Abstract

Stability Issues for Compounding Extemporaneously Prepared Oral Formulations for Pediatric Patients

Author(s): Schotik Debora

Issue: Jan/Feb 2001 - Compounding for Pediatric Patients

Page(s): 9-12

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Abstract

More than 80% of prescription drugs approved by the US Food and Drug Administration for human use are not approved for use in the pediatric population. When there is not a commercially available dosage form for pediatric use, it is the pharmacist’s responsibility to compound a stable and acceptable formula in accordance with good pharmacy practices, official standards and relevant scientific data. The author discusses the stability of formulations; factors affecting stability; types of oral liquids; beyond-use dating; flavors, taste and coloring; issues for administration of medications to children and stability studies (information sources, the pharmacist and the literature and US Food and Drug Administration updates).

Related Keywords

  • beyond-use date
  • children
  • coloring
  • emulsions
  • flavors
  • infants
  • oral formulations
  • oral liquids
  • pediatric
  • pediatric administration
  • solutions
  • stability
  • suspensions
  • taste
  • continuing education
  • quality control
  • endotoxins
  • pyrogens
  • gram-negative bacteria
  • lipopolysaccharide
  • endotoxin limit
  • endotoxin load
  • sterile preparations
  • standards
  • USP

Related Categories

  • PEDIATRICS
  • STABILITIES, COMPATIBILITIES
  • UNITED STATES PHARMACOPEIA CONVENTIONS

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