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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]
Bloom is a test used to measure the strength of a gel, most commonly gelatin.The test was originally developed and patented in 1925 by Oscar T. Bloom. [1] The test determines the weight in grams needed by a specified plunger (normally with a diameter of 0.5 inch) to depress the surface of the gel by 4 mm without breaking it at a specified temperature. [2]
Products that meet the requirements of the program can display the USP Verified Dietary Supplement Mark on their labels. [5] This is different from seeing the letters "USP" alone on a dietary supplement label, which means that the manufacturer is claiming to adhere to USP standards. USP does not test such products as it does with USP Verified ...
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.
In a dissolution process, a solute is changed from a pure phase—solid, liquid, or gas—to a solution phase. If the pure phase of the solute is a solid or gas (presuming the solvent itself is liquid), the process can be seen in two stages: the phase change into a liquid, and the mixing of liquids. The dissolution process is generally ...
The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products. [4] It is important when conducting these tests to ensure that the testing method does not either introduce bacteria into the test sample or kill bacteria in the test sample. [4]
Lipinski's rule of five, also known as Pfizer's rule of five or simply the rule of five (RO5), is a rule of thumb to evaluate druglikeness or determine if a chemical compound with a certain pharmacological or biological activity has chemical properties and physical properties that would likely make it an orally active drug in humans.
Tablet hardness testing is a laboratory technique used by the pharmaceutical industry to determine the breaking point and structural integrity of a tablet and find out how it changes "under conditions of storage, transportation, packaging and handling before usage" [1] The breaking point of a tablet is based on its shape. [2]