In Vitro Drug Dissolution: Modalities

MARÍA ESPERANZA RUIZ; ALAN TALEVI

The ADME Encyclopedia. A Comprehensive Guide on Biopharmacy and Pharmacokinetics

Springer

Lugar: Basel; Año: 2021; p. 1 - 11

Modalities of in vitro dissolution test refer to the different experimental setup that can be used to study the dissolution of a solid oral dosage form. In general, these include (1) classical compendial test, where the dissolution is assessed in one fixed volume vessel; (2) multi-compartment systems, designed to resemble two or more portions of the gastrointestinal tract; (3) systems designed to attain sink conditions, particularly for lipophilic drugs; and (4) combinations of the above.The evaluation of drug dissolution has more than a century of development, and 50 years as an official test, since it was in 1970 when the United States Pharmacopeia (USP) introduced the first 12 monographs that included dissolution testing [1]. Since then, interest in the dissolution test has not stopped growing, mainly due to its application to the study of solid drug products, in which the dissolution process is directly related to the bioavailability of the drug in the body. Although initially developed for solid oral formulations, over time dissolution test expanded beyond tablets and capsules to also include transdermal products, drug-eluting stents, pharmaceutical nanocarriers, bioenabling formulations, and so on.