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Liquid Formulations of Riluzole for Oral and Intravenous Use

Riluzole is a benzothiazole class of drug approved by FDA for the treatment of Amyotrophic Lateral Sclerosis (ALS). Riluzole is a voltage sensitive sodium channel blocker. The anti-glutamate uptake and antiexcitotoxic activity makes it a suitable candidate for many neurological conditions.

This invention is a stable liquid formulation of Riluzole that can be used for patients suffering from dysphagia. This formulation was well tolerated both orally and intravenously in rats. In comparison to commercially available Rilutek® tablets, the formulation has a faster rate of absorption and more sustained plasma levels with significantly longer elimination half-life.

Compared to the commercially available Teglutik®, this formulation is homogenous, has higher strength (10mg/ml), suitable for intravenous injection and intrathecal administration.

Applications

  • ALS
  • Spinal Cord injury
  • Other neurological indications

Problems Addressed

  • Patients with dysphagia have complications with swallowing oral dosage formulations
  • Currently available liquid dosage formulations for Riluzole are not homogenous
  • Multiple administration required with currently available formulations

Competitive Advantages

  • Homogenous formulation, accuracy of dosage
  • Oral, Intravenous and Intrathecal administration
  • High strength formulation
  • Ongoing Phase II/III Clinical trial for Spinal cord injury
  • Could be used in treatment of Spinal cord injury, ALS

Patents

  • Provisional Patent application Filed