Understanding and Predicting Pharmaceutical Product Shelf-Life
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.
KeywordsDosage Form Drug Product Active Pharmaceutical Ingredient Physical Stability Solid Dosage Form
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