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- Dissolution_testing abstract "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.In vitro drug dissolution data generated from dissolution testing experiments can be relatedto in vivo pharmacokinetic data by means of in vitro-in vivo correlations (IVIVC). Awell established predictive IVIVC model can be very helpful for drug formulationdesign and post-approval manufacturing changes.The main objective of developing and evaluating an IVIVC is to establish the dissolution test as a surrogate for human bioequivalence studies, as stated by the Food and Drug Administration (FDA). Analytical data from drug dissolution testing are sufficient in many cases to establish safety and efficacy of a drug product without in vivo tests, following minor formulation and manufacturing changes (Qureshi and Shabnam, 2001). Thus, the dissolution testing which is conducted in dissolution apparatus must be able to provide accurate and reproducible results.Several dissolution apparatuses exist. In United States Pharmacopeia (USP) General Chapter <711> Dissolution, there are four dissolution apparatuses standardized and specified. They are:• USP Dissolution Apparatus 1 - Basket (37°C)• USP Dissolution Apparatus 2 - Paddle (37°C)• USP Dissolution Apparatus 3 - Reciprocating Cylinder (37°C)• USP Dissolution Apparatus 4 - Flow-Through Cell (37°C)USP Dissolution Apparatus 2 is the most widely used apparatus among these four.The performances of dissolution apparatuses are highly dependent on hydrodynamics due to the nature of dissolution testing. The designs of the dissolution apparatuses and the ways of operating dissolution apparatuses have huge impacts on the hydrodynamics, thus the performances. Hydrodynamic studies in dissolution apparatuses were carried out by researchers over the past few years with both experimental methods and numerical modeling such as Computational Fluid Dynamics (CFD). The main target was USP Dissolution Apparatus 2. The reason is that many researchers suspect that USP Dissolution Apparatus 2 provides inconsistent and sometimes faulty data. The hydrodynamic studies of USP Dissolution Apparatus 2 mentioned above clearly showed that it does have intrinsic hydrodynamic issues which could result in problems. In 2005, Professor Piero Armenante from New Jersey Institute of Technology (NJIT) and Professor Fernando Muzzio from Rutgers University submitted a technical report to the FDA. In this technical report, the intrinsic hydrodynamic issues with USP Dissolution Apparatus 2 based on the research findings of Armenante's group and Muzzio's group were discussed. More recently, hydrodynamic studies were conducted in USP Dissolution Apparatus 4.".
- Dissolution_testing thumbnail APP4FC-22SU-ULTEM-300a.jpg?width=300.
- Dissolution_testing wikiPageID "12458572".
- Dissolution_testing wikiPageRevisionID "579532403".
- Dissolution_testing hasPhotoCollection Dissolution_testing.
- Dissolution_testing subject Category:Pharmaceutical_industry.
- Dissolution_testing subject Category:Quality_control.
- Dissolution_testing comment "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.In vitro drug dissolution data generated from dissolution testing experiments can be relatedto in vivo pharmacokinetic data by means of in vitro-in vivo correlations (IVIVC).".
- Dissolution_testing label "Dissolution testing".
- Dissolution_testing label "Dostępność farmaceutyczna".
- Dissolution_testing sameAs Dostępność_farmaceutyczna.
- Dissolution_testing sameAs m.02w6xjb.
- Dissolution_testing sameAs Q5282807.
- Dissolution_testing sameAs Q5282807.
- Dissolution_testing wasDerivedFrom Dissolution_testing?oldid=579532403.
- Dissolution_testing depiction APP4FC-22SU-ULTEM-300a.jpg.
- Dissolution_testing isPrimaryTopicOf Dissolution_testing.
