scholarly journals Development of liposomal drug formulations: quality attributes and methods for quality control

2018 ◽  
pp. 33-39
Author(s):  
E.V. Melnikova ◽  
D.V. Goryachev ◽  
A.A. Chaplenko ◽  
M.A. Vodyakova ◽  
A.R. Sayfutdinova ◽  
...  
Keyword(s):  
Quality Control ◽  
Gel Filtration ◽  
Chemical Properties ◽  
Drug Carriers ◽  
Quality Attributes ◽  
Scanning Calorimetry ◽  
Liposomal Drug ◽  
Wide Range ◽  
Drug Manufacturing ◽  
Major Trend

The use of nanostructured components in drug manufacturing and, more specifically, targeted drug delivery has recently become a major trend in the pharmaceutical industry. Nanodrugs encompass a wide range of pharmaceutical agents containing dendrimers, nanocrystals, micelles, liposomes, and polymer nanoparticles. Liposomes are the most well-studied nanoparticles and effective drug carriers. However, the more complex their structure is, the more process controls are needed and the more quality attributes have to be monitored, including the chemical properties of the liposomal fraction such as the shape, size and charge of the nanoparticle, conjugation efficacy, and distribution of the active ingredient. We believe that quality control of key liposome characteristics should rely on dynamic and laser light scattering coupled with electrophoresis, differential scanning calorimetry, cryo-electron microscopy, nuclear magnetic resonance, laser diffraction analysis, and gel filtration chromatography.

scholarly journals The state of cognitive functions after angioreconstructive operations on the carotid arteries

2019 ◽  
pp. 65-71
Author(s):  
M.M. Tanashyan ◽  
R.B. Medvedev ◽  
O.V. Lagoda ◽  
E.S. Berdnikovich ◽  
S.I. Skrylev ◽  
...  
Keyword(s):  
Gel Filtration ◽  
Chemical Properties ◽  
Drug Carriers ◽  
Scanning Calorimetry ◽  
Wide Range ◽  
Drug Manufacturing ◽  
Major Trend ◽  
Pharmaceutical Agents ◽  
Process Controls ◽  
Resonance Laser

The use of nanostructured components in drug manufacturing and, more specifically, targeted drug delivery has recently become a major trend in the pharmaceutical industry. Nanodrugs encompass a wide range of pharmaceutical agents containing dendrimers, nanocrystals, micelles, liposomes, and polymer nanoparticles. Liposomes are the most well-studied nanoparticles and effective drug carriers. However, the more complex their structure is, the more process controls are needed and the more quality attributes have to be monitored, including the chemical properties of the liposomal fraction such as the shape, size and charge of the nanoparticle, conjugation efficacy, and distribution of the active ingredient. We believe that quality control of key liposome characteristics should rely on dynamic and laser light scattering coupled with electrophoresis, differential scanning calorimetry, cryo-electron microscopy, nuclear magnetic resonance, laser diffraction analysis, and gel filtration chromatography.

scholarly journals Functional Protein-Based Bioinspired Nanomaterials: From Coupled Proteins, Synthetic Approaches, Nanostructures to Applications

2019 ◽  
Vol 20 (12) ◽  
pp. 3054
Author(s):  
Dong Zhang ◽  
Yi Wang
Keyword(s):  
Smart Materials ◽  
Organic Dyes ◽  
Drug Loading ◽  
Chemical Properties ◽  
Water Source ◽  
Drug Carriers ◽  
Functional Protein ◽  
Wide Range ◽  
Bioinspired Nanomaterials ◽  
Synthetic Approaches

Protein-based bioinspired nanomaterials (PBNs) combines the advantage of the size, shape, and surface chemistry of nanomaterials, the morphology and functions of natural materials, and the physical and chemical properties of various proteins. Recently, there are many exciting developments on biomimetic nanomaterials using proteins for different applications including, tissue engineering, drug delivery, diagnosis and therapy, smart materials and structures, and water collection and separation. Protein-based biomaterials with high biocompatibility and biodegradability could be modified to obtain the healing effects of natural organisms after injury by mimicking the extracellular matrix. For cancer and other diseases that are difficult to cure now, new therapeutic methods involving different kinds of biomaterials are studied. The nanomaterials with surface modification, which can achieve high drug loading, can be used as drug carriers to enhance target and trigger deliveries. For environment protection and the sustainability of the world, protein-based nanomaterials are also applied for water treatment. A wide range of contaminants from natural water source, such as organic dyes, oil substances, and multiple heavy ions, could be absorbed by protein-based nanomaterials. This review summarizes the formation and application of functional PBNs, and the details of their nanostructures, the proteins involved, and the synthetic approaches are addressed.

The Synthesis of High Molecular Weight Partially Hydrolysed Poly(vinyl alcohol) Grades Suitable for Nanoparticle Fabrication

2008 ◽  
Vol 8 (11) ◽  
pp. 5739-5747 ◽  
Author(s):  
Jasminder Chana ◽  
Ben Forbes ◽  
Stuart Allen Jones
Keyword(s):  
Vinyl Alcohol ◽  
High Probability ◽  
Chemical Properties ◽  
Synthetic Polymer ◽  
Partial Hydrolysis ◽  
Poly Vinyl Alcohol ◽  
Scanning Calorimetry ◽  
Manufacture Process ◽  
Wide Range ◽  
Hydrolysis Of

Poly(vinyl alcohol) (PVA) is a highly versatile synthetic polymer that is formed by full or partial hydrolysis of poly(vinyl acetate) (PVAc). A wide range of PVA partially hydrolysed grades are commercially available, but the amphiphilic grades of the polymer (30–60% hydrolysis), which probably the most interesting in terms of drug delivery, are not readily available. As a consequence few studies have assessed the application of low hydrolysis PVA polymers to form nanocarriers. The aims of this study were to synthesise amphiphilic grades of PVA on a laboratory scale, analyse their chemical properties and determine whether these grades could be used to form nanoparticles. PVA 30%, PVA 40%, PVA 50% and PVA 60% were synthesised via direct saponification of PVAc. All grades of PVA synthesised had degrees of hydrolysis close to those predicted from the stoichiometry of the saponification reaction. The PVA grades displayed <1.5% batch to batch variability (n = 3) in terms of percentage hydrolysis, demonstrating the manufacture process was both reproducible and predictable. Analysis of the polymer characteristics using 13C nuclear magnetic resonance and differential scanning calorimetry revealed that all PVA grades contained block distributions (i.e., η < 1) of vinyl alcohol monomers (η ranged from 0.33–0.45) with a high probability of adjacency calculated for the hydroxylated units (POH ranged 0.926–0.931). All the grades of PVA formed nanoparticles using a precipitation technique with a trend towards smaller particle size with increasing degree of PVA hydrolysis; PVA 30% resulted in significantly larger nanoparticles (225 nm) compared to PVA 40–60% (137–174 nm).

Physico-Chemical Properties of Recombinant Desulphatohirudin

1990 ◽  
Vol 63 (03) ◽  
pp. 499-504 ◽  
Author(s):  
A Electricwala ◽  
L Irons ◽  
R Wait ◽  
R J G Carr ◽  
R J Ling ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Gel Filtration ◽  
Chemical Properties ◽  
Alpha Helix ◽  
Apparent Molecular Weight ◽  
Correlation Spectroscopy ◽  
Nmr Studies ◽  
Recombinant Hirudin ◽  
Physico Chemical ◽  
Recombinant Molecule

SummaryPhysico-chemical properties of recombinant desulphatohirudin expressed in yeast (CIBA GEIGY code No. CGP 39393) were reinvestigated. As previously reported for natural hirudin, the recombinant molecule exhibited abnormal behaviour by gel filtration with an apparent molecular weight greater than that based on the primary structure. However, molecular weight estimation by SDS gel electrophoresis, FAB-mass spectrometry and Photon Correlation Spectroscopy were in agreement with the theoretical molecular weight, with little suggestion of dimer or aggregate formation. Circular dichroism studies of the recombinant molecule show similar spectra at different pH values but are markedly different from that reported by Konno et al. (13) for a natural hirudin-variant. Our CD studies indicate the presence of about 60% beta sheet and the absence of alpha helix in the secondary structure of recombinant hirudin, in agreement with the conformation determined by NMR studies (17)

Measurements method of the audio recordings acoustic quality indicator prepared for registration and processing in the Unified Biometric System

2019 ◽  
pp. 40-46 ◽  
Author(s):  
V.V. Savchenko ◽  
A.V. Savchenko
Keyword(s):  
Quality Control ◽  
Small Sample Size ◽  
Personal Data ◽  
Digital Processing ◽  
Small Sample ◽  
Practical Implementation ◽  
Acoustic Measurements ◽  
Pitch Frequency ◽  
Wide Range ◽  
Automated Quality Control

We consider the task of automated quality control of sound recordings containing voice samples of individuals. It is shown that in this task the most acute is the small sample size. In order to overcome this problem, we propose the novel method of acoustic measurements based on relative stability of the pitch frequency within a voice sample of short duration. An example of its practical implementation using aninter-periodic accumulation of a speech signal is considered. An experimental study with specially developed software provides statistical estimates of the effectiveness of the proposed method in noisy environments. It is shown that this method rejects the audio recording as unsuitable for a voice biometric identification with a probability of 0,95 or more for a signal to noise ratio below 15 dB. The obtained results are intended for use in the development of new and modifying existing systems of collecting and automated quality control of biometric personal data. The article is intended for a wide range of specialists in the field of acoustic measurements and digital processing of speech signals, as well as for practitioners who organize the work of authorized organizations in preparing for registration samples of biometric personal data.

PLGA+HA/βTCP scaffold incorporating simvastatin: a promising biomaterial for bone tissue engineering

2020 ◽  
Author(s):  
Mariane Beatriz Sordi ◽  
Ariadne Cristiane Cabral da Cruz ◽  
Águedo Aragones ◽  
Mabel Mariela Rodríguez Cordeiro ◽  
Ricardo de Souza Magini
Keyword(s):  
Tissue Engineering ◽  
Bone Tissue Engineering ◽  
Bone Tissue ◽  
Thermal Analyses ◽  
Chemical Properties ◽  
Biological Properties ◽  
Scanning Calorimetry ◽  
Evaporation Technique ◽  
Porosity Analysis ◽  
Biphasic Ceramic

The aim of this study was to synthesize, characterize, and evaluate degradation and biocompatibility of poly(lactic-co-glycolic acid) + hydroxyapatite / β-tricalcium phosphate (PLGA+HA/βTCP) scaffolds incorporating simvastatin (SIM) to verify if this biomaterial might be promising for bone tissue engineering. Samples were obtained by the solvent evaporation technique. Biphasic ceramic particles (70% HA, 30% βTCP) were added to PLGA in a ratio of 1:1. Samples with SIM received 1% (m:m) of this medication. Scaffolds were synthesized in a cylindric-shape and sterilized by ethylene oxide. For degradation analysis, samples were immersed in PBS at 37 °C under constant stirring for 7, 14, 21, and 28 days. Non-degraded samples were taken as reference. Mass variation, scanning electron microscopy, porosity analysis, Fourier transform infrared spectroscopy, differential scanning calorimetry, and thermogravimetry were performed to evaluate physico-chemical properties. Wettability and cytotoxicity tests were conducted to evaluate the biocompatibility. Microscopic images revealed the presence of macro, meso, and micropores in the polymer structure with HA/βTCP particles homogeneously dispersed. Chemical and thermal analyses presented very similar results for both PLGA+HA/βTCP and PLGA+HA/βTCP+SIM. The incorporation of simvastatin improved the hydrophilicity of scaffolds. Additionally, PLGA+HA/βTCP and PLGA+HA/βTCP+SIM scaffolds were biocompatible for osteoblasts and mesenchymal stem cells. In summary, PLGA+HA/βTCP scaffolds incorporating simvastatin presented adequate structural, chemical, thermal, and biological properties for bone tissue engineering.

pH-Dependent Thermal Stability of Vibrio cholerae L-asparaginase

2019 ◽  
Vol 26 (10) ◽  
pp. 743-750 ◽  
Author(s):  
Remya Radha ◽  
Sathyanarayana N. Gummadi
Keyword(s):  
Vibrio Cholerae ◽  
Conformational Changes ◽  
Kinetic Studies ◽  
Structural Features ◽  
Structure Stability ◽  
Kcal Mole ◽  
Scanning Calorimetry ◽  
Wide Range ◽  
Ph Dependent ◽  
Ph Range

Background:pH is one of the decisive macromolecular properties of proteins that significantly affects enzyme structure, stability and reaction rate. Change in pH may protonate or deprotonate the side group of aminoacid residues in the protein, thereby resulting in changes in chemical and structural features. Hence studies on the kinetics of enzyme deactivation by pH are important for assessing the bio-functionality of industrial enzymes. L-asparaginase is one such important enzyme that has potent applications in cancer therapy and food industry.Objective:The objective of the study is to understand and analyze the influence of pH on deactivation and stability of Vibrio cholerae L-asparaginase.Methods:Kinetic studies were conducted to analyze the effect of pH on stability and deactivation of Vibrio cholerae L-asparaginase. Circular Dichroism (CD) and Differential Scanning Calorimetry (DSC) studies have been carried out to understand the pH-dependent conformational changes in the secondary structure of V. cholerae L-asparaginase.Results:The enzyme was found to be least stable at extreme acidic conditions (pH< 4.5) and exhibited a gradual increase in melting temperature from 40 to 81 °C within pH range of 4.0 to 7.0. Thermodynamic properties of protein were estimated and at pH 7.0 the protein exhibited ΔG37of 26.31 kcal mole-1, ΔH of 204.27 kcal mole-1 and ΔS of 574.06 cal mole-1 K-1.Conclusion:The stability and thermodynamic analysis revealed that V. cholerae L-asparaginase was highly stable over a wide range of pH, with the highest stability in the pH range of 5.0–7.0.

Development and Certification of Formononetin Reference Material for Quality Control of Functional Foods and Botanical Supplements

2019 ◽  
Vol 15 (5) ◽  
pp. 553-559
Author(s):  
Ningbo Gong ◽  
Baoxi Zhang ◽  
Kun Hu ◽  
Zhaolin Gao ◽  
Guanhua Du ◽  
...  
Keyword(s):  
Quality Control ◽  
Reference Material ◽  
Functional Foods ◽  
Certified Reference Materials ◽  
Coulometric Titration ◽  
Pharmaceutical Formulations ◽  
Uncertainty Estimation ◽  
Expanded Uncertainty ◽  
Scanning Calorimetry ◽  
Botanical Supplements

Background: Formononetin is a common soy isoflavonoid that can be found abundantly in many natural plants. Previous studies have shown that formononetin possesses a variety of activities which can be applied for various medicinal purposes. Certified Reference Materials (CRMs) play a fundamental role in the food, traditional medicine and dietary supplement fields, and can be used for method validation, uncertainty estimation, as well as quality control. Methods: The purity of formononetin was determined by Differential Scanning Calorimetry (DSC), Coulometric Titration (CT) and Mass Balance (MB) methods. Results: This paper reports the sample preparation methodology, homogeneity and stability studies, value assignment, and uncertainty estimation of a new certified reference material of formononetin. DSC, CT and MB methods proved to be sufficiently reliable and accurate for the certification purpose. The purity of the formononetin CRM was therefore found to be 99.40% ± 0.24 % (k = 2) based on the combined value assignments and the expanded uncertainty. Conclusion: This CRM will be a reliable standard for the validation of the analytical methods and for quality assurance/quality control of formononetin and formononetin-related traditional herbs, food products, dietary supplements and pharmaceutical formulations.

scholarly journals Portable near Infrared Spectroscopy as a Tool for Fresh Tomato Quality Control Analysis in the Field

2021 ◽  
Vol 11 (7) ◽  
pp. 3209
Author(s):  
Karla R. Borba ◽  
Didem P. Aykas ◽  
Maria I. Milani ◽  
Luiz A. Colnago ◽  
Marcos D. Ferreira ◽  
...  
Keyword(s):  
Citric Acid ◽  
Near Infrared ◽  
Prediction Models ◽  
Quality Attributes ◽  
Internal Quality ◽  
Control Analysis ◽  
Tomato Quality ◽  
Wide Range ◽  
Different Types ◽  
Fresh Tomato

Portable spectrometers are promising tools that can be an alternative way, for various purposes, of analyzing food quality, such as monitoring in a few seconds the internal quality during fruit ripening in the field. A portable/handheld (palm-sized) near-infrared (NIR) spectrometer (Neospectra, Si-ware) with spectral range of 1295–2611 nm, equipped with a micro-electro-mechanical system (MEMs), was used to develop prediction models to evaluate tomato quality attributes non-destructively. Soluble solid content (SSC), fructose, glucose, titratable acidity (TA), ascorbic, and citric acid contents of different types of fresh tomatoes were analyzed with standard methods, and those values were correlated to spectral data by partial least squares regression (PLSR). Fresh tomato samples were obtained in 2018 and 2019 crops in commercial production, and four fruit types were evaluated: Roma, round, grape, and cherry tomatoes. The large variation in tomato types and having the fruits from distinct years resulted in a wide range in quality parameters enabling robust PLSR models. Results showed accurate prediction and good correlation (Rpred) for SSC = 0.87, glucose = 0.83, fructose = 0.87, ascorbic acid = 0.81, and citric acid = 0.86. Our results support the assertion that a handheld NIR spectrometer has a high potential to simultaneously determine several quality attributes of different types of tomatoes in a practical and fast way.

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