Ibuprofen Bioavailability Study

Summary

This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups. This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.

Timeline

Start

2017-04-10

Primary completion

2017-06-13

Completion

2017-06-13

Outcome

Met primary endpoint

paper AUC0-t (98.72-105.23) was contained entirely within the predefined 80.00%-125.00% lower and upper limits PMID 31202508 ↗

paper met the regulatory criteria for bioequivalence for AUC0-t and Cmax. PMID 31202508 ↗

Publications

• Sugar D, Francombe D, da Silva T, Hanid S, Hutchings S. Comparative Bioavailability Study of a New Orodispersible Formulation of Ibuprofen Versus Two Existing Oral Tablet Formulations in Healthy Male and Female Volunteers. Clin Ther. 2019 Aug;41(8):1486-1498. doi: 10.1016/j.clinthera.2019.04.040. Epub 2019 Jun 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibuprofen	Small molecule	400 mg	Oral

Indications

No indication recorded.