Background: A novel ibuprofen (IBU) formulation, Advil(®) Film-Coated Tablets (IBUNa), was developed.

Objective: Pharmacokinetic comparison of IBUNa versus other IBU formulations.

Study Design: Two randomized, single-dose, open-label, five-way crossover pharmacokinetic studies.

Setting: Inpatient research clinic.

Subjects: Seventy-one healthy adult volunteers.

Intervention: Study 1: In three periods, fasted subjects received 400-mg IBU dose equivalents as IBUNa 2 × 256 mg, Advil(®) Liqui-Gels(®) (IBULG) 2 × 200 mg, and Motrin(®) IB (IBUMot) 2 × 200 mg tablets. In two periods following a high-fat breakfast, subjects received 400-mg IBU dose equivalents as IBUNa 2 × 256 mg and IBULG 2 × 200 mg. Study 2: In five study periods, fasted subjects received 400-mg IBU dose equivalents as IBUNa 2 × 256 mg, Advil(®) FastGel(®) (IBUFG) 2 × 200 mg, Nurofen(®) (IBUNur) 2 × 200 mg, Advil(®) (IBUAdv) 2 × 200 mg, and Nurofen(®) Express containing IBU lysinate (IBULys) 2 × 342 mg.

Main Outcome Measure: Log-transformed area under the plasma concentration versus time curve to last observable concentration (AUCL) and maximum plasma concentration (C max) were the primary pharmacokinetic parameters; time to maximum measured plasma concentration (T max) was analyzed post hoc.

Results: IBUNa was bioequivalent to IBULG (fasted and fed) and IBUFG and IBULys (fasted) for rate (C max) and extent (AUCL) of IBU absorption. After fasting, AUCL was bioequivalent for IBUNa and IBUMot, IBUAdv, and IBUNur, but C max occurred significantly earlier with IBUNa. After fasting, median IBUNa T max was comparable to that for IBULG, IBUFG, and IBULys, but was much shorter than that for IBUMot, IBUNur, and IBUAdv. Food slowed absorption of IBUNa and IBULG similarly. All treatments were tolerated similarly.

Conclusion: IBUNa is absorbed faster but to a similar extent as standard IBU formulations.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4269818PMC
http://dx.doi.org/10.1007/s40268-014-0070-8DOI Listing

Publication Analysis

Top Keywords

subjects received
12
received 400-mg
12
400-mg ibu
12
ibu dose
12
dose equivalents
12
equivalents ibuna
12
ibuna 256
12
plasma concentration
12
ibuna
11
absorbed faster
8

Similar Publications

Pharmacologic Management of Heart Failure with Preserved Ejection Fraction (HFpEF) in Older Adults.

Drugs Aging

January 2025

Program for the Care and Study of the Aging Heart, Department of Medicine, Weill Cornell Medicine, 420 East 70th St, New York, NY, LH-36510063, USA.

There are several pharmacologic agents that have been touted as guideline-directed medical therapy for heart failure with preserved ejection fraction (HFpEF). However, it is important to recognize that older adults with HFpEF also contend with an increased risk for adverse effects from medications due to age-related changes in pharmacokinetics and pharmacodynamics of medications, as well as the concurrence of geriatric conditions such as polypharmacy and frailty. With this review, we discuss the underlying evidence for the benefits of various treatments in HFpEF and incorporate key considerations for older adults, a subpopulation that may be at higher risk for adverse drug events.

View Article and Find Full Text PDF

Purpose: To review the current evidence on the association between salivary protein profile and dental caries in children during mixed dentition stage.

Methods: This systematic review followed the PRISMA 2020 guidelines. Searches were run in PubMed, Scopus and Embase along with gray literature.

View Article and Find Full Text PDF

Purpose Of Review: Male breast cancer (MBC) is a rare entity which often arises in elderly people. Aim of this review is to evaluate the principal issues related to MBC in elderly, because the therapeutic management of disease is not only related to the biological behavior of the tumor, but also to the comorbidities and frailty of older population. A scoping literature review was performed on Pubmed and Cochrane Database using the following keywords: therapeutic management/ male/ breast cancer/ elderly patients.

View Article and Find Full Text PDF

Introduction: Obesity and its complications are associated with high morbidity/mortality and a significant healthcare cost burden in Spain. It is therefore essential to know the potential clinical and economic benefits of reducing obesity. The objective of this study is to predict the decrease in rates of onset of potential complications associated with obesity and the cost savings after a weight loss of 15% over 10 years in Spain.

View Article and Find Full Text PDF

Purpose Of Review: Addressing diabetes distress (DD), the emotional demands of living with diabetes, is a crucial component of diabetes care. Most individuals with type 2 diabetes and approximately half of adults with type 1 diabetes receive their care in the primary care setting. This review will provide guidance on addressing DD and implementing targeted techniques that can be tailored to primary care patients.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!