Abstract
There is a need to develop dosage forms suitable for children to improve drug treatment. Extemporaneous compounding of drugs for children is one way to meet these needs. However, excipients generally considered as safe in adults may not be appropriate in dosage forms intended for children. The aim was to optimize the composition of two pediatric liquid preparations by substituting paraben as a microbiological preservative and ethanol as a solubilizer, with excipients more suitable for pediatric use. The oral liquids were Naloxone 1 mg/mL and Propranolol 10 mg/mL. Twelve different formulations were tested with propranolol and naloxone, respectively, during the screening process to select appropriate formulations. Sodium benzoate and glycerol were used as a preservative and solubilizer, respectively, and different pH of the formulations were evaluated. The formulations were characterized according to dispensed dose (dosing accuracy), viscosity and osmolality. The optimized formulations from the screening process were tested with two amounts of sodium benzoate and microbiological assays were performed. These formulations were shown to have satisfactory preservative properties and dosing accuracy. The results showed that the oral liquids could be prepared without the addition of solubilizer and with lower osmolality (naloxone), thus reducing the risk of gastrointestinal side effects.
Highlights
Extemporaneous compounding of drugs for children is used in order to meet the need for drug formulations and doses suitable for children
The results were compared with the formulations accuracy), viscosity and osmolality
The results were compared with the formulations with with the original compositions
Summary
Extemporaneous compounding of drugs for children is used in order to meet the need for drug formulations and doses suitable for children. Many drugs are administered orally and only available as solid oral dosage forms, mainly tablets. These may be unsuitable for children due to lack of appropriate doses and swallowing difficulties among young children. It may be difficult to divide a commercially available solid dosage form in a correct and reproducible manner when administering the medicine to children [2,3,4]. There is a need for suitable pediatric formulations to improve drug treatment of children [7,8,9,10,11,12]. Oral suspensions and solutions may be an alternative to solid oral dosage forms and if no commercial liquid formulation is available, these can be manufactured extemporaneously
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call