In Vitro- In Vivo Correlation’s Dissolution Limits Setting

Roudier, Bertrand; Bm, Davit; Beyssac, Eric; Cardot, J

doi:10.1007/s11095-014-1349-8

Cited by 12 publications

(5 citation statements)

References 19 publications

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“…A credible IVIVC plays crucial role in development of pharmaceuticals; though building predictive mathematical models, (linear or non-linear), correlating an in-vitro property; rate or extent of drug release, of a dosage form to its in-vivo response; plasma drug concentration or amount absorbed, on assuming zero dissolution at time zero and complete dissolution at time t (Roudier et al, 2014).…”

Section: Resultsmentioning

confidence: 99%

Brain targeting stealth lipomers of combined antiepileptic-anti-inflammatory drugs as alternative therapy for conventional anti-Parkinson’s

Higazy

2020

Saudi Pharmaceutical Journal

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Section: Resultsmentioning

confidence: 99%

Brain targeting stealth lipomers of combined antiepileptic-anti-inflammatory drugs as alternative therapy for conventional anti-Parkinson’s

Higazy

2020

Saudi Pharmaceutical Journal

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“…Once IVIVC is established, it can guide the manufacturing process in many stages of drug product development. In addition, IVIVC can help set relevant in vitro dissolution specifications to ensure product quality [13,14] . Most significantly, when a level A IVIVC are established, the in vitro release method may be used as an alternative to measuring in vivo bioavailability.…”

Section: Research Papermentioning

confidence: 99%

Long-acting Oral Formulation of Doxycycline: In vitro-in vivo Correlation Studies

Arciniegas¹,

Bernad²,

Carlin³

et al. 2019

pharmaceutical-sciences

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The aim of this study was to establish and validate an in vitro-in vivo correlation that could predict the bioavailability of 4 oral long-acting formulations of doxycycline hyclate, acrylic acid and polymethacrylate matrices prepared using various proportions of doxycycline:acrylic acid:polymethacrylate for formulation 1 (1:0.25:0.0035), formulation 2 (1:0.5:0.0075), formulation 3 (1:1:0.015) and formulation 4 (1:2:0.0225) and a sample of doxycycline without excipients. In vitro dissolution profiles were obtained in phosphate buffer and hydrochloric acid media, which were fitted to several mathematical models. Plasma concentrations were obtained from 48 healthy dogs to achieve in vivo profiles. Therapeutic concentrations were observed for 60 h for formulation 1 and 4, 48 h for formulation 2 and 3 and 24 h for the sample of doxycycline. None of the pharmacokinetic parameter differed significantly between formulation 1 and 2 or between formulation 3 and 4; however, doxycycline differed significantly in comparison. The in vivo-in vitro correlation coefficient obtained from point-to-point analysis >0.999 for formulation 3 and 4 and >0.9581 for the others. To validate the model, the absorbed fractions for all formulations were estimated to predict plasma concentration profiles. In conclusion, adequate in vitro-in vivo correlation was established for longacting formulations of doxycycline indicating that in vitro dissolution tests could be used as a surrogate for bioavailability studies.

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“…A meaningful IVIVC can be used to guide formulation and/or process development changes in the various stages of drug product development. In addition, an IVIVC can be used to support and/or validate the use of an in vitro dissolution method and can help set clinically relevant dissolution specifications to ensure product quality [5]. Most importantly, when a Level A IVIVC is established and validated, the in vitro release method can be used as a surrogate for bioequivalence studies when pre-approval and post-approval changes are required (e.g.…”

Section: Introductionmentioning

confidence: 99%

In vitro–in vivo correlation for complex non-oral drug products: Where do we stand?

Shen

Burgess

2015

Journal of Controlled Release

132

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In vitro–in vivo correlation (IVIVC) is a predictive mathematical model describing the relationship between an in vitro property and a relevant in vivo response of drug products. Since the U.S. Food and Drug Administration (FDA) published a regulatory guidance on the development, evaluation, and applications of IVIVC for extended release (ER) oral dosage forms in 1997, IVIVC has been one of the most important issues in the field of pharmaceutics. However, even with the aid of the FDA IVIVC Guidance, only very limited Abbreviated New Drug Application (ANDA) submission for ER oral drug products included adequate IVIVC data to enable the completion of bioequivalence (BE) review within first review cycle. Establishing an IVIVC for non-oral dosage forms has remained extremely challenging due to their complex nature and the lack of in vitro release methods that are capable of mimicking in vivo drug release conditions. This review presents a general overview of recent advances in the development of IVIVC for complex non-oral dosage forms (such as parenteral polymeric microspheres/implants, and transdermal formulations), and briefly summarizes the knowledge gained over the past two decades. Lastly this review discusses possible directions for future development of IVIVC for complex non-oral dosage forms.

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In Vitro- In Vivo Correlation’s Dissolution Limits Setting

Cited by 12 publications

References 19 publications

Brain targeting stealth lipomers of combined antiepileptic-anti-inflammatory drugs as alternative therapy for conventional anti-Parkinson’s

Brain targeting stealth lipomers of combined antiepileptic-anti-inflammatory drugs as alternative therapy for conventional anti-Parkinson’s

Long-acting Oral Formulation of Doxycycline: In vitro-in vivo Correlation Studies

In vitro–in vivo correlation for complex non-oral drug products: Where do we stand?

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