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Accelerated stability testing v2

Accelerated stability testing exposes pharmaceutical products to elevated temperatures and humidity to accelerate potential degradation reactions. This allows prediction of a product's shelf life at normal storage conditions based on Arrhenius kinetics. International guidelines from ICH provide standardized temperature and humidity conditions for stability testing. Samples are taken at intervals during accelerated testing and degradation is quantified. Arrhenius plots of degradation rates at different temperatures allow extrapolation to normal conditions and estimation of shelf life.

Technology◦
Accelerated stability testing & ICH (Dr.) Mirza Salman Baig Assistant Professor (Pharmaceutics) AIKTC, School of Pharmacy,New Panvel Affiliated to University of Mumbai (INDIA)
• Federal food, drug and cosmetic act ask manufacturer to control processes to ensure safety, quality etc • This is GMP • FDA regulate this
Stability • Stability of pharmaceutical product may be defined as the capability of a formulation (in a specific container/closure system) to remain within its physical, chemical, microbiological, therapeutic and toxicological specification.
Stability testing • A method by which a product is exposed to elevated temperature, simulating what would happen over longer periods on the shelf life • Shelf life:- Time by which product remain stable and retain 90% of its initial potency. (10% degradation)
Hydrolysis Oxidation-reduction Racemisation Decarboxylation Ring cleavage Photolysis isomerisation Degradation reactions
Why? • The stability of pharmaceutical preparations should be evaluated by exposing the product to normal shelf conditions for a year or extended periods. • The rate of decomposition is slow at room temperature .Such a method is time consuming and uneconomical.
Objective of accelerated stability study • To predict the shelf life of a pharmaceutical product by accelerating the rate of decomposition ,preferably by increasing the temperature. • Stability study to predict the shelf life of the product, by accelerating the rate of decomposition, preferably by increasing the temperature of reaction conditions.
Advantage • With the advancement in branch of kinetics, shelf life of a dosage form can be predicted within months based on accelerated stability reports • Preparations are subjected to high stresses during stability testing. • Common high stresses include : – Temperature – Humidity – Light
ICH Guidelines • These guidelines provide definitions of key terms & principles used in the stability testing of drug substances & drug products. • Q 1A (R2) :Stability testing of new drug substances & products. • Q 1B :Photo stability testing of new drug substances &products. • Q 1C :Stability testing for new dosage forms.
ICH • ICH outlined a combination of temperature & humidities for stability studies for most of the drug products. These include..... ❖ -15O C ±5 C ❖ 05O C±3 C /Ambient humidity ❖ 25O C±2 C/60%RH±5%, ❖ 30O C±2 C/60% RH±5%, ❖ 40O C±2 C/75%RH±5%.
Arrhenius equation
Shelf Life • The formulation is stored at different elevated temperatures, to accelerate the rate of degradation • Samples are withdrawn at different time intervals • K value determined by plotting the appropriate function of concentration vs time. • Slope of straight line in a graph permits the estimation of k value.
Undecomposed drug available at elevated temperatures (conc vs time)
Shelf Life • Log k values are plotted against reciprocal of absolute temperature • Resulting the straight line extrapolated to room temperature (k 25O C ) read the corresponding log k value on y-axis. • Substitute the k value in the appropriate equation to get the shelf life of the product.
Extrapolate graph to room temp (20 C then find k and hence t90% using rate of reaction equation)
Shelf life can be determined if we know k and order of reaction Order of reactiont Equation t1/2 (Half life) t90% 0 k0= x/t OR x=k0t t1/2= a/2k0 t0.9= 0.9a/k 1 k= 2.303/t . log a/(a-x) t1/2= 0.693/k t0.9=2.303/k 2 k = 1/t . x/a(a-x) t1/2= 1/ak t0.9= 9/ak