Utilisation of the technique applied for transdermal therapeutic systems for the assessment of pharmaceutical availability of capsaicin and dihydrocapsaicin from preparations Kapsiplast® and Kapsiplast Plus®
Michał K. Kołodziejczyk 1/, Jan Wnuk 2/, Agnieszka Studzińska 2/, Marian M. Zgoda 1/
1/ Zakład Technologii Postaci Leku, Katedra Farmacji Stosowanej Uniwersytetu Medycznego w Łodzi
2/ 3M Viscoplast Wrocław
Introduction. Studies on pharmaceutical availability of biologically active substances in medicinal products and cosmetics administered to the skin and mucous membranes serves great applicatory complications. Thus, the assessment of the pharmaceutical availability of capsaicin and dihydrocapsaicin from marketed products and project plasters administered to the skin was subject to testing. In the studies in question, an innovative method used for transdermal therapeutic systems was applied.
Materials and Methods. Kapsiplast® and Kapsiplast Plus® plasters, manufactured by 3M Viscoplast were subject to testing. The analysis of capsaicin and dihydrocapsaicin in plasters was performed, and comparative release testing was carried out, whose results were elaborated mathematically and statistically in accordance to the current norms in force.
Results and discussion. The kinetics of release of capsaicin and dihydrocapsaicin medicinal products from two testing samples of the treatment plaster and their diffusion to the lipophilic acceptor liquid in the model system in "in vivo" conditions is symmetric to the ones of the reference material Kapsiplast®. The profiles of release curves for the preparations in question, described mathematically with the use of the function y=a+bx at high correlation coefficient - (r), indicate that the release process undergoes in accordance to the 0-order kinetics, and consequently it allows determination of the constant diffusion rate K and time t0,5.
Conclusions. Both tested samples of Kapsiplast Plus® (Sample 1, s. AB, d.w. 02.2005 and Sample 2, s. AE, d.w. 02.2005) and the reference preparation Kapsiplast® release biologically active substances in a symmetric way in the model system of the mass exchange process at the phase boundary with the use of lipophilic acceptor liquid. The above conditions expected biological efficacy as studies on the kinetics of the release process rate and its statistical analysis have shown.
Key words: skin, plasters, transdermal systems, pharmaceutical availability, release, capsaicin, dihydrocapsaicin, Kapsiplast, Kapsiplast Plus