Stability Issues for Compounding Extemporaneously Prepared Oral Formulations for Pediatric Patients
Author(s): Schotik Debora
Issue: Jan/Feb 2001 - Compounding for Pediatric Patients
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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