Makedonsko Farmacevtski Bilten最新文献

{"title":"Application of ATR-FTIR as a screening method for analysis of biopharmaceutical preparations containing trastuzumab","authors":"Hrisanta Godzo, Olga Gigopulu, Jelena Acevska, Nikola Geskovski, Ana Poceva Panovska, Bobi Acevski, Frosina Dimoska, Marija Nuneva, Katerina Brezovska","doi":"10.33320/maced.pharm.bull.2023.69.03.124","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.124","url":null,"abstract":"In recent years, the number of therapeutic proteins introduced to the biopharmaceutical market has increased significantly, as medicine research and development have focused on protein-based therapies. Along with the introduction of biosimilar and biobetter medicines, the competitiveness of the biopharmaceutical market has grown considerably (Torres-Obreque et al., 2022). As a result, there is a global emergence of falsified biopharmaceuticals, especially monoclonal antibodies (mAbs), including trastuzumab, a humanized IgG1 mAb used as HER2-targeted therapy for the treatment of breast cancer (Maadi et al., 2021). In most of the seized falsified samples of medicines declared to contain mAbs (trastuzumab, rituximab, bevacizumab), no active pharmaceutical ingredient (API) was detected (Janvier et al, 2018). Therefore, suitable testing strategy and workflow should be defined in cases where falsification is suspected. Taking into account that mAbs are predominantly glycoproteins of high molecular weight (~ 150 kDa) with complex higher-order structure, their characterization can be rather challenging. Most of the analytical methods used for protein identification and characterization of mAbs (chromatography, electrophoresis, mass spectrometry and nuclear magnetic resonance) are time-consuming, expensive and require extensive sample preparation (Alhazmi et al., 2023). Therefore, implementation of fast, simple, and direct screening tools is of vast importance for the analytical quality control of these medicines. The use of vibrational spectroscopic techniques, particularly infrared (Hamla et al., 2022) for characterization of mAbs is drawing more attention since these are rapid and non-destructive methods. In this study, we demonstrate the potential use of Fourier transform infrared (FTIR) spectrophotometry, with attenuated total reflectance (ATR) for identification of trastuzumab in biopharmaceutical preparations.","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"77 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135249531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk-based assessment of the possibility for falsification during post-marketing surveillance of medicines","authors":"Angela Arsovska, Jelena Acevska Acevska, Katerina Brezovska, Hrisanta Godzo, Aneta Dimitrovska","doi":"10.33320/maced.pharm.bull.2023.69.03.112","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.112","url":null,"abstract":"The prevalence of falsified medicines and the figures undoubtedly differ between countries (WHO, 2017); nonetheless it is necessary to establish an effective system for post-marketing surveillance of the quality of medicines on a national level, in order to monitor, detect and diminish the appearance of substandard and falsified medicines on the market (Pisani et al., 2021). In most lowand middleincome countries, post-marketing surveillance is often limited to sporadic sampling or the collection of medicine samples as part of routine inspections. This may be due to poor planning, unclear oversight objectives, and/or limitations in the methodology for sampling or analysis. This means that while regulatory agencies may spend significant resources on medicine sourcing and analysis, these efforts often result in poor quality data that cannot be used to make evidence-based decisions (PQM, 2018). Additionally, the limited capacity of quality control laboratories and large quantities of medicines that need to be analyzed suggest that a risk-based approach can prioritize activities accordingly (EDQM, 2020). Article 30 of the Guidance on the manner of quality control of medicines of Republic North Macedonia (Official gazette, 2021) stipulates that all segments of trade should be covered when sampling medicines for regular quality control and the geographical and demographic criteria should be taken into account as well. However, there is no targeted strategy for identification and subsequently sampling of medicines that, at some point, may be at a higher risk of being falsified. The aim of this paper is to depict the critical aspects of market surveillance of medicines, which would facilitate the transition from a sporadic to a risk-based postmarketing surveillance program for monitoring of the quality of medicines present on the market in our country.","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"86 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135249532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of surfactant stabilizers on physico-chemical properties of PLGA nanoparticles loaded with tetrahydrocannabinol","authors":"Sara Ristevska, Hristina Litovin, Hrisanta Godzo, Teodora Tasevska, Lina Livrinska, Nikola Geskovski, Katerina Goracinova, Kristina Mladenovska, Renata Slaveska Raichki, Marija Glavash Dodov, Maja Simonoska Crcarevska","doi":"10.33320/maced.pharm.bull.2023.69.03.143","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.143","url":null,"abstract":"In the past years the Cannabis sativa extract has been extensively studied. Its` main components THC, or delta9-tetrahydrocannabinol and cannabidiol are widely researched due to their potential therapeutic benefits such as anti-inflammatory, immunomodulatory, neuroprotective, antioxidant, antiemetic activity etc. However, the limitations for THC medicinal use are related to its` bioavailability challenges such as poor water solubility and peroral bioavailability, rapid metabolism, fast initial half‐life (approximately 6 min) and high protein binding (Lucas et al., 2018). These problems might be overcome by encapsulation of THC into drug delivery carriers, such as nanoparticles. The aim of this study was to design and characterize PLGA nanoparticles loaded with THC by emulsion-based preparation method using two different surfactants as stabilizers.","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135637652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of calcium chloride on physical properties of blended alginate carboxymethyl cellulose wound dressings","authors":"Lina Livrinska, Teodora Tasevska, Dushko Shalabalija, Ljubica Mihailova, Marija Glavash Dodov, Radmil Polenakovikj, Trajche Velkovski, Maja Simonoska Crcarevska","doi":"10.33320/maced.pharm.bull.2023.69.03.144","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.144","url":null,"abstract":"Natural polymers have been used for a variety of biomedical and pharmaceutical applications due to their resemblance of extracellular matrix components. One of these applications is the use of polysaccharides in the fabrication of film wound dressings. Since alginate exhibits excellent film forming properties, in addition to its biocompatibility, it has been used in this research as a primary polymer, alongside with carboxymethyl cellulose. The addition of another polymer, as well as the process of crosslinking, are usual modifications made for the purpose of improving the physical and biological properties of alginate films (Aravamudhan et al.,2014). The aim of this study was to showcase the effect of cationic crosslinking on physical properties of blended alginate carboxymethyl cellulose wound dressing.","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135640555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Step by Step Preparation and Optimization of Lysozyme Hydrophobic Ion Pairing Complex","authors":"Alharith A.A. Hassan, Katalin Kristó, Géza Regdon Jr., Viktória Varga, Edit Csapó, Tamás Sovány","doi":"10.33320/maced.pharm.bull.2023.69.03.139","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.139","url":null,"abstract":"Clinical applications of therapeutically attractive peptides/proteins have been delayed due to several challenges including chemical and physiological barriers. Different approaches were employed to overcome these barriers, for example, by improving the encapsulation of proteins into nanocarriers by hydrophobic ion pairing (HIP) complexation. In this approach, ionizable functional groups of proteins are engaged in electrostatic interactions with a counterion containing one or more hydrophobic moieties resulting in an increased hydrophobicity of such hydrophilic macromolecules and therefore, improving their encapsulation into nanocarriers using, for example, emulsification techniques (Ristroph et al., 2021). A naturally occurring cationic single chain polypeptide lysozyme (LYZ), which is known for its antimicrobial activity, has been commonly employed as a model peptide in nonparenteral dosage forms. In different studies, HIP complex of LYZ with surfactants such as sodium dodecyl sulphate (SDS) was prepared. Variable complexation efficiencies were obtained in these reports as different levels of factors affecting the complexation process were used. For instance, variable pH values of the used mediums were proposed for the optimum complexation (Asuman Bozkır, 2015; Yoo et al., 2001). This study aimed to prepare and optimize the HIP complex of LYZ and SDS with the help of the quality by design (QbD) approach. Risk assessment (RA), as one of the QbD tools, was applied to identify and prioritize different parameters influencing the preparation of such complex. Мaterials and methods","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134918134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The application of carboxylic acids on the surface of titanate nanotubes for further functionalization","authors":"Ranim Saker, Géza Regdon jr., Tamás Sovány","doi":"10.33320/maced.pharm.bull.2023.69.03.138","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.138","url":null,"abstract":"Recently, the accelerated development in the field of nanotechnology brought numerous advantages to many aspects of human life. This rapid growing deserves an exceptional attention as it offers substantial contribution to the world of science with its novel, brilliant nano-sized products. Titanate nanotubes (TNTs) are one of these distinctive nanomaterials which were introduced as a superior replacement for their organic counterparts (carbon nanotubes). The special characteristics of TNTs such as their high mechanical strength, good wettability and biocompatibility make them one of the most promised nanoparticles that were recently discovered (Ranjous et al, 2019; Sipos et al, 2018). Altering surface properties of these newly synthesized materials could be required for several purposes such as reducing toxicity or enhancing permeability (Chia and Leong, 2016; Soenen et al, 2010; Ranjous et al, 2021). For this reason, this study aims to functionalize the surface of TNTs with different types of carboxylic acids (trichloroacetic acid, citric acid and acrylic acid) and investigate their ability to act as possible linkers for further functionalization later with additional molecules like polyethylene glycol (PEG) which supposed to improve aqueous solubility, prolong circulation time, reduce toxicity and prevent aggregation (Lipka et al, 2010; Mano et al, 2012).","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134918140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tracing the cellular uptake of nanostructured lipid carriers as delivery systems for miRNA","authors":"Ivana Ruseska, Amina Tucak-Smajić, Edina Vranić, Andreas Zimmer","doi":"10.33320/maced.pharm.bull.2023.69.03.146","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.146","url":null,"abstract":"Nowadays, nucleic acids are gaining much attention as leading therapeutics. MicroRNAs (miRNAs) are one part of this family of promising tools that can be used in the treatment of numerous diseases. However, the application of miRNAs is limited due to their poor stability and limited cellular uptake. Here, we developed cationic nanostructured lipid carriers (cNLCs) as delivery agents for miRNA. Furthermore, we used human serum album (HSA) as a coat for the cNLCs, to see how it will influence the uptake. These nanoparticles showed favorable physicochemical properties to be used as drug delivery systems, as they successfully complexed miRNA. Therefore, our next goal is to study and understand their cellular uptake. For this purpose, we traced the uptake of the miRNA/cNLCs in two different cell lines (3T3-L1 and MCF-7 cells) under varying experimental conditions.","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135640552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Principal Component Analysis to evaluate the stability impact of protein mutations: the case of SARS-CoV-2 K417T mutation","authors":"Done Stojanov, Marija Glavas Dodov, Aleksandar Velinov, Martina Nestorovska","doi":"10.33320/maced.pharm.bull.2023.69.03.133","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.133","url":null,"abstract":"The severe acute respiratory syndrome CoV-2 (SARSCoV-2), which was initially identified in the Wuhan Province, China spread worldwide rapidly. The intense escalation forced the WHO to declare a pandemic with 6.5 million deaths worldwide. The SARS-CoV-2 virus has a wide host range, as it uses the angiotensin-converting enzyme 2 (ACE2) as a target receptor in humans. A 211 amino acid region at the C-terminal domain of the S1 subunit of the coronavirus as the receptor/binding domain was identified through structural and biochemical analyses. This plays a crucial role in virus entry and is the main target of the host immune responses. The RBD mediates contact with the ACE2 receptor and RBD region in SARS-CoV-2 varies from the one in other SARS-CoV viruses in the five residues critical for ACE2 binding. As a result of these changes, the interaction of SARS-CoV-2 with its receptor stabilizes the two virus-binding hotspots on the surface of hACE2. Moreover, four-residue motif in the RBM of SARS-CoV2 leads to a more compact conformation of its hACE2binding bridge. While the SARS-CoV-2 S protein lost some of its key mutations which are associated with higher infectivity (Stojanov, 2021), many SARS-CoV-2 variants possess stronger virulence and infectivity and can produce immune escape. Several RBD residues mutated independently in multiple lineages. The RBD residues 331–524 of the Spike protein have been a prime focus in many studies. These mutations include N501Y in the Alpha, Beta, Gamma, and Omicron variants; K417 mutated to N in the Beta, Delta, and Omicron variants and to T in the Gamma variant, and E484 mutated to K in the Beta and Gamma variants and to A in the Omicron variant. The purpose of this study was to examine and analyse the impact of K417T mutation upon SARS-CoV-2 Sprotein/hACE2 complex stability through the process of PCA analysis.","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134918135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predictive model for determination of relative ABCB1 gene expression in different tissues","authors":"Zorica Naumovska, Aleknsandra Kapedanovska Nestorovska, Maja Simonoska Crcarevska, Zoran Sterjev, Aleksandar Dimovski, Ljubica Shuturkova","doi":"10.33320/maced.pharm.bull.2023.69.03.134","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.134","url":null,"abstract":"The ABCB1 gene has 14 single nucleotide polymorphisms that are associated with the pharmacokinetic response to drugs (Wang and Sadée, 2006). Three of them (C1236T, C3435T and G2677T/A are subject of most intensive research and their influence on the expression and activity of P-glycoprotein in humans and the pharmacokinetics of drugs that are substrates of this transporter has been confirmed with the large number of studies evaluating the influence of haplotype inheritance (Fukui et al., 2007; Wang et al., 2005). The aim of this paper is to create a predictive model that will be able to determine the relative expression of the ABCB1 gene in the blood and the correlation with the expression in the brain, liver, kidney, duodenum, jejunum, ileum and colon.","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134918141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fast, simple HPLC method for determination of Spironolactone related compounds","authors":"Marjan Piponski, Irena Slaveska Spirevska, Tanja Bakovska Stoimenova, Kristina Grncharoska, Martina Miloshevska, Milena Prculovska, Marika Bogoevska, Stefan Stefov","doi":"10.33320/maced.pharm.bull.2023.69.03.129","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.129","url":null,"abstract":"Spironolactone is chemically 7α-Acetylthio-17αhydroxy-3-oxopregn-4-ene-21-carboxylic acid γ-lactone. Spironolactone is a steroid and is renal competitive aldosterone antagonist which belongs to the class called potassium-sparing diuretic. Spironolactone acts initially via competitive binding of receptors at the aldosteronedependent sodium-potassium exchange site. This antagonism effect increases the excretion of water and sodium, while decreasing the excretion of potassium (K+ sparing diuretic). Due to this mechanism Spironolactone acts as a diuretic and also as an antihypertensive drug and is indicated for the treatment of congestive heart failure, oedema and ascites in cirrhosis and primary hyperaldosteronism. It is also used for treating hair loss and acne in women, adult acne vulgaris and can be used as a topical medication for treatment of male baldness (Hegazy at al., 2011). We develop and optimize an analytical method for the determination of related substances of Spironolactone that will be time efficient, robust, and with proven performance and the possibility of efficient separation of Spironolactone from the related substances listed as requirements in the monograph for Spironolactone in the European Pharmacopoeia (European Pharmacopoeia, 2023).","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"198 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134918142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}