Oral therapies: Adaptation of oral anticancer drug doses in patients who cannot swallow.
Dr Cécile Arellano & Dr Florent Puisset
Oral anticancer drugs are only available in dry form (capsules or tablets), which makes administration difficult for patients who cannot swallow (children, the elderly, intubated patients, etc.). The risk of environmental contamination by active ingredients, many of which are clastogenic, mutagenic or repro-toxic (CMR), means that opening capsules or crushing tablets is not recommended. The preparation of a drinkable liquid form by means of a galenic modification must therefore be carried out in premises and with equipment that guarantee the protection of those handling the product. In addition to the aspects of shaping and stability studies, the use of a modified formulation raises the question of changes in bioavailability, which cannot be predicted. In the absence of a study of the relative bioequivalence of oral anticancer agents according to galenic form, enabling doses to be adapted a priori, it is essential to carry out pharmacological therapeutic monitoring (STP) of patients treated with oral forms.
This project has two main areas of work:
– Development and validation of drinkable forms suitable for everyday use (validation of the rheological properties, homogeneity and physical and chemical stability of drinkable suspensions).
– Analysis of STP data using a population pharmacokinetic approach to assess the impact of a change in dosage form on the pharmacokinetic parameters of drugs.
- drinkable suspension,
- therapeutic monitoring,
- individualisation of treatments