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Article: Determination of Bupropion and Its Impurities via a Chaotropic Chromatography Method Following Analytical Quality-by-Design Principles for Method Development.

Gkountanas, Kostas / Malenović, Anđelija / Dotsikas, Yannis

2022 Volume 15, Issue 10

Abstract: A novel chaotropic chromatography method for the quantitative determination of bupropion and its impurities, following analytical quality-by-design (AQbD) principles, is presented. The analytical target profile (ATP) was defined on the basis of the ... ...

Abstract	A novel chaotropic chromatography method for the quantitative determination of bupropion and its impurities, following analytical quality-by-design (AQbD) principles, is presented. The analytical target profile (ATP) was defined on the basis of the efficient separation and reliable determination of bupropion and its five impurities in tablets. Preliminary experiments revealed the need for the addition of a gradient elution part. A screening fractional factorial experimental design was employed to select the critical method parameters (CMPs) and a Box-Behnken design (BBD) was utilized to investigate their influence on predefined critical method attributes (CMAs). In order to compute the design space (DS), where CMPs meet predefined acceptance limits with a high level of probability (
Language	English
Publishing date	2022-09-28
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2193542-7
ISSN	1424-8247
ISSN	1424-8247
DOI	10.3390/ph15101196
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Article: Dissolution Assay of Bupropion/Naltrexone Hydrochloride Salts of Bilayer Composition Tablets Following the Development and Validation of a Novel HPLC Method.

Apostolidi, Anna / Protopapa, Chrystalla / Siamidi, Angeliki / Vlachou, Marilena / Dotsikas, Yannis

Materials (Basel, Switzerland)

2022 Volume 15, Issue 23

Abstract: Compounded medicinal products containing bupropion hydrochloride (BUP·HCl) and naltrexone hydrochloride (NTX·HCl) are available as adjunct therapy for the management of weight in obese/overweight adults. The present work describes the development and ... ...

Abstract	Compounded medicinal products containing bupropion hydrochloride (BUP·HCl) and naltrexone hydrochloride (NTX·HCl) are available as adjunct therapy for the management of weight in obese/overweight adults. The present work describes the development and validation of a novel RP-HPLC method for a simultaneous quantitation during the dissolution of both drugs from compounded bilayer composition tablets. The method involves a Nucleosil 100-3 C-18 column (4.6 × 150 mm) and a mobile phase of a 70%/30%
Language	English
Publishing date	2022-11-27
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2487261-1
ISSN	1996-1944
ISSN	1996-1944
DOI	10.3390/ma15238451
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Article ; Online: Determination of Response Factors for Analytes Detected during Migration Studies, Strategy and Internal Standard Selection for Risk Minimization.

Kritikos, Nikolaos / Bletsou, Anna / Konstantinou, Christina / Neofotistos, Antonios-Dionysios / Kousoulos, Constantinos / Dotsikas, Yannis

Molecules (Basel, Switzerland)

2023 Volume 28, Issue 15

Abstract: Migration studies are one of the few domains of pharmaceutical analysis employing wide-scope screening methodologies. The studies involve the detection of contaminants within pharmaceutical products that arise from the interaction between the formulation ...

Abstract	Migration studies are one of the few domains of pharmaceutical analysis employing wide-scope screening methodologies. The studies involve the detection of contaminants within pharmaceutical products that arise from the interaction between the formulation and materials. Requiring both qualitative and quantitative data, the studies are conducted using Liquid Chromatography or Gas Chromatography coupled to a mass spectrometer (LC-MS and GC-MS). While mass spectrometry allows wide-scope analyte detection and identification at the very low Analytical Evaluation Threshold (AET) levels used in these studies, MS detectors are far from "universal response" detectors. Regulation brings the application of uncertainty factors into the picture to limit the risk of potential analytes detected escaping report and further evaluation; however, whether the application of a default value can cover any or all relevant applications is still debatable. The current study evaluated the response of species usually detected in migration studies, generating a suitable representative sample, analyzing said species, and creating a strategy and evaluation mechanism for acceptable classification of the detected species. Incorporating novel methodologies, i.e., Design of Experiments (DoE) for Design Space generation, the LC-MS-based methodology is also evaluated for its robustness in changes performed.
MeSH term(s)	Gas Chromatography-Mass Spectrometry ; Mass Spectrometry ; Chromatography, Liquid/methods
Language	English
Publishing date	2023-07-31
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	1413402-0
ISSN	1420-3049 ; 1431-5165 ; 1420-3049
ISSN (online)	1420-3049
ISSN	1431-5165 ; 1420-3049
DOI	10.3390/molecules28155772
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Article: Dried Blood Spots in Neonatal Studies: A Computational Analysis for the Role of the Hematocrit Effect.

Daousani, Chrysa / Karalis, Vangelis / Loukas, Yannis L / Schulpis, Kleopatra H / Alexiou, Konstantinos / Dotsikas, Yannis

Pharmaceuticals (Basel, Switzerland)

2023 Volume 16, Issue 8

Abstract: Dried blood spot (DBS) microsampling is extensively employed in newborn screening (NBS) and neonatal studies. However, the impact of variable neonatal hematocrit (Ht) values on the results can be a source of analytical error, and the use of fixed Ht for ... ...

Abstract	Dried blood spot (DBS) microsampling is extensively employed in newborn screening (NBS) and neonatal studies. However, the impact of variable neonatal hematocrit (Ht) values on the results can be a source of analytical error, and the use of fixed Ht for calibration (Ht
Language	English
Publishing date	2023-08-10
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2193542-7
ISSN	1424-8247
ISSN	1424-8247
DOI	10.3390/ph16081126
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Article ; Online: The relationship between neurotransmission-related amino acid blood concentrations and neuropsychological performance following acute exercise.

Parthimos, Theodore P / Schulpis, Kleopatra H / Karousi, Alexandra D / Loukas, Yannis L / Dotsikas, Yannis

Applied neuropsychology. Adult

2022 , Page(s) 1–15

Abstract: Amino acid neurotransmitters, including glutamate, phenylalanine, tyrosine, alanine, and glycine, underlie the majority of the excitatory and inhibitory neurotransmission in the nervous system, and acute exercise has been shown to modulate their ... ...

Abstract	Amino acid neurotransmitters, including glutamate, phenylalanine, tyrosine, alanine, and glycine, underlie the majority of the excitatory and inhibitory neurotransmission in the nervous system, and acute exercise has been shown to modulate their concentrations. We aimed to determine whether any correlation exists between the above-mentioned amino acid blood concentrations and the neuropsychological performance after an acute exercise intervention. Sixty basketball players were randomly assigned to one of two experimental conditions: exercise or inactive resting. All participants underwent a comprehensive neuropsychological assessment and blood samples were taken on a Guthrie card before and after the end of the experimental conditions. Amino acid blood concentrations were significantly elevated and cognitive performance significantly improved post-exercise on specific neuropsychological assessments. Significant intervention × group interaction effects were apparent for Trail Making Test part-B [F(1,58) = 20.46,
Language	English
Publishing date	2022-02-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	2673736-X
ISSN	2327-9109 ; 2327-9095
ISSN (online)	2327-9109
ISSN	2327-9095
DOI	10.1080/23279095.2022.2043327
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Zs.A 4952: Show issues

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Article ; Online: Utilization of a Single Experimental Design for the Optimization of Furosemide Modified-Release Tablet Formulations.

Vlachou, Marilena / Siamidi, Angeliki / Dotsikas, Yannis

Current drug delivery

2019 Volume 16, Issue 10, Page(s) 931–939

Abstract: Background: The loop diuretic drug furosemide is widely used for the treatment of edema in various conditions, such as pulmonary, cardiac and hepatic edema, as well as cardiac infarction. Furosemide, due to its poor water solubility and low ... ...

Abstract	Background: The loop diuretic drug furosemide is widely used for the treatment of edema in various conditions, such as pulmonary, cardiac and hepatic edema, as well as cardiac infarction. Furosemide, due to its poor water solubility and low bioavailability after oral administration of conventional dosage form, is categorized as class IV in the biopharmaceutical classification system. Objective: In the case of furosemide, this release profile is responsible for various physiological problems, acute diuresis being the most serious. This adverse effect can be circumvented by the modified release of furosemide from tablet formulations compared to those forms designed for immediate release. Methods: In this report, a D-optimal combined experimental design was applied for the development of furosemide containing bilayer and compression coated tablets, aiming at lowering the drug's burst release in the acidic environment of the stomach. A D-optimal combined design was selected in order to include all requirements in one design with many levels for the factors examined. The following responses were selected as the ones reflecting better criteria for the desired drug release: dissolution at 120 min (30-40%), 300 min (60-70%) and 480 min >95%. The new formulations, suggested by the Doptimal combined design, incorporated different grades of Eudragit ® polymers (Eudragit® E100 and Eudragit® L100-55), lactose monohydrate and HPMC K15M. The dissolution profile of furosemide from these systems was probed via in vitro dissolution experiments in buffer solutions simulating the pH of the gastrointestinal tract. Results: The results indicate that the use of Eudragit® E100 in conjunction with lactose monohydrate led to 21.32-40.85 % drug release, in the gastric medium, in both compression-coated and bilayer tablets. This is lower than the release of the mainstream drug Lasix® (t=120 min, 44.5% drug release), implying longer gastric retention and drug waste minimization. Conclusion: Furosemide's release in the intestinal environment, from compression coated tablets incorporating Eudragit® L100-55 and HPMC K15M in the inner core or one of the two layers of the bilayer tablets, was delayed, compared to Lasix®.
MeSH term(s)	Drug Compounding ; Drug Liberation ; Furosemide/chemical synthesis ; Furosemide/chemistry ; Research Design ; Tablets
Chemical Substances	Tablets ; Furosemide (7LXU5N7ZO5)
Language	English
Publishing date	2019-11-11
Publishing country	United Arab Emirates
Document type	Journal Article
ZDB-ID	2185284-4
ISSN	1875-5704 ; 1567-2018
ISSN (online)	1875-5704
ISSN	1567-2018
DOI	10.2174/1567201816666191029130324
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Zs.A 6415: Show issues

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Article ; Online: Hematocrit effect on dried blood spots in adults: a computational study and theoretical considerations.

Daousani, Chrysa / Karalis, Vangelis / Malenović, Anđelija / Dotsikas, Yannis

Scandinavian journal of clinical and laboratory investigation

2019 Volume 79, Issue 5, Page(s) 325–333

Abstract: Dried blood spots (DBS) are formed by deposition of a small amount of blood on specific adsorbent paper and its physical drying. DBS are employed as a sampling method in several fields of life sciences and drug research. A concern about DBS is the so- ... ...

Abstract	Dried blood spots (DBS) are formed by deposition of a small amount of blood on specific adsorbent paper and its physical drying. DBS are employed as a sampling method in several fields of life sciences and drug research. A concern about DBS is the so-called 'Hematocrit (Ht) effect', as a different Ht leads, due to different viscosity, to different spot size, affecting assay bias. Solutions have been proposed, including the correction of quantified concentrations with a suitable correction factor. In order to quantitatively assess Ht impact on the DBS measurements, a computational approach was developed and implemented in R
MeSH term(s)	Adult ; Calibration ; Computer Simulation ; Dried Blood Spot Testing/methods ; Female ; Hematocrit ; Humans ; Male ; Models, Theoretical ; Probability
Language	English
Publishing date	2019-06-01
Publishing country	England
Document type	Journal Article
ZDB-ID	3150-1
ISSN	1502-7686 ; 0036-5513
ISSN (online)	1502-7686
ISSN	0036-5513
DOI	10.1080/00365513.2019.1622033
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Ud II Zs.150: Show issues

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Article ; Online: Quantitation and evaluation of perinatal medium-chain and long-chain acylcarnitine blood concentrations in 12,000 full-term breastfed newborns.

Manta-Vogli, Penelope D / Schulpis, Kleopatra H / Loukas, Yannis L / Dotsikas, Yannis

Journal of pediatric endocrinology & metabolism : JPEM

2021 Volume 34, Issue 8, Page(s) 1023–1030

Abstract: Objectives: Medium-chain (MCA) and long-chain acylcarnitine (LCA) blood concentrations play a significant role in the fatty acid (FA) oxidation process, especially during the first days of life. Identification of their abnormal concentrations, : ... ...

Abstract	Objectives: Medium-chain (MCA) and long-chain acylcarnitine (LCA) blood concentrations play a significant role in the fatty acid (FA) oxidation process, especially during the first days of life. Identification of their abnormal concentrations, Methods: Breastfed full-term infants (n = 12,000, 6,000 males, 6,000 females) with BW 2,000-3,999 g were divided into four equal groups: Group A, 2,000-2,499 g, B 2,500-2,999 g, C 3,000-3,499 g, and D 3,500-3,999 g. Samples were collected as DBS and acylcarnitines were determined Results: MCA and LCA blood concentrations were determined significantly lower in group A (low birth weight infants) in both sexes. Infants with BW > 3,500 g (group D), were characterized by lower levels of C10, C10:1, C14, C14:1 acylcarnitines and higher levels of C16 and C18:1 acylcarnitines, as compared to the other groups of this study. Conclusions: Concentration patterns in full-term breastfed newborns in relation to sex and mainly BW found in this study could be very helpful for neonatologists, especially for newborns of group A.
MeSH term(s)	Biomarkers/blood ; Birth Weight ; Breast Feeding/statistics & numerical data ; Carnitine/analogs & derivatives ; Carnitine/blood ; Carnitine/chemistry ; Female ; Follow-Up Studies ; Humans ; Infant, Newborn ; Lipid Metabolism, Inborn Errors/blood ; Lipid Metabolism, Inborn Errors/diagnosis ; Male ; Neonatal Screening/methods ; Prognosis
Chemical Substances	Biomarkers ; acylcarnitine ; Carnitine (S7UI8SM58A)
Language	English
Publishing date	2021-06-24
Publishing country	Germany
Document type	Evaluation Study ; Journal Article
ZDB-ID	1231070-0
ISSN	2191-0251 ; 0334-018X
ISSN (online)	2191-0251
ISSN	0334-018X
DOI	10.1515/jpem-2020-0741
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Zs.A 2258: Show issues

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Article ; Online: Achievements in robotic automation of solvent extraction and related approaches for bioanalysis of pharmaceuticals.

Alexovič, Michal / Dotsikas, Yannis / Bober, Peter / Sabo, Ján

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

2018 Volume 1092, Page(s) 402–421

Abstract: Currently, the growing demand on quick, easy and ecological sample pretreatment methods is unquestionable. Such challenge involves also approaches focusing on the analysis of pharmaceuticals and other endogenous compounds in biological matrices, termed ... ...

Abstract	Currently, the growing demand on quick, easy and ecological sample pretreatment methods is unquestionable. Such challenge involves also approaches focusing on the analysis of pharmaceuticals and other endogenous compounds in biological matrices, termed as Bioanalysis. Solvent extraction such as liquid-liquid extraction (LLE), derived liquid phase microextraction (LPME) and related approaches such as solid liquid extraction (SLE), proved to be applicable in bioanalysis, as numerous papers have been published in this field. However, their manual performances may suffer from a long-term and laborious preparation, due to the inherent complexity of the biological samples. A high sample-throughput (enabling measurement of tens or hundreds of samples on a daily basis) can be achieved when automation of sample pretreatment is performed, resulting in decreased imprecision and low waste production of hazardous solvents and risky biological materials. Here, robotic systems have a key role, especially when multiple processing (e.g., 96-well plate format) and coupling to modern analytical instrumentation (e.g. LC-MS) are combined. A thorough overview on the up-to-date automations of LLE, LPME, SLE and solid LLE via robotics, is therefore presented. Pharmaceuticals and related compounds determined in classical liquid biological samples (i.e. plasma/serum, whole blood, urine, saliva etc.) and modern dried matrix spots (DMS) were considered as analytes of interest. The methodologies were critically compared to manual setups and among themselves.
MeSH term(s)	Automation, Laboratory ; Liquid-Liquid Extraction ; Pharmaceutical Preparations/analysis ; Pharmaceutical Preparations/chemistry ; Pharmaceutical Preparations/isolation & purification ; Robotics ; Solvents/chemistry
Chemical Substances	Pharmaceutical Preparations ; Solvents
Language	English
Publishing date	2018-08-15
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	1180823-8
ISSN	1873-376X ; 0378-4347 ; 1570-0232 ; 1387-2273
ISSN (online)	1873-376X
ISSN	0378-4347 ; 1570-0232 ; 1387-2273
DOI	10.1016/j.jchromb.2018.06.037
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Zs.A 813: Show issues

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Article ; Online: Chemometrically Assisted Optimization of Pregabalin Fluorescent Derivatization Reaction with a Novel Xanthone Analogue and Validation of the Method for the Determination of Pregabalin in Bulk via a Plate Reader.

Kritikos, Nikolaos / Iliou, Aikaterini / Kalampaliki, Amalia D / Gikas, Evangelos / Kostakis, Ioannis K / Michel, Benoît Y / Dotsikas, Yannis

Molecules (Basel, Switzerland)

2022 Volume 27, Issue 6

Abstract: Quantitation of chromophore-free analytes is always a challenge. To this purpose, derivatization of the analyte constitutes a common strategy, leading to a product with a strong signal. In the current study, a novel xanthone analogue was utilized for the ...

Abstract	Quantitation of chromophore-free analytes is always a challenge. To this purpose, derivatization of the analyte constitutes a common strategy, leading to a product with a strong signal. In the current study, a novel xanthone analogue was utilized for the first time for the derivatization of pregabalin, a model analyte with a primary amine moiety that lacks a chromophore. The fact that only the xanthene-based derivative, formed after the derivatization reaction fluoresces, enables avoiding its chromatographic separation from the reagent and thus reducing the analysis time of a series of samples in 1-2 min via a plate reader. The reaction conditions were optimized via a central composite design (CCD), with fluorescence signal as the measure of the yield. The following factors that affect the derivatization reaction were chosen: (a) temperature, (b) reaction time, and (c) triethylamine solution volume used to drive the reaction to completion. After the identification of the optimal conditions, the method was validated according to ICH guidelines, using a fluorescence plate reader for signal measurement (λ
MeSH term(s)	Amines ; Coloring Agents ; Indicators and Reagents ; Pregabalin ; Xanthones
Chemical Substances	Amines ; Coloring Agents ; Indicators and Reagents ; Xanthones ; Pregabalin (55JG375S6M)
Language	English
Publishing date	2022-03-17
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	1413402-0
ISSN	1420-3049 ; 1431-5165 ; 1420-3049
ISSN (online)	1420-3049
ISSN	1431-5165 ; 1420-3049
DOI	10.3390/molecules27061954
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Zs.MO 81: Show issues

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