Percutaneous ibuprofen therapy with Trauma-Dolgit gel: bioequivalence studies

Area of Science:

• Pharmacokinetics
• Topical drug delivery
• Pain management

Background:

• Ibuprofen is a common nonsteroidal anti-inflammatory drug (NSAID) used for pain and inflammation.
• Topical formulations offer localized delivery, potentially reducing systemic side effects.
• Understanding the kinetic profile of topical ibuprofen is crucial for efficacy and safety.

Purpose of the Study:

• To determine the plasma and tissue kinetics of ibuprofen following topical application of 5% Trauma-Dolgit gel.
• To assess the bioequivalence of topical ibuprofen compared to oral forms.
• To evaluate the safety and efficacy of topical ibuprofen from a pharmacokinetic perspective.

Main Methods:

• Two bioequivalence studies were conducted.
• Ibuprofen concentrations were measured in plasma and various tissues (subcutaneous tissue, tendon, muscles, joint capsule).
• Pharmacokinetic parameters were analyzed after topical application in patients and volunteers.

Main Results:

• High ibuprofen concentrations were observed in subcutaneous tissue, tendon, muscles, and joint capsule, largely within the therapeutic range.
• Plasma ibuprofen concentrations remained very low, even below therapeutically relevant levels after repeated application.
• The topical ibuprofen preparation was found to be bioequivalent to oral forms.

Conclusions:

• Topical 5% ibuprofen gel leads to significant local tissue concentrations.
• Systemic absorption of ibuprofen from the topical gel is minimal, suggesting a favorable safety profile.
• The topical formulation is bioequivalent, safe, and effective for localized pain and inflammation management.