title: Challenge of paediatric compounding to solid dosage forms sachets and hard capsules - Finnish perspective.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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.
authors.affiliation: Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
authors.forename: Mia
authors.initials: M
authors.lastname: Sivén
authors.affiliation: Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
authors.forename: Satu
authors.initials: S
authors.lastname: Kovanen
authors.affiliation: Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
authors.forename: Outi
authors.initials: O
authors.lastname: Siirola
authors.affiliation: Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
authors.forename: Tuomas
authors.initials: T
authors.lastname: Hepojoki
authors.affiliation: HUS Pharmacy, HUS Hospitals, Helsinki, Finland.
authors.forename: Sari
authors.initials: S
authors.lastname: Isokirmo
authors.affiliation: HUS Pharmacy, HUS Hospitals, Helsinki, Finland.
authors.forename: Niina
authors.initials: N
authors.lastname: Laihanen
authors.affiliation: HUS Pharmacy, HUS Hospitals, Helsinki, Finland.
authors.forename: Tiina
authors.initials: T
authors.lastname: Eränen
authors.affiliation: Department of Environmental Sciences, Faculty of Biological and Environmental Sciences, University of Helsinki, Helsinki, Finland.
authors.forename: Jukka
authors.initials: J
authors.lastname: Pellinen
authors.affiliation: Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Juppo
mesh_terms: D002214:Capsules / Q000737:chemistry*; D002482:Cellulose / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004339:Drug Compounding / Q000379:methods; D005079:Excipients / Q000737:chemistry; D005387:Finland; D007785:Lactose / Q000737:chemistry; D010372:Pediatrics / Q000379:methods; D013607:Tablets / Q000737:chemistry*
chemical_list: D002214:Capsules; D005079:Excipients; D013607:Tablets; D002482:Cellulose; D007785:Lactose; C109691:microcrystalline cellulose
keywords: capsule; compounding; content uniformity; paediatric; sachet