What Is Dissolution Test?
Dissolution testing evaluates the dissolving behavior (rate and extent) of solid pharmaceutical dosage forms in an in vitro simulation of the human gastrointestinal environment.
For orally administered drugs, they initially enter the gastrointestinal tract upon ingestion by humans. Only after dissolution can drug molecules traverse the gastrointestinal wall, entering the bloodstream and producing therapeutic effects.
The dissolution test reflects the quality, processes, bioavailability, and bioequivalence of drugs, making it an essential tool in pharmaceutical research and development. It plays a vital role in understanding how drugs are released in the human body and how they exert their effects.
How Is Drug Dissolution Measured?
The dissolution test employs a Dissolution Apparatus, a specialized device designed to simulate the dissolution of drugs in the human body. It comprises several key components:
- Containe - Used to hold the dissolution medium (typically a buffered solution simulating gastric or intestinal fluids).
- Temperature Control Device - Maintains a constant temperature in the dissolution medium, usually set at 37°C to mimic the body's internal temperature.
- Sampling Device - At specific time points, a certain volume of the sample is extracted for high-performance liquid chromatography (HPLC) analysis to determine the drug's concentration in the dissolution medium, reflecting the extent of drug release. When the dissolution levels at different time points are compared, we evaluate the dissolution behavior.
- Stirring Device - Used to ensure full contact between the drug and the dissolution medium, employing methods such as the basket method and the paddle method. The Basket Method uses a rotating basket to hold the liquid, while the Paddle Method uses a rotating paddle to stir the dissolution medium.
These components work together to test a drug's dissolution, supporting pharmaceutical research and quality control.
Services Process
Method Selection & Project Planning
This pivotal stage focuses on gathering crucial data related to drug samples to develop a more appropriate analysis plan.
Key considerations include the specific drug formulation type, determining the appropriate pH range, selecting the dissolution medium (e.g., buffered solutions simulating gastric or intestinal fluids), and choosing between the paddle or basket method based on the drug's characteristics.
The test duration, typically 6 hours for regular formulations and 24 hours for extended-release products, depends on the formulation's nature.
Analysis
Under controlled conditions, our skilled analysts closely monitor the dissolution process, meticulously recording the time required for complete drug dissolution.
Reporting
Upon completion of the tests, our team conducts an exhaustive analysis of the data and provides clients with comprehensive reports, offering detailed insights and any relevant recommendations.
Protheragen-ING adheres to a structured service process to provide dependable and precise results. If you have specific requirements or inquiries, please feel free to contact us. We respond to your needs within 2-4 working days.
