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.