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April 7, 2023 Anurag group of institutions,School of Pharmacy
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ACCELERATED STABILITY STUDIES
NAME : SRIKANTH BANDIH.T.NO : 11H61S0303DEPARTMENT : PHARMACEUTICS
April 7, 2023 Anurag group of institutions,School of Pharmacy
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C0NTENTS:
Definition
Why….?
Objectives
ICH guidelines
How to Perform?
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DEFINITION:
A method by which a product is exposed to elevated temperature simulating what would happen over longer periods on the shelf life.
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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.
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OBJECTIVES:
To predict the shelf life of a pharmaceutical product by accelerating the rate of decomposition ,preferably by increasing the temperature.
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ICH guidelines: Describes regarding sampling times ,storage conditions& specific test parameters for each dosage form.
The FDA & The expert working group of the ICH of technical requirements for the registration of pharmaceuticals for human use have published guidelines for conducting the actual studies.
The ICH guidelines includes 4 batches:Batch-Q(Quality)Batch-S(Safety)Batch-E(Efficacy)Batch-M(Multidisciplinary)
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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. Q 1D :Bracketing & Matrixing designs for stability testing of new drug substances & products. Q 1E :Evaluation for stability data.
ICH guidelines (Cont.d)
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Ich guidelines (Cont.d)
These guidelines provide definitions of key terms & principles used in the stability testing of drug substances& drug products.
ICH outlined a combination of temperature & humidities for stability studies for most of the drug products. These include….. -15 C ±5 C 5 C ±3 C /Ambient humidity 25 C±2 C /60%RH±5%, 30 C±2 C/60% RH±5%, 40 C±2 C/75%RH±5%.
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Ich guidelines(Cont.d) For liquid products , stored in semi permeable containers , subject to water loss , exposure to lower humidities like….. 25 C ±2 C/40% RH±5%, 30 C ±2 C/40% RH±5%, 40 C ±2 C/15% RH±5% is needed.
Also a high intensity light cabinet& a cycling chamber capable of cycling both temperature and humidity are needed.
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STABILITY CABINETS:
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STABILITY CABINETS:
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How to perform? Drug liquid preparations are stored at elevated temperatures viz.,50C, 60 C, 70 C, 80 C, 100 C, 121 C. In addition ,the samples should be studied at 40 C,75%RH & incubator temperature. To confirm the results obtained from Accelerated stability studies, it is necessary to simultaneously conduct experiments at room temperature i.e., 30 C,70% RH & or refrigerator temperature i.e.,4-5 C. During different time intervals , samples are withdrawn. The sampling may be done at: 3 month intervals during the 1st year, 6 month intervals during the 2nd year& yearly there after.
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The drug content is estimated using a stability indicating assay method.
In this…..1. Draw a plot by taking
any conc. like C or log C against Time.
2. Graph is drawn for different elevated temperatures.
3. Lenear relationships are obtained & These have different slope.
4. K value for each temperature are calculated.
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5. Log k values are then plotted against reciprocal of absolute temperature.
6. Extrapolate the straight line to room temperature(25-30 C)& read the log k/k25 value on Y axis.
7. Substitute the k25 value in the equation of appropriate order to get shelf life of the product under normal shelf conditions.
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Bibliography:BOOKS:1) Gilbert S. Banker , Christopher T. Rhodes , Modern
Pharmaceutics, 4th Edition, Revised& Expanded.2) C. V. S. Subrahmanyam , J. Thimma setty , Sarasija Suresh
& V. Kusum Devi, Pharmaceutical engineering principles& Practices, New Delhi,2010.
INTERNET:3) www.ich.org4) www.gmp-compliance.org5) www.pharma.gally.ch6) www.who.int7) www.sensitech.com
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