Disintegration Test

What Is Disintegration?

Disintegration refers to the process in which solid pharmaceutical dosage forms (such as tablets, capsules, granules, and pills) break down into smaller particles under specified test conditions.

The disintegration test measures the time required for this process. However, disintegration does not imply complete dissolution of the dosage form or its active ingredients.

It simply means that there are no undissolved materials remaining on the mesh of the test apparatus, such as insoluble coatings on tablets or gelatin capsules, melted fat substances, and so on.

Why Measure Disintegration?

In pharmaceutical research and development, the disintegration test holds significant importance.

• For specific dosage forms, if they cannot disintegrate within the specified time, it means that the drug cannot be released within the human body, thereby affecting therapeutic effectiveness.
• For new drugs, because of limited knowledge about various properties, the disintegration test can provide a comprehensive understanding of their stability characteristics. This further helps to assess factors like bioavailability, safety, and efficacy of the drug, all of which serve as references for the design of the downstream formulation process, ensuring drug safety, efficacy, and quality control.

How to Measure Disintegration?

The disintegration test is typically performed using a disintegration apparatus.

The drug is placed in a solution with specific temperature and pH conditions, simulating the conditions in the human gastrointestinal tract. The time required for the dosage form to disintegrate is observed.

Services Process

Initial Consultation & Project Planning

To ensure successful implementation of the project, our dedicated team collaborates closely with clients to gather essential information about the drug formulation. We determine crucial details such as the dosage form, whether it is a suppository, tablet, or capsule, and the specific dimensions of the pharmaceutical product.

These details are fundamental in choosing the right analytical methods and equipment, which may vary according to the type of formulation. Our team will provide clients with a comprehensive project plan.

Analysis and Observation

Our tests are conducted under controlled conditions and the analysts closely monitor the disintegration process, recording the time it takes for the drug to break down completely.

Data Analysis & Reporting

Our team performs a thorough analysis of the test data and then provides detailed reports of testing results, along with any relevant recommendations or insights, ensuring accuracy and reliability.

Protheragen-ING's services follow a structured process to ensure accurate and reliable results. If you have any specific requirements, please feel free to contact us, and we will respond within 2-4 working days.