In Vitro–In Vivo Correlation: Importance of Dissolution in IVIVC

Cardot, J; Beyssac, Eric; Alric, Monique

doi:10.14227/dt140107p15

Cited by 117 publications

(103 citation statements)

References 16 publications

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“…20,21) To describe a relationship between in vitro characteristics of a dosage form and the in vivo response, a predictive mathematical model is used to define the in vitro-in vivo correlation (IVIVC) level. [22][23][24] A level A IVIVC is the highest correlation level that can be achieved and represents a point-to-point relationship between in vitro dissolution and in vivo absorption. 22,25,26) This correlation is considered more informative than the other levels of correlation and is useful from a regulatory point of view.…”

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confidence: 99%

Development of a Dissolution Method for Gliclazide Modified-Release Tablets Using USP Apparatus 3 with in Vitro–in Vivo Correlation

et al. 2018

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Gliclazide (GLZ) is a second generation hypoglycemic drug used for the treatment of Type 2 diabetes mellitus. The low solubility of GLZ has been described as the rate limiting step for drug dissolution and absorption, thus a prediction of its in vivo behavior based on a discriminative dissolution test should lead to a relevant in vitro-in vivo correlation (IVIVC). The aim of this study was to develop a dissolution method for GLZ modified-release (MR) tablets using an United States Pharmacopeia (USP) apparatus 3 through its evaluation by an IVIVC analysis. Various dissolution parameters were evaluated to establish an in vitro method for GLZ tablets. The final dissolution conditions, referred to as method 3, utilized a 400 µm mesh and 30 dips per minute over a total period of 10 h that included 1h in HCl media (pH 1.2), 2h in acetate buffer solution (pH 4.5), 1 h in phosphate buffer solution (PBS; pH 5.8), 5h in PBS (pH 6.8) and finally 1h in PBS (pH 7.2). The calculated point-to-point IVIVC (R 2 0.9970) was significantly greater than other methods. The robustness of method 3 suggests it could be applied to pharmaceutical equivalence studies and for quality control analyses of GLZ.

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mentioning

confidence: 99%

Development of a Dissolution Method for Gliclazide Modified-Release Tablets Using USP Apparatus 3 with in Vitro–in Vivo Correlation

et al. 2018

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“…In vivo performance of a dosage formulation or new chemical entity can be simulated from the in vitro dissolution data after establishing a definitive IVIVC [19][20][21][22][23] . The biopharmaceutics classification system (BCS) proceeds with a predictive approach for developing correlation between physicochemical criteria of drug formulations and its in vivo bioavailability.…”

Section: Biowaiver-computational Pharmacokinetics and Ivivcmentioning

confidence: 99%

“…The biopharmaceutics classification system (BCS) proceeds with a predictive approach for developing correlation between physicochemical criteria of drug formulations and its in vivo bioavailability. BCS is not the direct IVIVC; IVIVC develops a mathematical relation between in vitro and in vivo data by either linear or non-linear correlation [19][20][21][22][23][24][25] . As per FDA guidelines IVIV correlation ranges from A-D with multiple level C correlation, the details of which have been presented in Table 2.…”

Section: Biowaiver-computational Pharmacokinetics and Ivivcmentioning

confidence: 99%

“…Development of pharmacokinetic simulation models which are computational or mathematical tools help to interpret drug kinetics in living environment under specified conditions and can waive off bioequivalence requirements called bio-waiver studies. Establishment of in vitro-in vivo correlation (IVIVC) provides a justified explanation for bio-waiver during scale up or post approval changes [16][17][18][19][20][21][22][23][24][25] . Thus the editorial encompasses the broad areas highlighting phyto-synergy, targeting of different signaling pathways of type 2 diabetes and how computational pharmacokinetics and development of IVIVC serves the purpose of bio-waiver.…”

Section: Introductionmentioning

confidence: 99%

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Computational pharmacokinetics and in vitro-in vivo correlation of anti-diabetic synergistic phyto-composite blend

De¹,

Bhandari²,

Chakravorty³

et al. 2015

WJD

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Despite tremendous strides in modern medicine stringent control over insulin resistance or restoration of normoglycemia has not yet been achieved. With the growth of molecular biology, omics technologies, docking studies, and in silico pharmacology, modulators of enzymes and receptors affecting the molecular pathogenesis of the disease are being considered as the latest targets for anti-diabetic therapy. Therapeutic molecular targets are now being developed basing on the up or down regulation of different signaling pathways affecting the disease. Phytosynergistic antidiabetic therapy is in vogue both with classical and non-classical medicinal systems. However its chemoprofiling, structural and pharmacokinetic validation awaits providing recognition to such formulations for international acceptance. Translational health research with its focus on benchside product development and its sequential transition to patient bedside puts the pharma RDs to a challenge to develop bio-waiver protocols. Pharmacokinetic simulation models and establishment of in vitro-in vivo correlation can help to replace in vivo bioavailability studies and provide means of quality control for scale up and post approval modification. This EDITORIAL

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“…It is also used as a tool for developing in-vitro dissolution specification [8]. In vitro-in vivo correlation is normally expected for highly permeable drugs or drugs under dissolution rate-limiting conditions.…”

Section: Estimationmentioning

confidence: 99%

Biopharmaceutical Classification System in Invitro/ In-vivo Correlation: Concept and Development Strategies in Drug Delivery

Nainar¹,

Rajiah²,

Angamuthu³

et al. 2012

Trop. J. Pharm Res

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In Vitro–In Vivo Correlation: Importance of Dissolution in IVIVC

Cited by 117 publications

References 16 publications

Development of a Dissolution Method for Gliclazide Modified-Release Tablets Using USP Apparatus 3 with <i>in Vitro–in Vivo</i> Correlation

Development of a Dissolution Method for Gliclazide Modified-Release Tablets Using USP Apparatus 3 with <i>in Vitro–in Vivo</i> Correlation

Computational pharmacokinetics and in vitro-in vivo correlation of anti-diabetic synergistic phyto-composite blend

Biopharmaceutical Classification System in <i>Invitro/ In-vivo</i> Correlation: Concept and Development Strategies in Drug Delivery

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