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Questions and Answers
What is the primary purpose of conducting stability studies?
What does the shelf life (t90) of a pharmaceutical product represent?
Which guideline is NOT listed under the international guidelines for conducting stability studies?
In stability testing, what is determined by plotting the appropriate function of concentration against time?
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How can the energy of activation be calculated in stability testing?
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What is the main purpose of accelerated stability studies?
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Which condition set corresponds to long term stability studies?
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What is the frequency interval for in-use stability studies?
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Which climatic zones determine the shelf conditions for pharmaceutical products?
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When is an intermediate stability study used as an alternative?
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Study Notes
Purpose and Guidelines of Stability Studies
- Evaluate the impact of climatic variations on product stability
- Determine appropriate storage conditions
- Predict product shelf life at proposed storage conditions
- Help choose the optimum formula and package
- Regional and international guidelines: EDA, ICH, WHO, EMEA, FDA
Concept of Stability Testing
- Samples incubated in specially designed chambers at defined conditions for a defined period
- Analysis at specified intervals
- Results determine shelf life at proposed conditions
- Study type and significance determined by conditions and duration of incubation
- Accelerated degradation by storing at elevated temperatures
- Samples withdrawn at different time intervals
- Order of reaction determined by plotting concentration against time
- Straight line in graph permits estimation of k value from slope
- Arrhenius plot: Log k values plotted against reciprocal of absolute temperature, energy of activation calculated
- Extrapolate to room temperature (k25) or refrigerated temperature and read log k value on y-axis
- Shelf life (t90) calculated using k value
Types of Stability Studies
- R&D and excursion evaluation
- Accelerated stability for product life prediction and optimum formula/package selection
- Stress testing (forced degradation)
- Studies required by authorities
- Long-term stability (real-time stability)
- In-use stability and after reconstitution stability
Study Conditions and Significance
Long-term Stability
- Study conditions: actual conditions (e.g., 25°C, 60% RH)
- Study period: proposed product shelf life
- Intervals: 0,3,6,9,12,18,24,36 months
- Significance: confirm product stability and shelf life
Accelerated Stability
- Study conditions: challenging conditions (e.g., 40°C, 75% RH)
- Study period: 6 months
- Intervals: 0,1,3,6 months
- Significance:
- Help predict shelf life
- Provide data on stability upon excursions in conditions (e.g., transport)
- Help select optimum formula and packaging material
Intermediate Stability
- Study conditions: moderate conditions (30°C, 65% RH)
- Study period: 12 months
- Intervals: 0,3,6,9,12 months
- Significance:
- Alternative to accelerated studies for predicting shelf life for products stored at 25°C, 60% RH when the product fails accelerated conditions
In-use Stability and Stability after Re-constitution
- Study conditions: conditions labeled on drug product box or in the inner leaflet for storage after opening, reconstitution, or mixing with solutions
- Study period: as described in product inserted leaflet
- Significance: confirm product stability during conventional use
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Description
This quiz covers the importance of stability studies in pharmaceuticals, including evaluating the impact of climate on product stability, determining storage conditions, and predicting shelf life. It also touches on guidelines from regional and international authorities.
