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000. The relationship and difference between disintegration and dissolution

(Last Update: Mar 24, 2018)

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1. Disintegration is one of the indexes for the quality inspection of solid drug, and is a system for measuring the disintegration rate of the drug in the human body (stomach), depending on the disintegrating agent. It is generally studied with the disintegration time limit.

2. The factors that affect the disintegration of tablets include the nature of the raw auxiliary materials, the composition of the prescription, the production process, the variety and dosage of the disintegration agent. It is still not perfect to rely on the disintegration time limit check as absorption standard of all tablets, capsules and solid preparation in body, because particle size of the drug dissolved is often between 1.6-2.0 mm through the disintegration instrument screen, but the drugs can be absorbed by the body only in a solution state , so the disintegration is just the initial stage of dissolution, and the next continuous  dispersion and dissolution processes is unable to control by the  disintegration time limit check, and the solid preparation disintegration is also affected by the prescription design, preparation, storage and many complex factors in the body, so disintegration time limit check cannot objectively reflect the relationship and impact between the drug and excipient.

3. Based on the analysis above, the dissolution concept appears on solid preparations, also known as dissolution rate, referring to the rate and extent of the drug to dissolve out of the tablets, capsules and granules and other solid preparations under the specified solvent and conditions. The process to determine the dissolution rate of the solid preparation is called the dissolution test, which is a kind of test method to simulate the oral solid preparations to disintegrate and dissolve out of body. Drug dissolution testing is an effective means to evaluate the preparation quality and technology level, in some extent, which can reflect the difference of the principal agent crystal types, particle sizes, prescription compositions, varieties and properties of the auxiliary material, production process, and is also effective standard to evaluate the bio-availability and uniformity of active components, and can effectively distinguish the difference of the bio-availability of one kind of drugs, therefore which is one of the seized test items to control the drug quality.

4. Solid preparation dissolution study status: dissolution refers to the rate and extent of the drug to dissolve out of the tablets, capsules and granules and other solid preparations under the specified solvent and conditions, which is a external test method to control the medicinal preparation quality, based on experiments, taking the dissolution as theory, and processing the dissolution test data with the mathematical analysis method ,and a method  to study the impacts of the principal agent prescription compositions in the solid preparation, properties of the auxiliary material, particle sizes and production process on the quality of the preparation.

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