Advances in In Vivo Predictive Dissolution Testing of Solid Oral Formulations: How Closer to In Vivo Performance?

  • Meera Shrivas
  • Dignesh Khunt
  • Meenakshee Shrivas
  • Manisha Choudhari
  • Rajeshwari Rathod
  • Manju MisraEmail author
Review Article


Dissolution has become an indispensable tool to predict the in vivo performance of dosage form, especially in recent times, because of the increasing complexity of new drugs discovered. Several attempts have been made to modify dissolution, so that it mimics the in vivo behavior to maximum possible accuracy and minimizes the probability of in vivo bioequivalence failures. In this context, several advancements have been reported including drug dissolution/absorption simulating system, bionic system, dissolution/permeation model, biphasic dissolution system, Caco-2 cell monolayer in combination with compendial dissolution apparatus, artificial stomach duodenum model, dynamic gastric model, Netherlands Organization for Applied Scientific Research gastrointestinal model, and many more. The present review highlights the recent advancements in dissolution methods with a focus on in vivo predictive dissolution methods, their advantages and disadvantages, and key factors governing the results obtained. The impact of maintaining sink conditions and use of biorelevant media is also discussed briefly.


Dissolution/permeation model In vivo predictive dissolution Biorelevant Microdialysis 



Active pharmaceutical ingredient


Artificial stomach–duodenum


Area under the curve




Biopharmaceutical classification system


Colorectal adenocarcinoma


Drug dissolution chip


Dynamic gastric model




Food and Drug Administration


Gastrointestinal tract simulator


Gastrointestinal tract


In vivo predictive dissolution


In vitro–in vivo correlation




Quality by design


Quartz crystal microbalance


Research and development


Supersaturated drug delivery systems


TNO intestinal model


TIM advanced gastric compartment


United States Pharmacopeia





The authors want to thank the Ministry of Chemicals and Fertilizers for providing the funding and the Department of Science and Technology for providing the funding to authors in the form of INSPIRE faculty award (Grant number LSBM-13; SERB EMR/2016/007966).

Funding Information

This work was supported by the National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad.

Supplementary material

12247_2019_9392_MOESM1_ESM.pdf (2.3 mb)
ESM 1 (PDF 2377 kb)


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© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Pharmaceutics, Drug Discovery LabNational Institute of Pharmaceutical Education and Research (NIPER)GandhinagarIndia

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