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A Need for Propylene Glycol-Free Ascorbic Acid Oral Liquid

Author(s):  McElhiney Linda F

Issue:  Nov/Dec 2004 - Endotoxin
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Page(s):  458-460

A Need for Propylene Glycol-Free Ascorbic Acid Oral Liquid Page 1
A Need for Propylene Glycol-Free Ascorbic Acid Oral Liquid Page 2
A Need for Propylene Glycol-Free Ascorbic Acid Oral Liquid Page 3

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Abstract:  Most commercially available oral liquid preparations of ascorbic acid contain propylene glycol. At high doses, this common food and drug additive is know to increase the risk of serum hyperosmolality, with a marked osmolar gap, lactic acidosis, seizures, and cardiac arrhythmias. This is a particular danger in children. Concern about propylene glycol toxicity prompted the World Health Organization to establish a maximum daily dose of 25 mg/kg/day, but the toxic dose is not known. A stable ascorbic acid preparation can be formulated without propylene glycol. A formula and method are provided.

Related Keywords: Linda F. McElhiney, PharmD, RPh, burns, burn units, vitamin C, children, propylene glycol, toxic effects, liquid formulations, adverse effects, ascorbic acid syrup, formulation: ascorbic acid 100-mg/mL syrup

Related Categories: EXCIPIENTS, FORMULATIONS, PEDIATRICS

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