transdermal therapeutic system | Acta Medica Marisiensis

Objective: The aim of this study was to develop and validate two HPLC methods for the quantification of meloxicam and tenoxicam from transdermal therapeutic systems.
Methods: Based on 1.0% hydroxypropyl methylcellulose 15000, transdermal patches containing meloxicam or tenoxicam were prepared by solvent evaporation technique. Analytical performances of the HPLC methods for the quantification of meloxicam and tenoxicam from such systems were assessed in terms of specificity, linearity, detection limit, quantification limit, recovery and precision.
Results and discussion: The linearity of the method was assessed through a calibration curve in the 1.0 – 75.0 μg∙mL-¹ concentration range, with a regression coefficient higher than 0.999. The detection limit and the quantification limit were found to be 0.46 μg∙mL-¹ and 1.39 μg∙mL-¹, for meloxicam; and 0.88 μg∙mL-¹, respectively 2.64 μg∙mL-¹ for tenoxicam. According to the European Pharmacopeia 5.0 the mean recovery was found to be between 75% and 125%. As performance criteria for precision was used the RSD% which were lower than 2.0% for both methods.
Conclusions: The proposed liquid chromatography methods provide selective, linear and precise results for the quantification of meloxicam and tenoxicam from transdermal therapeutic systems. The presence of a single peak in the chromatograms of the analyzed transdermal patches with meloxicam or tenoxicam, certify the successful determination of the active pharmaceutical ingredient in the prepared patches.

Evaluation of Mechanical Properties of Nonsteroidal Anti-Inflammatory Matrix Type Transdermal Therapeutic Systems

Paula Antonoaea¹, Nicoleta Todoran¹, Emőke Rédai¹, Adriana Ciurba¹, Cătălina Bogdan², Mirela Moldovan², Daniela Lucia Muntean³

1 Department of Pharmaceutical Technology, University of Medicine and Pharmacy of Tîrgu Mureș, Romania
2 Department of Dermatopharmacy and Cosmetics, “Iuliu Hațieganu” University of Medicine and Pharmacy Cluj-Napoca, Romania
3 Department of Analytical Chemistry and Drug Analysis, University of Medicine and Pharmacy of Tîrgu Mureș, Romania

DOI: 10.1515/amma-2017-0011

Objective: Transdermal therapeutic systems (TTSs) represent an intensely studied alternative to oral delivery of non-steroid anti-inflammatory drugs (NSAIDs) in the treatment of rheumatic diseases due to its ability of avoiding the side effects of the oral route. This study aims to present the evaluation of the mechanical properties of three NSAIDs (meloxicam, tenoxicam and indomethacin) individually included in four type of polymeric matrixes, as part of new formulations development process.
Methods: 12 products in form of TTS matrixes were prepared by solvent casting evaporation technique, using hydroxypropyl methylcellulose (HPMC 15000, HPMC E5) and/or ethylcellulose as matrix-forming polymers. Each of the resulted products was evaluated by determining the water vapor absorption, desorption or transmission in controlled atmosphere humidity (evaluation of porosity); the elongation capacity, tensile strength and bioadhesiveness (evaluation of mechanical properties).
Results: The analysis of three groups of the experimental data expressed as averages on each group was necessary, in order to identify the parameters which statistically are critically influenced by the ingredients associated in the TTSs matrix compositions. Analysis by normality tests, variance and correlation tests (Anova, Pearson) enabled evaluation of the effect of NSAID type vs. the effect of polymer matrix type on the parameters of the NSAID TTS matrix.
Conclusions: Meloxicam incorporated in the structure of HPMC 15000 polymeric matrix favors its viscoelastic structure. Ethylcellulose functions as plasticizer and supports the matrix bioadhesiveness. HPMC E5 does not meet the requirements for TTS preparation in the used experimental conditions.