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A ppt on accelerated stability studies
 

A ppt on accelerated stability studies

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    A ppt on accelerated stability studies A ppt on accelerated stability studies Presentation Transcript

    • NAME : SRIKANTH BANDI H.T.NO : 11H61S0303 DEPARTMENT : PHARMACEUTICS14 June 2012 Anurag group of institutions,School of Pharmacy 1
    • C0NTENTS:DefinitionWhy….?ObjectivesICH guidelinesHow to Perform? 14 June 2012 Anurag group of institutions,School of Pharmacy 2
    •  A method by which a product is exposedto elevated temperature simulating whatwould happen over longer periods on theshelf life. 14 June 2012 Anurag group of institutions,School of Pharmacy 3
    •  The stability of pharmaceuticalpreparations should be evaluated byexposing the product to normal shelfconditions for a year or extendedperiods. The rate of decomposition isslow at room temperature .Such amethod is time consuming anduneconomical.14 June 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.14 June 2012 Anurag group of institutions,School of Pharmacy 5
    •  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)14 June 2012 Anurag group of institutions,School of Pharmacy 6
    •  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 stabilitytesting of new drug substances & products. Q 1E :Evaluation for stability data. 14 June 2012 Anurag group of institutions,School of Pharmacy 7
    •  These guidelines provide definitions of key terms & principles used inthe stability testing of drug substances& drug products. ICH outlined a combination of temperature & humidities for stabilitystudies 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%. 14 June 2012 Anurag group of institutions,School of Pharmacy 8
    •  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 chambercapable of cycling both temperature and humidity are needed.14 June 2012 Anurag group of institutions,School of Pharmacy 9
    • STABILITY CABINETS:14 June 2012 Anurag group of institutions,School of Pharmacy 10
    • STABILITY CABINETS:14 June 2012 Anurag group of institutions,School of Pharmacy 11
    •  Drug liquid preparations are stored at elevated temperaturesviz.,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 stabilitystudies, it is necessary to simultaneously conduct experiments atroom temperature i.e., 30 C,70% RH & or refrigerator temperaturei.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& 14 June 2012 yearly there after. Anurag group of institutions,School of Pharmacy 12
    •  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.14 June 2012 Anurag group of institutions,School of Pharmacy 13
    • 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.14 June 2012 Anurag group of institutions,School of Pharmacy 14
    • 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.org2) www.gmp-compliance.org3) www.pharma.gally.ch4) www.who.int5) www.sensitech.com 14 June 2012 Anurag group of institutions,School of Pharmacy 15
    • 14 June 2012 Anurag group of institutions,School of Pharmacy 16