NDLI: Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro, Immediate Release, and Intravenous Data

Please wait, while we are loading the content...

Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

Therapeutic Paint of Cidofovir/Sucralfate Gel Combination Topically Administered by Spraying for Treatment of orf virus Infections

Effects of Drug Transporters on Volume of Distribution

Prediction of Hepatic Clearance in Human From In Vitro Data for Successful Drug Development

Role of Physiological Intestinal Water in Oral Absorption

A Review of Imaging Agent Development

Predicting Drug–Drug Interactions: An FDA Perspective

Measuring Endocannabinoid Hydrolysis: Refining our Tools and Understanding

Peptide Kappa Opioid Receptor Ligands: Potential for Drug Development

Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro, Immediate Release, and Intravenous Data

A Multi-Tiered Analytical Approach For the Analysis and Quantitation of High-Molecular-Weight Aggregates in a Recombinant Therapeutic Glycoprotein

Inhibitors of Endocannabinoid-Metabolizing Enzymes Reduce Precipitated Withdrawal Responses in THC-Dependent Mice

Simulations of the Nonlinear Dose Dependence for Substrates of Influx and Efflux Transporters in the Human Intestine

Structure-Based Prediction of the Nonspecific Binding of Drugs to Hepatic Microsomes

Handling Data Below the Limit of Quantification in Mixed Effect Models

An Investigation into the Importance of “Very Rapid Dissolution” Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology

“Fit-for-Purpose” Method Validation and Application of a Biomarker (C-terminal Telopeptides of Type 1 Collagen) in Denosumab Clinical Studies

The AAPS Journal : Volume 11, Issue 1, March 2009

The AAPS Journal : Volume 10

The AAPS Journal : Volume 9

The AAPS Journal : Volume 8

The AAPS Journal : Volume 7

The AAPS Journal : Volume 6

The AAPS Journal : Volume 5

The AAPS Journal : Volume 4

The AAPS Journal : Volume 3

The AAPS Journal : Volume 2

The AAPS Journal : Volume 1

Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro, Immediate Release, and Intravenous Data

Content Provider	Springer Nature Link
Author	Lukacova, Viera Woltosz, Walter S. Bolger, Michael B.
Copyright Year	2009
Abstract	The aim of this study was to demonstrate the value of mechanistic simulations in gaining insight into the behaviors of modified release (MR) formulations in vivo and to use the properly calibrated models for prediction of pharmacokinetics (PK) and pharmacodynamics (PD). GastroPlus$^{TM}$ (Simulations Plus, Inc.) was used to fit mechanistic models for adinazolam and metoprolol that describe the absorption, PK, and PD after intravenous (i.v.) and immediate release (IR) oral (p.o.) administration. The fitted model for adinazolam was then used to predict the PD profile for a MR formulation and to design a new formulation with desired onset and duration of action. The fitted metoprolol model was used to gain insight and to explain the in vivo behaviors of MR formulations. For each drug, a single absorption/PK model was fitted that provided simulated plasma concentration–time profiles closely matching observed in vivo profiles across several different i.v. and p.o doses. Sedation score profiles of adinazolam were fitted with an indirect PD model. For metoprolol, the fitted absorption/PK model for IR p.o. doses was used to select in vitro dissolution conditions that best matched the in vivo release of MR doses. This model also explained differences in exposure after administration of MR formulations with different release rates. Mechanistic absorption/PK models allow for detailed descriptions of all processes affecting the two drugs’ bioavailability, including release/dissolution, absorption, and intestinal and hepatic first pass extraction. The insights gained can be used to design formulations that more effectively overcome identified problems.
Starting Page	323
Ending Page	334
Page Count	12
File Format	PDF
ISSN	12341234
Journal	The AAPS Journal
Volume Number	11
Issue Number	2
e-ISSN	15507416
Language	English
Publisher	Springer US
Publisher Date	2009-05-09
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	gastrointestinal absorption mechanistic simulation modified release pharmacodynamics pharmacokinetics Pharmacy Biotechnology Biochemistry Pharmacology/Toxicology
Content Type	Text
Resource Type	Article

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

In Vitro–In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation

Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro , Immediate Release, and Intravenous Data

Pharmacokinetics and pharmacodynamics of gliclazide from immediate and modified release formulation tablets in rats.

Developing In Vitro–In Vivo Correlation of Risperidone Immediate Release Tablet

Elucidation of Arctigenin Pharmacokinetics After Intravenous and Oral Administrations in Rats: Integration of In Vitro and In Vivo Findings via Semi-mechanistic Pharmacokinetic Modeling

Characterising Drug Release from Immediate-Release Formulations of a Poorly Soluble Compound, Basmisanil, Through Absorption Modelling and Dissolution Testing

Study of In Vitro Drug Release and Percutaneous Absorption of Fluconazole from Topical Dosage Forms

Concepts and Challenges in Quantitative Pharmacology and Model-Based Drug Development

Modelling and PBPK Simulation in Drug Discovery

Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro, Immediate Release, and Intravenous Data

Similar Documents

In Vitro–In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation

Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro , Immediate Release, and Intravenous Data

Pharmacokinetics and pharmacodynamics of gliclazide from immediate and modified release formulation tablets in rats.

Developing In Vitro–In Vivo Correlation of Risperidone Immediate Release Tablet

Elucidation of Arctigenin Pharmacokinetics After Intravenous and Oral Administrations in Rats: Integration of In Vitro and In Vivo Findings via Semi-mechanistic Pharmacokinetic Modeling

Characterising Drug Release from Immediate-Release Formulations of a Poorly Soluble Compound, Basmisanil, Through Absorption Modelling and Dissolution Testing

Study of In Vitro Drug Release and Percutaneous Absorption of Fluconazole from Topical Dosage Forms

Concepts and Challenges in Quantitative Pharmacology and Model-Based Drug Development

Modelling and PBPK Simulation in Drug Discovery

Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro, Immediate Release, and Intravenous Data