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

机译:Riluzole口腔悬浮液用于治疗肌营养的外侧硬化:质地和与食物增稠剂的相容性评估

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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.
机译:Riluzole 5mg / ml口服悬浮液是唯一的持牌液体药物,用于口服肌萎缩侧面硬化剂(ALS)。由于超过80%的ALS患者开发吞咽困难,口服液体制剂提供了重要的治疗方法。通过药物包装中包含的渐变口服给药注射器给予Riluzole 5mg / ml口服悬浮液。其浓度(5mg / ml)与小且易于测量的体积(10mL)一致,以每天两次递送规定的50mg剂量。这项工作有双重目标。首先是根据国际吞咽饮食标准化倡议(IDDSI)流动试验来评估Riluzole 5mg / ml口服悬浮液的质地。该实验的结果表明,Riluzole 5mg / ml口服悬浮液基本上落在温和的IDDSI描述符下。这是一个重要的特征,因为厚液促进了吞咽困难患者的更安全的吞咽。作为第二个目的,我们评估了科学目的,利脲5 mg / ml口服悬浮液与市场上一些最常见的食物增稠剂的相容性。在制备后和室温下2小时后,评价用增稠剂的蓖麻嘧啶5mg / ml口服悬浮液的抗苯磺酸5mg / ml口服悬浮液,并在室温下两小时后评价外观,pH,Riluzole测定和Riluzole相关物质。 Riluzole 5mg / ml口服悬浮液导致与测试的所有市场上的增稠剂相容。

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