Job Description
Dissolution testing is a critical component of pharmaceutical development and quality assurance.
* Optimising drug formulations by evaluating dissolution profiles to ensure consistent release characteristics and therapeutic efficacy.
* Ensuring batch-to-batch consistency in drug performance across different batches, ensuring consistent therapeutic outcomes for patients.
* Complying with regulatory requirements from authorities such as EMA, requiring dissolution testing data to assess the quality, safety, and efficacy of pharmaceutical products.
* Assessing bioavailability by determining the rate and extent of drug dissolution, influencing its pharmacokinetic profile and clinical effectiveness.
To conduct dissolution testing effectively, several key steps are involved:
* Sample preparation, including standardised procedures to ensure uniformity and accuracy in testing.
* Selecting a suitable dissolution medium, taking into account factors such as drug solubility, intended route of administration, and physiological conditions.
* Configuring apparatus using specialised equipment such as paddles, baskets, or flow-through cells to simulate different physiological conditions within the gastrointestinal tract.
* Controlling testing conditions, including temperature, agitation speed, and sampling intervals, carefully controlled to ensure reproducibility and accuracy of results.
* Analysing dissolution profiles, collecting samples at specified time points and analysing them using techniques like UV-visible spectroscopy or chromatography to determine the concentration of the drug in the dissolution medium.
This process helps determine the rate and extent of drug release, impacting its absorption and therapeutic effectiveness.
Dissolution testing is performed using specially designed apparatus to mimic conditions within the gastrointestinal tract.