A ppt on accelerated stability studies

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A ppt on accelerated stability studies

  1. 1. NAME : SRIKANTH BANDI H.T.NO : 11H61S0303 DEPARTMENT : PHARMACEUTICS14 June 2012 Anurag group of institutions,School of Pharmacy 1
  2. 2. C0NTENTS:DefinitionWhy….?ObjectivesICH guidelinesHow to Perform? 14 June 2012 Anurag group of institutions,School of Pharmacy 2
  3. 3.  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
  4. 4.  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
  5. 5.  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
  6. 6.  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
  7. 7.  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
  8. 8.  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
  9. 9.  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
  10. 10. STABILITY CABINETS:14 June 2012 Anurag group of institutions,School of Pharmacy 10
  11. 11. STABILITY CABINETS:14 June 2012 Anurag group of institutions,School of Pharmacy 11
  12. 12.  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
  13. 13.  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
  14. 14. 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
  15. 15. 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
  16. 16. 14 June 2012 Anurag group of institutions,School of Pharmacy 16

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