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

Davide Zanon, Chiara Volpato, Riccardo Addobbati, Stefano Loiacono, Alessandra Maestro, Egidio Barbi, Natalia Maximova, Maria Grazia Mamolo, Daniele Zampieri

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Abstract

Background: 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. Objective: To develop a sterile and stable sterile gel capable of remaining in place over time for topical anaesthesia. Method: Different formulations were analysed by HPLC, by UV and fluorimetric detection. Two different sterilisation methods were tested. Main outcome: To maintain the original stability of the gel also after sterilisation process. Results: Four different gels were prepared and analysed; the most stable gel lasts over 3 months with a degradation less than 10%. Conclusion: 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.

Original languageEnglish
Article number104962
JournalEuropean Journal of Pharmaceutical Sciences
Volume136
DOIs
Publication statusPublished - Aug 1 2019

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ASJC Scopus subject areas

  • Pharmaceutical Science

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