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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 USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. [2] If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF".
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]
Partition coefficients can be measured experimentally in various ways (by shake-flask, HPLC, etc.) or estimated by calculation based on a variety of methods (fragment-based, atom-based, etc.). If a substance is present as several chemical species in the partition system due to association or dissociation , each species is assigned its own K ow ...
In statistical thermodynamics, the UNIFAC method (UNIQUAC Functional-group Activity Coefficients) [1] is a semi-empirical system for the prediction of non-electrolyte activity in non-ideal mixtures. UNIFAC uses the functional groups present on the molecules that make up the liquid mixture to calculate activity coefficients .
Another method by which sustained release is achieved is through an osmotic controlled-release oral delivery system, where the active compound is encased in a water-permeable membrane with a laser drilled hole at one end. As water passes through the membrane the drug is pushed out through the hole and into the digestive tract where it can be ...
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 ]
The calculation process requires the availability of a great deal of vapor–liquid equilibrium data for the components present in the distillation feed, and the calculation procedure is very complex. [2] [3] In an industrial distillation column, the N t required to achieve a given separation also depends upon the amount of reflux used. Using ...