Nayak, Smita
Review of accelerated stability assessment program (asap) for predicting shelf life - Vol.53(8-9), Aug-Sep - Mumbai Indian Journal of Pharmaceutical Science 2021 - 17-20p.
Accelerated Stability Assessment Program (ASAP) is an emerging tool for assessing stability of solid APIs and solid dosage forms. It
includes studying the dosage form under scientifically selected accelerated conditions targeting the same extent of degradation for each
condition (isoconversion). Here, a modified Arrhenius equation is applied to estimate the effect of temperature and relative humidity
on degradation rates and packaging configurations. Precise shelf life estimations can be arrived at within a few weeks by using this
tool. In this review, elements of ASAP have been elicited in brief. Also, comparison of ASAP with conventional stability testing has been
carried out for ease of understanding. The review discusses design protocol, setting up of study, analysis, review modelling of data.
The prospective applications and shortcomings of ASAP as well as regulatory outlook are discussed herewith.
PHARMACEUTICS
Review of accelerated stability assessment program (asap) for predicting shelf life - Vol.53(8-9), Aug-Sep - Mumbai Indian Journal of Pharmaceutical Science 2021 - 17-20p.
Accelerated Stability Assessment Program (ASAP) is an emerging tool for assessing stability of solid APIs and solid dosage forms. It
includes studying the dosage form under scientifically selected accelerated conditions targeting the same extent of degradation for each
condition (isoconversion). Here, a modified Arrhenius equation is applied to estimate the effect of temperature and relative humidity
on degradation rates and packaging configurations. Precise shelf life estimations can be arrived at within a few weeks by using this
tool. In this review, elements of ASAP have been elicited in brief. Also, comparison of ASAP with conventional stability testing has been
carried out for ease of understanding. The review discusses design protocol, setting up of study, analysis, review modelling of data.
The prospective applications and shortcomings of ASAP as well as regulatory outlook are discussed herewith.
PHARMACEUTICS