Stability evaluation of 7 % chloral hydrate syrup contained in mono and multi-dose bottles under room and refrigeration conditions.

BUSTOS-FIERRO, C; OLIVERA, ME.; MANZO, PG.; BERTOLOTO, G.; JIMENEZ KAIRUZ, AF.

Rósario

Congreso; 2ra. Reunión Internacional de Ciencias Farmacéuticoas RICiFa 2012.; 2012

Universidad Nacional de Rosario

Introduction Chloral hydrate is a sedative widely used in pediatrics, especially in diagnostic procedures that require immobility, such as computed tomography and magnetic resonance. It is also used in intensive care units and pediatric emergency departments (1,2). Currently, there are no commercially available liquid formulations of chloral hydrate, so it is considered a medicine not available. This shortage is overcome in the hospital setting, through extemporaneous preparations (3). The aim of this work was to evaluate the stability of extemporaneously prepared 7 % chloral hydrate syrup under different conditions of storage and dispensing. Methods Three batches of 7% chloral hydrate syrup were prepared. Each batch was stored in 50 light-resistant glass containers of 60 mL with child-resistant caps and in two bottles of 1000 mL to simulate two forms of dispensing, mono and multi-dose, respectively. The batches were divided in two groups, one stored at room conditions (20±1 °C) and the other under refrigeration (5±2 °C). The physical, chemical and microbiological stability was evaluated for 180 days, by appearance, pH, specific gravity and microbiological determinations. USP potentiometric titration of 10% hydrate chloral syrup was modified to drug concentration assayed on 7% syrups. Stability was defined as retention of at least 95% of the initial chloral hydrate concentration (4,5), the absence of both visible particulate matter, or color and/or odor changes and the compliance with microbiological attributes of non-sterile pharmaceutical products. Results Chemical and physical stability results are shown in table 1. At least 98% of the initial chloral hydrate concentration remained throughout the 180-day study period. There were no detectable changes in color, odor, specific gravity and pH and no visible microbial growth in compliance with pharmacopoeia specifications. These results were not affected by different storage conditions or by the frequent opening or closing of the multi-dose containers. Conclusions Extemporaneously compounded 7% chloral hydrate syrup was stable for at least 180 days when stored in mono or multi-dose light-resistant glass containers at room temperature or under refrigeration.