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[Intravenous multi vitamin formulation to use in pediatric total parenteral nutrition]
1Escuela de Química y Farmacia, Universidad de Valparaíso, Hospital Dr Gustavo Fricke, Viña del Mar, Chile. patricia.carreno@uv.cl
Insights
A new parenteral multivitamin solution for pediatric patients was developed, offering a stable, safe, and cost-effective alternative. This formulation meets pediatric nutritional needs, unlike adult versions previously used in Chile.
Area of Science:
- Pharmaceutical Sciences
- Pediatric Nutrition
- Formulation Development
Context:
- Chilean market lacks specific intravenous multivitamin formulations for pediatric patients.
- Adult multivitamin formulations are currently used, potentially not meeting pediatric requirements.
- Total parenteral nutrition (TPN) in pediatrics necessitates appropriate vitamin supplementation.
Purpose:
- To develop and characterize a stable, aqueous parenteral multivitamin solution suitable for pediatric patients.
- To ensure the formulation meets quality control standards including organoleptic, microbiologic, and pyrogen testing.
- To assess the compatibility and stability of the vitamin solution within TPN formulae.
Summary:
- A new parenteral multivitamin solution was successfully prepared and formulated for pediatric use.
- Quality control confirmed the absence of microbial contamination and pyrogens, with stability for one month at 4°C.
- The formulation demonstrated compatibility with TPN solutions and was found to be cost-effective.
Impact:
- Provides a safe and effective multivitamin option for pediatric patients requiring TPN.
- Offers significant cost savings compared to using adult formulations.
- Addresses a critical unmet need in the Chilean pediatric healthcare market.
Background:
No intravenous multivitamin formulation is available at the Chilean market that fulfills the requirements of pediatric patients on total parenteral nutrition. Therefore, adult formulations must be used.
Aim:
To prepare a parenteral aqueous multivitamin solution, to be used in pediatric patients.
Material And Methods:
The solution was prepared, mixing vitamins according to their stability and compatibility, in a horizontal laminar flow hood. The quality control for this formulation at times zero and 30 days consisted of an organoleptic analysis, microbiologic and pyrogen controls and vitamin quantification. In addition, the effect of vitamin solution incorporation on the stability of total parenteral nutrition formulae was evaluated. The approximated production cost was calculated.
Results:
The ampoules did not show changes on the organoleptic characteristics. No bacterial contamination or pyrogens were detected. Total parenteral nutrition solutions were not modified after the incorporation of the vitamins. The vitamin solution was stable for one month at 4 degrees C.
Conclusions:
The manufacture of this formulation results in significant savings, because it has a low manufacturing cost and fulfills pediatric requirements.