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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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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, Loyd V. Allen, Jr., PhD, RPh, 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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