Challenge of paediatric compounding to solid dosage forms sachets and hard capsules - Finnish perspective

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Siven , M , Kovanen , S , Siirola , O , Hepojoki , T , Isokirmo , S , Laihanen , N , Eränen , T , Pellinen , J & Juppo , A M 2017 , ' Challenge of paediatric compounding to solid dosage forms sachets and hard capsules - Finnish perspective ' , Journal of Pharmacy and Pharmacology , vol. 69 , no. 5 , pp. 593-602 . https://doi.org/10.1111/jphp.12648

Title: Challenge of paediatric compounding to solid dosage forms sachets and hard capsules - Finnish perspective
Author: Siven, Mia; Kovanen, Satu; Siirola, Outi; Hepojoki, Tuomas; Isokirmo, Sari; Laihanen, Niina; Eränen, Tiina; Pellinen, Jukka; Juppo, Anne M.
Contributor organization: University of Helsinki
Faculty of Pharmacy
Specialist Training Programme in Industrial Pharmacy (-2013)
Division of Pharmaceutical Chemistry and Technology
Pharmaceutical Design and Discovery group
Environmental Sciences
Anne Juppo / Principal Investigator
Drug Research Program
Date: 2017-05
Language: eng
Number of pages: 10
Belongs to series: Journal of Pharmacy and Pharmacology
ISSN: 0022-3573
DOI: https://doi.org/10.1111/jphp.12648
URI: http://hdl.handle.net/10138/309088
Abstract: Objectives The study evaluated the quality of compounded sachets and hard gelatine capsules and their feasibility in paediatric drug administration. Methods Commercial tablets were compounded to sachets and capsules in hospital environment, and the uniformity of content and simulated drug dose were determined. Key findings Compounded 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. Conclusions Compounded 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.
Subject: capsule
compounding
content uniformity
paediatric
sachet
ORAL POWDERS
STABILITY
NIFEDIPINE
HYDROCHLORIDE
MEDICINES
317 Pharmacy
Peer reviewed: Yes
Rights: cc_by_nc
Usage restriction: openAccess
Self-archived version: acceptedVersion


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