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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]
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.
In pharmaceutics, sink condition is a term mostly related to the dissolution testing procedure.. It means using a sheer volume of solvent, usually about 5 to 10 times greater than the volume present in the saturated solution of the targeted chemical (often the API, and sometimes the excipients) contained in the dosage form being tested.
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.
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.
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Modern tablet presses reach output volumes of up to 1,700,000 tablets per hour. These huge volumes require frequent in-process quality control for the tablet weight, thickness and hardness. Due to efforts to reduce rejects rates and machine down-time, automated tablet testing devices are used on-line with the tablet press or off-line in the IPC ...