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Always the Right Dose? Content Uniformity in Over 100 Different Formulations Tested

Author(s):  Dijkers Eli, Polonini Hudson, de Oliveira Ferreira Anderson

Issue:  Sep/Oct 2020 - Volume 24, Number 5
View All Articles in Issue

Page(s):  408-412

Always the Right Dose? Content Uniformity in Over 100 Different Formulations Tested Page 1
Always the Right Dose? Content Uniformity in Over 100 Different Formulations Tested Page 2
Always the Right Dose? Content Uniformity in Over 100 Different Formulations Tested Page 3
Always the Right Dose? Content Uniformity in Over 100 Different Formulations Tested Page 4
Always the Right Dose? Content Uniformity in Over 100 Different Formulations Tested Page 5

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Abstract:  There is still an evident need for nonsterile compounded medications for pediatric and elderly patients in cases where patients require dose adjustments or have swallowing difficulties. Pharmacists generally have the choice between compounding capsules or oral liquids. In daily pharmacy practice, extemporaneous capsules are from time to time seen as a better alternative to oral liquid medication, although various published studies indicate that weight variation and/or uniformity of content can be significantly out of specification for compounded capsules. In contrast, analyses with the ready-to-use oral liquid vehicle SyrSpend SF in 104 different formulations with 89 unique active pharmaceutical ingredients showed results that all 6.414 samples analyzed were within specification. It can, therefore, be argued that SyrSpend SF could be a better way to assure content uniformity compared to manually compounded, small-batch extemporaneous capsules.

Related Keywords: Eli Dijkers, PharmD, PhD, Hudson Polonini, BPharm, PhD, Anderson de Oliveira Ferreira, BPharm, PhD, capsules, oral liquid preparations, drug content uniformity, dosing consistency, drug safety, chemical stability, physical stability, SyrSpend SF, children, elderly

Related Categories: EXCIPIENTS, GERIATRICS, PEDIATRICS, PEER-REVIEWED, QUALITY CONTROL, DOSAGE FORMS/DRUG CARRIERS

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