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Dongseong Shin,1 Sook Joung Lee,2 Yu-Mi Ha,3 Young-Sim Choi,3 Jae-Won Kim,3 Se-Rin Park,3 Min Kyu Park3 1Clinical Trials Center, Gachon University Gil Medical Center, Incheon, 2Department of Rehabilitation Medicine, 3Department of Clinical Pharmacology and Therapeutics, Dong-A University College of Medicine and Hospital, Busan, South Korea Objective: Prostaglandin E2 (PGE2) synthesis is modulated by COX2. Changes in PGE2 could be used to quantify the COX2 inhibition after ibuprofen administration. This study investigated the pharmacokinetic and pharmacodynamic relationships for COX2 inhibition according to three formulations of ibuprofen in healthy male subjects.Materials and methods: A randomized, open-label, single-dose, three-treatment, six-sequence crossover study was performed in 36 healthy South Korean male volunteers. Enrolled subjects received the following three 200 mg ibuprofen formulations: ibuprofen arginine, solubilized ibuprofen capsule, and standard ibuprofen. Pharmacokinetic and pharmacodynamic blood samples were collected for 16 hours following treatment. For pharmacodynamic evaluations, lipopolysaccharide (LPS)-induced PGE2 inhibition at each time point compared to predose was measured. Noncompartmental analysis was used for pharmacokinetic assessment, and time-weighted average inhibition (WAI) of PGE2 was applied to the pharmacodynamic evaluation.Results: After a single oral dose of the ibuprofen formulations, the median times to maximum concentration were 0.42, 0.5, and 1.25 hours in ibuprofen arginine, solubilized ibuprofen capsule, and ibuprofen, respectively. The maximum observed plasma concentration was lower in ibuprofen, and the area under the plasma concentration–time curve was comparable among the three formulations. A significant difference was observed between fast-acting formulations and standard ibuprofen tablets for both maximum concentration and time taken to reach it. Individual formulations had an effect on PGE2 WAI during the 8 hours following treatment, resulting in significantly lower WAI in standard ibuprofen: ibuprofen arginine 18.4%, solubilized ibuprofen capsule 18.4%, and standard ibuprofen 11.6%.Conclusion: Rapid absorption and higher peak concentration were observed in ibuprofen arginine and the solubilized ibuprofen capsule. Additionally, fast-acting formulations had more predominant inhibitory activity on the COX2 enzyme. Keywords: ibuprofen, different formulation, COX2-inhibitory effects

OBJECTIVE: To determine the diagnostic value of voice analysis to screen for patients with high risk of clinically significant aspiration. DESIGN: A total of 93 patients referred for a videofluoroscopic swallowing study were included in the study. Voice analyses were performed before and after videofluoroscopic swallowing study, and five acoustic variables were measured, including average fundamental frequency, relative average perturbation, shimmer percentage, noise-to-harmonic ratio, and voice turbulence index. The patients were divided into two groups based on the results of the videofluoroscopic swallowing study: a high-risk group with patients who had the ingested materials on or below the vocal cords and a low-risk group with patients who did not have the ingested materials on or below the vocal cords. The changes of each acoustic variable before and after the videofluoroscopic swallowing study were compared between the two groups. RESULTS: Relative average perturbation, shimmer percentage, noise-to-harmonic ratio, and voice turbulence index were significantly increased after videofluoroscopic swallowing study in the high-risk group as compared with the low-risk group (P < 0.05). The change of average fundamental frequency, however, was not significantly different between the two groups (P > 0.05). According to the receiver operating characteristics curve, the sensitivity of these acoustic variables in detecting aspiration or penetration ranged from 68.9% to 91.1% and specificity ranged from 68.8% to 97.9%. Relative average perturbation was the most accurate variable, with a sensitivity of 91.1% and a specificity of 97.9% in predicting aspiration or penetration. The combination of relative average perturbation and noise-to-harmonic ratio increased the sensitivity to 100% but reduced the specificity to 77.1%. CONCLUSION: Voice analysis is a safe, noninvasive, and reliable screening tool for patients with dysphagia and can detect patients at high risk of clinically significant aspiration, thereby augmenting clinical bedside examination. [ABSTRACT FROM AUTHOR]