Trends in the Analysis of Biopharmaceuticals by HPLC

2020 ◽  
Vol 16 (1) ◽  
pp. 52-58
Author(s):  
Angela Tartaglia ◽  
Marcello Locatelli ◽  
Victoria Samanidou
Keyword(s):  
Living Organism ◽  
Point Of View ◽  
European Medicines Agency ◽  
Low Molecular Weight ◽  
Immune Disorders ◽  
Biological Drugs ◽  
Post Translational Modifications ◽  
Regulatory Guidelines ◽  
Structural Point

Background: Biopharmaceuticals are biological drugs consisting of a complex compound that can be produced by a living organism or derive from it. Biopharmaceuticals are very complicated compounds from structural point of view and for this reason, they cannot be fully characterized in terms of their structure with current analytical methods as it happens instead of low molecular weight chemicals drugs. Introduction: The regulatory guidelines require the characterization of the primary or higher sequence of these molecules and the characterization of any post-translational modifications. The use of biopharmaceuticals has really grown in the last few years: in 2016, the number of biopharmaceuticals approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in humans’ diseases was 1357. From 2013 to 2016, 73 of these compounds were approved for the treatment of cancer, inflammation, immune disorders, infections, anemia and cardiovascular diseases. Aim/Conclusion: The aim of the present review is to provide an overview of recent approaches for the characterization of biopharmaceutical products in HPLC that have been presented in the literature in the last years.

scholarly journals Crystallographic and structural characterization of heterometallic platinum compounds Part VII. Heterohepta- and heterooctanuclear clusters

2014 ◽  
Vol 13 (1) ◽  
Author(s):  
Milan Melnik ◽  
Peter Mikuš ◽  
Clive E. Holloway
Keyword(s):  
Structural Characterization ◽  
Structural Parameters ◽  
Bond Distance ◽  
Point Of View ◽  
Platinum Compounds ◽  
Metal Atoms ◽  
Platinum Clusters ◽  
Structural Point

AbstractThis review classifies and analyzes over fifty heterohepta- and heterooctanuclear platinum clusters. There are eight types of metal combinations in heteroheptanuclear: Pt6M, Pt5M2, Pt4M3, Pt3M4, Pt2M5, PtM6, Pt3Hg2Ru2 and Pt2Os3Fe2. The seven metal atoms are in a wide variety of arrangements, with the most common being one in which the central M atom (mostly M(I)) is sandwiched by two M3 triangles. Another arrangement often found is an octahedron of M6 atoms asymmetrically capped by an M atom. The shortest Pt-M bond distances (non-transition and transition) are 2.326(1) Å (M = Ga) and 2.537(6) Å (M = Fe). The shortest Pt-Pt bond distance is 2.576(2) Å.In heterooctanuclear platinum clusters there are eight types of metal combinations: Pt6M2, Pt4M4, Pt3Ru5, Pt2M6, PtM7, Pt2W4Ni2, PtAu6Hg and PtAu5Hg2. From a structural point of view, the clusters are complex with bicapped octahedrons of eight metal atoms prevailing. The shortest Pt-M bond distances (non-transition and transition) are 2.651(3) Å (M = Hg) and 2.624(1) Å (M = Os). The shortest Pt-Pt bond distance is 2.622(1) Å. These values are somewhat longer than those in the heteroheptanuclear clusters. Several relationships between the structural parameters were found, and are discussed and compared with the smaller heterometallic platinum clusters

scholarly journals Structural and Functional Characterization of Low-molecular-weight Heparins: Impact on the Development of Guidelines for Generic Products

2009 ◽  
Vol 15 (2) ◽  
pp. 137-144 ◽  
Author(s):  
Cafer Adiguzel ◽  
Walter P. Jeske ◽  
Debra Hoppensteadt ◽  
Jeanine M. Walenga ◽  
Vinod Bansal ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Functional Characterization ◽  
Current Data ◽  
European Medicines Agency ◽  
Low Molecular Weight ◽  
Low Molecular Weight Heparins ◽  
Biological Drugs ◽  
Biologic Drugs ◽  
The Us ◽  
Us Fda

Low-molecular-weight heparins (LMWHs) are poly-pharmacologic drugs used to treat thrombotic and cardiovascular disorders. Recently, several generic versions of branded LMWHs have been introduced. Although generic versions of LMWHs exhibit similar profiles, marked differences in their biological and pharmacologic properties have been demonstrated. Several studies have demonstrated differences in terms of anti-Xa activity and tissue factor pathway inhibitor release. The current data emphasize the need to consider multiple functional parameters when defining bioequivalence of biologic drugs and also underscore the importance of further pharmacologic studies involving animal and human clinical trials. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are currently developing guidelines for the acceptance of complex biological drugs including LMWHs. The US FDA considers these drugs as follow-on agents whereas the EMEA classifies these drugs as biosimilar agents. Until clear guidelines are developed, generic interchange of LMWHs may not be feasible.

scholarly journals Synthesis and Characterization of Some Ester-type Biolubricants of Soiabean Fatty Acids

2017 ◽  
Vol 54 (2) ◽  
pp. 386-389 ◽  
Author(s):  
Sorina Boran ◽  
Sabina Nitu
Keyword(s):  
Fatty Acids ◽  
Point Of View ◽  
Synthesis And Characterization ◽  
Synthetic Ester ◽  
Microwave Reactor ◽  
Tribotechnical Properties ◽  
Physico Chemical ◽  
Hydroxyl Compounds ◽  
Structural Point

Growing demands from industry for the use of eco-friendly lubricants led research towards finding environmentally friendly products with superior lubricating characteristics. Vegetable oils and synthetic ester oils are competitive base oils used to obtain lubricants with good physico-chemical, rheological and tribotechnical properties, biodegradable lubricants without negative environmental impacts. In this study we aimed the synthesis and characterization of bioesters with lubricant properties, using as acid component the soybean oil fatty acids in conjunction with the following hydroxyl compounds n-buthanol (P1) and 1,2-propilenglycole (P2), respectively. These complex esters were synthesized in a microwave reactor in a single stage in the presence of the catalyst at the reflux temperature. Characterization was carried out in the respective of structural point of view and as a lubricant.

Studies on a Levonorgestrel-Releasing Trade Plastic Device and on a Similar Polyurethane Foam Used as a Levonorgestrel Carrier

2019 ◽  
Vol 56 (3) ◽  
pp. 543-547
Author(s):  
Flavius Olaru ◽  
Dana Stoian ◽  
Delia Berceanu Vaduva ◽  
Alina Corpade ◽  
Florin Birsasteanu ◽  
...  
Keyword(s):  
Skin Irritation ◽  
Oral Route ◽  
Point Of View ◽  
Intrauterine Devices ◽  
Daily Amount ◽  
Pu Foam ◽  
The One ◽  
Structural Point ◽  
Copper Iud

Hormonal Intrauterine Devices (IUD) were developed based on copper IUD with the role to release a daily amount of hormones. From a structural point of view Levonorgestrel-IUD (L-IUD) is a small T-shaped piece of plastic, which contains levonorgestrel. When compared with the oral route of L-IUD administration, it provides some advantages because it releases levonorgestrel directly into the uterus. Our aims were: (1) to compare the thickness of uterine jonctional zone (UJZ) in two groups of patients with and without inserted L-IUD, (2) to evaluate the changes in thickness of UJZ after the insertion of L-IUD in two patients with adenomyosis, and (3) to obtain and to characterize a similar T-shaped polyurethane (PU) foam used as a levonorgestrel delivery system. On the one hand, the results confirm that L-IUD is effective in thinning the UJZ and in the treatment of adenomyosis, while on the other hand, the characterization of the PU materials (Zetasizer measurements, their thermal degradation, UV-Vis spectra and skin irritation tests) revealed that this polymer can be used as a safety and prolonged levonorgestrel carrier.

Masonry: the brittle or plastic material?

2019 ◽  
pp. 22-28
Keyword(s):  
Plastic Material ◽  
Experimental Studies ◽  
Point Of View ◽  
Plastic Properties ◽  
Plastic Deformations ◽  
Base Materials ◽  
Stress States ◽  
Creep Deformations ◽  
Structural Point

The results of experimental studies of masonry on the action of dynamic and static (short-term and long-term) loads are presented. The possibility of plastic deformations in the masonry is analyzed for different types of force effects. The falsity of the proposed approach to the estimation of the coefficient of plasticity of masonry, taking into account the ratio of elastic and total deformations of the masonry is noted. The study of the works of Soviet scientists revealed that the masonry under the action of seismic loads refers to brittle materials in the complete absence of plastic properties in it in the process of instantaneous application of forces. For the cases of uniaxial and plane stress states of the masonry, data on the coefficient of plasticity obtained from the experiment are presented. On the basis of experimental studies the influence of the strength of the so-called base materials (brick, mortar) on the bearing capacity of the masonry, regardless of the nature of the application of forces and the type of its stress state, is noted. The analysis of works of prof. S. V. Polyakov makes it possible to draw a conclusion that at the long application of the load, characteristic for the masonry are not plastic deformations, but creep deformations. It is shown that the proposals of some authors on the need to reduce the level of adhesion of the mortar to the brick for the masonry erected in earthquake-prone regions in order to improve its plastic properties are erroneous both from the structural point of view and from the point of view of ensuring the seismic resistance of structures. It is noted that the proposal to assess the plasticity of the masonry of ceramic brick walls and large-format ceramic stone with a voidness of more than 20% is incorrect, and does not meet the work of the masonry of hollow material. On the basis of the analysis of a large number of research works it is concluded about the fragile work of masonry.

The Analyses of Learning Strategies in English as a Second Language: Theoretical Classification and Measurement Test

2020 ◽  
Vol 4 (2) ◽  
pp. 118-129
Author(s):  
Asti Gumartifa ◽  
◽  
Indah Windra Dwie Agustiani
Keyword(s):  
Language Learning ◽  
Learning Outcomes ◽  
Learning Strategies ◽  
Learning Process ◽  
English Learners ◽  
English Language ◽  
Point Of View ◽  
Effective Learning ◽  
The Impact

Gaining English language learning effectively has been discussed all years long. Similarly, Learners have various troubles outcomes in the learning process. Creating a joyful and comfortable situation must be considered by learners. Thus, the implementation of effective learning strategies is certainly necessary for English learners. This descriptive study has two purposes: first, to introduce the classification and characterization of learning strategies such as; memory, cognitive, metacognitive, compensation, social, and affective strategies that are used by learners in the classroom and second, it provides some questionnaires item based on Strategy of Inventory for Language Learning (SILL) version 5.0 that can be used to examine the frequency of students’ learning strategies in the learning process. The summary of this study explains and discusses the researchers’ point of view on the impact of learning outcomes by learning strategies used. Finally, utilizing appropriate learning strategies are certainly beneficial for both teachers and learners to achieve the learning target effectively.

Crimes against marriage and family before Criminal Code 1968

2020 ◽  
Vol 15 (1-3) ◽  
pp. 44-59
Author(s):  
Lidia Peneva
Keyword(s):  
Criminal Code ◽  
Point Of View ◽  
Marriage And Family ◽  
Historical Method ◽  
Legal Method ◽  
The Subject ◽  
The Republic ◽  
Criminal Groups ◽  
The Moment ◽  
Structural Point

Crimes against marriage and family are a particular group of social relation­ships that the law has defended properly in view of the high public significance and value they enjoy. At the moment they are regulated in Chapter VI, Section I, of the specific part of the Penal Code the Repub­lic of Bulgaria. The subject matter of this Statement will, however, be the legisla­tive provisions concerning these criminal­ized acts in retrospect. The purpose of the study is to show by historical method and through the comparatively legal method the development of these criminal groups during the periods of various criminal laws in Bulgaria. This will also provide a basis for reflection on possible de lege ferenda proposals. This report from a structural point of view will be divided into three distinct points, marking each of the penal laws in the Republic of Bulgaria, which were in force before 1968.

The Algorithm of Characterization of an Action as a Jointly Committed Crime

2018 ◽  
pp. 37-44
Keyword(s):  
Criminal Code ◽  
Point Of View

The article discusses a sequence of activities to identify a crime as jointly committed. The requirements to the algorithm of such activities are formulated. Programme-based and targeted methods applied by the authors allowed detecting a range of stages of the algorithm. The first four stages aim at defining mandatory elements of a crime allowing to characterize it as a jointly committed action. The rest of the stages focus on identifying a type of criminal complicity. In the article, each stage is described. It is emphasized that in each stage there is a special objective. At the same time, all these stages, taken together, constitute a separate module of the program of criminal characterization of an action. From the authors’ point of view, algorithms are necessary not only for detection of crimes and their criminal characterization, but also for answering the question on existence of criminal complicity in each case. Also the authors give their opinions on interpretation of criminal complicity as a legal category. In particular, it is emphasized that not all of crimes merely committed with participation of two or more persons should be understood as jointly committed. It is joint participation that makes a crime jointly committed. Various forms of criminal complicity and types of co-offenders are considered in the article as well. In various crimes, criminal complicity manifests itself differently. Therefore the proposed algorithm can be applied only after identification a specific article of the Russian Criminal Code stipulating the responsibility for the crime committed.

Biopolymers with Medical Applications Optimized method for obtaining chitosan-based delivery systems

2018 ◽  
Vol 69 (7) ◽  
pp. 1756-1759 ◽  
Author(s):  
Luminita Confederat ◽  
Iuliana Motrescu ◽  
Sandra Constantin ◽  
Florentina Lupascu ◽  
Lenuta Profire
Keyword(s):  
Drug Delivery ◽  
Drug Delivery Systems ◽  
Average Diameter ◽  
Delivery Systems ◽  
Cross Linking ◽  
Low Molecular Weight ◽  
Polymeric Systems ◽  
Chitosan Microparticles ◽  
Degree Of Swelling

The aim of this study was to optimize the method used for obtaining microparticles based on chitosan � a biocompatible, biodegradable, and nontoxic polymer, and to characterize the developed systems. Chitosan microparticles, as drug delivery systems were obtained by inotropic gelation method using pentasodiumtripolyphosphate (TPP) as cross-linking agent. Chitosan with low molecular weight (CSLMW) in concentration which ranged between 0.5 and 5 %, was used while the concentration of cross-linking agent ranged between 1 and 5%. The characterization of the microparticles in terms of shape, uniformity and adhesion was performed in solution and dried state. The size of the microparticles and the degree of swelling were also determined. The structure and the morphology of the developed polymeric systems were analyzed by Fourier transform infrared spectroscopy (FTIR) and scanning electron microscopy (SEM).The average diameter of the chitosan microparticles was around 522 �m. The most stable microparticles were obtained using CSLMW 1% and TPP 2% or CSLMW 0.75%and TPP 1%. The micropaticles were spherical, uniform and without flattening. Using CSLMW in concentration of 0.5 % poorly cross-linked and crushed microparticles have been obtained at all TPP concentrations. By optimization of the method, stable chitosan-based micropaticles were obtained which will be used to develop controlled release systems for drug delivery.

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