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The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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A medication’s effectiveness largely depends on its appropriate dosage and the route of administration. Dosage ensures that a sufficient drug concentration is maintained in the bloodstream to elicit the desired therapeutic effect without causing toxicity. The route of administration affects the drug's bioavailability, rate of absorption, and onset of action, which are crucial for achieving optimal therapeutic outcomes. Drug dosage calculations are critical to tailoring therapy to...
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Simulating shelf life determination by two simultaneous criteria.

Micha Peleg1, Mark D Normand1

  • 1Department of Food Science, University of Massachusetts, Amherst, MA 01003, United States.

Food Research International (Ottawa, Ont.)
|April 24, 2017
PubMed
Summary
This summary is machine-generated.

Shelf life prediction for food and pharmaceuticals depends on marker degradation. The order of marker degradation can change with storage temperature, impacting shelf-life predictions, especially under non-isothermal conditions.

Keywords:
Accelerated storageChemical markersDietary supplementsNon-enzymatic browningShelf life criteriaVitamins degradation

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Area of Science:

  • Food Science
  • Pharmaceutical Science
  • Chemical Kinetics

Background:

  • Product shelf life is determined by marker concentrations crossing thresholds.
  • Different markers yield varying shelf-life predictions for identical storage conditions.

Purpose of the Study:

  • To investigate how storage temperature profiles affect the order of marker degradation.
  • To determine if accelerated storage studies accurately predict real-time degradation order.

Main Methods:

  • Simulated degradation reactions following zero or first-order kinetics.
  • Modeling temperature-dependent rate constants using an exponential model.
  • Simulated Maillard reaction product synthesis kinetics.

Main Results:

  • The order of marker threshold crossing is sensitive to storage temperature profiles (isothermal vs. non-isothermal).
  • Accelerated storage order may not reflect actual storage order unless degradation kinetics are identical.
  • A freely downloadable software tool was developed for simulations and threshold crossing calculations.

Conclusions:

  • Shelf-life prediction accuracy depends on considering the interplay between marker degradation kinetics and temperature profiles.
  • The methodology can be extended to multiple markers for comprehensive shelf-life assessment.
  • Accurate shelf-life prediction requires careful consideration of storage conditions beyond simple accelerated testing.