Stability of a novel Lidocaine, Adrenaline and Tetracaine sterile thermosensitive gel: A ready-to-use formulation

• Published in: European journal of pharmaceutical sciences 2019-08, Vol.136, p.104962, Article 104962
• Main Authors: Zanon, Davide, Volpato, Chiara, Addobbati, Riccardo, Loiacono, Stefano, Maestro, Alessandra, Barbi, Egidio, Maximova, Natalia, Mamolo, Maria Grazia, Zampieri, Daniele
• Format: Article
• Language: English
• Subjects: Anesthetics, Local - chemistry; Chemistry, Pharmaceutical - methods; Epinephrine - chemistry; Gels - chemistry; Lidocaine - chemistry; Pain - drug therapy; Pain Measurement - methods; Tetracaine - chemistry
• ISSN: 0928-0987; 1879-0720
• DOI: 10.1016/j.ejps.2019.104962

Superficial wounds that require suturing are often the reason children visit the Paediatric Emergency Department. Suturing is usually accompanied by perilesional administration of lidocaine, a local anaesthetic drug that improves pain tolerance. In paediatric patients, this approach has a low compliance because lidocaine has to be injected, which in children generates fear and anxiety, a sterile anaesthetic gel could improve the child compliance. To develop a sterile and stable sterile gel capable of remaining in place over time for topical anaesthesia. Different formulations were analysed by HPLC, by UV and fluorimetric detection. Two different sterilisation methods were tested. To maintain the original stability of the gel also after sterilisation process. Four different gels were prepared and analysed; the most stable gel lasts over 3 months with a degradation less than 10%. The use of Poloxamer 407 guarantees stability of the preparation, showing a reduction in oxidative reaction, and gives the gel the right texture for application to a bleeding wound. [Display omitted]