A new anti-inflammatory drug in a liquid formulation needs to undergo stability testing to ensure it has an adequate she
Posted: Thu Dec 02, 2021 5:21 am
A new anti-inflammatory drug in a liquid formulation needs to
undergo stability testing to ensure it has an adequate shelf life.
The drug decomposes according to first-order kinetics. Kinetic
studies are performed at a number of different temperatures. From
the kinetic data, an activation energy of + 156 kJ mol-1 is
determined.
(a) Determine the degradation rate constant and the half-life
for the active in the formulation, if the initial drug
concentration is 12.0 mg/mL and the concentration after 34 weeks is
5.42 mg/mL, when stored at 25 °C.
(b) The shelf life of the drug formulation is dependent on the
concentration of the active remaining at least to 90% of its
initial concentration. Determine the shelf life of the drug
formulation when it is stored at 25 °C.
(c) Using Ea = +156 kJ mol-1, estimate the expected increase in
shelf life if the product is stored in the fridge at an average
temperature of 6 °C.
undergo stability testing to ensure it has an adequate shelf life.
The drug decomposes according to first-order kinetics. Kinetic
studies are performed at a number of different temperatures. From
the kinetic data, an activation energy of + 156 kJ mol-1 is
determined.
(a) Determine the degradation rate constant and the half-life
for the active in the formulation, if the initial drug
concentration is 12.0 mg/mL and the concentration after 34 weeks is
5.42 mg/mL, when stored at 25 °C.
(b) The shelf life of the drug formulation is dependent on the
concentration of the active remaining at least to 90% of its
initial concentration. Determine the shelf life of the drug
formulation when it is stored at 25 °C.
(c) Using Ea = +156 kJ mol-1, estimate the expected increase in
shelf life if the product is stored in the fridge at an average
temperature of 6 °C.