Sprinkle study (applesauce) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2008-12-19 15:52 (6391 d 13:34 ago) – Posting: # 2953
Views: 5,580

Dear Dr Clasha!

❝ Grapefruit juice [...]


... contains furanocoumarins which bind to cytochrome P450-3A4 and reduce the first-pass metabolism of drugs which are metabolised by this CYP subfamily.

❝ i think that it is same as applesauce


I don’t think so. Search the forum…
Since many children are not able or do not like to swallow intact capsules, it would be advantageous for compliance, if the content could be sprinkled on applesauce and administered without the capsule cover. In order to assist administration, maintenance of the galenic principle after dispersion of the content of the capsule on food is generally assessed in a “sprinkle study” (pH of applesauce ~3.5).

EMEA/CHMP
Reflection Paper: Formulations of Choice for the Paediatric Population
EMEA/CHMP/PEG/194810/2005 (23 June 2005)

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