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3PC-034 Content uniformity of extemporaneous compounded suspensions
  1. E Dijkers1,
  2. H Polonini2,
  3. A Ferreira2
  1. 1Global Innovation Project Manager, Fagron Bv, Rotterdam, The Netherlands
  2. 2Ortofarma Analytical Services, Ortofarma Analytical Services, Matias Barbosa, Brazil


Background and importance There is still a need for non-sterile compounded medications for paediatric and elderly patients (eg, when dose adjustments are required or there are swallowing difficulties). Pharmacists generally have the choice between compounding capsules or oral liquids. Extemporaneous compounded oral liquids are often a more convenient and better adhered alternative to capsules, as they are swift to prepare and can allow dosing flexibility. Given their importance, drug substance content should be within the predetermined range, determined as content uniformity, as defined by the various pharmacopoeias: United States Pharmacopoeia, European Pharmacopoeia and British Pharmacopoeia.

Aim and objectives SyrSpend SF is an oral liquid vehicle range that has specific rheological properties to ensure dosing consistency throughout therapy. In this study, we present the content uniformity of a wide range of different active pharmaceutical ingredients in SyrSpend SF under refrigerated conditions and at room temperature, compared with what is known for the content uniformity of extemporaneous prepared capsules.

Material and methods In the study, 6414 samples were analysed by high performance liquid chromatography (HPLC-UV) for 93 different active pharmaceutical ingredients at controlled room temperature (15–25°C) and 105 active pharmaceutical ingredients under refrigerated conditions (2–8°C). Calculations were only performed until the maximum beyond use date of the sample. Acceptance values (AVs) were calculated for all of the different active pharmaceutical ingredients, at all time points and temperatures.

Results The mean AVs for room temperature and the controlled refrigerated temperature were 3.12 and 3.17, respectively (AV should be <15.0), indicating that all active pharmaceutical ingredients complied with the content uniformity specifications. The mean concentration of all samples was 100.30% at room temperature and 100.34% at the refrigerated temperature.

Conclusion and relevance Compounded oral liquids in SyrSpend SF showed little variation in content for all active pharmaceutical ingredients, and when evaluated according to the pharmacopoeia content uniformity guidelines, all were well within the criteria defined. This indicates that compounding oral liquids in SyrSpend SF could be a suitable alternative when compounding individualised medication for patients.

Conflict of interest Corporate sponsored research or other substantive relationships:

The study was sponsored by Fagron BV.

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