Dissolution Test

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.

Dissolution Test

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:

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.


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