An open-label, in-use study assessing the warming sensation accompanying IFF Flavour 316282 and the acceptability and local tolerability of a syrup containing paracetamol and pseudoephedrine for the short-term treatment of symptoms of an upper respiratory tract infection

Abstract

Objective:The primary objective was to assess the warming sensation caused by IFF Flavour 316282 in a syrup used for short-term treatment by patients suffering from nasal congestion and mild to moderate body pain, headache, fever or sore throat associated with an upper respiratory tract infection.Methods:A single cohort, single treatment arm, open-label study. Subjects received one 30 mL dose of syrup containing IFF Flavour 316282, paracetamol and pseudoephedrine and recorded onset and disappearance of any warming sensation in the mouth/throat. Subjects’ assessments of strength and appeal of the sensation, taste, texture and acceptability of the product was investigated using questionnaires.Results:A total of 56 subjects were included; 53 (94.6%) experienced a warming sensation. The median duration of the warming sensation was 114 s (95% confidence interval: 87–120 s). All subjects rated the syrup as excellent, good or fair for treating their symptoms; 100% and 94.6% of subjects respectively described texture and taste as excellent, good or fair. There were no safety concerns, and the syrup was well tolerated. Most subjects liked the warming sensation.Conclusions:IFF Flavour 316282 in a syrup for treatment of upper respiratory tract infection symptoms is associated with a warming sensation. The syrup is well tolerated, safe and palatable.

Evaluation of the warming sensation, acceptability, and local tolerability of an acetylcysteine oral solution containing the flavoring agent IFF flavor 316282 in the treatment of productive cough

“…Just over half of the subjects considered the warming sensation to be “just about right,” whereas most of the others thought the warming sensation was “too weak” or “much too weak.” Most also indicated that they liked the warming sensation, with only 7 subjects (12.4%) indicating that they disliked it even slightly. In previous studies of other cough and cold products containing IFF flavor 316282, a majority of subjects also indicated that the warming sensation was pleasantly warming, whereas a number of others would have preferred it to be stronger [ 5 , 6 ]. Taken together, these data suggest that the warming sensation may be considered a desirable feature in a cough and cold product, perhaps contributing to a soothing sensation.…”

“…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 formulation contains a flavoring agent (flavor 316282; International Flavors & Fragrances (IFF), New York, NY, USA) in a concentration of 0.15% weight/volume, which has been previously shown to produce a warming sensation in the throat [ 5 , 6 ]. 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).…”