Neonatal Parenteral Nutrition Formulations Research Articles

Stability Testing of Modified Amino Acid Solutions in Neonatal Parenteral Nutrition Formulations

ABSTRACT Context: Aqueous neonatal parenteral nutrition (PN) formulations are made up of glucose, amino acids (AAs), and electrolytes. Different AA solutions are used to make these formulations. Most licensed products do not meet the nutritional needs of preterm neonates specifically for arginine. Therefore, AA solutions with additional arginine need to be developed and proven stable before being tested for clinical efficacy. PN formulations containing modified AA solutions with 15% arginine were tested in this study. Aims: This study aims to design a stability testing protocol and assign a shelf life to the modified PN formulations being tested. Methods: Physical tests including appearance, pH, optical rotation, ultraviolet absorbance, and subvisible particle count tests as well as chemical analysis using AA assay were performed in this study. Results: Resampling of PN bag samples posed a risk for oxidation and hence single sampling of fresh PN bags for each test point is the best practice for PN stability testing trials. AA assay is a feasible method to ensure AA stability in PN formulations. Conclusion: Modified PN formulations with 15% arginine were stable for 90 days without the addition of the trace element solution. Upon the addition of trace elements, the shelf life was limited to 7 days.

Application Protocol of Standardized Neonatal Parenteral Nutrition Formulations

With the improvements in medical technology, more premature infants and infants with congenital intestinal malformations or other conditions who need parenteral nutrition (PN) support can survive. PN technology has become an important therapeutic strategy in neonatal intensive care units. Due to differences in the qualifications of medical staffs, hospital pharmacy management, hospital level, etc, the composition and preparation methods of PN prescription vary greatly in different regions and hospitals in China. In addition, delays in the starting time of PN, unreasonable formula of nutrition components, poor prescription review, large workload involved in the preparation of PN for nurses, and waste of drugs are prone to happen. In view of these issues, our hospital independently developed standardized formulas of neonatal PN solution, which has been approved in Australia as a patented invention. Herein, we reported the composition and application protocol of this standardized PN solution for newborns.

Neonatal parenteral nutrition formulation: where are we?

Introduction: the introduction of parenteral nutrition in preterm infants has meant a major advance in their prognosis, being the last few years very fruitful in terms of publication of guidelines in this area. Objectives: to know the formulation and preparation procedures of neonatal parenteral nutrition (NPN) in Spanish hospitals. Methods: a multi-centre survey was conducted in Pharmacy Services on the aforementioned processes. Results: fifty-five hospitals met inclusion criteria. Electronic prescription systems were use by 51 %, 65.5 % always formulated individually, while 34.4 % had predesigned formulas. Tricameral preparations were used by 13.0 %. In 52.7 % of cases, first day nutrition was prepared on demand, starting before 8 hours of life in 88.1 % of cases. Inorganic phosphate was the first option in 10.4 %, vitamins, trace elements and zinc were added daily in 92.7 %, 90.9 % and 70.9 % of cases, respectively. NPN including lipids in the same bag was formulated by 45.4 % of the hospitals, compared to 34.5 % where it was administered separately in all cases. In 50.9 % of hospitals they never added heparin to their NPN. The 89.1 % used photoprotected bags. The stability of the admixture varied from 24 hours to 15 days. Conclusion: the elaboration of the PPN in Spain is subject to great variability. There is controversy regarding the use of heparin and ternary mixtures, which is reflected in the variability of clinical practice.

Diseño, implementación y análisis de un sistema de cálculo de fórmulas de nutrición parenteral en neonatos con apoyo del farmacéutico

En este estudio se diseñó una hoja de cálculo para formulación de nutriciones parenterales neonatales, en base a los requerimientos sugeridos por la literatura internacional, y se comparó con los datos obtenidos de la formulación por el método manual y una calculadora online. Vale señalar que ni el método manual ni el de la calculadora online consideraban las características de cada marca comercial de los medicamentos usados en las nutriciones parenterales. Esta hoja de cálculo le permitió al farmacéutico acceder a datos relevantes tanto del paciente como de la formulación, lo que redundó en una correcta validación. Se realizó un estudio retrospectivo de 40 nutriciones parenterales neonatales formuladas en el Hospital Luis Gabriel Dávila entre los meses de enero y noviembre de 2014, incluyéndose únicamente los pacientes que recibieron siete o más días de nutrición parenteral.

An investigation into the physical stability of a neonatal parenteral nutrition formulation.

The physical stability of a neonatal parenteral nutrition formulation has been examined using differential interference contrast (DIC) microscopy. In vitro studies indicated that particle size increases occur immediately after mixing the Intralipid emulsion with the amino acid/glucose solution, while simulation of clinical administration indicated that larger droplets were observed at the end of the catheter approximately 1 h after administration commenced. Microscopic observation of adjacent droplets of the two fluids showed reversible aggregation occurring almost immediately. It was concluded that the current method of administering this neonatal emulsion does not prevent droplet coalescence.

WEGENER'S GRANULOMATOSIS

Early postnatal growth failure is well described in very preterm infants. It reflects the nutritional deficits in protein and energy intake that accumulate in the first few weeks after birth. This coincides with the period of maximum parenteral nutrition (PN) dependency, so that protein intake is largely determined by intravenous amino acid (AA) administration. The contribution of PN manufacture, supply, formulation, prescribing and administration to the early postnatal nutritional deficit is discussed, focusing on total AA intake. The implications of postnatal deficits in AA and energy intake for growth are reviewed, with particular emphasis on early head/brain growth and long-term neurodevelopmental outcome. The rationale for maximising AA acid intake as soon as possible after birth is explained. This includes the benefits for very early postnatal nutritional intake and metabolic adaptation after birth. These benefits relate to total AA intake and so have to be interpreted with some caution, given the very limited evidence base surrounding the balance of individual AAs in neonatal PN formulations. This work mostly predates current nutritional recommendations and therefore may not provide a true reflection of individual AA utilisation in current clinical practice.