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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]
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.
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".
Gravimetric analysis describes a set of methods used in analytical chemistry for the quantitative determination of an analyte (the ion being analyzed) based on its mass. The principle of this type of analysis is that once an ion's mass has been determined as a unique compound, that known measurement can then be used to determine the same analyte's mass in a mixture, as long as the relative ...
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 ...
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.
Typically, dementia is associated with classic symptoms like confusion and memory loss. But new research finds that there could be a less obvious risk factor out there: your cholesterol levels ...
As the stomach has an aqueous environment, it is the first place where the pill can dissolve. The rate of dissolution is a key element in controlling the duration of a drug's effect. For this reason, different forms of the same medication can have the same active ingredients but different dissolution rates.