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      Application of the HPLC Method in Parenteral Nutrition Assessment: Stability Studies of Ondansetron

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          Abstract

          Ondansetron (OND) is a serotonin type 3 receptor antagonist that exhibits antiemetic activity. From the clinical point of view, vomiting and nausea prevention is an important task. Anticancer treatment and recovery impact the patient’s overall state by affecting appetite, well-being, and physical activity, and consequently, nutrition quality. Depending on the patient’s indication and condition, parenteral nutrition is administered to meet full nutritional requirements. In addition, antiemetic drugs can be added to the parenteral nutrition (PN) admixture to treat chemo- or radio-therapy-induced nausea and vomiting. However, adding any medication to the PN admixture can result in the instability of the composition in the overall admixture. This study aimed to develop the HPLC method of determination of OND in Lipoflex special, one of the most popular, ready-to-use PN admixtures. The proposed HPLC method and the sample preparation procedure were suitable for analyzing OND in PN admixture stored under various conditions, such as exposure to sunlight and temperature. It was found that the decomposition of OND during the seven-day storage did not exceed 5% and did not depend on external factors. Based on the conducted research, it is recommended to add OND to Lipoflex special, and it is possible to store such an admixture for seven days.

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          Most cited references37

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          ESPEN guideline on clinical nutrition and hydration in geriatrics

          Malnutrition and dehydration are widespread in older people, and obesity is an increasing problem. In clinical practice, it is often unclear which strategies are suitable and effective in counteracting these key health threats.
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            ESPEN Guidelines on Parenteral Nutrition: non-surgical oncology.

            Parenteral nutrition offers the possibility of increasing or ensuring nutrient intake in patients in whom normal food intake is inadequate and enteral nutrition is not feasible, is contraindicated or is not accepted by the patient. These guidelines are intended to provide evidence-based recommendations for the use of parenteral nutrition in cancer patients. They were developed by an interdisciplinary expert group in accordance with accepted standards, are based on the most relevant publications of the last 30 years and share many of the conclusions of the ESPEN guidelines on enteral nutrition in oncology. Under-nutrition and cachexia occur frequently in cancer patients and are indicators of poor prognosis and, per se, responsible for excess morbidity and mortality. Many indications for parenteral nutrition parallel those for enteral nutrition (weight loss or reduction in food intake for more than 7-10 days), but only those who, for whatever reason cannot be fed orally or enterally, are candidates to receive parenteral nutrition. A standard nutritional regimen may be recommended for short-term parenteral nutrition, while in cachectic patients receiving intravenous feeding for several weeks a high fat-to-glucose ratio may be advised because these patients maintain a high capacity to metabolize fats. The limited nutritional response to the parenteral nutrition reflects more the presence of metabolic derangements which are characteristic of the cachexia syndrome (or merely the short duration of the nutritional support) rather than the inadequacy of the nutritional regimen. Perioperative parenteral nutrition is only recommended in malnourished patients if enteral nutrition is not feasible. In non-surgical well-nourished oncologic patients routine parenteral nutrition is not recommended because it has proved to offer no advantage and is associated with increased morbidity. A benefit, however, is reported in patients undergoing hematopoietic stem cell transplantation. Short-term parenteral nutrition is however commonly accepted in patients with acute gastrointestinal complications from chemotherapy and radiotherapy, and long-term (home) parenteral nutrition will sometimes be a life-saving maneuver in patients with sub acute/chronic radiation enteropathy. In incurable cancer patients home parenteral nutrition may be recommended in hypophagic/(sub)obstructed patients (if there is an acceptable performance status) if they are expected to die from starvation/under nutrition prior to tumor spread.
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              Anti-nausea effects and pharmacokinetics of ondansetron, maropitant and metoclopramide in a low-dose cisplatin model of nausea and vomiting in the dog: a blinded crossover study

              Background Nausea is a subjective sensation which is difficult to measure in non-verbal species. The aims of this study were to determine the efficacy of three classes of antiemetic drugs in a novel low dose cisplatin model of nausea and vomiting and measure change in potential nausea biomarkers arginine vasopressin (AVP) and cortisol. A four period cross-over blinded study was conducted in eight healthy beagle dogs of both genders. Dogs were administered 18 mg/m2 cisplatin intravenously, followed 45 min later by a 15 min infusion of either placebo (saline) or antiemetic treatment with ondansetron (0.5 mg/kg; 5-HT3 antagonist), maropitant (1 mg/kg; NK1 antagonist) or metoclopramide (0.5 mg/kg; D2 antagonist). The number of vomits and nausea associated behaviours, scored on a visual analogue scale, were recorded every 15 min for 8 h following cisplatin administration. Plasma samples were collected to measure AVP, cortisol and antiemetic drug concentrations. Results The placebo treated group vomited an average number of 7 times (range 2–13). None of the dogs in either the ondansetron or maropitant treated groups vomited during the observation period. The onset of nausea-like behaviour in the placebo-treated group occurred at t3.5h and peaked at t4.75h with nausea behaviour score of 58.5 ± 4.6 mm. Ondansetron and maropitant reduced overall the area under the curve of nausea behaviour score by 90% and 25%, respectively. Metoclopramide had no effect on either vomiting or nausea. Cisplatin-induced nausea and vomiting caused concomitant increases in AVP and cortisol. In the placebo-treated group, AVP and cortisol increased from t2.5h, peaked at t5h (11.3 ± 2.9 pmol L−1 and 334.0 ± 46.7 nmol/L, respectively) and returned to baseline by t8h. AVP and cortisol increases were completely prevented by ondansetron and only partially by maropitant, while metoclopramide had no effect. The terminal half-lives (harmonic mean ± pseudo SD) for ondansetron, maropitant and metoclopramide were 1.21 ± 0.51, 5.62 ± 0.77 and 0.87 ± 0.17 h respectively. Conclusions 5-HT3 receptor antagonist ondansetron demonstrates the greatest anti-emetic and anti-nausea efficacy of the three drugs. AVP and cortisol appear to be selective biomarkers of nausea rather than emesis, providing a means of objectively measuring of nausea in the dog.
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                Author and article information

                Contributors
                Journal
                PROCCO
                Processes
                Processes
                MDPI AG
                2227-9717
                March 2021
                March 03 2021
                : 9
                : 3
                : 453
                Article
                10.3390/pr9030453
                a725e243-474a-44ac-8395-daf3bc07e95d
                © 2021

                https://creativecommons.org/licenses/by/4.0/

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