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

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Abstract

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.

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Abbreviations

API:

Active pharmaceutical ingredient

ASD:

Artificial stomach–duodenum

AUC:

Area under the curve

BA/BE:

Bioavailability/bioequivalence

BCS:

Biopharmaceutical classification system

Caco:

Colorectal adenocarcinoma

DDC:

Drug dissolution chip

DGM:

Dynamic gastric model

D/P:

Dissolution/permeation

FDA:

Food and Drug Administration

GIS:

Gastrointestinal tract simulator

GIT:

Gastrointestinal tract

iPD:

In vivo predictive dissolution

IVIVC:

In vitro–in vivo correlation

M-D/P:

Microdialysis–dissolution/permeation

QbD:

Quality by design

QCM:

Quartz crystal microbalance

R&D:

Research and development

SSDDs:

Supersaturated drug delivery systems

TIM:

TNO intestinal model

TIMagc:

TIM advanced gastric compartment

USP:

United States Pharmacopeia

UV:

Ultraviolet

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Acknowledgments

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

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

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  1. Department of Pharmaceutics, Drug Discovery Lab, National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, Gandhinagar, Gujarat, 382355, India

    Meera Shrivas, Dignesh Khunt, Meenakshee Shrivas, Manisha Choudhari, Rajeshwari Rathod & Manju Misra

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  1. Meera Shrivas
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Shrivas, M., Khunt, D., Shrivas, M. et al. Advances in In Vivo Predictive Dissolution Testing of Solid Oral Formulations: How Closer to In Vivo Performance?. J Pharm Innov 15, 296–317 (2020). https://doi.org/10.1007/s12247-019-09392-6

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