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Understanding and Predicting Pharmaceutical Product Shelf-Life

  • Kenneth C. Waterman

Abstract

Pharmaceutical products are assigned a shelf-life which determines the time when a product is considered to be safe and effective under a relevant storage condition. A number of factors are used to assign that shelf-life. Among these factors are the chemical stability of the active pharmaceutical ingredient (API) in its dosage form, and specifically whether any degradation products are potentially hazardous to a patient. In addition, any factors which affect an API’s bioavailability can also limit shelf-life. These factors not only include loss of API potency due to degradation, but also loss of activity due to precipitation (for liquid dosage forms) or slowing of API release in the gastrointestinal tract. Accelerating the aging process allows the development and production of pharmaceutical products without waiting for the entire shelf-life to elapse before assigning a value. Such factors as temperature and relative humidity can be used to accelerate these processes effectively allowing for accurate and precise predictions.

Keywords

Dosage Form Drug Product Active Pharmaceutical Ingredient Physical Stability Solid Dosage Form 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

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    ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Substances and Products, http://www.ich.org/LOB/media/MEDIA419.pdf.
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Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Pfizer Global Research and DevelopmentGrotonUSA

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