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      • Carbohydrates
      • Cellulose
      • Cellulose Esters
      • Cellulose Ethers
      • CMC and Croscarmellose Sodium
      • Converted Starch
      • Dried Starch
      • Microcrystalline Cellulose
      • Modified Starch
      • Starch
      • Sugars
      • Sugar Alcohols
    • Petrochemicals
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      • Glycols
      • Mineral Hydrocarbons
      • Mineral Oils
      • Mineral Waxes
      • Petrolatum
      • Polyethylene Glycol (PEG)
      • Povidones
      • Propylene Glycol
      • Other Petrochemical Excipients
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      • Fatty Alcohols
      • Glycerin
      • Mineral Stearates
      • Pharmaceutical Oils
      • Other Oleochemical Excipients
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Startseite » News » Potentially harmful excipients in neonatal medicines: a pan-European observational study

Potentially harmful excipients in neonatal medicines: a pan-European observational study

8. December 2015
Potentially harmful excipients in neonatal medicines: a pan-European observational study

Potentially harmful excipients in neonatal medicines: a pan-European observational study

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.

 

Methods: All medicines administered to neonates during 1 day with individual prescription and demographic data were registered in a web-based point prevalence study. Excipients were identified from the Summaries of Product Characteristics. Determinants of EOI administration (geographical region, gestational age (GA), active pharmaceutical ingredient, unit level and hospital teaching status) were identified using multivariable logistical regression analysis.

Results: Overall 89 neonatal units from 21 countries participated. Altogether 2095 prescriptions for 530 products administered to 726 neonates were recorded. EOI were found in 638 (31%) prescriptions and were administered to 456 (63%) neonates through a relatively small number of products (n=142; 27%). Parabens, found in 71 (13%) products administered to 313 (43%) neonates, were used most frequently. EOI administration varied by geographical region, GA and route of administration. Geographical region remained a significant determinant of the use of parabens, polysorbate 80, propylene glycol and saccharin sodium after adjustment for the potential covariates including anatomical therapeutic chemical class of the active ingredient.

More

Georgi Nellis, Tuuli Metsvaht, Heili Varendi, Karolin Toompere, Jana Lass, Inge Mesek, Anthony J Nunn, Mark A Turner, Irja Lutsar, ESNEE consortium, Potentially harmful excipients in neonatal medicines: a pan-European observational study, 2015 Jul;100(7):694-9, doi: 10.1136/archdischild-2014-307793. Epub 2015 Apr 8.
Tags: excipientsformulation

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  • Sources
    • Handbook of Pharmaceutical Excipients – 9th Edition
    • EINECS Numbers
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    • FDA Inactive Ingredient List
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      • ADM
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      • Biogrund
      • Budenheim
    • C-G
      • Captisol
      • Croda
      • Cyclolab
      • DFE Pharma
      • DuPont Pharma Solutions
      • Evonik
      • Fuji Chemical Industries
      • Gattefossé
      • Gangwal Healthcare
    • I-O
      • ingredientpharm
      • IOI Oleochemical
      • JRS Pharma
      • Kerry
      • KLK Oleo Life Science
      • Lactalis Ingredients Pharma
      • Lipoid
      • Dr. Paul Lohmann
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    • ExciPerience – The great excipient event!
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