Hospital Pharmacy - June 2017 - 428

717393
research-article2017

HPXXXX10.1177/0018578717717393Hospital PharmacyDijkers et al.

Article

Limited Influence of Excipients in
Extemporaneous Compounded
Suspensions

Hospital Pharmacy
2017, Vol. 52(6) 428-432
© The Author(s) 2017
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https://doi.org/10.1177/0018578717717393
DOI: 10.1177/0018578717717393
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Eli Dijkers1, Valerie Nanhekhan1, Astrid Thorissen1,
Diego Marro2, and Marta Uriel2

Abstract
Objective: The objective of this study was to identify whether compounding oral suspensions with SyrSpend SF based
on tablets or capsules is a suitable alternative for using raw pharmaceutical materials. Methods: Suspensions based on
5 different tablets and capsules were studied in SyrSpend SF. The summary of product characteristics of these different
tablets and capsules were obtained from the manufacturer. Our hypothesis was that, if the maximum beyond-use date
of the study was reached, the excipient did not seem to have an influence on the stability of the active pharmaceutical
ingredient (API) within the studied time frame. Results: All excipients used in flecainide acetate, labetalol HCl, and
tiagabine HCl tablets as well as in celecoxib and oseltamivir capsules did not seem to influence the beyond-use date of
the overall suspension based on SyrSpend SF. Conclusion: Although using raw materials as API sources is preferred,
oral suspensions with SyrSpend SF prepared from crushed tablets or opened capsules could be a possible alternative.
Based on this study, a wide range of different excipients does not seem to impact the beyond-use date of different APIs
compounded in SyrSpend SF.
Keywords
compatibility, stability, oral suspension, compounding, excipients

Community and hospital pharmacists are often required to
compound extemporaneous oral liquids in case of patients
with dose adjustments, for patients unable to swallow oral
solid medication or when patients are receiving their medication via an enteral feeding tube.1 To assure patient safety and
compliance, a number of aspects need to be considered,
including chemical, physical, and microbiological stability
and palatability of the compounded medication.
In practice, due to convenience or availability of raw
pharmaceutical ingredients, (hospital) pharmacists often
resort to capsules or tablets as the source of their active
pharmaceutical ingredient (API). These commercial solid
dosage forms are formulated with-among others-excipients promoting dilution, flow and disintegration, colorants,
flavors, and binding agents.2 Stability of the oral liquid is
therefore no longer just determined by the interaction of the
API with the vehicle alone, but also by the chemical and
physical interaction of the API with the excipients.1,3 As
formulation of oral liquids is often only partially supported
by pharmacopoeia and other scientific evidence, assigning
a beyond-use date (BUD) by the (hospital) pharmacist can
be challenging.
A wide range of APIs is currently being studied in SyrSpend
SF, a commercial oral suspension base. Compatibility results

with SyrSpend SF have been published for more than 70 different APIs.4-21 In all of these studies, the compatibility was
assessed by measuring the percentage recovery at varying
time points throughout a 90-day period at controlled room
and/or at controlled refrigerated temperature. The majority of
the compatibility studies have been performed with raw pharmaceutical APIs. In case of celecoxib, flecainide acetate,
labetalol hydrochloride, oseltamivir phosphate, and tiagabine
hydrochloride where no raw pharmaceutical material was
available, commercially available tablets or capsules were
used. High-performance liquid chromatography with diode
array detection was used for both the compatibility study and
a forced degradation study. The latter was executed with the
aim of identifying all degradation products that may be produced during storage of the samples. All APIs except for

1

Fagron, Rotterdam, The Netherlands
Universidad San Jorge, Villanueva de Gállego Zaragoza, Spain

2

Corresponding Author:
Eli Dijkers, Hospital Pharmacist, Global Compounding Knowledge
Manager, Fagron BV, Lichtenauerlaan 182, 3062 ME Rotterdam,
The Netherlands.
Email: eli.dijkers@fagron.com
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