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This study is essential to analyze the toxicity and release of bioactive compounds in R. tuberosa L. extract microcapsules coated with gum Arabic and to provide information on the use of microcapsules as a drug delivery system with controlled release of active ingredients. Investigations focused on the effect of pH and timing on discharge kinetics, as well as toxicity evaluation. The release of active ingredients from microcapsules was carried out in medium variations, namely pH 2.2 and pH 7.4, with release durations of 30, 60-, 90-, 120-, and 150-min. Bioactive compounds were released by 59.23% at pH 2.2 and 58.21% at pH 7.4 within 150 min. The BSLT (brine shrimp lethal toxicity) assay was used using brine shrimp larvae (Artemia salina L.), resulting in a non-toxic classification as evidenced by an LC50 value of 5729 μg/mL. Microcapsules in optimum conditions were then characterized using FTIR (Fourier-Transform Infrared) and SEM (scanning electron microscopy) instruments. The FTIR analysis showed variations in functional groups in R. tuberosa L. extracts, gum Arabic, and microcapsules. Furthermore, the SEM examination highlighted the morphology of microcapsules that were mostly spherical.

This study is essential to analyze the toxicity and release of bioactive compounds in R. tuberosa L. extract microcapsules coated with gum Arabic and to provide information on the use of microcapsules as a drug delivery system with controlled release of active ingredients. Investigations focused on the effect of pH and timing on discharge kinetics, as well as toxicity evaluation. The release of active ingredients from microcapsules was carried out in medium variations, namely pH 2.2 and pH 7.4, with release durations of 30, 60-, 90-, 120-, and 150-min. Bioactive compounds were released by 59.23% at pH 2.2 and 58.21% at pH 7.4 within 150 min. The BSLT (brine shrimp lethal toxicity) assay was used using brine shrimp larvae (Artemia salina L.), resulting in a non-toxic classification as evidenced by an LC50 value of 5729 µg/mL. Microcapsules in optimum conditions were then characterized using FTIR (Fourier-Transform Infrared) and SEM (scanning electron microscopy) instruments. The FTIR analysis showed variations in functional groups in R. tuberosa L. extracts, gum Arabic, and microcapsules. Furthermore, the SEM examination highlighted the morphology of microcapsules that were mostly spherical. [ABSTRACT FROM AUTHOR]

Diclofenac sodium, a Non-Steroidal Anti-Inflammatory medicine, is efficacious in treating osteoarthritis. However, it might cause adverse gastrointestinal symptoms and may lead to liver metabolic complications when used orally. Hence, the development of an efficacious treatment, specifically the diclofenac sodium patch with a membrane, is imperative. The goal of this research was to identify the optimal formulation for a membrane-type diclofenac sodium patch with Nanostructured Lipid Carrier (NLC) as a reservoir, using a solvent casting technique with HPMC 606 as the rate-controlling membrane. Diclofenac sodium patch with NLC Formula 1 was determined to be the most effective formula, as it showed good physical attributes such as drug content and drug homogeneity above 85%, spherical particles, a higher release flux of 12.246 ± 0.60 µg/cm²/min1/2 compared to Formula 2 and Formula 3, and the release kinetics in all formula followed the Higuchi model. Using the most optimal patch formula, a penetration test showed a higher flux penetration of 0.329 ± 0.01 µg/cm²/min compared to the comparison, which involved a diclofenac sodium patch with physical mixture. The research suggested that diclofenac sodium patch with NLC holds significant potential as a transdermal drug delivery system. [ABSTRACT FROM AUTHOR]

Indonesian red betel (Piper crocatum) has been used traditionally to cure wounds and to prevent diseases as well as an antiseptic, while the leaves were also reported to inhibit the growth of bacteria. On the other hand, polyvinyl alcohol (PVA) is a suitable biomaterial with a wide range of applications after being transformed into hydrogels. This paper reports on the encapsulation of P. crocatum extract in PVA hydrogel synthesized by the freeze-thaw method with varying compositions and its characterizations. The internal morphology of the composite hydrogels did show some phase separation between the liquid and solid phases, while the analysis of the Fourier-transform infrared spectra confirmed that the P. crocatum extract was successfully encapsulated in the hydrogels. The hydrogels were amorphous due to the scattering of the liquid trapped within the pores. The extract was stable within the range of the room to body temperature since no significant mass decomposition of the extract was observed. The compressive modulus and the fracture stress of the composite hydrogel decreased as the fraction of extract increased due to the unfrozen ethanol fraction during the freeze-thaw process. The composite hydrogels loaded by P. crocatum extract possessed antibacterial activity against Staphylococcus aureus (gram-positive) and Pseudomonas aeruginosa (gram-negative). The release of extract from the hydrogels was immediate release following the pseudo-fickian diffusion for most of the composite hydrogels. This report thus suggests that the composite hydrogels are potential antibacterial products and can be applied for a biomedical device that requires antibacterial activity.

Dietary supplements are widely consumed in the EU and the USA. Based on their similarity to pharmaceuticals, consumers mistakenly believe that dietary supplements have also been approved for safety and efficacy. However, in the absence of mandatory testing, data on supplement quality is scarce. Thus, we applied liquid chromatography coupled with tandem mass spectrometry to analyse the quality of dietary supplements containing tryptophan (Trp). We examined 22 supplements in tablets or capsules, produced in the USA, Great Britain, Germany, France, Czech Republic, and Poland. Trp release, crucial for bioavailability and efficiency, was assessed. Additionally, we performed a qualitative analysis of the main ingredient and screened for contaminants. Among the contaminants, we detected Trp's metabolites, condensation products of Trp and carbonyl compounds, Trp degradation products, degradation products of kynurenine, and other contaminants such as glucosamine and melatonin. The main ingredient content was in the range of 55–100% in capsules and 69–87% in tablets. Surprisingly, almost no Trp release was noted from some supplements. Our study confirms the need to advance research on supplements. We believe that the high-quality analysis of supplements based on reliable analytical techniques will be an important contribution to the discussion on the regulatory framework of these products. [ABSTRACT FROM AUTHOR]

This study examined the controlled release of cetylpyridinium chloride (CPC) from a tissue conditioner (TC) containing CPC-montmorillonite (CPC-Mont), the associated antimicrobial activity, and oral mucosa irritation. The CPC release test was performed daily for 28 days in three test solutions: distilled water, 0.2 M NaCl, and 0.2 M HCl. The antimicrobial activities for 7, 14, 21, and 28 days against Candida albicans, Staphylococcus aureus, and Streptococcus mutans were assessed according to the JIS Z 2801/ISO 22196 standard. An oral mucosa irritation test was conducted using cheek pouches in five male hamsters according to the ISO 10993-10:2010 standard. The amount of CPC released each day and the cumulative amount released over 28 days (6.12 mg) were less than the daily safe maximum of sore throat medicines (8 mg). Additionally, TC with CPC-Mont could sustain antimicrobial activity against adherent bacteria for 14 days and has no oral mucosa irritation potential. [ABSTRACT FROM AUTHOR]

The release of metal elements from stainless-steel products in contact with food may endanger human health. To protect human health, different countries or international organisations have formulated corresponding regulations or technical guidelines. Limits for only five metal elements are stipulated in the China National Food Safety Standard (GB 4806.9) and food simulants and test conditions are fixed regardless of the actual use condition. In this study, inductively coupled plasma mass spectroscopy and inductively coupled plasma optical emission spectroscopy were used to measure the concentrations of six metal contaminants and impurities and 11 metals and alloy component released from stainless-steel sheets on Chinese market. The effects were also investigated on metal release of six grades (201, 202, 304, 430, 443, and 30Cr13) and 6 exposure conditions (food simulant 5 g L−1 citric acid or 4 vol% acetic acid, contact temperature 70 °C or 100 °C, and contact time 2 h, 0.5 h, or 0.5 h followed by ambient temperature for 24 h). For reusable stainless-steel sheets, especially for grade 30Cr13, it was essential to perform three consecutive release tests to check compliance. However, there was no need to conduct three consecutive release tests for the other five grades if the results of the first test met the regulations. It was recommended that 5 g L−1 citric acid should be used as food simulant and contact temperature and time should be based on the actual using conditions. No relationships were found between metal release amounts and contact test temperature or time. The specific release limits for Pb, Cr, As, Cd, and Ni should be lowered and Al, Mn, and Fe be added in GB 4806.9. The results of this study can be a reference for further analysis of the release behaviour of metal elements in actual stainless-steel products. [ABSTRACT FROM AUTHOR]

Dietary supplements are widely consumed in the EU and the USA. Based on their similarity to pharmaceuticals, consumers mistakenly believe that dietary supplements have also been approved for safety and efficacy. However, in the absence of mandatory testing, data on supplement quality is scarce. Thus, we applied liquid chromatography coupled with tandem mass spectrometry to analyse the quality of dietary supplements containing tryptophan (Trp). We examined 22 supplements in tablets or capsules, produced in the USA, Great Britain, Germany, France, Czech Republic, and Poland. Trp release, crucial for bioavailability and efficiency, was assessed. Additionally, we performed a qualitative analysis of the main ingredient and screened for contaminants. Among the contaminants, we detected Trp’s metabolites, condensation products of Trp and carbonyl compounds, Trp degradation products, degradation products of kynurenine, and other contaminants such as glucosamine and melatonin. The main ingredient content was in the range of 55–100% in capsules and 69–87% in tablets. Surprisingly, almost no Trp release was noted from some supplements. Our study confirms the need to advance research on supplements. We believe that the high-quality analysis of supplements based on reliable analytical techniques will be an important contribution to the discussion on the regulatory framework of these products.

To control circulating vaccine-derived type 2 poliovirus outbreaks, a more genetically stable novel Oral Poliovirus Vaccine type 2 (nOPV2) was developed by targeted modifications of Sabin 2 genome. Since the use of OPV2 made of Sabin 2 strain has been stopped, it is important to exclude the possibility that batches of nOPV2 are contaminated with Sabin 2 virus. Here, we report the development of a simple quantitative one-step reverse-transcription polymerase chain reaction assay for the detection and quantitation of Sabin 2 virus in the presence of overwhelming amounts of nOPV2 strain. The method is specific and linear within 8 log10 range even in the presence of relevant amounts of nOPV2 virus. It is sensitive, with a lower limit of detection of 0.2 CCID50/mL (an equivalent of 198 genome copies per mL), and generates reproducible results. This assay can be used for quality control and lot release of the nOPV2.

Objectives: As commercially available pregabalin preparations are limited to oral administration, it is impossible to use it as an adjuvant analgesic for neuropathic cancer‐related pain in terminally ill cancer patients with oral feeding difficulties. The objective of this study was to develop a pregabalin suppository to be available at hospitals. Methods: Pregabalin suppositories were prepared using bases comprising six different compositions of Witepsol H‐15, Witepsol S‐55, and Witepsol E‐75. The suppository release test and stability test were performed in vitro. The pharmacokinetics and pharmacodynamics of the suppositories were assessed in rats. Key findings: In the in vitro releasing test, the pregabalin suppositories with H‐15, H‐15 : S‐55 = 1 : 1, H‐15 : S‐55 = 2 : 1, H‐15 : S‐55 = 1 : 2 released approximately 100% of the pregabalin within 180 min. Among these pregabalin suppositories, only the suppository with H‐15 : S‐55 = 2 : 1 demonstrated an equivalent AUC0−∞ with the oral administration group. Consistent with the results of the pharmacokinetic study, the pregabalin suppository with H‐15 : S‐55 = 2 : 1 exhibited antinociceptive effects. In addition, the pregabalin suppository with H‐15 : S‐55 = 2 : 1 was stable for 12 weeks when refrigerated with light shielding. Conclusions: The pregabalin suppositories prepared in this study may be applicable for pain control for terminally cancer ill patients with oral feeding difficulties. [ABSTRACT FROM AUTHOR]

In this study, the effect of pulp temperature on coal flotation was investigated. Waste vegetable oil was used as collector. Experiments were carried out at different temperatures (5, 25, 50, and 75°C) and the pros and cons of each temperature for flotation performance were revealed. While flotation performance was lower in higher pulp temperatures (50 and 75°C), flotation performance was found higher in lower pulp temperatures (5 and 25°C). Highest combustible recovery values were obtained at 25°C pulp temperature, and the lowest ash product was obtained at 75°C. However, the lowest combustible recovery value was obtained in flotation at 75°C. [ABSTRACT FROM AUTHOR]

Purpose of review: The goal of this paper is to provide an overview in evaluating the patient with suspected or known anteroinferior glenohumeral instability. Recent findings: There is a high rate of recurrent subluxations or dislocations in young patients with history of anterior shoulder dislocation, and recurrent instability will increase likelihood of further damage to the glenohumeral joint. Proper identification and treatment of anterior shoulder instability can dramatically reduce the rate of recurrent dislocation and prevent subsequent complications. Overall, the anterior release or surprise test demonstrates the best sensitivity and specificity for clinically diagnosing anterior shoulder instability, although other tests also have favorable sensitivities, specificities, positive likelihood ratios, negative likelihood ratios, and inter-rater reliabilities. Summary: Anterior shoulder instability is a relatively common injury in the young and athletic population. The combination of history and performing apprehension, relocation, release or surprise, anterior load, and anterior drawer exam maneuvers will optimize sensitivity and specificity for accurately diagnosing anterior shoulder instability in clinical practice. [ABSTRACT FROM AUTHOR]

Polymer flooding is a well-known commercial method among enhanced oil recovery (EOR) methods. Despite its successful development, this method could still be improved considerably by utilizing new polymeric materials and systems. The main objective of this study is the implementation of smart-covered polymer particles (SCPP) prepared by multistep inverse emulsion polymerization, to improve polymer flooding efficiency. Successive to the average molecular weight determination of the core polymer using the dilute solution method, the dissolution behaviour of SCPPs is examined at reservoir temperature in a specific setup. In addition to investigating the efficiency of SCPP flooding, polymer flooding experiments in a micromodel setup are examined. The flooding efficiency of conventional polyacrylamide and the newly developed SCPP solutions are compared with the water flooding process. Our results provide new insight into the ability of coated polymers to enhance the recovery efficiency of polymer flooding processes. [ABSTRACT FROM AUTHOR]

The NIH test is currently used to assess the potency of rabies vaccine, a key criterion for vaccine release. This test is based on mice immunization followed by intracerebral viral challenge. As part of global efforts to reduce animal experimentation and in the framework of the development of Sanofi Pasteur next generation, highly-purified vaccine, produced without any material of human or animal origin, we developed an ELISA as an alternative to the NIH test. This ELISA is based on monoclonal antibodies recognizing specifically the native form of the viral G-protein, the major antigen that induces neutralizing antibody response to rabies virus. We show here that our ELISA is able to distinguish between potent and different types of sub-potent vaccine lots. Satisfactory agreement was observed between the ELISA and the NIH test in the determination of the vaccine titer and their capacity to discern conform from non-conform batches. Our ELISA meets the criteria for a stability-indicating assay and has been successfully used to develop the new generation of rabies vaccine candidates. After an EPAA international pre-collaborative study, this ELISA was selected as the assay of choice for the EDQM collaborative study aimed at replacing the rabies vaccine NIH in vivo potency test. [ABSTRACT FROM AUTHOR]

Calcium carbonate particles are promising candidates as proteins carriers for their controlled delivery in the body. The present paper aims at investigating the protein encapsulation by in situ precipitation of calcium carbonate particles prepared by a process based on supercritical CO 2 and using a new type of degradable well-defined double hydrophilic block copolymers composed of poly(ethylene oxide) and polyphosphoester blocks acting as templating agent for the calcium carbonate. For this study, lysozyme was chosen as a model for therapeutic protein for its availability and ease of detection. It was found that by this green process, loading into the CaCO 3 microparticles with a diameter about 2 μm can be obtained as determined by scanning electron microscopy. A protein loading up to 6.5% active lysozyme was measured by a specific bioassay ( Micrococcus lysodeikticus ). By encapsulating fluorescent-labelled lysozyme (lysozyme-FITC), the confocal microscopy images confirmed its encapsulation and suggested a core–shell distribution of lysozyme into CaCO 3 , leading to a release profile reaching a steady state at 59% of release after 90 min. [ABSTRACT FROM AUTHOR]

This study shows a reliable procedure to prescribe the preferential use of a material for food contact. Release tests with optimized parameters were performed on six different stainless steel accepted for the use in food contact: AISI 420, AISI 430, AISI 202, AISI 303, AISI 304, and AISI 316. Total reflection X-ray fluorescence spectroscopy was used to measure the concentration of Cr, Mn and Ni in contact solutions from release tests. Results show that AISI 202 and 430 release the lowest amount of Mn, Cr and Ni. While, AISI 420 is the worst material, exceeding the limit set in the Italian regulation for all the three metals of interest. One sample was selected to test the reproducibility of TXRF measurements performed in three different laboratories around the world. Results show that quantitative analyses by means of TXRF satisfy the requirements of this field of application. [ABSTRACT FROM AUTHOR]

Abstract: A simple, precise and accurate method was developed and validated for the determination of allicin release from alliin/alliinase double-layer tablets. According to Appendix XC II of Chinese Pharmacopoeia 2010 edition Volume II, a small glass-method was adopted at the rotational speed of 100r/min using 100mL phosphate buffer (pH 6.8) as release medium. The release amount was determined by HPLC with a C18 column (250mm×4.6mm, 5μm) using the mobile phase consisting of methanol −0.4% carboxylic acid (65:35) at a flow rate of 1mL/min and UV detection at 242nm. The current method demonstrates good linearity over the range 4.052–405.2μg/mL (r 2=0.9999) with an average recovery of 105.5%(RSD=1.25%). The accumulative release of alliin/alliinase double-layer tablets had good homogeneity for within- and between-batches. The method established is simple, accurate and repeatable for the determination of allicin release from alliin/alliinase double-layer tablets. [Copyright &y& Elsevier]

To control circulating vaccine-derived type 2 poliovirus outbreaks, a more genetically stable novel Oral Poliovirus Vaccine type 2 (nOPV2) was developed by targeted modifications of Sabin 2 genome. Since the use of OPV2 made of Sabin 2 strain has been stopped, it is important to exclude the possibility that batches of nOPV2 are contaminated with Sabin 2 virus. Here, we report the development of a simple quantitative one-step reverse-transcription polymerase chain reaction assay for the detection and quantitation of Sabin 2 virus in the presence of overwhelming amounts of nOPV2 strain. The method is specific and linear within 8 log10 range even in the presence of relevant amounts of nOPV2 virus. It is sensitive, with a lower limit of detection of 0.2 CCID50/mL (an equivalent of 198 genome copies per mL), and generates reproducible results. This assay can be used for quality control and lot release of the nOPV2. [ABSTRACT FROM AUTHOR]

The physicochemical properties, especially pH value of dental medicines, have significant influence on the health of oral cavity tissues. The pH of formulations should correspond to the value of saliva pH (5.5–8.0). For carbomer-based gels, the required pH value is obtained by neutralizing them with alkaline components, which leads to their structuring (thickening). This affects the physical properties of the gel, its residence time at the application site and the rate of release of active pharmaceutical ingredient. Therefore, the main purpose of this study is to evaluate the rheological, textural, and biopharmaceutical properties of Carbomer Polacril® 40P-based dental gel depending on the pH value. Evaluation of the rheological properties of gel preparations were performed by measuring the structural viscosity of the samples as a function of pH and temperature. The textural properties of the gel were evaluated by performing tests regarding back extrusion and spreadability. Carbomer Polacril® 40P-based gels haven't shown noticeable thixotropic behavior, and were characterized by plastic flow in the whole studied pH range. The structural viscosity at the selected average pH value hasn't differed at storage (25 °C) and application (37 °C) temperature. Texture studies of dental gels have shown a strong correlation with rheoparameters. Their rheological behavior and textural properties haven't changed significantly between the pH range of 5.5–6.6. The relatively narrow range of working pH values does not affect the change in the viscosity of the preparation significantly and, consequently, does not affect the release of APIs from the developed Carbomer Polacril® 40P-based dental gel. [ABSTRACT FROM AUTHOR]