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Poor Preservation Efficacy Versus Quality and Safety of Pediatric Extemporaneous Liquids

MPharm undergraduate student, The School of Pharmacy, University of London, London, England

Kate Keen, BSc

Research and Teaching Technician, Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London

Catherine Tuleu, PhD MRPharmS

Lecturer, Department of Pharmaceutics; Deputy Director, Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London

Ian Chi-Kei Wong, PhD MRPharmS

Professor and Director of the Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London

Paul F Long, PhD

Senior Lecturer in Molecular Microbiology, Microbiology Group, Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London

Reprints: Dr. Long, Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London, 29/39 Brunswick Square, London WC1N 1AX United Kingdom, fax 44 207 753 5868, paul.long{at}pharmacy.ac.uk

BACKGROUND: Most medicines are available only as solid, adult-strength dosage forms from which oral extemporaneous liquids are often prepared for children. There are few comprehensive reference lists for the preparation of pediatric extemporaneous formulations. Some pediatric reformulations are made by diluting the suspending vehicle, and a shelf life of up to 3 months can be used without documented microbial stability. Although most commercially available ready-to-use vehicles are supplied as preserved formulations, it is still common practice in many European dispensaries to prepare and dilute these vehicles as required for specific prescriptions.

OBJECTIVE: To determine what influence dilution of vehicles has on the preservation efficiency of extemporaneous formulations.

METHODS: Suspending vehicles were made by diluting methylcellulose 1% and simple syrup, BP (British Pharmacopoeia) in ratios of 1:1 and 1:4. The efficacy of antimicrobial preservation was tested according to the 2007 standards required by the BP.

RESULTS: Dilution in ratios greater than 1:1 failed the BP 2007 criteria. Such dilution represents a potential biohazard, especially to premature, newborn, or immunocompromised children, exposing them not only to possible organoleptic changes of the preparation, but also to ingestion of either dangerous numbers of microorganisms or medicines that may have undergone biotransformation, rendering them inactive or toxic.

CONCLUSIONS: Significant concerns have been raised regarding the quality of extemporaneous preparations. We call for further research in this neglected area to address issues of antimicrobial preservation, including revision of existing quality assurance monographs. Moreover, these monographs should take into account testing that simulates multiple dosing from a single storage container during the intended in-use shelf life of multidose extemporaneous preparations.

Key Words: compounding, extemporaneous, pediatrics, preservatives, stability, vehicles

Published Online, April 17, 2007. www.theannals.com, DOI 10.1345/aph.1H611

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