The Relative Bioavailability of Ibuprofen After Administration With a Novel Soft Chewable Drug Formulation. Issue 2 (25th April 2017)

• Record Type: Journal Article
• Authors: Hattrem, Magnus N.; Dille, Morten J.; Seternes, Tore; Ege, Thorfinn; Draget, Kurt I.
• Is Part Of: Clinical pharmacology in drug development. Volume 7:Issue 2(2018)
• Page Start: 168
• Page End: 176
• Publication Date: 2017-04-25
• Subjects: soft‐chew formulation -- ibuprofen -- bioavailability -- taste masking -- dysphagia; Drugs -- Testing -- Periodicals; Drug development -- Periodicals; Clinical pharmacology -- Periodicals; 615.580724
• DOI: 10.1002/cpdd.357
• Languages: English
• ISSNs: 2160-7648

Abstract

Abstract: The first aim of the present study was to evaluate the bioavailability of ibuprofen dispersed in a novel soft chewable formulation compared with a traditional ibuprofen tablet; its second was to map the quality of taste masking and patient product satisfaction. In a phase 1, single‐center, open‐label, randomized, crossover study, healthy subjects received a soft‐chew formulation or a hard tablet (reference), both containing 100 mg ibuprofen. Serial blood samples were collected over 24 hours to assess ibuprofen bioavailability. Taste and satisfaction after chewing the novel formulation 3 or 8 times were evaluated with a questionnaire. The soft‐chew formulation showed comparable bioavailability to the reference tablet. The highest peak plasma concentration was observed after 3 chews, and the relative bioavailability was approximately 8% higher compared to 8 chews. The overall flavor was well appreciated, and chewing 3 times was significantly preferred ( P = .043) over chewing 8 times. Soft chewable drug formulations may improve compliance and potentially benefit several subpopulations who experience dysphagia.