Parenteral nutrition admixtures for pediatric patients compounded with highly refined fish oil-based emulsion: Assessment of physicochemical stability

Forchielli, Maria Luisa; Bonoli, Alessandra; Preite, I.; Stancari, A.; Maselli, S.; Guarguaglini, A.M.; Mignini, Irene; Masi, Massimo; Puggioli, C.; Bersani, G.

doi:10.1016/j.clnu.2013.12.011

Cited by 11 publications

(13 citation statements)

References 7 publications

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“…49 Our parenteral formulations should be stable given the fact that the pH range is within 6.1–6.8, that there is nil phosphate, that calcium level are low (<0.6 mmol/L) in all the formulations, and that the formulations are used within 2 hours after compounding. 50–52 …”

Section: Experimental Methodsmentioning

confidence: 99%

Nutrition Modulation of Cardiotoxicity and Anticancer Efficacy Related to Doxorubicin Chemotherapy by Glutamine and ω‐3 Polyunsaturated Fatty Acids

Xue

Denkinger

Schlotzer

et al. 2015

J Parenter Enteral Nutr

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Background Doxorubicin (DOX) has been one of the most effective antitumor agents against a broad spectrum of malignancies. However, DOX-induced cardiotoxicity forms the major cumulative dose-limiting factor. Glutamine and ω-3 polyunsaturated fatty acids (PUFAs) are putatively cardioprotective during various stresses and/or have potential chemosensitizing effects during cancer chemotherapy. Methods Antitumor activity and cardiotoxicity of DOX treatment were evaluated simultaneously in a MatBIII mammary adenocarcinoma tumor-bearing rat model treated with DOX (cumulative dose 12 mg/kg). Single or combined treatment of parenteral glutamine (0.35 g/kg) and ω-3 PUFAs (0.19 g/kg eicosapentaenoic acid and 0.18 g/kg docosahexaenoic acid) was administered every other day, starting 6 days before chemotherapy initiation until the end of study (day 50). Results Glutamine alone significantly prevented DOX-related deterioration of cardiac function, reduced serum cardiac troponin I levels, and diminished cardiac lipid peroxidation while not affecting tumor inhibition kinetics. Single ω-3 PUFA treatment significantly enhanced antitumor activity of DOX associated with intensified tumoral oxidative stress and enhanced tumoral DOX concentration while not potentiating cardiac dysfunction or increasing cardiac oxidative stress. Intriguingly, providing glutamine and ω-3 PUFAs together did not consistently confer a greater benefit; conversely, individual benefits on cardiotoxicity and chemosensitization were mostly attenuated or completely lost when combined. Conclusions Our data demonstrate an interesting differentiality or even dichotomy in the response of tumor and host to single parenteral glutamine and ω-3 PUFA treatments. The intriguing glutamine × ω-3 PUFA interaction observed draws into question the common assumption that there are additive benefits of combinations of nutrients that are beneficial on an individual basis.

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Section: Experimental Methodsmentioning

confidence: 99%

Nutrition Modulation of Cardiotoxicity and Anticancer Efficacy Related to Doxorubicin Chemotherapy by Glutamine and ω‐3 Polyunsaturated Fatty Acids

Xue

Denkinger

Schlotzer

et al. 2015

J Parenter Enteral Nutr

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show abstract

“…It is a fact that there is no monograph in European Pharmacopeia so adoption of the methods proposed in USP <729> chapter at this time appears appropriate and should be standard for all extemporaneously compounded pharmaceutical PN admixtures. Finally, we would like to emphasize once again that Forchielli et al published a very significant manuscript and further studies on clinical safety practice should be encouraged [1].…”

Section: Dear Editormentioning

confidence: 96%

“…We read with an interest the article by Forchielli et al, because we agree that stability study in the parenteral nutrition (PN) is of fundamental importance, because it influences the efficacy and safety of the patient [1]. The combination of quantities of different components makes the range of variations so wide that theoretical stability prediction is practical impossible.…”

Section: Dear Editormentioning

confidence: 97%

“…First of all, lipid emulsions can be safely infused when particle diameter ranges between 0.4 and 1.0 micron [1]. Several attempts were made in various pharmacopeias to establish the standard physical and chemical attributes, but without success.…”

Section: Dear Editormentioning

confidence: 98%

“…Authors evaluate the stability of a highly refined fish oil emulsion in PN admixtures containing LCT or LCT/MCT triglycerides and different calcium content [1]. The authors state that composition of admixtures usually covers the nutritional needs of children and neonates, but in fact calcium contents between 2.5 and 7 mmol per litre is too low for neonates, according to the guidelines and clinical practice [2].…”

Section: Dear Editormentioning

confidence: 99%

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Parenteral nutrition admixtures for pediatric patients compounded with highly refined fish oil-based emulsion: Assessment of physicochemical stability – Letter to Editor

Piętka¹,

Kłęk²

2015

Clinical Nutrition

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Physical Stability of Medium‐Chain Triglyceride/Long‐Chain Triglyceride Emulsion Injections From 5 Manufacturers in High‐Concentration Electrolyte–Based Total Nutrient Admixtures

Zhao

Gao

Jiao

et al. 2020

J Parenter Enteral Nutr

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Background Lipid emulsion injections for parenteral nutrition are an important source of energy and essential fatty acids. Yet stability and compounding challenges remain. We compared the physicochemical stability of 5 commercial medium‐chain triglyceride/long‐chain triglyceride (MCT/LCT)–based lipid emulsions compounded in total nutrient admixtures (TNAs). Methods Stability of the MCT/LCT‐based TNAs was assessed when compounded with high concentrations of electrolytes. We measured mean droplet diameter (MDD), percentage of fat residing in globules ≥5 μm (PFAT5), pH, and osmolality immediately after compounding (time 0) and 6, 12, 18, 24, 36, 48, 60, and 72 hours later. Repeated‐measures analyses of variance were used to evaluate changes in stability over time, and post hoc tests were used to assess group differences. Results Over 72 hours, MDD of TNAs ranged from 0.206 to 0.713 μm, PFAT5 from 0.58% × 10−3to 43.18% × 10−3, pH from 5.769 to 5.879, and osmolality from 1304 to 1357 mOsm/kg. MDDs and PFAT5s showed a tendency to increase gradually over the first 24 hours and then decrease or remained stable after that. We identified some significant differences in MDDs and PFAT5s among the 5 MCT/LCT‐based TNAs, although all met the United States Pharmacopeia <729> standards. Conclusions The stability of some commercial MCT/LCT‐based TNAs under high concentrations of electrolytes exhibits differences over the 72 hours after compounding. Clinicians should pay attention, therefore, to possible performance differences of injectable lipid emulsions produced by different manufacturers when compounded in TNAs under high electrolyte concentrations.

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Parenteral nutrition admixtures for pediatric patients compounded with highly refined fish oil-based emulsion: Assessment of physicochemical stability

Cited by 11 publications

References 7 publications

Nutrition Modulation of Cardiotoxicity and Anticancer Efficacy Related to Doxorubicin Chemotherapy by Glutamine and ω‐3 Polyunsaturated Fatty Acids

Nutrition Modulation of Cardiotoxicity and Anticancer Efficacy Related to Doxorubicin Chemotherapy by Glutamine and ω‐3 Polyunsaturated Fatty Acids

Parenteral nutrition admixtures for pediatric patients compounded with highly refined fish oil-based emulsion: Assessment of physicochemical stability – Letter to Editor

Physical Stability of Medium‐Chain Triglyceride/Long‐Chain Triglyceride Emulsion Injections From 5 Manufacturers in High‐Concentration Electrolyte–Based Total Nutrient Admixtures

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