A survey on IVIVC/IVIVR development in the pharmaceutical industry – Past experience and current perspectives

Nguyễn, Mai Ánh; Flanagan, Talia; Brewster, Marcus E.; Kesisoglou, Filippos; Beato, Stefania; Biewenga, Jeike; Crison, John R.; Holm, René; Li, R.; Mannaert, Erik; McAllister, Mark; Mueller-Zsigmondy, Martin; Muenster, Uwe; Ojala, K.; Page, Susanne; Parr, Alan; Rossenu, Stefaan; Timmins, Peter; Peer, Achiel Van; Vermeulen, An; Langguth, Peter

doi:10.1016/j.ejps.2017.02.029

Cited by 51 publications

(23 citation statements)

References 22 publications

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“…Developing PBPK models in lieu of preclinical and clinical trials supports in detaching the parameters associated with animal or human being from both drug and study design (Jamei, ). Simulation programs adopting advanced compartmental absorption and transit/PBPK modeling could be a powerful tool for companies for simulation of IVIVC which could address ethical issues, decrease financial cost of clinical trials and new drug development (Cook, ; Nguyen et al, ).…”

Section: Physiologically Based Pharmacokinetic (Pbpk) Models In Ivivcmentioning

confidence: 99%

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An updated overview with simple and practical approach for developing in vitro–in vivo correlation

Jacob

Nair

2018

Drug Development Research

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Preclinical Research & Development An in vitro-in vivo correlation (IVIVC) is as a predictive mathematical model that demonstrates a key role in the development, advancement, evaluation and optimization of extended release, modified release and immediate release pharmaceutical formulations. A validated IVIVC model can serve as a surrogate for bioequivalence studies and subsequently save time, effort and expenditure during pharmaceutical product development. This review discusses about different levels of correlations, general approaches to develop an IVIVC by mathematical modelling, validation, data analysis and various applications. In the current setting, the dearth of success associated with IVIVC is due to complexity of underlying scientific principles as well as the practice of fitting/matching in vivo plasma level-time data with in vitro dissolution profile. Hence, a simple, straightforward practical means to predict plasma drug levels by convolution technique and percentage drug absorbed computed from in vitro dissolution profile based on deconvolution method are illustrated. The bioavailability/bioequivalence assessment and evaluation are frequently validated by the pharmacokinetic parameters such as maximum concentration, time to reach maximum concentration, and area under the curve. The implementation of a quality by design manufacturing based on in vivo bioavailability and clinically relevant dissolution specification are recommended because corresponding design safe space will guarantee that all batches from relevant products are met with sufficient quality and bioperformance. Recently, United States Food and Drug Administration and European Medicines Agency have proposed that in silico/physiologically based pharmacokinetic modelling can be used in decision making during preclinical experiments as well as to recognize the dissolution profiles that can forecast and ensure the desired clinical performance.

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Section: Physiologically Based Pharmacokinetic (Pbpk) Models In Ivivcmentioning

confidence: 99%

“…Simulation programs adopting advanced compartmental absorption and transit/PBPK modeling could be a powerful tool for companies for simulation of IVIVC which could address ethical issues, decrease financial cost of clinical trials and new drug development (Cook, 2012;Nguyen et al, 2017).…”

Section: Challengesmentioning

confidence: 99%

An updated overview with simple and practical approach for developing in vitro–in vivo correlation

Jacob

Nair

2018

Drug Development Research

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“…In vitro dissolution methods can only monitor the effect of formulation on in vivo drug dissolution. Thus, while there are a range of potential methods that can be used to establish an in vitro-in vivo relationship (IVIVR) (43), a more precise prediction of in vivo dissolution may best be achieved using in silico physiologically based pharmacokinetic (PBPK) models (44).…”

Section: Enhancing the Likelihood Of In Vitro-in Vivo Relationships (mentioning

confidence: 99%

Primer on the Science of In Vitro Dissolution Testing of Oral Dosage Forms and Factors Influencing its Biological Relevance

Fahmy¹,

Martinez²

2019

Dissolution Technol.

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In vitro dissolution testing can serve as an effective and efficient tool for evaluating the influence of formulation and manufacturing variables on drug release characteristics. The targeted purpose will determine the method used and the implications of the test results. Regardless of its intended purpose, it is necessary to understand the factors influencing in vitro dissolution outcomes to avoid the introduction of error into the data interpretation. This will influence the selection of the in vitro test procedure, ensuring that the method can identify changes in the critical formulation and manufacturing variables. There is also a need to understand the rate limiting factors influencing in vivo product bioavailability both from a dissolution and an absorption perspective. Finally, to achieve in vivo biorelevance, it is necessary to understand how the selected in vitro dissolution test method reflects the variables impacting in vivo product dissolution behavior. This primer summarizes and integrates these diverse variables, fostering an appreciation of the strengths and potential pitfalls that may be encountered during the generation and analysis of in vitro dissolution profiles associated with oral dosage forms. This understanding is needed for developing a well-designed dissolution test procedure that is appropriately fit for purpose.

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“…Two independent surveys have listed inherent compound properties and lack of a one-size-fits-all predictive dissolution method among the top difficulties in establishing in vitro to in vivo correlations. 1,2 Generally, predictive in vitro dissolution testing is a fit-for-purpose approach, assembled by combining multicompartment apparatuses, compendial or biorelevant media, as well as attempting to mimic the fluid behavior at the sites of release and absorption through adjustments to volume and agitation rate. In fact, a reasonable prediction of drug concentration profile at the absorbing site is a condition sine qua non to develop successful IVIVCs.…”

Section: Introductionmentioning

confidence: 99%

Integrating Drug- and Formulation-Related Properties With Gastrointestinal Tract Variability Using a Product-Specific Particle Size Approach: Case Example Ibuprofen

Cristofoletti

Hens

Patel

et al. 2019

Journal of Pharmaceutical Sciences

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Keywords:absorption dissolution physiologically based pharmacokinetic (PBPK) modeling in vitro-in vivo (IVIVC) correlation(s) mechanistic modeling particle size a b s t r a c tIn the present study, an in vitroein vivo extrapolation of dissolution integrated to a physiologically based pharmacokinetics modeling approach, considering a product-specific particle size distribution and a selfbuffering effect of the drug, is introduced and appears to be a promising translational modeling strategy to support drug product development, manufacturing changes and setting clinically relevant specifications for immediate release formulations containing ibuprofen and other weak acids with similar properties.

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A survey on IVIVC/IVIVR development in the pharmaceutical industry – Past experience and current perspectives

Cited by 51 publications

References 22 publications

An updated overview with simple and practical approach for developing in vitro–in vivo correlation

An updated overview with simple and practical approach for developing in vitro–in vivo correlation

Primer on the Science of In Vitro Dissolution Testing of Oral Dosage Forms and Factors Influencing its Biological Relevance

Integrating Drug- and Formulation-Related Properties With Gastrointestinal Tract Variability Using a Product-Specific Particle Size Approach: Case Example Ibuprofen

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