Topic
IVIVC
About: IVIVC is a research topic. Over the lifetime, 429 publications have been published within this topic receiving 8328 citations.
Papers published on a yearly basis
Papers
Journal Article•
01 Jan 2006-Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences
TL;DR: FDA guidance, development, evaluation, and validation of an IVIVC to grant biowaivers, and to set dissolution specifications for oral dosage forms, biopharmaceutics classification systems (BCS), BCS biowaIVERS, application of BCS inIVIVC development and concept of mapping are represented.
Abstract: A key goal in pharmaceutical development of dosage forms is a good understanding of the in vitro and in vivo performance of the dosage forms. One of the challenges of biopharmaceutics research is correlating in vitro drug release information of various drug formulations to the in vivo drug profiles (IVIVC). Thus the need for a tool to reliably correlate in vitro and in vivo drug release data has exceedingly increased. Such a tool shortens the drug development period, economizes the resources and leads to improved product quality. Increased activity in developing IVIVCs indicates the value of IVIVCs to the pharmaceutical industry. IVIVC can be used in the development of new pharmaceuticals to reduce the number of human studies during the formulation development as the main objective of an IVIVC is to serve as a surrogate for in vivo bioavailability and to support biowaivers. It supports and/or validates the use of dissolution methods and specification settings. This is because the IVIVC includes in vivo relevance to in vitro dissolution specifications. It can also assist in quality control for certain scale-up and post-approval changes (SUPAC). With the proliferation of modified-release products, it becomes necessary to examine the concept of IVIVC in greater depth. Investigations of IVIVC are increasingly becoming an integral part of extended release drug development. There must be some in vitro means of assuring that each batch of the same product will perform identically in vivo. This review article represents the FDA guidance, development, evaluation, and validation of an IVIVC to grant biowaivers, and to set dissolution specifications for oral dosage forms, biopharmaceutics classification systems (BCS), BCS biowaivers, application of BCS in IVIVC development and concept of mapping. The importance of dissolution media and methodology and pharmacokinetic studies in the context of IVIVC has been highlighted. The review also covers the literature examples of IVIVCs regarding internal and external validation, compendial dissolution assessment, formulation dependency of IVIVCs, and IVIVCs of pure enantiomers versus racemate drugs. The same principles of IVIVC used for oral extended release products may be applied for non-oral products such as parenteral depot formulations and novel drug delivery systems as well.
369 citations
20 Nov 2014
TL;DR: This review summarizes the methods used to study real-time (37°C) drug release from nanoparticulate drug delivery systems and establish an IVIVC, describing the principle of each method along with their advantages and disadvantages, including challenges with set-up and sampling.
Abstract: This review summarizes the methods used to study real-time (37°C) drug release from nanoparticulate drug delivery systems and establish an IVIVC. Since no compendial standards exist, drug release is currently assessed using a variety of methods including sample and separate (SS), continuous flow (CF), dialysis membrane (DM) methods, and a combination thereof, as well as novel techniques like voltametry and turbidimetry. This review describes the principle of each method along with their advantages and disadvantages, including challenges with set-up and sampling. The SS method allows direct measurement of drug release with simple set-up requirements, but sampling is cumbersome. With the CF method, sampling is straightforward but the set-up is time consuming. Set-up as well as sampling is easier with the DM, but it may not be suitable for drugs that bind to the membrane. Novel methods offer the possibility of real-time drug release measurement but may be restricted to certain types of drugs. Of these methods, Level A IVIVCs have been obtained with dialysis, alone or in combination with the sample and separate technique. Future efforts should focus on developing mathematical models that describe drug release mechanisms as well as facilitate formulation development of nano-sized dosage forms.
358 citations
TL;DR: A simple extension of the BCS classes to include sub-specification of acid, base and neutral for classes II and IV is proposed, believing this sub-classification is a step toward developing a more science-based mechanistic in vivo predictive dissolution (IPD) methodology.
308 citations
Uppsala University1, AstraZeneca2, Katholieke Universiteit Leuven3, Simulations Plus, Inc.4, Janssen Pharmaceutica5, University of Mainz6, Lundbeck7, Medical Products Agency8, Bayer HealthCare Pharmaceuticals9, National and Kapodistrian University of Athens10, University of Manchester11, University of Greifswald12, University of Strathclyde13
TL;DR: This review summarizes the current knowledge on anatomy and physiology of the human gastrointestinal tract in comparison with that of common laboratory animals with emphasis on in vivo methods for testing and prediction of oral dosage form performance.
289 citations
TL;DR: The FDA Guidance which deals with the development, evaluation methods and criteria, and applications of IVIVCs will be discussed and an interesting challenge is presented to look at appropriate methods for dissolution testing and for development of in vitro/in vivo correlations for products such as injectable depot formulations.
165 citations
Related Topics (5)
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| Year | Papers |
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| 2025 | 6 |
| 2024 | 11 |
| 2023 | 19 |
| 2022 | 49 |
| 2021 | 28 |
| 2020 | 28 |