Easy pediatric drug intake : a necessity
Infants or young children are easily prone to false passages, the product passing down the trachea towards the lungs instead of going into the oesophagus. Health services indicate that 80% of children that are victims of false passage are under the age of 3. Medication, especially when in the form of a small tablet, can be the cause of this serious, perhaps even fatal event.
Without medical opinion, tablets and capsules are not indicated for children under the age of 6. The liquid pharmaceutical form (syrups, solutions, suspensions, drops, emulsions…) is always preferable according to the French Higher Health Authority. In its practical sheets for carers, this body reminds that “oral liquid forms are to be favoured over dry forms”.
It recommends that paediatric forms be packaged in single-dose forms in order to prevent dosage errors.
Proving effectiveness and providing child safety
Children are not tiny adults, therefore most medication on the market is not really suitable for their age. (Note that the paediatric population includes all patients under the age of 18). The complexity of this market and the difficulties in conducting research on this target require major investment and do not encourage the pharmaceutical industry to carry out the required clinical trials.
To facilitate the development of paediatric medication and its accessibility, and to make sure it is subject to quality clinical studies, European regulation (N°1901/2006) became applicable on 26 January 2007. It imposes a duty on pharmaceutical firms to submit a Paediatric Investigation Plan (PIP) to the European Paediatric Committee (PDCO).
This document is mandatory in the following cases:
- before any new application to market a pharmaceutical speciality,
- before any applications to modify an authorisation to market for a new indication, pharmaceutical form or administration method,
- when applying for a PUMA (paediatric-use marketing authorisation) for paediatric use.
In exchange, the firms benefit from increased protection measures once development in the context of a PIP is implemented.
Liquid stick pack: technology that fulfils these constraints for children…and adults
The development of new paediatric medication is a genuine challenge because of the heterogeneous nature of a population with specific needs. There is a considerable difference between an infant and a 16-18 year old adolescent.
Single dose liquid stick pack technology fulfils the needs for children. It is more appropriate than tablets or capsules and prevents the risk of false passages, in particular in very young children.
Another of its advantages is the use of aromas and sweeteners to hide the taste (often unpleasant) of the active ingredient and thus favour the acceptance of the treatment by children. Finally, it offers portable and pre-dosed doses that are more accessible to take the right dose at the right time.
It also avoids wasting open, partially used bottles that have exceeded their expiry date and can no longer be taken. To conclude, the liquid stick pack form is ideal for children because it makes it possible to avoid false passages, but is also suitable for adults, in particular those that have an active or nomad lifestyle, or even more generally to all patients who have difficulties swallowing. In this practical form, the treatment, which is easy to carry anywhere and any time, adapts to all living conditions. A considerable strength that makes a difference.