Propylene Glycol in Neonates: Never Prescribed, Frequently Administered, Hardly Evaluated
نویسنده
چکیده
In addition to therapeutic compounds, drug formulations routinelyalso contain excipients needed as co-solvents, preservatives, colorants, surfactantsand/or sweeteners. The majority of these excipients that have been used for many years, and are Generally Regarded As Safe, reflected in the ‘GRAS’ status [1,2]. Examples of excipients are lactose, aspartame, ethanol, propylene glycol, benzyl alcohol, sorbitol, xylitol, mannitol, poly-ethylene glycol, and also propylene glycol. Propylene glycol (PG) is an unintentional, but frequently co-administered excipient together with a therapeutic compound in a formulation despite the fact that PG exposure potentially results in hyperosmolarity, lactic acidosis and renal/hepatic toxicity [3,4]. Toxicity is generally considered to be related to PG accumulation with plasma osmolar changes as first sign of potential subsequent toxicity [3,4]. Median PG clearance in noncritically ill adult patients is 15.9 l/h, and was only modestly lower (-10 %) in critically ill adults (14.6 l/h). Overall PG clearance is in part explained by primary renal elimination (glomerular filtration rate, 45%), in part by hepatic metabolism (alcohol dehydrogenase, 55%) to lactate and pyruvate [3]. However, this does not linearly apply in neonates, commonly exposed to PG.
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تاریخ انتشار 2012