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Three Drug Stability Lives

Author(s):  Newton David W

Issue:  May/Jun 2000 - Compounding for the Ear, Nose and Throat
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Abstract:  The effect of environmental conditions and formulation factors on the chemical, physical and aesthetic lives of drug dosage forms is important. The lives of drug dosage forms depend on their specific formulations and packaging, in addition to their conditions of exposure. In this article, the author discusses the main threats to chemical and physical drug lives; chemical life; an example equation; physical life; drug-expiration date; disobeying expiration dates; beyond-use dates and labeled storage temperature. Tables provide information regarding three drug lives and their measurement parameters, environmental threats to chemical and physical stability of dosage forms and Q10 values for use in the example equation; figures show the shelf life for cefuroxime and milk. The author concludes that the three lives of a drug product can be evaluated scientifically and subjectively. Because of potential patient noncompliance, damage to product elegance from excessive environmental exposure might cause as much patient harm as chemical and physical damage – or more harm. Drug manufacturers, compounders, dispensers, distributors, packagers and transporters must ensure that drug products retain their full pharmaceutical integrity and potency before they become the possessions of consumers and patients.

Related Keywords: aesthetic, beyond-use dates, chemical, crystal, crystalline, damage, degradation, elegance, enviornment, expiration date, instability, integrity, life, pH, physical, polymorphs, potency, quality, stability, standards, storage, temperature, three lives

Related Categories: STABILITIES, COMPATIBILITIES, UNITED STATES PHARMACOPEIA CONVENTIONS

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