title: The influence of dissolution conditions on the drug ADME phenomena.
abstract: In this work, a review of the apparatuses available to mimic what happens to a drug (or to foodstuffs) once ingested is presented. Similarly, a brief review of the models proposed to simulate the fate of a drug administered to a living body is reported. Then, the release kinetics of extended release of diclofenac from a commercial enteric-coated tablet was determined both in a conventional dissolution tester (USP Apparatus 2, Method A) as well as in an apparatus modified to reproduce a given pH evolution, closer to the real one than the one suggested by USP. The two experimental release profiles were reported and discussed; therefore, they were adopted as input functions for a previously proposed pharmacokinetic model. The obtained evolutions with time of plasma concentration were presented and used to assess the effectiveness of the commercial pharmaceutical products. The importance of a correct in vitro simulation for the design of pharmaceutical dosage systems was thus emphasized.
authors.affiliation: Dipartimento di Ingegneria Industriale, Università degli Studi Salerno, Fisciano, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Cascone
authors.forename: Felice
authors.initials: F
authors.lastname: De Santis
authors.forename: Gaetano
authors.initials: G
authors.lastname: Lamberti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Titomanlio
mesh_terms: D000042:Absorption; D002626:Chemistry, Pharmaceutical / Q000379:methods; D003692:Delayed-Action Preparations; D004008:Diclofenac / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics; D006863:Hydrogen-Ion Concentration; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry; D010599:Pharmacokinetics; D012995:Solubility; D013608:Tablets, Enteric-Coated / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics; D014018:Tissue Distribution
chemical_list: D003692:Delayed-Action Preparations; D004364:Pharmaceutical Preparations; D013608:Tablets, Enteric-Coated; D004008:Diclofenac