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Spotlight on excipients in paediatric dosage forms

Mon, 07/03/2016

Medication for children is frequently not commercially available.The majority of children can't swallow tablets or capsules until the age of six. In many cases, an oral liquid dosage form is a suitable alternative. The Australian Pharmaceutical Formulary (APF) lists several Children's Formulary (CF) formulations for the preparation of oral liquid dosage forms.  

However, when reviewing some formulations, one may find excipients listed that may not be suitable for some paediatric patients. For example, dexamethasone suspension CF 1 mg/mL contains 15% ethanol (90% v/v) and 40% glycerol, two ingredients that may cause adverse events in young vulnerable patients.  

Our team at Fagron is dedicated to formulate our bases and vehicles with only well-tolerated ingredients. Our popular suspending vehicle, SyrSpend® SF PH4, is free from ethanol, glycerol, sugar, gluten or lactose and is often used to make oral liquid dosage forms for paediatric patients.  

Fagron has performed a stability study with dexamethasone 1 mg/mL in SyrSpend® SF PH4 which confirmed a physical, chemical and microbiological stability of 90 days. This study and over 100 more stability studies performed by Fagron support pharmacists every day to prepare oral liquid dosage forms for vulnerable patient groups.