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In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]
Models of testers include the Monsanto (or Stokes) Hardness Tester from 1930, the Pfizer Hardness Tester from 1950, the Strong Cob Hardness Tester and the Heberlain (or Schleeniger) Hardness Tester. Lubricants prevent ingredients from clumping together and from sticking to the tablet punches or capsule filling machine.
The tablet is pushed against a stationary anvil until it fractures. A reading is taken from a scale indicator. [5] Kraemer Elektronik's tablet testing system was the first automatic tablet hardness testing system for auto-regulation at tablet presses, invented by German mechanical engineer Mr. Norbert Kraemer in Darmstadt, Germany.
Typically, the parameter derived from the biological property is AUC or Cmax, while the physicochemical property is the in vitro dissolution profile. The main roles of IVIVC are: To use dissolution test as a surrogate for human studies. To supports and/or validate the use of dissolution methods and specifications.
A tablet is usually a compressed preparation that contains: 5-10% of the drug (active substance); 80% of fillers, disintegrants, lubricants, glidants, and binders; and; 10% of compounds which ensure easy disintegration, disaggregation, and dissolution of the tablet in the stomach or the intestine.
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During the dissolution testing, "sink condition" is a mandatory requirement, otherwise when the concentration begins to get too close to the saturation point, even though the total soluble amount still remains constant, the dissolution rate will gradually begin to reduce in significant amounts, enough to corrupt the test results. . [2] [3] [4]
Under Florida guidelines, a private juvenile prison that fails this test comes up for review again within six months. A subsequent failure can result in contract termination. Yet these reviews often fail to probe conditions inside facilities, merely assessing whether required policies are in place, not necessarily whether they are followed.
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