Riluzole Oral Suspension for the Treatment of Amyotrophic Lateral Sclerosis: Texture and Compatibility with Food Thickeners Evaluation

Giuseppe Colombo, Roberta Artico and Daniele Barbareschi
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Giuseppe Colombo: Pharmaceutical Technology Laboratory, Italfarmaco SpA, 20126 Milan, Italy
Roberta Artico: Pharmaceutical Technology Laboratory, Italfarmaco SpA, 20126 Milan, Italy
Daniele Barbareschi: Pharmaceutical Technology Laboratory, Italfarmaco SpA, 20126 Milan, Italy

J, 2020, vol. 3, issue 3, 1-14

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.

Keywords: ALS; dysphagia; Riluzole oral suspension; HPLC; patient compliance; liquid formulation (search for similar items in EconPapers)
JEL-codes: I1 I10 I12 I13 I14 I18 I19 (search for similar items in EconPapers)
Date: 2020
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