Romanian Society of Pharmaceutical Sciences
 

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IN-VIVO SAFETY AND EFFICACY EVALUATION OF A NOVEL POLYMERIC BASED LIDOCAINE FORMULATION FOR TOPICAL ANALGESIA

ANDREI LUCA 1,9, COSMIN-TEODOR MIHAI 1, GABRIELA-DUMITRIȚA STANCIU 1, VERONICA BILD 1,2, ELENA COJOCARU 3, ROBERT ANCUCEANU 4, VALERIA HARABAGIU 5, CRISTIAN PEPTU 5, CATALINA ANIȘOARA PEPTU 6, MAGDALENA-MARIA LEON-CONSTANTIN 1,7*, TEODORA ALEXA-STRATULAT 1,8

1.CEMEX Laboratory, University of Medicine and Pharmacy „Gr. T. Popa”, 9-13 Mihail Kogălniceanu Street, Iași, Romania
2 .Pharmacodynamics and Clinical Pharmacy Department, University of Medicine and Pharmacy „Gr. T. Popa”, 16 Universității Str., 700115, Iași, Romania
3 .Morphofunctional Sciences Department, Discipline of Pathology, University of Medicine and Pharmacy „Gr. T. Popa”, 16 Universității Str., 700115, Iași, Romania
4 .A&B Pharm Corp., Roman, Romania
5 .“Petru Poni” Institute of Macromolecular Chemistry, Aleea Grigore Ghica Voda 41A, 700487 Iași, Romania
6 .Department of Natural and Synthetic Polymers, Faculty of Chemical Engineering and Environmental Protection, „Gheorghe Asachi” Technical University of Iași, Dimitrie Mangeron Street, 73, 700050, Romania
7 .First Medical Department, Discipline of Medical Semiology, University of Medicine and Pharmacy „Gr. T. Popa”,16 Universității Str., 700115, Iași, Romania
8 .Medical Oncology-Radiotherapy Department, University of Medicine and Pharmacy „Gr. T. Popa”, 16 Universității Str., 700115, Iași, Romania
9 .Pneumology Department, University of Medicine and Pharmacy „Gr. T. Popa”, 16 Universității Str., 700115, Iași, Romania

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Topical analgesics currently available still have efficacy, local tolerability and price issues. The aim of this study was to assess the efficacy of a new lidocaine-based spray (CX001) on experimental pain.Safety was assessed by histology examination of skin and liver tissue of CX001-treated mice. The effect of CX001 on nociceptive and inflammatory pain was assessed by periodic evaluation of the rat’s response to thermal and mechanical stimuli and compared with EMLA© (reference topical analgesic).CX001-treated mice had no significant skin or liver modification. CX001’s analgesic effect was superior to EMLA© in terms of response to mechanical stimuli in both the nociceptive and inflammatory pain model. The two drugs had similar effects in terms of thermal stimuli. Our lidocaine-based innovative formula represents a novel platform for acquiring topical analgesia. CX001 is safe and more effective than the reference cream for mechanically-induced nociceptive and inflammatory pain.