Abstract
This is a pharmacokinetic test of two formulations that contain 20 mg of Isotretinoin, with the aim to compare the bioavailability between the Test Product (Isoface® from Procaps Laboratory SA, Colombia) and the Reference Product (Roaccutane® from Catalent Laboratory Germany, Eberbach GMBH, Germany), to declare the bioequivalence between both formulations. An open, crossed study was developed, randomized, of two periods and two sequences, with 40 mg single dose of isotretinoin, on fasting conditions, on 24 healthy male Colombian volunteers; the washout was 14 days in between each period. To present the results, curves of the plasma concentration ratio vs. Time until hour 72 were performed; with the aim to identify the concentration provided by the Test formulation, the basal status of each volunteer was eliminated from the analysis, which was built with 3 former concentrations to the test medicine administration. The analytical method used in this study was high resolution liquid chromatography with tandem mass spectrometry detector, HPLC MS/MS, for plasma Isotretinoin identification and quantification. The main pharmacokinetic parameters for the Test Product vs. the Reference Product were Tmax 2.6 vs. 2.8 h, Cmax 190.5 vs. 186.5 ng/mL for the AUC0-t 3003.8 vs. 2933.5 h*ng/mL and AUC0-∞ 3726.3 vs. 3521.2 h*ng/mL. The confidence interval calculation of data with logarithmic transformation, showed confidence intervals for the variables Tmax, Cmax, AUCo-t and AUCo-∞, with values between 80-125; values approved by the FDA and EMA European Medicines Agency, in their Bioavailability and Bioequivalence Guides, to accept the Bioequivalence hypothesis between the two formulations in study, and thereby declare Bioequivalence and interchange ability of the Test Product from Procaps Laboratory, with the Reference Product from Roche Laboratory.
Highlights
Retinoids are intracrine and paracrine mediators of the cell differentiation, intervening in the reproduction, proliferation and apoptosis, by binding to the nuclear retinoic receptors
Its effects on acne and other dermatological serious conditions are due to its action on the four pathogenetic factors:
Sebum suppression Isotretinoin is an effective agent in the reduction of sebaceous glands size
Summary
Retinoids are intracrine and paracrine mediators of the cell differentiation, intervening in the reproduction, proliferation and apoptosis, by binding to the nuclear retinoic receptors. There are two types of retinoic receptors, the RXRs (x retinoid receptors) and the RARs (retinoic acid receptors). Each one of them, is as well divided into a, b and g. All these receptors are structurally alike, but show different affinities towards the different retinoid types, and, their body distribution differs, which explains the multiplicity of physiological processes they intervene [1]. Its effects on acne and other dermatological serious conditions are due to its action on the four pathogenetic factors:
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
