Liquid suppository systems composed of poloxamers and bioadhesive polymers were easy to administer to the anus and mucoadhesive to the rectal tissues without leakage after the dose. However, a liquid ...suppository system containing diclofenac sodium could not be developed using bioadhesive polymers, since the drug was precipitated in this preparation. To develop a liquid suppository system using sodium chloride instead of bioadhesive polymers, the physicochemical properties such as gelation temperature, gel strength and bioadhesive force of various formulations composed of diclofenac sodium, poloxamers and sodium chloride were investigated. The mixtures of P 407 (15%) and P 188 (15–20%) existed as a liquid at room temperature, but gelled at physiological temperature. Diclofenac sodium significantly increased the gelation temperature and weakened the gel strength and bioadhesive force, while sodium chloride did the opposite. Furthermore, the poloxamer gels with less than 1.0% of sodium chloride, in which the drug was not precipitated, were inserted into the rectum of rabbits without difficulty and leakage, and retained in the rectum of rats for at least 6 h. Our results suggested that a thermosensitive liquid suppository system with sodium chloride and poloxamers was a more physically stable and convenient rectal dosage form for diclofenac sodium.
The prevalence of obesity among women is increasing. Obesity is associated with various metabolic syndromes; conventional treatments are limited and may induce serious adverse events due to ...polytherapy regimens. Currently, demands for complementary and alternative medicine that has a proven safety profile for the treatment of obesity with or without metabolic risk factors are increasing.Our team of preclinical experts reported a significant anti-obesity effect of the Korean herbal medicine, Galgeun-tang (GGT). Thus, we designed this trial to explore the effects of GGT among obese women to accumulate optimal clinical evidence.Obesity is not only a component of metabolic syndrome and a factor associated with an increased risk of cardiovascular disease but is also related to insulin resistance. Previous research has confirmed that an increasing body mass index is highly related with increased risk of metabolic syndrome among overweight and obese individuals. The effectiveness of the Korean medicine herbal formula, GGT on obesity has been previously reported. The objective of this study is to assess the efficacy and safety of GGT for weight loss among obese Korean women with or without high risk for metabolic syndrome.
This study is a randomized, double-blinded, placebo-controlled, multi-center clinical trial. A total of 160 participants will be randomly distributed in 2 groups, the GGT group or the placebo group in a 1:1 ratio using a web-based randomization system. Each group will be administered GGT or placebo 3 times a day for 12 weeks. The primary endpoint is to assess the change in weight from baseline. The secondary endpoints are the following: the changes in body composition measurements, anthropomorphic measurements, obesity screening Laboratory tests, patient self-reported questionnaires, and economic evaluation outcomes. Adverse events will also be reported.
The findings of this study will confirm methodologies regarding the efficacy and safety of GGT for weight loss among obese Korean women with or without metabolic risk factors.
Biocides are commonly used as spray- or trigger-type formulations, thus dermal and respiratory exposure to biocide aerosol is unavoidable. However, little is known about the impact of aerosolization ...on the local toxicity of biocides on the skin or the airway. We compared the local toxicity of biocides after direct or aerosol exposure on reconstructed human skin epidermis and upper airway models. Three biocides, 1,2-benzisothiazol-3(2H)-one (BIT), 2-phenoxyethanol (PE), and 2-phenylphenol (OPP), most widely used in the market were selected. When the biocide was treated in aerosols, toxicity to the skin epidermis and upper airway tissue became significantly attenuated compared with the direct application as determined by the higher tissue viabilities. This was further confirmed in histological examination, wherein the tissue damages were less pronounced. LC-MS/MS and GC/MS analysis revealed that concentrations of biocides decreased during aerosolization. Importantly, the toxicity of biocides treated in 3 μm (median mass aerodynamic diameter (MMAD)) aerosols was stronger than that of 5 μm aerosol, suggesting that the aerosol particle size may affect biocide toxicity. Collectively, we demonstrated that aerosolization could affect the local toxicity of biocides on the skin epidermis and the upper airway.
Condensed phosphates are deliberately added to the fishery and processed marine food products on purpose to increase the weight of products. However, excessive intake overwhelming bodily homoeostasis ...can result in phosphate toxicity such as mineral and bone disorders, associated with chronic kidney diseases, and cardiovascular events. Rapid analysis for condensed phosphates is required to detect the illegal adulteration of processed marine products. We optimised an analytical method using ion chromatography for the rapid and selective detection of condensed phosphates in various kinds of fishery and processed marine products. We compared the performance of three columns (IonPac AS11, AS11-HC, and AS16) for the detection of condensed phosphates with respect to time of analysis and sensitivity. The IonPac AS11 column exhibited the shortest retention time for the major condensed phosphates (pyro-, tri-, and trimetaphosphate), the highest sensitivity for trimetaphosphate, and good repeatability and precision. Microwave and boiling processing were examined as methods to prevent hydrolysis of condensed phosphates into orthophosphate, which is critical in distinguishing intentionally added condensed phosphates from naturally occurring orthophosphate. Microwave treatment was determined to be the more effective method to suppress hydrolysis of condensed phosphates to orthophosphate. Furthermore, microwave processing could be used for thawing the frozen samples, saving extra effort and time. We confirmed that the method exhibits good recovery (80% or more) and precision (%RSD < 10%) for samples with various matrices. With the method, 14 kinds of fishery and processed marine food products were successfully analysed for condensed phosphates. Especially, we identified that phosphate levels in the processed shrimp and dried shredded squid samples exceeded the maximum allowable levels specified in the CODEX standard. We believe that our method would be useful for the rapid analysis of condensed phosphates in various types of fishery and processed marine food products.
Preservatives are essential additives in dishwashing detergents and wet wipes. Ensuring the safe use of preservatives in products is important for public health, as some preservatives are associated ...with health issues. In this study, the content of 12 preservatives in 105 dishwashing detergents and 105 wet wipes was determined, where these compounds are commonly found, among consumer products. A realistic exposure estimation was considered by using Korean consumer-specific exposure parameters for adults and babies. A probabilistic risk assessment was conducted by applying the Monte Carlo simulation method. Benzoic acid (41%) and cetylpyridinium chloride (30%) were the most commonly used preservatives in dishwashing detergents and wet wipes, respectively, although their content in different products (benzoic acid: 0.28–19.4 mg/g in dishwashing detergents; cetylpyridinium chloride: 0.003–0.64 mg/g in wet wipes) varied widely. The calculated median and upper-limit margin of safety (MOS) values related to systemic health effects and skin sensitization from exposure to preservatives largely exceeded the target MOS, which confirmed the safety of the products. Exposure to preservatives from wet wipes was several times higher in babies than in adults. Sensitivity analysis revealed that the amount of the product used, frequency of use, and weight fraction of the preservative were the major contributors to the exposure to preservatives from dishwashing detergents and wet wipes.
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•Twelve preservatives in 105 dishwashing detergents and 105 wet wipes were analyzed.•Benzoic acid in dishwashing detergents and CPC in wet wipes were frequently found.•A realistic exposure was estimated using Korean consumer-specific parameters.•No health concerns were observed for preservatives in upper-limit exposure groups.•Frequency of use and weight fraction of preservative mainly contributed to risks.
The effect of simulants, repeated use, washing, and oiling on the release of toxic metals from metallic kitchen utensils was investigated. The release of As, Cd, Cr, Ni, and Pb from kitchen utensils ...composed of stainless steel, aluminum, copper alloy, and cast iron into food simulants was quantified using inductively coupled plasma-mass spectrometry. The results show that this release of toxic metals was highly dependent on pH. Generally, the release of toxic metals tended to decrease with repeated use, and the release of Cr and Ni from stainless steel samples was significantly higher in the first test, compared to the third test. The washing conditions affected the release of As and Cr, whose release levels were higher when washing only with water and with a steel wool pad, respectively. Furthermore, oiling cast iron cookware reduced the release of As, Cd, Cr, and Ni into acidic simulants by 66%, 83%, 71%, and 15%, respectively. The margin of exposure (MOE) was calculated for each toxic metal; the calculated MOE values indicated that it is improbable that the current level of exposure from metallic kitchen utensils would pose a health risk in Korea.
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•Toxic metal release from kitchen utensils into food simulants was investigated.•Simulant influence on the metal release under worst-case conditions was investigated.•Toxic metal release from metallic kitchen utensils decreased with repeated use.•Release levels of arsenic and chromium were affected by washing methods.•Calculated margin of exposures indicated an acceptable level of concern in Korea.
Mineral oil hydrocarbons (MOH) are widely used in the food industry for applications such as printing inks, additives, adhesives, and processing aids for food additives. Recently, the migration of ...MOH from food contact paper and board into foods has raised public health concerns. In this study, a total of 110 food contact paper and board samples, including baking and cooking paper (23), baking cups (28), food packaging bags (22), lunch boxes (8), party plates (26), and straws (3) were evaluated to quantify the content and short-term migration levels of MOH. The MOH were separated into mineral oil saturated hydrocarbons (MOSH)/polyolefin oligomeric saturated hydrocarbons (POSH) and mineral oil aromatic hydrocarbons (MOAH) via a validated on-line liquid chromatography−gas chromatography−flame ionisation detection (LC-GC-FID) technique. The coating materials of the sample products comprised polyethylene, polypropylene, polyethylene terephthalate, and silicone. The effects of the coating materials on the content and migration of MOH/POSH were evaluated. Quantitative analysis of the MOH in the samples showed that the MOSH/POSH and MOAH content varied widely, ranging from 16 to 5626 mg kg
−1
for MOH, regardless of the coating materials. Short-term migration of MOSH/POSH was observed only in samples with polyolefinic coatings, such as polyethylene and polypropylene, in experiments conducted at 25 °C for 10 min, although the extent of MOAH migration for all samples was at the trace level. The migration of MOSH/POSH was detected within the range of 0.93 to 62.3 μg L
−1
in 22 samples, and the migration of MOAH was detected within the range of 0.80 to 2.6 μg L
−1
in only 4 samples. These results demonstrate that although the short-term migration potential of MOH is generally negligible, the migration of MOSH/POSH into wet fatty foods can be accelerated by polyolefinic coatings, even within a very short time.
•Plastic additives and NIAS from food packaging were investigated.•Real-life consumption and worst-case conditions for migration tests were considered.•Repetitive microwave heating accelerated ...migration and degradation of additives.•Risk assessment confirmed that there is a low level of safety concern.
Convenience foods are currently popular among busy, modern consumers. However, the migration of plastics additives and non-intentionally added substances (NIAS) from packaging materials has raised concern about the potential health risks. The migration of nine compounds, including additives (butylated hydroxytoluene and 2,2,4-trimethyl-1,3-pentanediol diisobutyrate), and NIAS that originated from additives degradation products (phenol, 2-ethyl-1-hexanol, acetophenone, 4-propylbenzaldehyde, 2,6-di-tert-butylbenzoquinone, 2,4-di-tert-butylphenol, and methyl-3-(3,5-ditertbutyl-4-hydroxyphenyl)) from convenience food packaging was evaluated in migration tests employing food simulants under real-life consumption and worst-case scenario conditions. Their migration level in the food simulants was quantified by gas chromatography-mass spectrometry. Most of the compounds had a low frequency of detection and the detected compounds varied depending on the individual samples, regardless of the packaging materials. The worst-case migration tests showed that repetitive microwave heating considerably accelerated the migration and degradation of the additives due to polymer swelling, although a single microwave heating had little effect on the migration. Risk assessment confirmed that the current level of exposure of Korean consumers to the substances from convenience food packaging is unlikely to pose a health risk, even in the worst-case scenario.
To date, graphene oxide (GO), an oxidized version of graphene, has been utilized in many research areas including bioapplications such as drug delivery and bioanalysis. Unlike other spherical or ...polygonal nanomaterials, GO exhibits a sheet-like structure, which in itself suggests interesting applications based on its shape. Here we show that GO can protect cells from internalization of toxic hydrophobic molecules, nanoparticles, and nucleic acids such as siRNA and plasmid DNA by interacting with cell surface lipid bilayers without noticeably reducing cell viability. Furthermore, the cytoprotective effect of GO against the internalization of extracellular materials enabled spatial control over gene transfection through region-selective gene delivery only into GO-untreated cells, and not into the GO-treated cells.
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