Abstract
Objective: This open-label study sought to evaluate the warming sensation produced by IFF flavor 316282 in an acetylcysteine oral solution in subjects with productive cough. Materials: 2% acetylcysteine oral solution (200 mg per 10 mL) containing IFF flavor 316282. Methods: Subjects (N = 57; mean age 38.7 years; 58% female) with a productive cough lasting < 7 days and rated as mild to moderate in severity received 10 mL of study product. Warming sensation intensity was assessed using a 100-mm visual analog scale, its onset and duration using stopwatches, its acceptability using a 9-point scale (from “dislike extremely” to “like extremely”) and the taste, texture, and overall acceptability of the solution using 5-point scales (from “unacceptable” to “excellent”). Results: 53 (93.0%) subjects perceived a warming sensation within 10 minutes of swallowing the solution; median onset was ~ 14 seconds, and median duration was ~ 2.8 minutes. Warming sensation intensity increased from baseline by a mean of 29.2 mm when evaluated 60 seconds after ingestion. 30 subjects (52.6%) thought the warming sensation was “just about right”; 25 (43.9%) considered it “too weak” or “much too weak.” Most subjects had positive overall ratings (“fair,” “good,” or “excellent”) of the taste (79.0%), texture (96.5%), and solution (91.2%). No treatment-emergent adverse events were reported, and no evidence of oral mucosal irritation was found. Conclusion: The addition of IFF flavor 316282 to a 2% acetylcysteine oral solution produced a warming sensation with rapid onset and relatively short duration, which the majority of subjects found acceptable.
Highlights
Acetylcysteine is a mucolytic agent with established efficacy and tolerability in acute and chronic bronchopulmonary diseases accompanied by impaired formation and transport of mucus, including bronchitis and the common cold, and as an antidote for acetaminophen overdose [1, 2]
This open-label study sought to evaluate the warming sensation produced by International Flavors & Fragrances (IFF) flavor 316282 in an acetylcysteine oral solution in subjects with productive cough
Subjects (N = 57; mean age 38.7 years; 58% female) with a productive cough lasting < 7 days and rated as mild to moderate in severity received 10 mL of study product
Summary
Acetylcysteine is a mucolytic agent with established efficacy and tolerability in acute and chronic bronchopulmonary diseases accompanied by impaired formation and transport of mucus, including bronchitis and the common cold, and as an antidote for acetaminophen overdose [1, 2]. A new oral solution formulation containing acetylcysteine (200 mg per 10 mL) has been developed for subjects with bronchitis associated with the common cold and characterized by productive cough. By reducing the viscosity of mucus secretions, the oral solution aids in the elimination of mucus from the respiratory tract by expectoration, thereby facilitating productive cough. The present study was designed to assess the warming sensation, acceptability, tolerability, and safety of the new oral solution formulation containing acetylcysteine 200 mg per 10 mL with IFF flavor 316282 in subjects with a productive cough caused by an upper respiratory tract infection (URTI)
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