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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.
Sodium croscarmellose also resolves formulators′ concerns over long-term functional stability, reduced effectiveness at high tablet hardness levels, and similar problems associated with other products developed to enhance drug dissolution. It is a very commonly used [2] pharmaceutical additive approved by the U.S. Food and Drug Administration ...
In this case, a broad therapeutic window is necessary to avoid toxicity; otherwise, the risk is unwarranted and another mode of administration would be recommended. [3] Appropriate half-lives used to apply sustained methods are typically 3–4 hours and a drug dose greater than 0.5 grams is too high. [4] [5]
In addition, a slow release system will maintain drug concentrations within a therapeutically acceptable range for longer than quicker releasing delivery systems as these result in more pronounced peaks in plasma concentration. The dissolution rate is described by the Noyes–Whitney equation:
In its proposed rule, the FDA would require manufacturers to test a sample of each batch of a talc-containing cosmetic product for asbestos by using methods such as polarized light and ...
* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).
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