Difference: Disintegration and Dissolution test in pharma industry

The disintegration test measures the time it takes for a drug to break down, whereas the dissolution test measures the amount of drug that dissolves.

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Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
Rakesh Dahiya

Last Updated on January 3, 2024 by The Health Master

Disintegration test and Dissolution test

The pharmaceutical industry is highly regulated, and drug manufacturers must comply with various standards set by regulatory agencies.

One of the most critical quality control measures is to test the drug’s ability to dissolve and disintegrate in the body. This test ensures that the drug is absorbed correctly in the body and produces the desired effect.

There are two types of tests used to evaluate the quality of drugs: disintegration tests and dissolution tests.

In this article, we will discuss the differences between these two tests and their significance in the pharmaceutical industry.

Also read: Dissolution test: Importance in Pharma Industry

Disintegration Test

The disintegration test measures the time it takes for a drug to break down into small particles in the stomach or intestinal fluids.

This test is necessary because the drug’s ability to break down in the stomach or intestines is critical for its absorption. If a drug does not break down, it cannot be absorbed by the body, and its effectiveness is reduced.

Therefore, the disintegration test is an essential quality control measure to ensure that the drug is of high quality.

The disintegration test is performed using a disintegration apparatus, which consists of a basket-rack assembly and a glass tube.

The basket-rack assembly holds six plastic tubes, each containing a tablet or capsule. The glass tube is filled with simulated gastric or intestinal fluid.

The basket-rack assembly is then immersed in the fluid, and the time it takes for the tablets or capsules to break down is recorded.

The time it takes for the drug to disintegrate should be within the range specified in the in the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United State Pharmacopoeia (USP), etc., against the monographs of the particular dosage form.

Dissolution Test

The dissolution test measures the amount of drug that dissolves in a liquid medium under controlled conditions.

This test is necessary because the drug’s ability to dissolve in the stomach or intestinal fluids affects its bioavailability.

Bioavailability refers to the amount of drug that reaches the bloodstream and produces a therapeutic effect.

If a drug does not dissolve, it cannot be absorbed by the body, and its effectiveness is reduced. Therefore, the dissolution test is an essential quality control measure to ensure that the drug is of high quality.

The dissolution test is performed using a dissolution apparatus, which consists of a paddle or basket apparatus and a glass vessel.

The paddle or basket is rotated at a constant speed in the liquid medium, and the amount of drug that dissolves is measured at specific time intervals.

The time it takes for the drug to dissolve should be within the range specified in the in the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United State Pharmacopoeia (USP), etc., against the monographs of the particular dosage form.


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Disintegration VS Dissolution

Table comparing disintegration and dissolution in the pharmaceutical industry:

AspectDisintegrationDissolution
DefinitionThe process by which a solid dosage form breaks apartThe process by which a solid substance dissolves in a liquid medium
PurposeTo assess the ability of a dosage form to break down into smaller particlesTo evaluate the rate and extent at which a drug substance dissolves
Test MethodDisintegration testing using specialized apparatusDissolution testing using dissolution apparatus
OutcomeDetermination of the time required for disintegrationMeasurement of drug release from the dosage form
Parameters MeasuredDisintegration timeDissolution rate and extent
ImportanceEnsures that the dosage form disintegrates effectivelyEnsures that the drug is released and available for absorption in the body
ApplicabilitySolid dosage forms such as tablets, capsules, and granulesSolid dosage forms, including immediate-release and extended-release formulations
Regulatory StandardsDefined by pharmacopoeias such as IP, USP, EP, and JPDefined by pharmacopoeias such as IP, USP, EP, and JP
SignificanceCan impact drug absorption and therapeutic effectivenessEssential for establishing bioequivalence of generic drugs
ExamplesTablet breaking down into smaller particlesActive ingredient dissolving to form a solution

Differences between Disintegration Test and Dissolution Test

While both tests are essential quality control measures in the pharmaceutical industry, there are several differences between them.

Here are some of the key differences between the disintegration test and dissolution test:

1. Purpose

The disintegration test measures the time it takes for a drug to break down into small particles in the stomach or intestinal fluids. The dissolution test measures the amount of drug that dissolves in a liquid medium under controlled conditions.

2. Apparatus

The disintegration test is performed using a disintegration apparatus, which consists of a basket-rack assembly and a glass tube. The dissolution test is performed using a dissolution apparatus, which consists of a paddle or basket apparatus and a glass vessel.

3. Conditions

The disintegration test is performed in simulated gastric or intestinal fluids, whereas the dissolution test is performed in a liquid medium under controlled conditions.

4. Time Frame

The time frame for disintegration test and dissolution test should be within the range specified in the in the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United State Pharmacopoeia (USP) etc against the monographs of the particular dosage form.

For example: Unless otherwise stated in the individual monograph, the time frame is as under:

Type of TabletDisintegration Time in IPDisintegration Time in USP
UncoatedNot more than 15 minutesNot more than 30 minutes
Enteric-coatedNot more than 60 minutesNot more than 2 hours
BuccalNot more than 30 minutesNot more than 60 minutes
SublingualNot more than 3 minutesNot more than 5 minutes

5. Results

The disintegration test measures the time it takes for a drug to break down, whereas the dissolution test measures the amount of drug that dissolves.

6. Performance

While the disintegration test and dissolution test are both critical quality control measures, they serve different purposes and are used at different stages of drug development.

The disintegration test is typically performed during the pre-formulation and formulation stages of drug development. During pre-formulation, the disintegration test is used to determine the best form of the drug to be developed, while during formulation, the test is used to optimize the dosage form.

On the other hand, the dissolution test is typically performed during the development of the drug product. This test is used to ensure that the drug product meets the regulatory standards for bioavailability and that the amount of drug that is released is consistent over time.

Important

It is important to note that the results of the disintegration test and dissolution test can be affected by various factors such as the temperature, pH, and composition of the simulated fluids used in the tests.

Therefore, it is essential to conduct these tests under standardized and controlled conditions to ensure accurate and reproducible results.

Conclusion:

The disintegration test and dissolution test are two critical quality control measures used in the pharmaceutical industry to ensure that drugs are of high quality and meet regulatory standards.

These tests serve different purposes and are used at different stages of drug development. While the tests may have some similarities, they differ in their apparatus, conditions, time frame, and results.


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