Background The sterile multidose anaesthetic Lidocaine HCl 2% gel that is extently applied in the most of our hospital wards is a galenic preparation from our hospital pharmacy. The authors have formulated our own prescription and producing process and proved that the extemporaneous preparation met the requirements regarding pH, content of the active substance and sterility. With determination of the microbiological integrity and shelf live of this preparation The authors wanted to ensure safe use of this preparation.
Purpose To correctly determine microbiological integrity and expiring date of the preparation.
Materials and methods On the samples of 13 series of prepared and kept at the room temperature (cca. 25°C) one, two and three years, of sterile multidose anaesthetic Lidocaine HCl 2% gel The authors performed quantitative analysis tests-1. extraction with chlorophorm and 2. anhydrouse titration with perchloric acid. On the same samples The authors performed sterility tests. Of each serial 3 samples were examined and the average value were analysed. Tests (according USP 31.Ed, Chemical tests and assays) of the content of lidocaine HCl for shelf life examinations were done at Control and analytical laboratory at the Department for infusion solutions production in our hospital. Sterility tests were performed in the microbiological department of Centre for public health, Bitola. Ingredients used for this preparation were: powder Lidocaine HCl (Sigma – Aldrich, USA, USP),Carboxymethylcellulose Na, high viscosity (Sigma-Aldrich, USA, USP), Aqua sterillisata (our hospital Department for infusion solutions production, Ph.Eur).
Results Quantitative examinations of lidocaine HCl in the series of samples indicated that the average content of the active substance meets the pharmacopoeial requirements within an one year period. The numeric results of all examinations will be presented on the poster at the congress. Average pH=6.7 and meets the pharmacopoeal requirements too. Sterility control tests confirmed the sterility for one year too.
Conclusions The authors formulated our own prescription and producing process for sterile multidose anaesthetic Lidocaine HCl 2% gel with expiring date of one year in the hospital pharmacy of the Clinical hospital in Bitola and The authors ensured safe use of this preparation.