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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]
An orally disintegrating tablet or orally dissolving tablet (ODT) is a drug dosage form available for a limited range of over-the-counter (OTC) and prescription medications. ODTs differ from traditional tablets in that they are designed to be dissolved on the tongue rather than swallowed whole.
The mechanical strength of tablets is assessed using a combination of simple failure and erosion tests, and more sophisticated engineering tests. The simpler tests are often used for quality control purposes, whereas the more complex tests are used during the design of the formulation and manufacturing process in the research and development phase.
Effervescent or carbon tablets are tablets which are designed to dissolve in water and release carbon dioxide. The carbon dioxide is generated by a reaction of a compound containing bicarbonate , such as sodium bicarbonate or magnesium bicarbonate , with an acid such as citric acid or tartaric acid .
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.
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]
Increased surface area, which may enhance an active ingredient's dissolution rate and hence bioavailability; Improved tablet-to-tablet content uniformity due to a larger number of particles per unit weight; Controlled particle size distribution of dry granulation or mix to promote better flow of mixture in tablet machine
An enteric coating is a polymer barrier applied to oral medication that prevents its dissolution or disintegration in the gastric environment. [1] This helps by either protecting drugs from the acidity of the stomach, the stomach from the detrimental effects of the drug, or to release the drug after the stomach (usually in the upper tract of the intestine). [2]