Position paper: recommendation on the adoption of breathing patterns for infants and small children in general chapter 2.9.44. Preparations for nebulisation
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Published on: July 14, 2023
J Jauernig1, J Mitchell, E Berg
1Novartis Pharma, Basel, Switzerland.
Insights
This paper recommends specific breathing patterns for nebuliser therapy in neonates and young children. These tailored patterns improve the assessment of medication delivery for paediatric patients.
Area of Science:
- Pharmacology
- Paediatric Medicine
- Respiratory Therapy
Background:
- Nebuliser therapy is common for infants and children.
- Current European Pharmacopoeia guidelines propose adult breathing patterns for nebulisation assessments.
- This is inappropriate for paediatric populations, potentially affecting drug delivery evaluation.
Purpose of the Study:
- To propose age-appropriate breathing patterns for nebuliser therapy in paediatric patients.
- To inform the development of the European Pharmacopoeia general chapter 2.9.44.
- To aid in the evaluation of active substance delivery for paediatric preparations.
Main Methods:
- Review of existing literature and physiological data on paediatric respiratory patterns.
- Development of three distinct breathing pattern recommendations: neonate, 12-month-old infant, and 4-year-old child.
- Position paper summarizing these recommendations.
Main Results:
- Specific breathing patterns proposed for neonates, infants (12 months), and young children (approx. 4 years).
- These patterns are designed to be physiologically relevant for each age group.
- Recommendations focus on optimizing the assessment of active substance delivery rate and total delivery.
Conclusions:
- Standard adult breathing patterns are inadequate for paediatric nebuliser assessments.
- Implementing age-specific breathing patterns is crucial for accurate evaluation of paediatric nebuliser preparations.
- This work supports the development of more relevant pharmacopoeial standards for paediatric drug delivery.
Abstract:
The treatment of infants and small children with nebuliser-based therapy is commonplace. However, the breathing pattern proposed for general chapter 2.9.44 covering preparations for nebulisation, in development for the European Pharmacopoeia, is that of an adult at rest. This position paper is a concise summary of recommendations for 3 breathing patterns that would be applicable to a neonate, a 12-month-old infant, and a child approximately 4 years old. The information presented herein is intended to inform the development of the proposed general chapter with the intention that information be provided to assist those involved with the evaluation of preparations for paediatric use in the choice of more appropriate breathing patterns for the assessment of active substance delivery rate and total active substance delivered.
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