Dissolution Testing

Dissolution testing is a laboratory technique used to assess how quickly a solid dosage form dissolves in a specified solvent, mimicking conditions within the gastrointestinal tract.
This process helps determine the rate and extent of drug release, impacting its absorption and therapeutic effectiveness.
Dissolution testing plays a vital role in pharmaceutical development and quality assurance for several reasons:
Optimising Drug Formulations
By evaluating dissolution profiles, manufacturers can optimise drug formulations to ensure consistent release characteristics and therapeutic efficacy.
Ensuring Batch-to-Batch Consistency
Dissolution testing helps maintain uniformity in drug performance across different batches, ensuring consistent therapeutic outcomes for patients.
Regulatory Compliance
Regulatory authorities, such as EMA, require dissolution testing data to assess the quality, safety, and efficacy of pharmaceutical products, making it a critical component of regulatory submissions.
Assessing Bioavailability
The rate and extent of drug dissolution directly impact its bioavailability, influencing its pharmacokinetic profile and clinical effectiveness.
To conduct dissolution testing effectively, several key steps are involved:
Sample Preparation
Solid dosage forms are prepared according to standardized procedures to ensure uniformity and accuracy in testing.
Selection of Dissolution Medium
Choosing the appropriate dissolution medium is crucial and depends on factors such as drug solubility, intended route of administration, and physiological conditions.
Apparatus Setup
Dissolution testing is performed using specialised apparatus such as paddles, baskets, or flow-through cells, simulating different physiological conditions within the gastrointestinal tract.
Controlled Testing Conditions
Testing conditions, including temperature, agitation speed, and sampling intervals, are carefully controlled to ensure reproducibility and accuracy of results.
Analysis of Dissolution Profiles
Samples collected at specified time points are analysed using techniques like UV-visible spectroscopy or chromatography to determine the concentration of the drug in the dissolution medium.
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