and are exclusively obtained by synthesis. Their chemical structure determines a range of physicochemical properties which were recognized as unique. Due to the susceptibility to chemical modifications, ability to create short, long or complex polymer particles, siloxanes found an application in many areas of human life. Siloxanes differ in particle size, molecular weight, shape and chemical groups. As a result, this determines the different physico-chemical properties, that directly affect the safety or the risk of their use. The areas that can be a source of danger to human health will be commented in this paper.

Research paper thumbnail of Forced Degradation Studies of Ivabradine and In Silico Toxicology Predictions for Its New Designated Impurities

Frontiers in Pharmacology, 2016

All activities should aim to eliminate genotoxic impurities and/or protect the API against degrad... more All activities should aim to eliminate genotoxic impurities and/or protect the API against degradation. There is a necessity to monitor impurities from all classification groups, hence ivabradine forced degradation studies were performed. Ivabradine was proved to be quite durable active substance, but still new and with insufficient stability data. Increased temperature, acid, base, oxidation reagents and light were found to cause its degradation. Degradation products were determined with the usage of HPLC equipped with Q-TOF-MS detector. Calculations of pharmacological and toxicological properties were performed for six identified degradation products. Target prediction algorithm was applied on the basis of Hyperpolarization-activated cyclic nucleotide-gated cation channels, as well as more general parameters like logP and aqueous solubility. Ames test and five cytochromes activities were calculated for toxicity assessment for selected degradation products. Pharmacological activity of photodegradation product (UV4), which is known as active metabolite, was qualified and identified. Two other degradation compounds (Ox1 and N1), which were formed during degradation process, were found to be pharmacologically active.

Research paper thumbnail of Influence of β-Cyclodextrin on Coupling Reactions of o-Nitrobenzenediazonium Salt with Pyrrole

ChemInform, 2006

ABSTRACT ChemInform is a weekly Abstracting Service, delivering concise information at a glance t... more ABSTRACT ChemInform is a weekly Abstracting Service, delivering concise information at a glance that was extracted from about 200 leading journals. To access a ChemInform Abstract, please click on HTML or PDF.

Research paper thumbnail of Double layer adhesive silicone dressing as a potential dermal drug delivery film in scar treatment

International journal of pharmaceutics, Jan 15, 2015

The present studies focused on the evaluation of design of an adhesive silicone film intended for... more The present studies focused on the evaluation of design of an adhesive silicone film intended for scar treatment. Developed silicone double layer film was examined in terms of its future relevance to therapy and applicability on the human skin considering properties which included in vitro permeability of water vapor and oxygen. In order to adapt the patches for medical use in the future there were tested such properties as in vitro adhesion and occlusion related to in vivo hydration. From the silicone rubbers double layer silicone film was prepared: a non-adhesive elastomer as a drug carrier (the matrix for active substances - enoxaparin sodium - low molecular weight heparin) and an adhesive elastomer, applied on the surface of the matrix. The novel adhesive silicone film was found to possess optimal properties in comparison to commercially available silicone dressing: adhesion in vivo, adhesion in vitro - 11.79N, occlusion F=85% and water vapor permeability in vitro - WVP=105g/m(2...

Research paper thumbnail of Determination of API content in a pilot-scale blending by near-infrared spectroscopy as a first step method to process line implementation

Acta poloniae pharmaceutica

Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufact... more Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufacturing control of a medicinal product powder mixture containing active pharmaceutical ingredient (API). Aiming at initiating a Process Analytical Technology (PAT) activity, the first step was a stationary mode at-line evaluation. In this, the content of pharmaceutical active compound in the powder mixtures intended to the direct tabletting was estimated based on recorded NIR spectra. Five formulations containing different quantities of API were prepared and analyzed also by a reference method--UV-Vis spectroscopy. A chemometric model was developed for calculation of the API amount in the mixtures. The Principal Component Regression (PCR) and Partial Least Squares (PLS) algorithms were used to obtain a model useful in further implementation for the PAT recommendations, into in-line blending control.

Research paper thumbnail of Determination of the chemical structure of potential organic impurities occurring in the drug substance opipramol

Die Pharmazie, 2010

The tricyclic antipsychotic and antidepressant drug opipramol (opipramole) was examined with rega... more The tricyclic antipsychotic and antidepressant drug opipramol (opipramole) was examined with regard to the chemical structure of its organic impurities. Impurities were isolated from the technical product by chromatographic methods and their chemical structures were established by 1H NMR, MS and FTIR and further confirmed by comparison with commercially available products or with products obtained by independent synthesis, and in one case additionally by X-ray structure analysis.

Research paper thumbnail of Problematyka lotnych związków organicznych w farmacji

Research paper thumbnail of Direct Human Contact with Siloxanes (Silicones) – Safety or Risk Part 1. Characteristics of Siloxanes (Silicones)

Siloxanes are commonly known as silicones. They belong to the organosilicon compounds and are exc... more Siloxanes are commonly known as silicones. They belong to the organosilicon compounds and are exclusively obtained by synthesis. Their chemical structure determines a range of physicochemical properties which were recognized as unique. Due to the susceptibility to chemical modifications, ability to create short, long or complex polymer particles, siloxanes found an application in many areas of human life. Siloxanes differ in particle size, molecular weight, shape and chemical groups. As a result, this determines the different physico-chemical properties, that directly affect the safety or the risk of their use. The areas that can be a source of danger to human health will be commented in this paper.

Research paper thumbnail of Determination of API content in a pilot-scale blending by near-infrared spectroscopy as a first step method to process line implementation

Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufact... more Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufacturing control of a medicinal product powder mixture containing active pharmaceutical ingredient (API). Aiming at initiating a Process Analytical Technology (PAT) activity, the first step was a stationary mode at-line evaluation. In this, the content of pharmaceutical active compound in the powder mixtures intended to the direct tabletting was estimated based on recorded NIR spectra. Five formulations containing different quantities of API were prepared and analyzed also by a reference method--UV-Vis spectroscopy. A chemometric model was developed for calculation of the API amount in the mixtures. The Principal Component Regression (PCR) and Partial Least Squares (PLS) algorithms were used to obtain a model useful in further implementation for the PAT recommendations, into in-line blending control.

Research paper thumbnail of Consequences of New Approach to Chemical Stability Tests to Active Pharmaceutical Ingredients

There is a great need of broaden look on stability tests of active pharmaceutical ingredients (AP... more There is a great need of broaden look on stability tests of active pharmaceutical ingredients (APIs) in comparison with current requirements contained in pharmacopeia. By usage of many modern analytical methods the conception of monitoring the changes of APIs during initial stage of their exposure to harmful factors has been developed. New knowledge must be acquired in terms of identification of each degradation products, especially volatile ones. Further research as toxicology prediction during in silico studies of determined and identified degradation products is necessary. In silico methods are known as computational toxicology or computer-assisted technologies which are used for predicting toxicology of pharmaceutical substances such as impurities or degradation products. This is a specialized software and databases intended to calculate probability of genotoxicity or mutagenicity of these substances through a chemical structure-based screening process and algorithm specific to ...

Research paper thumbnail of Spectroscopic evaluation on pseudopolymorphs of sodium naproxen

Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Research paper thumbnail of Short term monitor of photodegradation processes in ranitidine hydrochloride observed by FTIR and ATR-FTIR

Journal of Food and Drug Analysis

The effects of degradation of ranitidine hydrochloride exposed to UVB radiation (l = 310 nm) and ... more The effects of degradation of ranitidine hydrochloride exposed to UVB radiation (l = 310 nm) and oxygen in a weathering chamber were studied by Fourier Transform Infrared spectroscopy (FTIR) and Attenuated Total Reflectance Fourier Transform Infrared spectroscopy (ATR-FTIR). ATR-FTIR profile indicated that the degradation was spatially heterogeneous. Significant amounts of photoproducts were detected only in a directly irradiated layer. Major damage/change was reflected in the appearance of broad, extended group of signals near the wavenumber 3600-3200 cm-1 or/and 3500-3400 cm-1. We examined whether FTIR-ATR technique is a great tool to observe the simplest and the first changes on the surface of a substance in powder.

Research paper thumbnail of Experimental and predicted physicochemical properties of monopropanolamine-based deep eutectic solvents

Journal of Molecular Liquids

Research paper thumbnail of Definitions and analytical procedures concerning pharmaceutical compound stability and the shelf-life of the drug product

Research paper thumbnail of Sacharides and their derivatives as pharmaceutical additives

Research paper thumbnail of Light-sensitive medicinal compounds – the actual review of studies and strategies in proceedings

Research paper thumbnail of Studies on the influence of β-cyclodextrin derivatives on the physical stability of famotidine

Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Research paper thumbnail of Recent breakthroughs in the stability testing of pharmaceutical compounds

TrAC Trends in Analytical Chemistry

Research paper thumbnail of Physical and Mechanical Evaluation of Silicone-Based Double-Layer Adhesive Patch Intended for Keloids and Scar Treatment Therapy

Polymers

Growing interest in silicone elastomers for pharmaceutical purposes is due to both their benefici... more Growing interest in silicone elastomers for pharmaceutical purposes is due to both their beneficial material effect for scar treatment and their potential as drug carriers. Regarding their morphological structure, silicone polymers possess unique properties, which enable a wide range of applicability possibilities. The present study focused on developing a double-layer adhesive silicone film (DLASil) by evaluating its physical and mechanical properties, morphology, and stability. DLASil suitability for treatment of scars and keloids was evaluated by measurement of tensile strength, elasticity modulus, and elongation. The results indicated that mechanical and physical properties of the developed product were satisfying.

Research paper thumbnail of Consequences of New Approach of Chemical Stability Tests of Active Pharmaceutical Ingredients (APIs)

Frontiers in Pharmacology

There is a great need of broaden look on stability tests of active pharmaceutical ingredients (AP... more There is a great need of broaden look on stability tests of active pharmaceutical ingredients (APIs) in comparison with current requirements contained in pharmacopeia. By usage of many modern analytical methods the conception of monitoring the changes of APIs during initial stage of their exposure to harmful factors has been developed. New knowledge must be acquired in terms of identification of each degradation products, especially volatile ones. Further research as toxicology prediction during in silico studies of determined and identified degradation products is necessary. In silico methods are known as computational toxicology or computer-assisted technologies which are used for predicting toxicology of pharmaceutical substances such as impurities or degradation products. This is a specialized software and databases intended to calculate probability of genotoxicity or mutagenicity of these substances through a chemical structure-based screening process and algorithm specific to a given software program. Applying of new analytical approach is proposed as the usage of PAT tools, XRD, HS-SPME GC-MS/MS, LC-MS/MS for stability testing. Described improvements should be taken into account in case of each drug existing already in the market as well as being implemented as new one.

Research paper thumbnail of Direct Human Contact with Siloxanes (Silicones) – Safety or Risk Part 1. Characteristics of Siloxanes (Silicones)

Frontiers in Pharmacology

Siloxanes are commonly known as silicones. They belong to the organosilicon compounds and are exc... more Siloxanes are commonly known as silicones. They belong to the organosilicon compounds and are exclusively obtained by synthesis. Their chemical structure determines a range of physicochemical properties which were recognized as unique. Due to the susceptibility to chemical modifications, ability to create short, long or complex polymer particles, siloxanes found an application in many areas of human life. Siloxanes differ in particle size, molecular weight, shape and chemical groups. As a result, this determines the different physico-chemical properties, that directly affect the safety or the risk of their use. The areas that can be a source of danger to human health will be commented in this paper.

Research paper thumbnail of Forced Degradation Studies of Ivabradine and In Silico Toxicology Predictions for Its New Designated Impurities

Frontiers in Pharmacology, 2016

All activities should aim to eliminate genotoxic impurities and/or protect the API against degrad... more All activities should aim to eliminate genotoxic impurities and/or protect the API against degradation. There is a necessity to monitor impurities from all classification groups, hence ivabradine forced degradation studies were performed. Ivabradine was proved to be quite durable active substance, but still new and with insufficient stability data. Increased temperature, acid, base, oxidation reagents and light were found to cause its degradation. Degradation products were determined with the usage of HPLC equipped with Q-TOF-MS detector. Calculations of pharmacological and toxicological properties were performed for six identified degradation products. Target prediction algorithm was applied on the basis of Hyperpolarization-activated cyclic nucleotide-gated cation channels, as well as more general parameters like logP and aqueous solubility. Ames test and five cytochromes activities were calculated for toxicity assessment for selected degradation products. Pharmacological activity of photodegradation product (UV4), which is known as active metabolite, was qualified and identified. Two other degradation compounds (Ox1 and N1), which were formed during degradation process, were found to be pharmacologically active.

Research paper thumbnail of Influence of β-Cyclodextrin on Coupling Reactions of o-Nitrobenzenediazonium Salt with Pyrrole

ChemInform, 2006

ABSTRACT ChemInform is a weekly Abstracting Service, delivering concise information at a glance t... more ABSTRACT ChemInform is a weekly Abstracting Service, delivering concise information at a glance that was extracted from about 200 leading journals. To access a ChemInform Abstract, please click on HTML or PDF.

Research paper thumbnail of Double layer adhesive silicone dressing as a potential dermal drug delivery film in scar treatment

International journal of pharmaceutics, Jan 15, 2015

The present studies focused on the evaluation of design of an adhesive silicone film intended for... more The present studies focused on the evaluation of design of an adhesive silicone film intended for scar treatment. Developed silicone double layer film was examined in terms of its future relevance to therapy and applicability on the human skin considering properties which included in vitro permeability of water vapor and oxygen. In order to adapt the patches for medical use in the future there were tested such properties as in vitro adhesion and occlusion related to in vivo hydration. From the silicone rubbers double layer silicone film was prepared: a non-adhesive elastomer as a drug carrier (the matrix for active substances - enoxaparin sodium - low molecular weight heparin) and an adhesive elastomer, applied on the surface of the matrix. The novel adhesive silicone film was found to possess optimal properties in comparison to commercially available silicone dressing: adhesion in vivo, adhesion in vitro - 11.79N, occlusion F=85% and water vapor permeability in vitro - WVP=105g/m(2...

Research paper thumbnail of Determination of API content in a pilot-scale blending by near-infrared spectroscopy as a first step method to process line implementation

Acta poloniae pharmaceutica

Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufact... more Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufacturing control of a medicinal product powder mixture containing active pharmaceutical ingredient (API). Aiming at initiating a Process Analytical Technology (PAT) activity, the first step was a stationary mode at-line evaluation. In this, the content of pharmaceutical active compound in the powder mixtures intended to the direct tabletting was estimated based on recorded NIR spectra. Five formulations containing different quantities of API were prepared and analyzed also by a reference method--UV-Vis spectroscopy. A chemometric model was developed for calculation of the API amount in the mixtures. The Principal Component Regression (PCR) and Partial Least Squares (PLS) algorithms were used to obtain a model useful in further implementation for the PAT recommendations, into in-line blending control.

Research paper thumbnail of Determination of the chemical structure of potential organic impurities occurring in the drug substance opipramol

Die Pharmazie, 2010

The tricyclic antipsychotic and antidepressant drug opipramol (opipramole) was examined with rega... more The tricyclic antipsychotic and antidepressant drug opipramol (opipramole) was examined with regard to the chemical structure of its organic impurities. Impurities were isolated from the technical product by chromatographic methods and their chemical structures were established by 1H NMR, MS and FTIR and further confirmed by comparison with commercially available products or with products obtained by independent synthesis, and in one case additionally by X-ray structure analysis.