08. November 2017
The excipients benzyl alcohol, propylene glycol and ethanol are present in medications used in the neonatal intensive care unit. Exposure to high levels can have adverse effects in a neonatal population. The objective was to quantify excipient exposure in very low birth weight (VLBW) neonates and identify risk factors associated with greater exposure.
27. September 2017
everal medicines frequently used in neonates and infants contain potentially harmful excip-ients like ethanol, propylene glycol (PG), methyl-and propyl-parabens. Especially preterm neonates may bechronically exposed as a result of being poly-medicated for extended periods.
28. January 2017
Introduction Many drugs are unavailable in suitable oral paediatric dosage forms, and pharmacists often have to compound drugs to provide paediatric patients with an acceptable formulation in the right dose. Liquid formulations offer the advantage of dosing flexibility and ease of administration to young patients, but drug substances often show poor aqueous solubility. The objective of this work was to study different solvents and matrices to design a liquid formulation for poorly water soluble...
03. February 2016
The objective of the study was to design and optimize a disintegrating pellet formulation of microcrystalline cellulose by non-aqueous extrusion process for a water sensitive drug using various statistical tools. Aspirin was used as a model drug. Disintegrating matrix pellets of aspirin using propylene glycol as a non-aqueous granulation liquid and croscarmellose as a disintegrant was developed. Plackett–Burman design was initially conducted to screen and identify the significant factors....
08. December 2015
Objective: We aimed to describe administration of eight potentially harmful excipients of interest (EOI)-parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride-to hospitalised neonates in Europe and to identify risk factors for exposure. More
08. September 2015
Propylene glycol is a well-documented causative agent of allergic contact dermatitis (ACD). It is also reported to cause systemic dermatitis after ingestion of foods or medicines containing it and after intravenous injection of a medicine with propylene glycol in its base. More
08. June 2015
The STEP stands for Safety and Toxicity of Excipients for Paediatrics. The Safety and Toxicity of Excipients for Paediatrics (STEP) Database is a user-designed resource developed by European Paediatric Formulation Initiative (EuPFI) and United States Paediatric Formulation Initiative (USPFI) in collaboration for storage and rapid/effortless access to the safety and toxicological data of excipients that is scattered over various sources and presents it in one freely accessible source. It is a...
29. December 2014
http://www.businesswire.com/news/home/20141226005014/en/Spectrum-Pharmaceuticals-Files-Drug-Application-FDA-Captisol-Enabled™#.VKGD-50HAIM