Abstract
Riluzole 5 mg/mL oral suspension is the only licensed liquid medicine to treat Amyotrophic Lateral Sclerosis (ALS) orally. As more than 80% of ALS patients develop dysphagia, an oral liquid formulation provides an important therapeutic option. The Riluzole 5 mg/mL oral suspension is administered by means of the graduated oral dosing syringe included in the medicine package. Its concentration (5 mg/mL) is consistent with a small and easy to measure volume (10 mL) to deliver the prescribed 50-mg dose twice daily. This work had a dual objective. The first was to evaluate the texture of the Riluzole 5 mg/mL oral suspension according to the International Dysphagia Diet Standardisation Initiative (IDDSI) flow test. Results of this experiment indicated that Riluzole 5 mg/mL oral suspension would basically fall under the “mildly thick” IDDSI descriptors. This is an important feature because thick fluids facilitate a safer swallow in patients with dysphagia. As a second objective, we evaluated for scientific purposes the compatibility of Riluzole 5 mg/mL oral suspension with some of the most common food thickeners available on the market. Intimate mixtures of the Riluzole 5 mg/mL oral suspension with thickeners were evaluated for appearance, pH, Riluzole assay and Riluzole related substances immediately after preparation and after two hours at room temperature. Riluzole 5 mg/mL oral suspension resulted to be compatible with all the marketed thickeners tested.
Highlights
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease affecting nerve cells in the brain and the spinal cord
The aim of this work is to evaluate the texture of Riluzole 50 mg/10 mL (5 mg/mL) oral suspension according to the International Dysphagia Diet Standardisation Initiative (IDDSI) flow test and to evaluate its chemical compatibility with some of the most common food thickeners available on the market
One objective of this work was to evaluate the texture of Riluzole 5 mg/mL oral suspension according to the IDDSI flow test
Summary
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease affecting nerve cells in the brain and the spinal cord. These cells are needed to keep our muscles moving. With voluntary muscle action progressively affected, people may lose the ability to speak, eat, move and breathe. The disease leads to paralysis and death typically within 2–5 years following the of diagnosis, at least 1 in people live more than 10 years after experiencing the signs of the disease. Death occurs because of respiratory failure, aspiration pneumonia, malnutrition, and dehydration [1,2,3]
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