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A PPT On Accelerated Stability Studies

The document discusses accelerated stability testing of pharmaceutical products. It defines accelerated stability testing as exposing products to elevated temperatures to simulate longer shelf life periods. The objectives are to predict shelf life by accelerating decomposition rates using increased temperatures. International guidelines like ICH provide definitions and principles for stability testing, outlining temperature and humidity conditions. Drug products are stored at elevated temperatures and sampled periodically, with content estimated using stability indicating assays to calculate degradation rates and predict shelf life at room temperature.

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Shrikanth Varma Bandi
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4K views

A PPT On Accelerated Stability Studies

The document discusses accelerated stability testing of pharmaceutical products. It defines accelerated stability testing as exposing products to elevated temperatures to simulate longer shelf life periods. The objectives are to predict shelf life by accelerating decomposition rates using increased temperatures. International guidelines like ICH provide definitions and principles for stability testing, outlining temperature and humidity conditions. Drug products are stored at elevated temperatures and sampled periodically, with content estimated using stability indicating assays to calculate degradation rates and predict shelf life at room temperature.

Uploaded by

Shrikanth Varma Bandi
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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NAME : SRIKANTH BANDI H.T.

NO : 11H61S0303 DEPARTMENT : PHARMACEUTICS

12 July 2012

Anurag group of institutions,School of Pharmacy

C0NTENTS:
Definition Why.?

Objectives
ICH guidelines How to Perform?
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A method by which a product is exposed

to elevated temperature simulating what would happen over longer periods on the shelf life.

12 July 2012

Anurag group of institutions,School of Pharmacy

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.
12 July 2012 Anurag group of institutions,School of Pharmacy 4

To

predict the shelf life of a pharmaceutical product by accelerating the rate of decomposition ,preferably by increasing the temperature.

12 July 2012

Anurag group of institutions,School of Pharmacy

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.

12 July 2012

Anurag group of institutions,School of Pharmacy

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 C2 C /60%RH5%, 30 C2 C/60% RH5%, 40 C2 C/75%RH5%.

12 July 2012

Anurag group of institutions,School of Pharmacy

For liquid products , stored in semi permeable containers ,

subject to water loss , exposure to lower humidities like.. 25 C 2 C/40% RH5%, 30 C 2 C/40% RH5%, 40 C 2 C/15% RH5% is needed.
Also a high intensity light cabinet& a cycling chamber

capable of cycling both temperature and humidity are needed.

12 July 2012

Anurag group of institutions,School of Pharmacy

STABILITY CABINETS:

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Anurag group of institutions,School of Pharmacy

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STABILITY CABINETS:

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Anurag group of institutions,School of Pharmacy

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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& 12 July 2012 Anurag group of institutions,School of Pharmacy 12 yearly there after.

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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Anurag group of institutions,School of Pharmacy

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5.

6.

7.

Log k values are then plotted against reciprocal of absolute temperature. Extrapolate the straight line to room temperature(25-30 C)& read the log k/k25 value on Y axis. 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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Anurag group of institutions,School of Pharmacy

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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: 1) www.ich.org 2) www.gmp-compliance.org 3) www.pharma.gally.ch 4) www.who.int 5) www.sensitech.com
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Anurag group of institutions,School of Pharmacy

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