Vitux AS, Oslo, Norway.
Department of Biotechnology, Norwegian University of Science and Technology, Trondheim, Norway.
Clin Pharmacol Drug Dev. 2018 Feb;7(2):168-176. doi: 10.1002/cpdd.357. Epub 2017 Apr 25.
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.
本研究的首要目的是评估新型软咀嚼制剂中布洛芬的生物利用度与传统布洛芬片剂的比较；其二是绘制味觉掩蔽质量和患者产品满意度的图谱。在一项 1 期、单中心、开放标签、随机、交叉研究中，健康受试者接受了软咀嚼制剂或硬片（参比），两者均含有 100 毫克布洛芬。采集 24 小时内的连续血样以评估布洛芬的生物利用度。咀嚼新型制剂 3 或 8 次后的口感和满意度通过问卷调查进行评估。软咀嚼制剂显示出与参比片剂相当的生物利用度。最高的血浆峰浓度出现在咀嚼 3 次后，与咀嚼 8 次相比，相对生物利用度约高 8%。整体口感受到高度赞赏，咀嚼 3 次明显优于咀嚼 8 次（P =.043）。软咀嚼药物制剂可能会提高顺应性，并可能使几种吞咽困难的亚人群受益。
