Tablet testing disintegration

Determination of the time for a tablet to disintegrate when immersed in some test fluid has been a requirement in most compendia for many years. For many years, it was the only test available to evaluate the release of medicaments from a dosage unit. We now recognize the severe limitations of such tests in assessing this property—hence, the introduction of dissolution rate requirements. 

A disintegration test with discs is performed for indapamide tablets. The apparatus is described in USP XXII under section [701] Disintegration (36). The test is accomplished by placing a tablet in each of the six tubes of the basket. The amount of time needed for the tablets to disintegrate completely in 0.1 N hydrochloric acid at 37°C is recorded. The disintegration test needs to be repeated for 12 additional tablets if one or two tablets fail to disintegrate completely. Of the 18 tablets, not less than 16 of the tablets must disintegrate completely. 

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).

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. 

FW Goodhart, RH McCoy, FC Ninger. New in vitro disintegration and dissolution test method for tablets and capsules. J Pharm Sci 62 304-310, 1973. 

Garlic supplements - powder tablets or capsules, steam-distilled oil, vegetable oil macerate extract, or extract aged in dilute alcohol - are widely available and are taken by millions. Since the active principle, allicin, is not present in garlic bulb, the supplements rely on the presence of precursor alliin and enzyme alliinase. In tests on 24 commercial brands of enteric-coated tablets, all except one gave low dissolution allicin release 83% of the brands released less than 15% of their potential allicin.78,79 Relevant factors were impaired enzyme activity caused by excipients and slow tablet disintegration. Caveat emptor ... 

Disintegration official in Brit Pharmacon and USP PMA Tablet Committee proposes 1% solubility threshold USP and NF Joint Panel on Physiological Availability chooses dissolution as a test chooses an apparatus Initial 12 monograph standards official Variables assessment more laboratories, three Collaborative Studies by PMA and Acad. Pharm. Sci First calibrator tablets pressed First Case default proposed to USP... 

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. 

In one case, the formulation barely released any drug under the pH 1.2 condition. This could be traced back to the disintegration behavior, as little or no disintegration was observed at the low pH. Subsequently, a full-change method was used to determine whether exposure to low pH would harm release at pH 6.8 (Fig. 3). As can be seen from the graph, release was almost as complete when tested after exposure to pH 1.2 for an hour as when the tablet was placed in a pH 6.8 medium from the outset. These results underscore the... 

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. 

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. 

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