Poor preservation efficacy versus quality and safety of pediatric extemporaneous liquids.

Ghulam, A., Keen, K., Tuleu, C., Wong, I.C.K. and Long, P.F. (2007) Poor preservation efficacy versus quality and safety of pediatric extemporaneous liquids. Annals of Pharmacotherapy, 41 (5). pp. 857-860. 10.1345/aph.1H611.

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DOI: 10.1345/aph.1H611

Abstract

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 Extenporaneous 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.

Item Type:Article
Additional Information:Full text available electronically from the School of Pharmacy Library.
Departments, units and centres:Department of Practice and Policy > Centre for Paediatric Pharmacy Research
ID Code:1477
Journal or Publication Title:Annals of Pharmacotherapy
Deposited By:Library Staff
Deposited On:23 Mar 2010 14:46
Last Modified:04 Nov 2011 10:33

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