Stability of a novel Lidocaine, Adrenaline and Tetracaine sterile thermosensitive gel: A ready-to-use formulation.
Journal
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
ISSN: 1879-0720
Titre abrégé: Eur J Pharm Sci
Pays: Netherlands
ID NLM: 9317982
Informations de publication
Date de publication:
01 Aug 2019
01 Aug 2019
Historique:
received:
06
03
2019
revised:
09
05
2019
accepted:
17
06
2019
pubmed:
25
6
2019
medline:
7
1
2020
entrez:
25
6
2019
Statut:
ppublish
Résumé
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.
Sections du résumé
BACKGROUND
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
OBJECTIVE
To develop a sterile and stable sterile gel capable of remaining in place over time for topical anaesthesia.
METHOD
METHODS
Different formulations were analysed by HPLC, by UV and fluorimetric detection. Two different sterilisation methods were tested.
MAIN OUTCOME
RESULTS
To maintain the original stability of the gel also after sterilisation process.
RESULTS
RESULTS
Four different gels were prepared and analysed; the most stable gel lasts over 3 months with a degradation less than 10%.
CONCLUSION
CONCLUSIONS
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.
Identifiants
pubmed: 31233867
pii: S0928-0987(19)30225-8
doi: 10.1016/j.ejps.2019.104962
pii:
doi:
Substances chimiques
Anesthetics, Local
0
Gels
0
Tetracaine
0619F35CGV
Lidocaine
98PI200987
Epinephrine
YKH834O4BH
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
104962Informations de copyright
Copyright © 2019 Elsevier B.V. All rights reserved.