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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]
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:
The rate of dissolution is a key target for controlling the duration of a drug's effect, and as such, several dosage forms that contain the same active ingredient may be available, differing only in the rate of dissolution. If a drug is supplied in a form that is not readily dissolved, it may be released gradually and act for longer.
The drug (active substance) itself needs to be soluble in aqueous solution at a controlled rate. Such factors as particle size and crystal form can significantly affect dissolution. Fast dissolution is not always ideal. For example, slow dissolution rates can prolong the duration of action or avoid initial high plasma levels.
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 2019, the FDA approved Johnson & Johnson’s proprietary form of the drug, Spravato, a nasal spray that treats severe depression. Similar to ketamine, the drug is offered at doctor’s offices ...
Read together with questions and answers. FDA: Safety Reporting Requirements for INDs and BA/BE Studies. [ 25 ] This guidance focuses on expedited safety reporting requirements for human drug and biological products that are being investigated under an IND and for drugs that are the subjects of bioavailability (BA) and bioequivalence (BE ...
Particle size and surface area influence the release of a drug from a dosage form that is administered orally, rectally, parenterally, and topically.Higher surface area brings about intimate contact of the drug with the dissolution fluids in vivo and increases the drug solubility and dissolution.