Disintegration tests

Deaggregation of solid dosage form (e.g., tablet or capsule) into its primary particles is termed as disintegration, and is thereby distinguished from drug dissolution. But in 

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Tablet-disintegration tests consist of cychcal immersion in a suitable dissolving fluid of pharmaceutical tablets contained in a basket. Acceptable tablets disintegrate completely by the end of the specified test period United State.s Fharmacopeia, 17th rev.. Mack Pub. Co., Easton, Pa., 1965, p. 919).

Wilson, A. D., Abel, G. Lewis, B. G. (1974). The solubility and disintegration test for zinc phosphate dental cements. British Dental Journal, 137, 313-17. 

The USP disintegration test is typical of most and is described in detail in a monograph of that volume. Briefly, it consists of an apparatus in which a tablet can be introduced into each of six cylindrical tubes, the lower end of which is covered by a 0.025 in.2 wire mesh. The tubes are then raised and lowered through a distance of 5.3-5.7 cm at a rate of29-32 strokes per minute in a test fluid maintained at 37 2°C. Continuous agitation of the tablets is ensured by this stroking mechanism and by the presence of a specially designed plastic disk, which is free to move up and down in the tubes. 

The test apparatus chosen for disintegration testing and dissolution testing should be one of those described in the Ph Eur unless another pharmacopoeial or a noncompendia method can be justified. The test conditions and the proposed release rates should be justified in terms of batch reproducibility. 

A dissolution test was first described in the JP in 1981 (18). General rules for capsules and tablets stated that the requirements of the disintegration test must be met unless otherwise specified. Several specific capsule and tablet monographs included new dissolution tests. 

Stressed Enteric Test SET) Essentially the same test as the Enteric Test (ET), but in this case, the 100 tablets were placed in a friability tester for four minutes at 25 rpm prior to being submitted for the enteric disintegration test in artificial gastric juice. 

Batch size (kg) Disintegration test Dissolution test ... 

Shallow convex tablets (jin) containing 300 mg HPMC K15M and 1% magnesium stearate were prepared by direct compression. Disintegration tests were performed in triplicate, using the BP 1988 method, in 600 ml of media at 37°C using discs. Tests were run for a maximum of 2 h. 

A modified USP XXI disintegration test apparatus (4000 ml beaker instead of 1000 ml low-form beaker) was used to control the finished systems. 

Louie-Helm, J., and Berner, B. Formulation of an erodible, gastric retentive oral dosage form using in vitro disintegration test data, U.S. Patent 20030091630, 2003. 

Tablet disintegration test, United States Pharmacopeia, 17th rev. edn., Mack Pub. Co., Easton, PA, 1965, pp. 919—921. 

Linder rotating furnace procedure, 36 research and control methods, 32 tablet disintegration test, 36 tensile testing, 32 see also Strength of agglomerates Suppliers of size enlargement equipment, 177... 

Tablet disintegration test, 36 Tensile strength testing...

Most pharmacopeias include a disintegration test which can be applied to tablets and capsules and the detailed monograph is given in the pharmacopeias (see Section 6.1.5.1). 

All USP tablets must pass a test for disintegration, which is conducted in vitro using a testing apparatus. The detailed monograph for disintegration testing is described in the many pharmacopeias [2,3],... 

Measurement of pH or scintigraphy In vitro disintegration testing In vitro dissolution testing In vitro drug transport studies In vitro drug metabolism studies... 

Disintegration tests allow for precise measurement of the formation of fragments, granules, or aggregates from solid dosage forms, but do not provide information on the dissolution rate of the active drug. The disintegration test serves as a component in the overall quality control of tablet manufacture. 

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