• Mia Sivén, Satu Kovanen, Outi Siirola, Tuomas Hepojoki, Sari Isokirmo, Niina Laihanen, Tiina Eränen, Jukka Pellinen, and Anne M Juppo.
• Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
• J. Pharm. Pharmacol. 2017 May 1; 69 (5): 593-602.

ObjectivesThe study evaluated the quality of compounded sachets and hard gelatine capsules and their feasibility in paediatric drug administration.MethodsCommercial tablets were compounded to sachets and capsules in hospital environment, and the uniformity of content and simulated drug dose were determined.Key FindingsCompounded formulations were successfully obtained for a range of drug substances; dipyridamole, spironolactone, warfarin and sotalol formulations were within acceptable limits for uniformity of content, in most cases. However, some loss of drug was seen. The type and amount of excipients were found to affect uniformity of content; good conformity of capsules was obtained using lactose monohydrate as filler, whereas microcrystalline cellulose was a better choice in sachets. In capsules, content uniformity was obtained for a range of drug doses. If the drug is aimed to be administered through a nasogastric tube, solubility of the drug and excipients should be considered, as they were found to affect the simulated drug dose in administration.ConclusionsCompounded sachets and capsules fulfilled the quality requirements in most cases. In compounding, the choice of excipients should be considered as they can affect conformity of the dosage form or its usability in practice. Quality assurance of compounded formulations should be taken into consideration in hospital pharmacies.© 2016 Royal Pharmaceutical Society.

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