Position paper: recommendation on the adoption of breathing patterns for infants and small children in general chapter 2.9.44. Preparations for nebulisation.

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.