In this trial, a topical formulation of a 1% liposome TH cream was compared to a conventional TH formulation. Permeation was evaluated through a synthetic membrane. The study provided information on the rate of diffusion and percentage of drug release and also compared the penetration dynamics in the layers of the stratum corneum of both formulations. Liposome TH cream was able to deliver the active ingredient to a larger number of SC layers, with a higher amount of drug, which is very promising for the treatment of superficial mycoses.
Objective: To evaluate the bioequivalence between two formulations of ketoprofen after administration of a 150 mg extended release tablet (L.P. ProfenidBI®), 150 mg modified release tablets. Methods: A single-dose cross-over, randomized study was performed under fasting conditions with two treatments, two periods, two sequences (2 × 2) with a 7-day washout period between each dose in 28 healthy volunteers. Subjects were randomly assigned to each of the administration sequences. The pharmacokinetic parameters evaluated were: C max , AUC 0-t and AUC 0-∞ . For the bioequivalence analysis, the AUC 0-t was calculated from the time of administration to the 12 th hour, posology requested for the medication test, by the trapezoidal method; Software: Excel. The means and Confidence Intervals were compared between 80% -125% for the quotient of C max , T max , AUC 0-t and AUC 0-∞ . Results: C max 8.3529 ± 1.9176 μg/mL vs. 7.7175 ± 2.1751 μg/mL, T max 0.75 h vs. 1.25 h, AUC 0-12 25.9560 ± 4.9846 μg/mL/hr vs. 24.9015 ± 5.1507 μg/mL/ hr and AUC 0-∞ 27.0147 ± 5.1099 μg/mL/hr vs. 25.6400 ± 5.1144 μg/mL/h, respectively. 95% IC: C max 106.26% -107.85%, AUC 0-12 101.11% -101.78% and AUC 0-∞ 100.53% -102.94%. Conclusion: The test formulation Ketoprofen 150 mg LP, manufactured by LETI S.A.V. Laboratories, is bioequivalent with respect to the reference product ProfenidBI® 150 mg controlled release tablets, manufactured by Sanofi-Aventis Pharmaceuticals LTDA Laboratories, as the Values obtained from AUC and C max were maintained in the range of 80% -125%.
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