scholarly journals Detection of Beta-Glucan Contamination in Nanotechnology-Based Formulations

Molecules ◽  
2020 ◽  
Vol 25 (15) ◽  
pp. 3367
Author(s):  
Barry W. Neun ◽  
Edward Cedrone ◽  
Timothy M. Potter ◽  
Rachael M. Crist ◽  
Marina A. Dobrovolskaia
Keyword(s):  
Large Family ◽  
Pharmaceutical Products ◽  
Review Literature ◽  
Long Term Effects ◽  
Beta Glucan ◽  
Drug Products ◽  
Regulatory Guidance ◽  
Immune Mediated ◽  
Beta Glucans ◽  
Anaphylactoid Reactions

Understanding the potential contamination of pharmaceutical products with innate immunity modulating impurities (IIMIs) is essential for establishing their safety profiles. IIMIs are a large family of molecules with diverse compositions and structures that contribute to the immune-mediated adverse effects (IMAE) of drug products. Pyrogenicity (the ability to induce fever) and activation of innate immune responses underlying both acute toxicities (e.g., anaphylactoid reactions or pseudoallergy, cytokine storm) and long-term effects (e.g., immunogenicity) are among the IMAE commonly related to IIMI contamination. Endotoxins of gram-negative bacteria are the best-studied IIMIs in that both methodologies for and pitfalls in their detection and quantification are well established. Additionally, regulatory guidance documents and research papers from laboratories worldwide are available on endotoxins. However, less information is currently known about other IIMIs. Herein, we focus on one such IIMI, namely, beta-glucans, and review literature and discuss the experience of the Nanotechnology Characterization Lab (NCL) with the detection of beta-glucans in nanotechnology-based drug products.

scholarly journals Immunomodulating Effects of Fungal Beta-Glucans: From Traditional Use to Medicine

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1333
Author(s):  
Hidde P. van Steenwijk ◽  
Aalt Bast ◽  
Alie de Boer
Keyword(s):  
Immune System ◽  
Good Health ◽  
Evidence Base ◽  
Health Claims ◽  
Bioactive Molecules ◽  
Current Status ◽  
Beta Glucan ◽  
Traditional Use ◽  
Beta Glucans ◽  
And Function

The importance of a well-functioning and balanced immune system has become more apparent in recent decades. Various elements have however not yet been uncovered as shown, for example, in the uncertainty on immune system responses to COVID-19. Fungal beta-glucans are bioactive molecules with immunomodulating properties. Insights into the effects and function of beta-glucans, which have been used in traditional Chinese medicine for centuries, advances with the help of modern immunological and biotechnological methods. However, it is still unclear into which area beta-glucans fit best: supplements or medicine? This review has highlighted the potential application of fungal beta-glucans in nutrition and medicine, reviewing their formulation, efficacy, safety profile, and immunomodulating effects. The current status of dietary fungal glucans with respect to the European scientific requirements for health claims related to the immune system and defense against pathogens has been reviewed. Comparing the evidence base of the putative health effects of fungal beta-glucan supplements with the published guidance documents by EFSA on substantiating immune stimulation and pathogen defense by food products shows that fungal beta-glucans could play a role in supporting and maintaining health and, thus, can be seen as a good health-promoting substance from food, which could mean that this effect may also be claimed if approved. In addition to these developments related to food uses of beta-glucan-containing supplements, beta-glucans could also hold a novel position in Western medicine as the concept of trained immunity is relatively new and has not been investigated to a large extent. These innovative concepts, together with the emerging success of modern immunological and biotechnological methods, suggest that fungal glucans may play a promising role in both perspectives, and that there are possibilities for traditional medicine to provide an immunological application in both medicine and nutrition.

scholarly journals Insights on the Functional Role of Beta-Glucans in Fungal Immunity Using Receptor-Deficient Mouse Models

2021 ◽  
Vol 22 (9) ◽  
pp. 4778
Author(s):  
Mark Joseph Maranan Desamero ◽  
Soo-Hyun Chung ◽  
Shigeru Kakuta
Keyword(s):  
Mouse Models ◽  
Deficient Mouse ◽  
Beta Glucan ◽  
Downstream Signaling ◽  
Beta Glucans ◽  
Fungal Immunity ◽  
Anti Fungal ◽  
Susceptibility And Resistance ◽  
Deficient Mice

Understanding the host anti-fungal immunity induced by beta-glucan has been one of the most challenging conundrums in the field of biomedical research. During the last couple of decades, insights on the role of beta-glucan in fungal disease progression, susceptibility, and resistance have been greatly augmented through the utility of various beta-glucan cognate receptor-deficient mouse models. Analysis of dectin-1 knockout mice has clarified the downstream signaling pathways and adaptive effector responses triggered by beta-glucan in anti-fungal immunity. On the other hand, assessment of CR3-deficient mice has elucidated the compelling action of beta-glucans in neutrophil-mediated fungal clearance, and the investigation of EphA2-deficient mice has highlighted its novel involvement in host sensing and defense to oral mucosal fungal infection. Based on these accounts, this review focuses on the recent discoveries made by these gene-targeted mice in beta-glucan research with particular emphasis on the multifaceted aspects of fungal immunity.

scholarly journals FACTS ON DRUG REGULATIONS

2018 ◽  
Vol 2 (3) ◽  
pp. 43-47
Author(s):  
Rajkumar Gupta
Keyword(s):  
Life Cycle ◽  
Drug Regulation ◽  
Pharmaceutical Products ◽  
Regulatory Requirements ◽  
Ministry Of Health ◽  
Drug Products ◽  
Drug Regulations ◽  
The Law ◽  
Basic Facts

The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable under the law. Further, compliance is not a one time job but it is an exercise to be performed over the life cycle of the drug products. It starts from development of the products and continues till the product is in market. The information, registration, permission and extensions/withdrawals are the primary regulatory requirements for the drug products. The main focus of drug regulations is to check that safety, quality and efficacy of the drug products over its lifecycle.

scholarly journals Regulatory Requirement and Step for Registration and Approval of Indian Drug Products in Overseas Market

2021 ◽  
Vol 68 (2) ◽  
Author(s):  
Rushikesh Aher ◽  
Pratik Aher ◽  
Tejas Ahire ◽  
Hitesh V. Shahare ◽  
Charulata T. Nemade
Keyword(s):  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Raw Material ◽  
Critical Parameters ◽  
Material Base ◽  
Technical Documentation ◽  
Regulatory Requirement ◽  
Drug Products ◽  
The World ◽  
Overseas Market

The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms of value. It has established itself as a global manufacturing and research hub. A large raw material base and the availability of a skilled workforce give the industry a definite competitive advantage. India has one of the lowest manufacturing costs in the world. The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for Indian companies to develop a single drug that can be simultaneously submitted in all the countries for approval. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. This article covers the processes involved and requirements like import-export code, technical documentation, filing and reviewing process of drug master file, certificate of pharmaceutical product, common technical document (CTD), eCTD, and ACTD, for the registration and approval of Indian drug products in the overseas market.

scholarly journals The Influence of Genotype and Environment on Arabinoxylan and Beta-glucan Contents in Grain of Spring Barley (Hordeum vulgare L.)

2014 ◽  
Vol 62 (3) ◽  
pp. 553-560 ◽  
Author(s):  
Pavel Macháň ◽  
Jaroslava Ehrenbergerová ◽  
Radim Cerkal ◽  
Karolína Benešová ◽  
Kateřina Vaculová
Keyword(s):  
Hordeum Vulgare ◽  
Spring Barley ◽  
Limiting Factors ◽  
Environment Interaction ◽  
Hordeum Vulgare L ◽  
Beta Glucan ◽  
Fungicide Treatment ◽  
Spring Variety ◽  
Beta Glucans ◽  
Growing Environment

Arabinoxylan and beta-glucan contents are limiting factors for a wider use of barley production. Arabinoxylan and beta-glucan contents were assessed in grain samples in sets of seven malting hulled varieties, three hull-less lines and one hull-less spring variety grown in the localities of Branišovice, Žabčice, and Kroměříž in 2009 to 2011. Further, the effect of growing technologies on the level of these non-starch polysaccharides was studied. Variability of arabinoxylan contents was affected most significantly by a genotype and growing technology whereas variability of beta-glucan contents was mostly affected by a genotype and growing environment (interaction of year with locality). The highest values of arabinoxylans and beta-glucans were determined in the grain samples of hull-less lines (KM 1057: 6.16% of arabinoxylans and KM 2084: 6.41% of beta-glucans) and on the contrary, the lowest values of arabinoxylans were found in the grain of hull-less variety AF Lucius (3.85%) and lowest amounts of beta-glucans were found in malting variety Radegast (3.92%). The samples of the growing technology without fungicide treatment had on average more arabinoxylans and beta-glucans than the fungicide non-treated ones.

scholarly journals Impact of yeast sediment beta-glucans on the quality indices of yoghurt

Food systems ◽  
2021 ◽  
Vol 4 (1) ◽  
pp. 12-18
Author(s):  
A. I. Chirsanova ◽  
A. V. Boistean ◽  
N. Chiseliță ◽  
R. Siminiuc
Keyword(s):  
Physicochemical Properties ◽  
Glycemic Index ◽  
Control Sample ◽  
Titratable Acidity ◽  
Laboratory Method ◽  
Beta Glucan ◽  
Food Category ◽  
Fermentation Time ◽  
Beta Glucans ◽  
Low Glycemic Index

The objective of the study was to investigate the potential application of beta-glucans obtained from yeast sediment resulting from the manufacture of local Viorica wine (2018 harvest). To determine the amount of beta-glucans in the yeast sediment, two were used: the calculation method and the laboratory method, obtaining similar quantities, 29.92 ± 0.47 and 28.17 ± 0.32 respectively. The beta -glucans obtained were incorporated in various concentrations (0.1%; 0.2%; 0.3%; 0.4% and 0.5%) in the yogurt obtained from skimmed milk. The effect of beta-glucan addition on the physicochemical properties of freshly prepared yogurts was investigated. The addition of beta-glucans positively influenced the formation of the gel relay resulting in a decrease in the fermentation time of yogurt. The final pH point of 4.5 was reached one hour earlier (in 4 hours) compared to the control sample (in 5 hours). The results showed that there are no significant changes in physicochemical properties (titratable acidity, pH, viscosity and syneresis). The results obtained report that beta-glucans can be used as a thickening agent for low-fat yogurts by shortening the fermentation period and not essentially changing the sensory characteristics. Experimental results showed that the glycemic index of yogurt samples with the addition of beta-glucans have similar values in the range of 28-30. Respectively, the yogurts under study are attributed to food category with low glycemic index.

scholarly journals Effects of cropping system and genotype on variability in important phytonutrients kontent of the barley grain for direct food use

2011 ◽  
Vol 49 (No. 10) ◽  
pp. 443-450 ◽  
Author(s):  
J. Ehrenbergerová ◽  
K. Vaculová ◽  
V. Psota ◽  
P. Havlová ◽  
V. Šerhantová
Keyword(s):  
Chemical Treatment ◽  
Cropping Systems ◽  
Starch Content ◽  
Cropping System ◽  
Barley Grain ◽  
Beta Glucan ◽  
Beta Glucans ◽  
Different Types ◽  
The Mean ◽  
Starch Composition

In a four-year period (1997–2000), selected phytonutrients, of which the beta-glucan content is most important for human health, were studied in caryopses of different types of barley varieties and lines (standard, waxy, hulless) from two cropping systems. It was significantly highest in the waxy variety Washonubet (4.93%). The whole group of waxy types of barley showed a significantly higher mean content of beta-glucans (4.75%) than the varieties with standard starch composition (4.12%), the starch content, however, was significantly higher in standard varieties (61.98%) than in waxy types (60.30%). The hulless varieties, however, had a significantly higher mean starch content (61.73%) than the hulled forms (61.07%) and a significantly higher protein content (13.82% versus 13.00%). The hulless intensive varieties and lines had a significantly higher content of beta-glucans (4.34%) and protein (13.95%) than the hulled intensive varieties (4.07%, 12.65%). Chemical treatment and fertilization increased significantly only the mean content of protein in caryopses (13.77%) compared to the variants with the absence of treatment (13.13%), the content of beta-glucans and starch increased insignificantly (by 0.12% and 0.27%). Years and varieties participated most in the variability of starch content (31.67%, 28.08%), varieties in the content of beta-glucans and protein (per 22%), and (21%) the interaction of varieties and years in the variability of these two nutrients.

scholarly journals Effectiveness of Oat-Hull-Based Ingredient as Fat Replacer to Produce Low Fat Burger with High Beta-Glucans Content

Foods ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. 1057 ◽  
Author(s):  
Carmine Summo ◽  
Davide De Angelis ◽  
Graziana Difonzo ◽  
Francesco Caponio ◽  
Antonella Pasqualone
Keyword(s):  
Lipid Content ◽  
Daily Intake ◽  
Consumer Preference ◽  
Nutritional Composition ◽  
Low Fat ◽  
Beta Glucan ◽  
Fat Replacer ◽  
Beta Glucans ◽  
High Beta ◽  
Cooking Yield

Low-fat beef burgers with high beta-glucan content was obtained using a gel made from an oat-hull-based ingredient as fat replacer. Two levels of fat substitution were considered: 50% (T1) and 100% (T2). The nutritional composition, cooking yield, textural properties, color characteristics and consumer preference were evaluated, in comparison with a burger without fat replacer (CTRL). After cooking, T2 burger showed a significant increase in the cooking yield and a very low lipid content (3.48 g 100 g−1) as well as a level of beta-glucans per single portion (2.96 g 100 g−1) near the recommended daily intake. In T1 burger, the decrease of lipid content was mitigated during the cooking process, because the beta-glucans added had a fat-retaining effect. Compared to CTRL, replacing fat led to a softer texture of cooked burgers evaluated by Texture Profile Analysis. The differences in color, significant in raw burgers, were smoothed with cooking. The consumer evaluation, carried out according to the duo-trio test, highlighted significant differences between CTRL and T2 burgers in terms of odor, taste, color and texture. The consumers expressed a higher preference for the T2 burger, probably due to its softer texture and greater juiciness.

Cross-linking of the beta-glucan receptor on human monocytes results in interleukin-1 receptor antagonist but not interleukin-1 production

Blood ◽  
1993 ◽  
Vol 82 (12) ◽  
pp. 3695-3700 ◽  
Author(s):  
DD Poutsiaka ◽  
M Mengozzi ◽  
E Vannier ◽  
B Sinha ◽  
CA Dinarello
Keyword(s):  
Receptor Antagonist ◽  
Mononuclear Cells ◽  
Human Peripheral Blood ◽  
Interleukin 1 ◽  
Beta Glucan ◽  
Peripheral Blood Mononuclear ◽  
Naturally Occurring ◽  
Beta Glucans ◽  
Or Gene ◽  
Plastic Surfaces

Abstract The beta-glucan receptor, found on monocytes and neutrophils, binds glucose polymers derived from fungi. Ligands for the receptor have various immunomodulatory effects, including increased microbicidal killing activity. We have investigated the effect of beta-glucans on the production of interleukin-1 (IL-1) and its naturally occurring inhibitor, the IL-1 receptor antagonist (IL-1Ra). Particulate beta- glucan induced IL-1Ra production from human peripheral blood mononuclear cells (PBMC) but did not stimulate IL-1 beta synthesis or gene expression in these same cells. Monomeric (soluble) beta-glucan did not induce IL-1Ra production. However, when preincubated with PBMC, monomeric beta-glucan significantly (P <.01) reduced particulate beta- glucan induction of IL-1Ra by 40%, suggesting that crosslinking of beta- glucan receptors is required for induction of IL-1Ra. In support of this, monomeric beta-glucan immobilized on plastic surfaces stimulated IL-1Ra production. Vitamin D3, which increases the functional capacity of beta-glucan receptors, increased IL-1Ra production induced by particulate beta-glucan, whereas dexamethasone suppressed IL-1Ra synthesis. Because of their differential effects on cytokine production, beta-glucans may be used to therapeutic advantage in the diseases in which IL-1 is implicated.

scholarly journals A Randomized Placebo-Controlled Clinical Trial to Evaluate the Medium-Term Effects of Oat Fibers on Human Health: The Beta-Glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT) Study

Nutrients ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 686 ◽  
Author(s):  
Arrigo F.G. Cicero ◽  
Federica Fogacci ◽  
Maddalena Veronesi ◽  
Enrico Strocchi ◽  
Elisa Grandi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lipid Profile ◽  
Plasma Lipids ◽  
Plasma Concentrations ◽  
Well Being ◽  
Controlled Clinical Trial ◽  
Intestinal Health ◽  
Beta Glucan ◽  
Double Blind ◽  
Beta Glucans

The Beta-glucan Effects on Lipid profile, glycemia and inTestinal health (BELT) Study investigated the effect of 3 g/day oat beta-glucans on plasma lipids, fasting glucose and self-perceived intestinal well-being. The Study was an 8-week, double-blind, placebo-controlled, cross-over randomized clinical trial, enrolling a sample of 83 Italian free-living subjects, adherent to Mediterranean diet, with a moderate hypercholesterolemia and a low cardiovascular risk profile. Beta-glucans reduced mean LDL-Cholesterol (LDL-C) levels from baseline by 12.2% (95%CI: −15.4 to −3.8) after 4 weeks of supplementation and by 15.1% (95%CI: −17.8 to −5.9) after 8 weeks of supplementation (p < 0.01 for both comparison and versus placebo). Between baseline and 4 weeks Total Cholesterol (TC) levels showed an average reduction of 6.5% (95%CI: −10.9 to −1.9) in the beta-glucan sequence; while non-HDL-C plasma concentrations decreased by 11.8% (95%CI: −14.6 to −4.5). Moreover, after 8 weeks of beta-glucan supplementation TC was reduced by 8.9% (95%CI: −12.6 to −2.3) and non-HDL-C levels by 12.1% (95%CI: −15.6 to −5.3). Decreses in TC and non HDL-C were significant also versus placebo (respectively p < 0.05 and p < 0.01 to both follow-up visits). Fasting plasma glucose and self-perceived intestinal well-being were not affected by both beta-glucan and placebo supplementation.

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