Romanian Society of Pharmaceutical Sciences

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DESIGN AND CHARACTERISATION OF NEW DERMAL POLYMERIC FILMS FOR TREATMENT OF INFLAMMATORY PAIN

PAULA ANTONOAEA 1#, ADRIANA CIURBA 1#, EMŐKE RÉDAI 1, ROBERT-ALEXANDRU
VLAD 1*, CORNELIA-TITIANA COTOI 1, MAGDALENA BÎRSAN 2, NICOLETA TODORAN 1

1Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, “George Emil Palade” University of
Medicine, Pharmacy, Science, and Technology of Târgu Mureș, 38 Gheorghe Marinescu Street, 540142, Târgu Mureș, Romania
2Department of Drug Industry and Pharmaceutical Biotechnology, Faculty of Pharmacy, “Grigore T. Popa” University of Medicine and Pharmacy from Iași, 700115 Iași, Romania

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This study aimed to develop two polymeric films containing indomethacin (IND) coded as F1 and F2. As a formulation variable, the propylene glycol (PG) concentration was used (F1-10%PG and F2-30%PG). DSC analysis was used to evaluate the compatibility between the film-forming agent and the IND. These two formulations were obtained through the solvent evaporation technique and evaluated for: uniformity of weight, elongation, folding endurance, behaviour in different humidity conditions, and the in vitro releasing test using a Franz cell. The DSC obtained results showed good compatibility between the film-forming agent and the IND. The analysis of the elongation behaviour considering an increased force and repeated folds obtained showed close results for both formulations. Also, in both cases, an increased tendency of drying through volatilization compared to the capacity of fixing water from the atmosphere was noticed, highlighting the importance of maintaining an exterior protection membrane when the film is applied to the skin. Through the in vitro dissolution test, after 30 h the cumulative amount of IND released was: F1 - 83 ± 4.44 µg/cm2; F2 - 127 ± 4.41 µg/cm2, which demonstrated that an increased concentration of PG favours an increased release of concentration of drug. The proper kinetic model that characterized the IND release was established using the Akaike index, also the F1-10%PG is fitted through the Korsmeyer-Peppas kinetics, whilst F2-30%PG is fitted through the First-order kinetic. In conclusion, pain transdermal therapy may represent an alternative to other forms of treatment, being eligible for patients with deglutition issues.