The Integrated Analytical Approach (IAA) is defined as “an integrated approach to study the bulk chemical composition (e.g., by spectroscopic methods) bulk structure (e.g. by rheological measurements), and surface characteristics (e.g. by surface tensiometry) on the same material sample and at the same time”. The IAA was successfully applied in structure-surface and chemical-surface correlations of different kinds of ointments and release/permeation of various active substances respectively. The surface tensiometry characterization of the release and permeation processes was performed by Solid-like methodology (SLM) using the Rossi number (χ) and variations of χ depending on the different properties of the liquid systems investigated. Our work focused on a short review of the recent applications of IAA, new investigations on the chemical-surface correlations of acceptor solutions (80 µl) sampled over time from a donor chamber of Franz cells during the ex-vivo permeation process of caffeine and release of carnitine. The quantitative analysis was carried out by an HPLC apparatus equipped with an Evaporative Light Scattering Detector and surface tensiometry investigations were carried out by contact angle method over time. The results demonstrated high correlation degrees (R2) between χ and quantitative data (µg/ml) for Franz cell A(R2=0.99), B(R2=0.98), C(R2=0.97), D(R2=0.97), E(R2=1) and defined a Liquid Surface Tensiometry Diagram (LSTD) of the release process of carnitine. The correlation degrees between χ and the concentration of carnitine (µg/cm2) in the ranges 90’-210’ (R2=0.86), 210’-270’ (R2=0.91), 270’-330’ (R2=0.89), 90’-300’ (R2=1), and 0’-270’ (R2=0.97) were satisfactory. Our work confirmed the wide applicability of IAA in the pharmaceutical technology field and demonstrated that the Rossi number is a parameter capable of "designing" a personalized diagram of a liquid system in release/permeation processes. The results encourage us to continue the application of SLM in the pharmaceutical technology field, opening at new perspectives in the characterization and control of pharmaceuticals also.

Application of integrated analytical approach to the investigation of release and permeation processes of active substances from ointments

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