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Technical approaches to evaluate the surfactant-enhanced biodegradation of biodiesel and vegetable oils.
Montagnolli, RN, Cruz, JM, Moraes, JR, Mendes, CR, Dilarri, G, Lopes, PRM, Bidoia, ED
Environmental monitoring and assessment. 2019;(9):565
Abstract
This research compared the effects of biosurfactant on the biodegradation of biodiesel and vegetable oils while validating two conceptually diverging methodologies. The two experimental setups were successfully modeled towards the effects of biosurfactants during biodegradation. We established the equivalence of both methodologies from the data output. As expected, the biosurfactants caused an increased oil uptake, thus increasing biodegradation performance. Cooking oils were favored by the microbial consortium as a carbon source when compared with biodiesel fuel, especially after use in food preparation. However, we found that biodiesel substrate standout with the highest biodegradation rates. Our results might indicate that a rapid metabolic change from the original compound initially favored biodiesels during the assimilation of organic carbon for a set specialized microbial inoculum. The data output was successfully combined with mathematical models and statistical tools to describe and predict the actual environmental behavior of biodiesel and vegetable oils. The models confirmed and predicted the biodegradation effectiveness with biosurfactants and estimated the required timeframe to achieve satisfactory contaminant removal.
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Evaluation of three experimental in vitro models for the assessment of the mechanical cleansing efficacy of wound irrigation solutions.
Klasinc, R, Augustin, LA, Below, H, Baguhl, R, Assadian, O, Presterl, E, Kramer, A
International wound journal. 2018;(1):140-147
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Abstract
The aim of this study was to compare different wound-rinsing solutions to determine differences in the efficiency and to evaluate three different in vitro models for wound cleansing. Different wound-rinsing solutions (physiological saline solution, ringer lactate solution for wound irrigation, water and a solution containing polihexanide and the surfactant undecylenamidopropyl-betain) were applied on standardised test models (one- and three-chamber model, flow-cell method and a biofilm model), each challenged with three different standardised wound test soils. In the one-chamber model saline showed a better effect on decontaminating proteins than the ringer lactate solution. In the flow-cell method, water performed better than physiological saline solution, whereas ringer lactate solution demonstrated the lowest cleansing effect. No obvious superiority between the two electrolyte-containing solutions was detectable in the biofilm model. Unfortunately, it was not possible to assess the protein decontamination qualities of the surfactant-containing solution because of the interference with the protein measurement. The flow-cell method was able to detect differences between different rinse solutions because it works at constant flow mechanics, imitating a wound-rinsing procedure. The three-chamber and the less-pronounced modified one-chamber method as well as the biofilm model had generated inhomogeneous results.
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Effect of the Wetting Agent Sodium Lauryl Sulfate on the Pharmacokinetics of Alectinib: Results From a Bioequivalence Study in Healthy Subjects.
Morcos, PN, Parrott, N, Banken, L, Timpe, C, Lindenberg, M, Guerini, E, Dall, G, Bogman, K, Sturm, C, Zeaiter, A, et al
Clinical pharmacology in drug development. 2017;(3):266-279
Abstract
The anaplastic lymphoma kinase (ALK) inhibitor alectinib is an effective treatment for ALK-positive non-small-cell lung cancer. This bioequivalence study evaluated the in vivo performance of test 3 formulations with the reduced wetting agent sodium lauryl sulfate (SLS) content. This randomized, 4-period, 4-sequence, crossover study compared alectinib (600 mg) as 25%, 12.5%, and 3% SLS hard capsule formulations with the reference 50% SLS clinical formulation in healthy subjects under fasted conditions (n = 49), and following a high-fat meal (n = 48). Geometric mean ratios and 90% confidence intervals (CIs) for Cmax , AUC0-last , and AUC0-∞ of alectinib, its major active metabolite, M4, and alectinib plus M4 were determined for the test formulations versus the reference formulation. Bioequivalence was concluded if the 90%CIs were within the 80% to 125% boundaries. The 25% SLS formulation demonstrated bioequivalence to the reference 50% SLS formulation for Cmax , AUC0-last , and AUC0-∞ of alectinib, M4, and alectinib plus M4 under both fasted and fed conditions. Further reductions in SLS content (12.5% and 3% SLS) did not meet the bioequivalence criteria. Cross-group comparisons showed an approximately 3-fold positive food effect. Reducing SLS to 25% resulted in a formulation that is bioequivalent to the current 50% SLS formulation used in alectinib pivotal trials.
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Comparison of the effectiveness of polyethylene glycol with and without electrolytes in constipation: a systematic review and network meta-analysis.
Katelaris, P, Naganathan, V, Liu, K, Krassas, G, Gullotta, J
BMC gastroenterology. 2016;:42
Abstract
BACKGROUND Polyethylene glycol is commonly used to manage constipation and is available with or without electrolytes. The addition of electrolytes dates back to its initial development as lavage solutions in preparation for gastrointestinal interventions. The clinical utility of the addition of electrolytes to polyethylene glycol for the management of constipation is not established. The objective of this systematic review and network meta-analysis (NMA) was to assess the relative effectiveness of polyethylene glycol with (PEG + E) or without electrolytes (PEG) in the management of functional constipation in adults. METHODS A systematic review was conducted to identify randomised controlled clinical trials that assessed the use of polyethylene glycol in functional constipation. The primary outcome was the mean number of bowel movements per week. RESULTS Nineteen studies were included in the NMA (PEG N = 9, PEG + E N = 8, PEG versus PEG + E N = 2; involving 2247 patients). PEG and PEG + E are both effective, increasing the number of bowel movements per week by 1.8 (95 % Crl 1.0, 2.8) and 1.9 (95 % Crl 0.9, 3.0) respectively versus placebo and by 1.8 (95 % Crl 0.0, 3.5) and 1.9 (95 % Crl 0.2, 3.6) respectively versus lactulose. There was no efficacy difference between PEG + E and PEG (0.1, 95 % Crl -1.1, 1.2) and there were no differences in safety or tolerability. CONCLUSIONS Polyethylene glycol with and without electrolytes are effective and safe treatments for constipation in adults. The addition of electrolytes to polyethylene glycol does not appear to offer any clinical benefits over polyethylene glycol alone in the management of constipation.
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Lactulose vs polyethylene glycol 3350--electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial.
Rahimi, RS, Singal, AG, Cuthbert, JA, Rockey, DC
JAMA internal medicine. 2014;(11):1727-33
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IMPORTANCE Hepatic encephalopathy (HE) is a common cause of hospitalization in patients with cirrhosis. Pharmacologic treatment for acute (overt) HE has remained the same for decades. OBJECTIVE To compare polyethylene glycol 3350-electrolyte solution (PEG) and lactulose treatments in patients with cirrhosis admitted to the hospital for HE. We hypothesized that rapid catharsis of the gut using PEG may resolve HE more effectively than lactulose. DESIGN, SETTING, AND PARTICIPANTS The HELP (Hepatic Encephalopathy: Lactulose vs Polyethylene Glycol 3350-Electrolyte Solution) study is a randomized clinical trial in an academic tertiary hospital of 50 patients with cirrhosis (of 186 screened) admitted for HE. INTERVENTIONS Participants were block randomized to receive treatment with PEG, 4-L dose (n = 25), or standard-of-care lactulose (n = 25) during hospitalization. MAIN OUTCOMES AND MEASURES The primary end point was an improvement of 1 or more in HE grade at 24 hours, determined using the hepatic encephalopathy scoring algorithm (HESA), ranging from 0 (normal clinical and neuropsychological assessments) to 4 (coma). Secondary outcomes included time to HE resolution and overall length of stay. RESULTS A total of 25 patients were randomized to each treatment arm. Baseline clinical features at admission were similar in the groups. Thirteen of 25 patients in the standard therapy arm (52%) had an improvement of 1 or more in HESA score, thus meeting the primary outcome measure, compared with 21 of 23 evaluated patients receiving PEG (91%) (P < .01); 1 patient was discharged before final analysis and 1 refused participation. The mean (SD) HESA score at 24 hours for patients receiving standard therapy changed from 2.3 (0.9) to 1.6 (0.9) compared with a change from 2.3 (0.9) to 0.9 (1.0) for the PEG-treated groups (P = .002). The median time for HE resolution was 2 days for standard therapy and 1 day for PEG (P = .01). Adverse events were uncommon, and none was definitely study related. CONCLUSIONS AND RELEVANCE PEG led to more rapid HE resolution than standard therapy, suggesting that PEG may be superior to standard lactulose therapy in patients with cirrhosis hospitalized for acute HE. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01283152.
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Randomised clinical trial: macrogol/PEG 3350+electrolytes versus prucalopride in the treatment of chronic constipation -- a comparison in a controlled environment.
Cinca, R, Chera, D, Gruss, HJ, Halphen, M
Alimentary pharmacology & therapeutics. 2013;(9):876-86
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BACKGROUND Constipation is a common condition for which PEG 3350 is an established treatment and prucalopride has recently been approved for this indication. AIM: To compare the efficacy, safety and impact on quality of life (QoL) of PEG 3350 plus electrolytes (PEG 3350+E) vs. prucalopride in females with chronic constipation (CC) in whom laxatives have previously failed to provide adequate relief. METHODS In this single-centre, randomised, double-blind, double-dummy study, patients with CC [<3 spontaneous complete bowel movements (SCBM)/week] remained in a controlled environment and received either a 26 g split dose of PEG 3350+E (N = 120) or 1-2 mg prucalopride (N = 120) daily for 28 days following a 14-day run-in period. The primary endpoint was the proportion of patients having ≥3 SCBMs during the last treatment week. RESULTS Non-inferiority of PEG 3350+E to prucalopride was demonstrated in the per-protocol population [difference, 10.1% (66.67% vs. 56.52%), 97.5% lower confidence interval (CI) -2.7%, above the preset margin of -20%] and approached superiority in the modified intent-to-treat population (difference, 9.8%, 97.5% lower CI, -3.1%). Statistically significant differences in favour of PEG 3350+E were observed for most secondary variables (bowel movements, stool weight, consistency, time to next SCBM, patient perception of straining and completeness of defecation). Colonic transit time was dramatically reduced in both arms. Both treatments were well tolerated. CONCLUSION PEG 3350+E was at least as effective as and generally better tolerated than prucalopride as a treatment for chronic constipation in this study population (NCT01251822; http://www.clinicaltrials.gov).
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Achieving quality in colonoscopy: bowel preparation timing and colon cleanliness.
Athreya, PJ, Owen, GN, Wong, SW, Douglas, PR, Newstead, GL
ANZ journal of surgery. 2011;(4):261-5
Abstract
BACKGROUND Colonoscopy is considered the gold standard for investigation of large bowel pathology. Numerous factors influence the efficacy of bowel preparation for colonoscopy. Inadequate bowel preparation can lead to missed pathology. Timing of fasting and bowel preparation, timing of procedure and possibly patient bowel habit and presence of diverticula may have an influence on the quality of the preparation. The aim of this study was to investigate the quality of cleansing of sodium picosulfate (Picoprep-3™, Pharmatel Fresenius Kabi Pty Ltd, Pymble, NSW, Australia) with different administration schedules and to evaluate whether patient's bowel patterns influence the quality of cleansing. METHODS Three hundred twenty-five patients (175 morning and 150 afternoon procedures) were interviewed prior to colonoscopy to evaluate bowel habit and timing of preparation administration. Quality of cleansing was then assessed during colonoscopy using a 5-point scale. Further factors analysed included the patient's prior bowel habit and the presence of diverticula at colonoscopy. Procedural end points evaluated included procedure total time, caecal intubation time and withdrawal times. RESULTS The quality of cleansing for individual bowel segments was worse for afternoon procedures (P < 0.05 for some segments) and for patients with prior constipation (P < 0.05 for descending colon segments). Caecal intubation times were shorter for patients with diarrhoea and longer for female patients, who also had shorter withdrawal times. No correlation was found between the procedural end points (total duration, caecal intubation time and withdrawal times) and the timing of fasting. CONCLUSIONS Quality of cleansing is significantly improved when bowel preparation is taken entirely the day prior to colonoscopy. Patients with prior constipation demonstrated poorer cleansing.
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Comparison between phase-transfer and cloud-point methodologies for the micellar extraction of biogenic amines.
Romero, L, Grisales, JO, Reta, M
Talanta. 2010;(4-5):1431-7
Abstract
We compared the recently developed surfactant-based extraction with sodium bis-[2-ethylhexyl]-sulphosuccinate (AOT) in heptane (the phase-transfer method) and the well established methodology with poly(oxyethylene)-7,5-(p-tert-octylphenyl) ether (Triton X-114; the cloud-point technique) to extract and preconcentrate biogenic amines. Both procedures were optimized and applied to the extraction of biogenic amines from a beer sample. In order to improve the degree and monitoring of the extraction otherwise achieved with underivatized amines, the fluorescent reagent dansyl chloride was used. Since the different procedures described in the literature are not in agreement, we optimized the derivatization reaction. Accordingly a systematic investigation of the experimental variables, one by one, yielded the following optimum conditions: dansyl chloride, 5mg/mL; 27 degrees C; reaction time, 25min; pH, 10.35 at ionic strength, 0.7mol/L. Both surfactant-based extraction procedures are simple and sensitive, but the use of AOT instead of Triton X-114 offers certain advantages. Detection limits of between 0.03 and 0.8pmol injected were obtained when AOT was used, whose range is similar to or better than the other published techniques; while the corresponding values for Triton X-114 were between 0.2 and 1.2pmol injected. The phase-transfer extraction is faster than the cloud-point method, and no heating is required. For both approaches, the recovery was very high for all the amines studied and the reproducibility quite good for almost all. Upon comparison of calibration curves in pure water with those in the presence of samples, matrix effects were detected.
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Effects of sodium lauryl sulphate (SLS), present in dentifrice, on volatile sulphur compound (VSC) formation in morning bad breath.
Peruzzo, DC, Salvador, SL, Sallum, AW, da Nogueira-Filho, GR
Journal of the International Academy of Periodontology. 2008;(4):130-6
Abstract
The purpose of the present investigation was to evaluate the effects of sodium lauryl sulphate (SLS), present in a commercial dentifrice, on the formation of volatile sulphur compounds (VSC) and tongue coating in a panel of periodontally healthy subjects. A two-step blinded, crossover, randomized study was carried out in 25 dental students with healthy periodontium; these were divided into two experimental groups: SLS (dentifrice with SLS) and WSLS (dentifrice without SLS). The volunteers received the designated dentifrice and a new toothbrush for a 3x/day brushing regimen for 2 periods of 30 days. A seven-day washout interval was used between the periods. The assessed parameters were: plaque index (PI), gingival index (GI), organoleptic breath (ORG), VSC levels by portable sulphide monitor before (H1) and after (H2) cleaning of the tongue, tongue coating wet weight (TC) and benzoyl-DL-arginine-naphthylamide (BANA) test from tongue coating samples. The intra-group analysis showed a decrease in the median of organoleptic scores from 3 to 2 after 30 days for the SLS group (p < 0.05). The inter-group analysis showed lower values in ORG and H1 for the SLS group (p < 0.05). There was no difference between the amount of TC in SLS and WSLS groups. In the BANA test, the presence of SLS did not affect the BANA number of +/- results (p > 0.05). These findings suggest that sodium lauryl sulphate (SLS), present in dentifrice, appears to prevent VSC formation in morning bad breath regardless of the amount of tongue coating in periodontally healthy subjects.
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A randomized, multicenter study comparing the safety and efficacy of sodium phosphate tablets with 2L polyethylene glycol solution plus bisacodyl tablets for colon cleansing.
Johanson, JF, Popp, JW, Cohen, LB, Lottes, SR, Forbes, WP, Walker, K, Carter, E, Zhang, B, Rose, M
The American journal of gastroenterology. 2007;(10):2238-46
Abstract
OBJECTIVE The safety and efficacy of NaP tablets have not been compared with 2L PEG lavage solution. A multicenter, investigator-blinded study was conducted to compare the colon-cleansing efficacy of a new NaP tablet formulation with that of 2L PEG solution plus bisacodyl tablets in adults undergoing colonoscopy. METHODS A total of 481 patients were randomized to receive either 32 tablets (48 g) of NaP or 2L PEG solution plus 4 (20 mg) bisacodyl tablets. Quality of colon cleansing was assessed using a 4-point scale (1 = excellent, 2 = good, 3 = fair, and 4 = inadequate), and the primary efficacy end point was mean overall colon-cleansing score. Safety assessments included recording of adverse events and changes in biochemical tests and vital signs. RESULTS A total of 411 patients were included in the efficacy analysis. The mean overall and ascending colon-cleansing scores for NaP tablets were significantly better than PEG plus bisacodyl (overall 1.5 vs 1.8, ascending 1.4 vs 1.8, P < 0.0001 for both). Patients treated with NaP tablets experienced significantly fewer adverse events (66%vs 82%, P= 0.0003) and gastrointestinal symptoms (64%vs 79%, P= 0.0001) compared with patients receiving PEG plus bisacodyl. Patients receiving NaP tablets were significantly less likely to experience abdominal distention, abdominal pain, and vomiting than patients receiving PEG plus bisacodyl (P < 0.0012). Transient fluctuations in laboratory parameters were observed in both treatment groups; however, the fluctuations were more common and of greater magnitude in the NaP group particularly in phosphorous, sodium, and potassium. CONCLUSION The colon-cleansing efficacy of the new 32-tablet NaP dosing regimen in this study was found to be significantly better than the 2L PEG solution plus bisacodyl tablets regimen. The 32-tablet NaP dosing regimen was associated with fewer adverse events. As expected electrolyte shifts were more common and of greater magnitude in the NaP group compared with the PEG plus bisacodyl group; however, both treatment groups demonstrated significant changes in electrolytes and creatinine.