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Published on: September 20, 2019
[Stability study of paediatric extemporaneous parenteral nutrition with lipids]
F Tuan1, M Montalto, Ma B Pell
1Laboratorio de Terapia Intravenosa LATIVSA, Rosario, Argentina. federicotuan@hotmail.com
Insights
The physical stability of parenteral nutrition (PN) is crucial for patient safety. This study found that the tested PN formulation remained stable, suggesting an extended beyond-use date is possible.
Area of Science:
- Pharmaceutical Sciences
- Formulation Stability
- Parenteral Nutrition
Context:
- The physical stability of extemporaneous parenteral nutrition (PN) is critical for patient safety and quality of care.
- Lipid emulsions, a key component of PN, can undergo physical instability through lipid globule coalescence.
Purpose:
- To determine the medium size and distribution of lipid globules in a total nutrient admixture (TNA).
- To evaluate the stability of a pediatric extemporaneous PN formula and establish its beyond-use date.
- To compare the globule size distribution of the final PN product with the raw lipid emulsion.
Summary:
- Lipid globule size and distribution were assessed in a pediatric extemporaneous PN formula using dynamic light scattering.
- Analyzed PN samples showed medium globule sizes within recommended limits.
- No significant changes in lipid globule size or distribution were observed after compounding the PN.
Impact:
- Findings suggest the evaluated extemporaneous PN formulation may have a longer beyond-use date than currently established.
- Further research on diverse PN formulas is recommended to optimize beyond-use date settings.
- This study contributes to ensuring the safety and efficacy of PN formulations.
Unlabelled:
Stability of extemporaneous parenteral nutrition is a critical aspect of these formulations, with impact in patient safety and quality of service. In lipid emulsions physical stability can be assessed by the increase in the number of lipid globules of size superior than 500 nm, generated by coalescence of small globules during time.
Objectives:
To determine medium size of the lipid globules that compose the internal phase of TNA, in order to evaluate its stability and establish beyond-use date of the parenteral nutrition. To evaluate distribution profile of the lipid globules in the parenteral nutrition and compare it with this of the lipid emulsion used as raw material.
Method:
Globule size assessment by dynamic light scattering in a paediatric extemporaneous parenteral nutrition formula of frequent use, stored in different periods of time and temperatures.
Results:
Medium globule size of the parenteral nutrition analyzed samples did not exceed the limit recommended by literature. Medium size and distribution of the lipid globules in the original lipid emulsion did not have significative changes after the compounding of the parenteral nutrition.
Discussion:
Obtained data allow to consider that the extemporaneous parenteral nutrition evaluated would have a beyond-use date superior than the one now in use. This research must be deepened by the study of other formulas of parenteral nutrition in order to optimize the setting of beyond-use date.
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