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Journal of Pharmaceutical Sciences May 2024Development of novel pharmaceutical drug modalities has created a need for frozen storage and transportation. Accurate and easy assessment of container closure integrity...
Development of novel pharmaceutical drug modalities has created a need for frozen storage and transportation. Accurate and easy assessment of container closure integrity (CCI) in frozen conditions remains a challenge. Thus, container closure systems (CCS) suitable for low temperatures have been primarily restricted to vials despite the growing popularity of prefillable syringes (PFS) for parenteral administration. A new dye ingress test method, suitable for testing at low temperatures, was developed and applied to PFS across a range of deep-frozen temperatures. The method is versatile and can easily be extended to other common CCS formats over a wide range of temperatures including storage on dry ice (-80 °C). This new method was paired with an orthogonal technique, laser-based CO headspace gas analysis, to evaluate the CCI of a glass PFS at temperatures from -50 °C to -80 °C. Both test methods showed comparable results and consistent CCI failure below a temperature of -70 °C. The primary mode of failure was the plunger-to-barrel interface, likely attributable to dimensional changes and loss of elasticity. This study demonstrates the temperature dependent CCI behavior of glass PFS and underscores the importance of thorough characterization of package integrity for deep frozen drug products.
Topics: Drug Packaging; Drug Storage; Syringes; Cold Temperature; Freezing; Glass
PubMed: 38070774
DOI: 10.1016/j.xphs.2023.11.033 -
JDS Communications Nov 2023The objective of this research was to evaluate the suitability of whey permeate powder for ice cream. Three white mixes were formulated with equivalent total solids,...
The objective of this research was to evaluate the suitability of whey permeate powder for ice cream. Three white mixes were formulated with equivalent total solids, fat, and carbohydrates, but different concentrations of lactose and added sugar. Vanilla ice creams contained either reduced lactose (RL, 3.8% lactose and 17% added sugar), standard lactose (SL, 5.8%; 15%), or high lactose (HL, 7.8%; 13%). Trained panelists evaluated 8 body and texture, and 6 flavor characteristics through 10 mo of storage. All ice creams maintained low mean scores (<4.0/15.0 cm) for crumbly, lacks freshness, nonfat dry milk flavor, and whey, and moderate mean scores (5.0-8.3/15.0 cm) for gummy, melt rate, melt viscosity, sweet, and vanilla flavor for 10 mo. In mo 1 and 10, consumers in Iowa (n = 94, n = 55) and in mo 4 and 6, consumers in Kansas (n = 44; n = 56) rated the acceptability of the ice creams. Overall acceptability, flavor, and texture acceptability for products did not significantly differ until mo 10, when HL mean scores decreased lower than SL ice cream mean scores. The lower scores are attributed to crumbly and sandy texture defects, noted by trained panelists, only for HL ice cream stored 10 mo. The research demonstrates that whey permeate powder can be used to produce ice creams of acceptable quality for up to 10 mo.
PubMed: 38045891
DOI: 10.3168/jdsc.2023-0382 -
Journal of Oral and Maxillofacial... 2023The process of decoverslipping is often required in a laboratory to review or examine an older slide which tends to fade over time, making it almost impossible to use it...
BACKGROUND
The process of decoverslipping is often required in a laboratory to review or examine an older slide which tends to fade over time, making it almost impossible to use it for research or study purposes. The sections then need to be re-stained which can only be done after removing the coverslip. The traditional method of decoverslipping using xylene is a time-consuming process. Various methods have been used in the past; however, none were found to be completely effective. Dry ice, the solid form of carbon dioxide, is an easily available, cheap cooling agent with a low freezing temperature (-78.5°C) which was evaluated for its efficacy in decoverslipping process, as an alternative to xylene.
MATERIALS AND METHOD
64 faded haematoxylin and eosin (H&E)-stained histopathology slides were randomly selected and segregated, according to duration of year, into eight major groups. Each group was further divided into four subgroups according to the time that the slides were subjected for decoverslipping. The slides were placed on dry ice and the time was set. Once the coverslip was removed, the slides were placed in xylene to remove any residual mountant. The tissue sections were evaluated for physical disfigurement followed by re-staining with H&E to check for any change in tissue morphology.
RESULT
The mean time taken for removal of coverslip using dry ice was 35 seconds.
CONCLUSION
This technique is easy, fast, and effective, with no tissue loss or compromise in staining quality, thereby preventing xylene toxicity and its effect on the environment.
PubMed: 38033942
DOI: 10.4103/jomfp.jomfp_332_22 -
Virus Research Jan 2024Infection with equid herpesvirus 1 (EHV-1), a DNA virus of the Herpesviridae family represents a significant welfare issue in horses and a great impact on the equine...
Infection with equid herpesvirus 1 (EHV-1), a DNA virus of the Herpesviridae family represents a significant welfare issue in horses and a great impact on the equine industry. During EHV-1 infection, entry of the virus into different cell types is complex due to the presence of twelve glycoproteins (GPs) on the viral envelope. To investigate virus entry mechanisms, specific combinations of GPs were pseudotyped onto lentiviral vectors. Pseudotyped virus (PV) particles bearing gB, gD, gH and gL were able to transduce several target cell lines (HEK293T/17, RK13, CHO-K1, FHK-Tcl3, MDCK I & II), demonstrating that these four EHV-1 glycoproteins are both essential and sufficient for cell entry. The successful generation of an EHV-1 PV permitted development of a PV neutralisation assay (PVNA). The efficacy of the PVNA was tested by measuring the level of neutralising serum antibodies from EHV-1 experimentally infected horses (n = 52) sampled in a longitudinal manner. The same sera were assessed using a conventional EHV-1 virus neutralisation (VN) assay, exhibiting a strong correlation (r = 0.82) between the two assays. Furthermore, PVs routinely require -80 °C for long term storage and a dry ice cold-chain during transport, which can impede dissemination and utilisation in other stakeholder laboratories. Consequently, lyophilisation of EHV-1 PVs was conducted to address this issue. PVs were lyophilised and pellets either reconstituted immediately or stored under various temperature conditions for different time periods. The recovery and functionality of these lyophilised PVs was compared with standard frozen aliquots in titration and neutralisation tests. Results indicated that lyophilisation could be used to stably preserve such complex herpesvirus pseudotypes, even after weeks of storage at room temperature, and that reconstituted EHV-1 PVs could be successfully employed in antibody neutralisation tests.
Topics: Humans; Animals; Horses; Herpesvirus 1, Equid; HEK293 Cells; Antibodies, Viral; Antibodies, Neutralizing; Herpesviridae Infections; Glycoproteins; Horse Diseases; Herpesvirus 4, Equid
PubMed: 37931881
DOI: 10.1016/j.virusres.2023.199262 -
The Science of the Total Environment Jan 2024The chemical composition of river waters represents an important matter of investigation to understand environment modifications in response to climate changes and...
The chemical composition of river waters represents an important matter of investigation to understand environment modifications in response to climate changes and global warming. Prolonged dry periods, heavy flood events, degradation of the lands and ice thawing, modify the chemical composition of river waters influencing the drivers governing the complex dynamics of river catchments where everything comes together. In this framework, Compositional Data Analysis (CoDA) offers methods in which the complex structure of the river water composition and the interrelationships among the various components are put into the proper context for their statistical analysis. In this research, we propose a new CoDA approach combining the robust Mahalanobis distance (D) calculus of ilr-transformed chemical variables and the perturbation difference, both with respect to a pristine compositional benchmark. The aim was to trace the change in the chemical composition of the Eastern Siberian River Chemistry Database where degradation of the permafrost for global warming produces important effects on natural waters. The findings indicate complex multiplicative laws and feedback mechanisms governing solutes in Eastern Siberian rivers, with high values of D found where permafrost is more discontinuous. Perturbations clearly discriminate chemical components more resilient to stresses induced by global changes (Ca, Mg and HCO) from those whose variability is not maintained under control (Cl, Na, SO). These outcomes open up a new scenario in searching for spatiotemporal resilience metrics to reveal rivers response to environmental changes.
PubMed: 37918739
DOI: 10.1016/j.scitotenv.2023.168120 -
Journal of Functional Biomaterials Sep 2023Human trabecular meshwork is a sieve-like tissue with large pores, which plays a vital role in aqueous humor outflow. Dysfunction of this tissue can occur, which leads...
Human trabecular meshwork is a sieve-like tissue with large pores, which plays a vital role in aqueous humor outflow. Dysfunction of this tissue can occur, which leads to glaucoma and permanent vision loss. Replacement of trabecular meshwork with a tissue-engineered device is the ultimate objective. This study aimed to create a biomimetic structure of trabecular meshwork using electrospinning. Conventional electrospinning was compared to cryogenic electrospinning, the latter being an adaptation of conventional electrospinning whereby dry ice is incorporated in the fiber collector system. The dry ice causes ice crystals to form in-between the fibers, increasing the inter-fiber spacing, which is retained following sublimation. Structural characterization demonstrated cryo-scaffolds to have closer recapitulation of the trabecular meshwork, in terms of pore size, porosity, and thickness. The attachment of a healthy, human trabecular meshwork cell line (NTM) to the scaffold was not influenced by the fabrication method. The main objective was to assess cell infiltration. Cryo-scaffolds supported cell penetration deep within their structure after seven days, whereas cells remained on the outer surface for conventional scaffolds. This study demonstrates the suitability of cryogenic electrospinning for the close recapitulation of trabecular meshwork and its potential as a 3D in vitro model and, in time, a tissue-engineered device.
PubMed: 37888155
DOI: 10.3390/jfb14100490 -
Frontiers in Veterinary Science 2023Information on slaughter procedures for farmed fish in aquaculture is limited, both in Europe and in Italy, due to a general lack of field data. The aim of this study...
Information on slaughter procedures for farmed fish in aquaculture is limited, both in Europe and in Italy, due to a general lack of field data. The aim of this study was to gather information on the procedures used to slaughter fish in Italy and to discuss them considering the WOAH and EFSA recommendations on fish welfare. Using a questionnaire survey, data were collected by official veterinarians in 64 slaughtering facilities where 20 different species of fish were slaughtered. The main species slaughtered were rainbow trout (; 29/64), followed by European sea bass (; 21/64), sea bream (; 21/64), Arctic char (; 14/64), European eel (; 11/64), sturgeon ( spp; 11/64), common carp (; 6/64), and brown trout ( L.; 5/64). The most applied stunning/killing methods were "asphyxia in ice/thermal shock" and "electric in water bath," followed by "percussion," "asphyxia in air," and "electric dry system." After the application of the method, the assessment of the fish level of unconsciousness was practiced in 72% of the facilities using more than one indicator, with "breathing" and "coordinated movements" the most practiced. The collected data showed a discrepancy between the available recommendations about the welfare of fish at slaughter and what is practiced in many production sites, but for many species precise recommendations are still not available.
PubMed: 37869496
DOI: 10.3389/fvets.2023.1253151 -
Chemosphere Dec 2023The environmental distribution of per- and polyfluoroalkyl substances (PFAS) in water, snow, sediment and soil samples taken along the west coast of Spitsbergen in the...
The environmental distribution of per- and polyfluoroalkyl substances (PFAS) in water, snow, sediment and soil samples taken along the west coast of Spitsbergen in the Svalbard archipelago, Norwegian Arctic, was determined. The contribution of potential local primary sources (wastewater, firefighting training site at Svalbard airport, landfill) to PFAS concentrations and long-range transport (atmosphere, ocean currents) were then compared, based on measured PFAS levels and composition profiles. In remote coastal and inland areas of Spitsbergen, meltwater had the highest mean ΣPFAS concentration (6.5 ± 1.3 ng L), followed by surface snow (2.5 ± 1.7 ng L), freshwater (2.3 ± 1.1 ng L), seawater (1.05 ± 0.64 ng L), lake sediments (0.084 ± 0.038 ng g dry weight (dw)) and marine sediments (
ice during the Arctic spring is an important diffuse local PFAS source. This source may become even more important with climate warming-induced melting of Arctic glaciers and ice sheets. Further studies of mobilisation and transport of PFAS in the Arctic region are needed to confirm this trend. Topics: Svalbard; Water Pollutants, Chemical; Environmental Monitoring; Fluorocarbons; Water; Lakes; Alkanesulfonates; Arctic Regions; Soil
PubMed: 37852382
DOI: 10.1016/j.chemosphere.2023.140463 -
Animals : An Open Access Journal From... Sep 2023Coliforms are relatively common in aquatic environments, but their concentrations can be increased by environmental changes and anthropogenic activities, thus impacting...
Coliforms are relatively common in aquatic environments, but their concentrations can be increased by environmental changes and anthropogenic activities, thus impacting fisheries resources. To determine the microbiological quality in the octopus production chain (capture, post-capture, processing and commercialization), total (TC) and fecal (FC) coliforms were quantified in sea water, fresh octopus, fresh water, ice and octopus in two presentations: packed in ice and boiled. Samples came from fishing zones Enmedio, Chopa and La Gallega at the Veracruz Reef System (VRS) during dry, rainy and windy seasons. The coliforms were determined using the most probable number technique (MPN). The most relevant results indicated that octopus packed in ice coming from the commercialization stage had FC levels >540 MPN/100 g, which exceeded the permissible limits (230 MPN/100 g). Therefore, these products present a risk for human consumption. Differences in FC were observed in octopuses between the three fishing zones (H = 8.697; = 0.0129) and among the three climatic seasons, increasing during the rainy season, highlighting La Gallega with 203.33 ± 63 MPN (H = 7.200; = 0.0273). The results provide evidence of the environmental and anthropogenic influences on coliform concentrations and the urgent need to implement an efficient cold chain throughout octopus production stages with adequate handling practices to reverse this situation.
PubMed: 37835655
DOI: 10.3390/ani13193049 -
International Journal of Molecular... Sep 2023Coconut is an important tropical and subtropical fruit and oil crop severely affected by cold temperature, limiting its distribution and application. Thus, studying its...
Coconut is an important tropical and subtropical fruit and oil crop severely affected by cold temperature, limiting its distribution and application. Thus, studying its low-temperature reaction mechanism is required to expand its cultivation range. We used growth morphology and physiological analyses to characterize the response of coconuts to 10, 20, and 30 d of low temperatures, combined with transcriptome and metabolome analysis. Low-temperature treatment significantly reduced the plant height and dry weight of coconut seedlings. The contents of soil and plant analyzer development (SPAD), soluble sugar (SS), soluble protein (SP), proline (Pro), and malondialdehyde (MDA) in leaves were significantly increased, along with the activities of superoxide dismutase (SOD), peroxidase (POD), and catalase (CAT), and the endogenous hormones abscisic acid (ABA), auxin (IAA), zeatin (ZR), and gibberellin (GA) contents. A large number of differentially expressed genes (DEGs) (9968) were detected under low-temperature conditions. Most DEGs were involved in mitogen-activated protein kinase (MAPK) signaling pathway-plant, plant hormone signal transduction, plant-pathogen interaction, biosynthesis of amino acids, amino sugar and nucleotide sugar metabolism, carbon metabolism, starch and sucrose metabolism, purine metabolism, and phenylpropanoid biosynthesis pathways. Transcription factors (TFs), including WRKY, AP2/ERF, HSF, bZIP, MYB, and bHLH families, were induced to significantly differentially express under cold stress. In addition, most genes associated with major cold-tolerance pathways, such as the ICE-CBF-COR, MAPK signaling, and endogenous hormones and their signaling pathways, were significantly up-regulated. Under low temperatures, a total of 205 differentially accumulated metabolites (DAMs) were enriched; 206 DAMs were in positive-ion mode and 97 in negative-ion mode, mainly including phenylpropanoids and polyketides, lipids and lipid-like molecules, benzenoids, organoheterocyclic compounds, organic oxygen compounds, organic acids and derivatives, nucleosides, nucleotides, and analogues. Comprehensive metabolome and transcriptome analysis revealed that the related genes and metabolites were mainly enriched in amino acid, flavonoid, carbohydrate, lipid, and nucleotide metabolism pathways under cold stress. Together, the results of this study provide important insights into the response of coconuts to cold stress, which will reveal the underlying molecular mechanisms and help in coconut screening and breeding.
Topics: Humans; Transcriptome; Cocos; Seedlings; Cold-Shock Response; Plant Proteins; Gene Expression Profiling; Hormones; Sugars; Nucleotides; Lipids; Gene Expression Regulation, Plant
PubMed: 37834015
DOI: 10.3390/ijms241914563