The Relative Bioavailability of Ibuprofen After Administration With a Novel Soft Chewable Drug Formulation

Area of Science:

• Pharmacology
• Drug Delivery Systems
• Clinical Pharmacology

Background:

• Traditional ibuprofen tablets present challenges for some patient populations.
• Novel drug formulations are needed to improve patient compliance and therapeutic outcomes.
• Soft chewable formulations offer an alternative dosage form for oral medications.

Purpose of the Study:

• To evaluate the bioavailability of a novel soft chewable ibuprofen formulation compared to a standard ibuprofen tablet.
• To assess taste masking quality and patient satisfaction with the soft chewable formulation.
• To determine the optimal chewing frequency for the soft chewable ibuprofen formulation.

Main Methods:

• A single-center, open-label, randomized, crossover study was conducted in healthy subjects.
• Participants received either a soft-chew formulation or a hard tablet (reference) containing 100 mg ibuprofen.
• Ibuprofen bioavailability was assessed via serial blood sampling over 24 hours; taste and satisfaction were evaluated using a questionnaire.

Main Results:

• The soft-chew formulation demonstrated comparable bioavailability to the reference ibuprofen tablet.
• Peak plasma concentration of ibuprofen was highest after 3 chews, with approximately 8% higher relative bioavailability compared to 8 chews.
• The soft chewable formulation was well-appreciated for its flavor, with a significant preference for chewing 3 times over 8 times (P = .043).

Conclusions:

• Novel soft chewable ibuprofen formulations exhibit comparable bioavailability to traditional tablets.
• This formulation offers good taste and patient satisfaction, with fewer chews being preferred.
• Soft chewable drug delivery systems hold potential for improving medication compliance, particularly for individuals with dysphagia.