Now showing 1 - 10 of 19
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    Bootstrap analysis for dissolution similarity factor f2 - bringing confidence for borderline results – a case study
    (Macedonian Pharmaceutical Association in cooperation with Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy., 2022)
    Tina Achkoska
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    Marijana Bozhinovska
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    Angela Arnaudova
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    Packa Antovska
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    In vitro dissolution testing is one of the most important tools for characterizing the performance of oral solid dosage forms. In order to demonstrate similarity between test and reference product, comparative dissolution profiles are performed. Selection of a suitable method for comparison of the dissolution profile of the reference product and the test product is of great importance especially in the case of biowaivers when similarity assessment is based on the in vitro data only. Various approaches have been developed for the comparison of dissolution profiles, however the usage of the f2 similarity factor is widely accepted due to its simplicity. When the conditions for using f2 similarity factor are not fulfilled due to high variable dissolution profiles, f2 bootstrap method is then recommended. The focus of this study is to see whether it is benefitial f2 bootstrap analysis to replace the usage of simple f2 for comparison of dissolution profiles that fulfill the prerequisites for using the f2 method in cases when borderline f2 results are obtained.
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    Mineral enrichment of milk – nutritional benefits and future perspectives
    (Macedonian Pharmaceutical Association, 2020-10-29)
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    Zhivikj, Zoran
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    The role of alcohol and patterns of alcohol-related deaths in Republic of North Macedonia within the period 2007-2020
    (Springer Link, 2023-11-10)
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    Zhivikj, Zoran
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    Excessive alcohol consumption is one of the most important factors in a substantial number of violent deaths. The aim of our study was to investigate alcohol-related deaths in the Republic of North Macedonia in the period from 2007 to 2020, in order to study the influence of elevated blood alcohol levels in violent deaths. Five hundred sixty-four post-mortem blood samples from alcohol-related death cases-natural deaths and violent deaths (suicides, accidents, and homicides)-were analyzed, and the results were evaluated according to sex, age, and cause of death. Among 564 cases, traffic accidents were the leading cause of violent death (54.3% of the cases) followed by suicides (19.9% of the cases). In the examined post-mortem samples, BAC values ranged from 0.15-6.20 g/L. The average age was 45 ± 16 years for the male and 49 ± 19 years for the female group. The biggest proportion of high BAC values was found in the group of accidents specifically road traffic accidents and accidental intoxication as well as in the group of bolus deaths. The analysis of BAC in the cases of violent deaths in the Republic of North Macedonia confirmed that consumption of alcohol is strongly related to violent deaths. The data obtained from this study could raise caution and give aid in a national strategy for the prevention of alcohol-related violent deaths.
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    A stability-indicating HPLC method for determination of folic acid and its related substances in tablets
    (Macedonian Pharmaceutical Association in cooperation with Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy., 2022)
    Kristina Grncharoska
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    Elena Lazarevska Todevska
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    Irena Slavevska Spirevska
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    Tanja Bakovska Stoimenova
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    In this study, a simple stability-indicating HPLC method for determination of folic acid and its related substances in tablets was optimized and validated. Chromatographic separation was performed on Inertsil C8, 250 x 4.6 mm, 5 μm, using isocratic elution with mobile phase consisting of methanol and phosphate buffer (pH=6,4) (12:88, v/v %). The injection volume was 5 μL and the eluted compounds were monitored at 280 nm. The flow rate was 0.7 mL/min and the column temperature was maintained at 30 ˚C. Forced degradation studies were conducted to investigate the stability-indicating ability of the method. The method was validated according to the ICH guideline requirements with respect to selectivity/specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. The results from the forced degradation study confirmed satisfactory resolution between folic acid and obtained specified impurities (imp. A, imp. C, imp. D, imp. E and PABA) as well as satisfactory resolution between all other formed degradation products, proving that the method is stability-indicating. The optimized and validated method is selective and precise, capable of detecting and quantifying all folic acid related substances. The obtained results from validation parameters imply that the proposed method is suitable for its purpose and can be used for routine quantification of folic acid and its related substances in tablets.
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    PCA based screening for melamine adulteration in supplements for sport nutrition using vibrational spectroscopy tools
    (Macedonian Pharmaceutical Association, 2023-09)
    Shutevska, Kristina
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    Bajatovska, Ana Marija
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    Zivikj, Zoran
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    Rapid quantification models for assessing melamine adulteration in sport nutrition supplements via benchtop and portable NIRS instruments
    (Elsevier, 2024-09-05)
    Kristina Shutevska
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    Ana Marija Bajatovska
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    Zoran Zhivikj
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    Marija Zafirova Gjorgievska
    Sport nutrition supplements (SNS) are vulnerable to adulteration with melamine, artificially augmenting their protein content as determined by conventional assay methodologies. Vibrational spectroscopy techniques are suitable for the detection of adulteration because they allow rapid analysis, require minimal sample preparation, and can perform numerous analyses in a short time. The aim of this study was to develop rapid quantification models for the determination of melamine adulteration in a variety of SNS matrices using NIRS (near-infrared spectroscopy) in combination with multivariate data processing. Moreover, a comparison of benchtop and portable NIR instruments was carried out. Employing a stepwise approach involving OPLS-DA and PLS analysis, matrix discrimination and prediction ability were investigated. The benchtop instrument effectively discriminated among matrices (R2Y = 0.964, Q2 = 0.933), while the portable device, although showing a slightly altered pattern, maintained favorable discrimination capability (R2Y = 0.966, Q2 = 0.931). The quantitative PLS models for each SNS matrix exhibited comparable statistical indicators for both instruments with reasonable errors for melamine content estimation and prediction (RMSEE: 0.3-2.4 %, RMSEP: 0.98-2.99 %). Higher estimation and prediction errors were observed for protein-containing samples in both acquisition modes, probably due to the tendency of protein agglomeration and adhesion to different surfaces, which affects the homogeneity of the powder. Despite data loss due to the narrower spectral range and lower resolution of the portable instrument, all models were found to be suitable for predicting melamine content in sport nutrition supplements.
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    Effect of prebiotic content on functional and physicochemical properties of Lactobacillus casei loaded chitosan-Ca-alginate microparticles
    (Macedonian Pharmaceutical Association, 2012-10)
    Petreska Ivanovska, Tanja
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    <jats:p>This study aims to evaluate the influence of different concentrations of fructooligosaccharide (FOS) as prebiotic on functional and physicochemical properties of Lactobacillus casei loaded chitosan-Ca-alginate microparticles prepared by spray-drying method, after preparation and 6-month storage at 4 °C. Prebiotic compound positively influenced the viability of L. casei during preparation of the microparticles and in storage conditions, while no significant difference of the probiotic viability was observed when different concentrations of FOS in a range of 1.5 - 5% w/w were applied. Having in regard that non-significant improvement in the functional and physicochemical properties of the microparticles with increased content of the FOS was observed, the concentration of 1.5% w/w was recommended as an optimal for preparation of synbiotic loaded microparticles.</jats:p>
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    Chemometrics approach for optimization of capillary electrophoretic conditions for the separation of insulin analogues
    (Avoxa - Mediengruppe Deutscher Apotheker Gmb, 2021-11-01)
    B Pajaziti,
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    M Andrási,
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    D Nebija,
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    B A Pajaziti,
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    Six insulin analogues with high degree of chemical similarity were separated using Capillary Electrophoresis (CE). In order to improve the method performance, optimization and development the Design of Experiment (DoE) approach has been used and this strategy provided related statistical models. This methodology delivered the information regarding the influence of main factors in the method development and explained the interaction of relevant factors in terms of shortening the analysis time. The response surface methodology (RSM) design employing Central Composite Face Centered (CCF) Design analyzed the effect of the most influencing factors, including background electrolyte pH and concentration, applied voltage and temperature. This study demonstrated that the approach of analyzing the influence of each parameter in the migration behavior of analyzed peptides was capable to assess the best electrophoretic conditions for the separation of insulin analogues.
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    The impact of doxycycline use in periodontitis related periopatogens
    (International Dental Journal and Elsevier, 2024-10)
    Spiro Spasovski
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    Lindita Zendeli Bexheti
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    Ivana Nedelkovska
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    Principal component analysis of sensory attributes of calcium- and magnesium enriched milk
    (Macedonian Pharmaceutical Association, 2020-10-29)
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    Zhivikj, Zoran
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    Shutevska, Kristina
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