Development of novel, biophysically designed fluids for swallowing disorders

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DESCRIPTION (provided by applicant): Swallowing disorders, known as dysphagia, are associated with increased mortality and morbidity, including malnutrition, dehydration, pulmonary complications, and reduced quality of life. More than 18 million adults (and millions more children) suffer from dysphagia. Dysphagia commonly causes thin liquids (e.g., water, coffee) to be aspirated or misdirected into the airway during swallowing, leading to significant risk of aspiration pneumonia. Rates of hospital discharge for Medicare beneficiaries with aspiration pneumonia as a primary diagnosis have risen by 93.5% in the last decade; the length of hospital stay and death rates has also increased. Annual healthcare costs of treating pneumonia in elders are $4.4 billion and pneumonia is responsible for 4.5 million visits to Emergency Rooms, hospitals, and clinics annually. Liquids that are more viscous ("thicker") are less likely to enter the airway because they move more slowly and cohesively than thin liquids allowing more time for sufficient airway protection. Dysphagia diagnosis involves undergoing a dynamic radiographic (fluoroscopic) evaluation of the swallowing mechanism, using fluids made radiopaque with barium sulfate particles. Successful dysphagia management strategy involves having prescribed dietary thickened liquids match the rheological parameters of the standardized diagnostic barium mixtures. However, currently available dietary liquids do not match the rheological characteristics of the diagnostic fluids, causing a critical disconnect between diagnosis and treatment practices. This disconnects places patients at greater risk for aspiration and dysphagia-related negative health sequelae (e.g., pneumonia). The goal of this Phase I SBIR submission is to develop fluids for hydration that are stable, safe to swallow, appealing, and possess pre-determined rheological properties consistent with standardized diagnostic barium products. This Aim is divided into two tasks: (1) Develop six fluid prototypes that meet identified rheological criteria (apparent viscosity, flow behavior and apparent yield stress) and match commercially available diagnostic standards and (2) Evaluate prototypes for shelf-life (rheological stability and organoleptic changes), swallowing safety and sensory perception (the latter two in human subjects). Swallow Solutions LLC has the knowledge and skills to bridge the gap between clinical need and existing products and to develop new products to provide dysphagic patients with adequate hydration and nutrition and to avoid the serious, costly health problems associated with aspiration. This expert multi-disciplinary team is ideally positioned to build the scientific foundation for clinical practice by developing commercially available, biophysically-designed, scientifically-based fluids for individuals with dysphagia.