Development of novel, biophysically designed fluids for swallowing disorders

Period of Performance: 08/18/2016 - 07/31/2017

$750K

Phase 2 SBIR

Recipient Firm

Swallow Solutions, LLC
Madison, WI 53719
Principal Investigator
Principal Investigator

Abstract

Swallowing disorders, known as dysphagia, are associated with increased mortality and morbidity, including malnutrition, dehydration, pulmonary complications, and reduced quality of life. More than 18M adults (and millions more children) suffer from dysphagia. This disorder commonly causes liquids, whether overly thin (water, coffee) or overly thickened, to be aspirated or misdirected into the airway during swallowing, leading to significant risk of aspiration pneumonia. Dysphagia and its associated health sequelae (e.g., aspiration pneumonia and dehydration), place a heavy burden on the health care system. Indeed, dysphagia accounts for 4.5M visits to emergency rooms, hospitals, and clinics annually, at a cost of ~$4.4 billion each year. Appropriately thickened liquids are less likely to enter the airway. Unlike thin liquids, they move more slowly and cohesively allowing more time for airway protection. Unlike overly thick liquids, they clear the oropharynx efficiently. Dysphagia diagnosis involves undergoing a dynamic radiographic evaluation of the swallowing mechanism, using diagnostic barium fluid standards covering a range of thicknesses. Successful dysphagia management involves prescribed dietary thickened liquids matching the rheological parameters of the diagnostic barium fluid standards. Currently available thickened liquids do not match the rheologic characteristics of the diagnostic standards, causing a critical disconnect between diagnosis and treatment. This disconnect places patients at greater risk for aspiration and dysphagia-related negative health sequelae (e.g., pneumonia). Swallow Solutions, LLC will build on its successful Phase I project to continue to bridge the gap between unmet clinical and nutritional needs and existing products. The insights gained in Phase I results will guide the development of a complete product line of ready-to-drink thickened beverages (SwallowSTRONG Thickened Beverages) to meet the unique needs of dysphagic patients. This Phase II proposal has three goals. (1) Complete development of a full complement of prototype ready- to-drink, thickened, and protein-enriched medical liquids that are shelf-stable and appealing, with pre- determined rheological and nutritional properties. (2) Demonstrate improved patient safety resulting from the full SwallowSTRONG Thickened Beverages product line compared to currently available thickened beverage options; (3) Develop the production process for the full product line of ready-to-drink, thickened beverages (with and without enhanced nutrition) at 2 target viscosities (nectar and thin honey) in 1?3 flavors each. Swallow Solutions will bridge the gap between clinical need and existing products. Safer products will provide dysphagic patients with needed hydration and nutrition and will avoid serious and costly dysphagia-related health problems. At the end of Phase II, Swallow Solutions will commercialize its SwallowSTRONG Thickened Beverages, meeting a vital clinical need and improving the health and quality of life for people with dysphagia.