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Compatibility of nitroglycerin, diazepam and chlorpromazine with a new multilayer material for infusion containers.

Kambia NK, Dine T, Dupin-Spriet T, Gressier B, Luyckx M, Goudaliez F, Brunet C

Faculté des Sciences Pharmaceutiques et Biologiques, Laboratoire de Pharmacologie, Pharmacocinétique et Pharmacie Clinique, 3 Rue du Professeur Laguesse, B.P. 83, 59006 Lille Cedex, France.

The stability and compatibility of three drugs: nitroglycerin, diazepam and chlorpromazine, with a new multilayer infusion bag were studied. The study was carried out comparatively with PVC bags with which these drugs are incompatible. The drugs were diluted in 5% dextrose or in 0.9% sodium chloride isotonic solutions. Solutions were stored during 8 or 48 h with or without any protection against light. Remaining concentrations of drug were determined by high-performance liquid chromatography (HPLC) during the storage. The admixtures were also monitored for precipitation, color change and pH. Whatever the isotonic solution used, the loss of drugs is in discredit of the use of PVC bags for their storage. So, these three drugs would not be stored in PVC bags. In multilayer bags, no loss of drugs and no color change were detected throughout the storage period. pH values were stable during the same storage period. These three drugs were compatible with multilayer bags in all tested conditions for 8 or 48 h. The leaching of the plasticizer di-(2-ethylhexyl) phthalate (DEHP), that is incorporated into PVC to make the bags soft and pliable was not detected in the three drug solutions during storage period. Our study confirms that these three drugs are incompatible with PVC bags, on the contrary the new materiel tested was proved to be interesting for drug storage.

Published 14 February 2005 in J Pharm Biomed Anal, 37(2): 259-64.
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