An integrated system for dissolution studies and magnetic resonance imaging of controlled release, polymer-based dosage forms—A tool for quantitative assessment of hydrogel formation processes

Controlled release (CR) dosage forms are often based on polymeric matrices, e.g., sustained-release tablets and capsules. It is crucial to visualise and quantify processes of the hydrogel formation during the standard dissolution study. A method for imaging of CR, polymer-based dosage forms during d...

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Veröffentlicht in:Journal of pharmaceutical and biomedical analysis 2008-11, Vol.48 (3), p.685-693
Hauptverfasser: Kulinowski, Piotr, Dorożyński, Przemysław, Jachowicz, Renata, Węglarz, Władysław P.
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container_end_page 693
container_issue 3
container_start_page 685
container_title Journal of pharmaceutical and biomedical analysis
container_volume 48
creator Kulinowski, Piotr
Dorożyński, Przemysław
Jachowicz, Renata
Węglarz, Władysław P.
description Controlled release (CR) dosage forms are often based on polymeric matrices, e.g., sustained-release tablets and capsules. It is crucial to visualise and quantify processes of the hydrogel formation during the standard dissolution study. A method for imaging of CR, polymer-based dosage forms during dissolution study in vitro is presented. Imaging was performed in a non-invasive way by means of the magnetic resonance imaging (MRI). This study was designed to simulate in vivo conditions regarding temperature, volume, state and composition of dissolution media. Two formulations of hydrodynamically balanced systems (HBS) were chosen as model CR dosage forms. HBS release active substance in stomach while floating on the surface of the gastric content. Time evolutions of the diffusion region, hydrogel formation region and “dry core” region were obtained during a dissolution study of L-dopa as a model drug in two simulated gastric fluids (i.e. in fed and fasted state). This method seems to be a very promising tool for examining properties of new formulations of CR, polymer-based dosage forms or for comparison of generic and originator dosage forms before carrying out bioequivalence studies.
doi_str_mv 10.1016/j.jpba.2008.06.025
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Psychology</subject><subject>General pharmacology</subject><subject>Hydrodynamically balanced systems</subject><subject>Hydrogel formation</subject><subject>Hydrogel, Polyethylene Glycol Dimethacrylate - chemistry</subject><subject>Hydrogen-Ion Concentration</subject><subject>Hypromellose Derivatives</subject><subject>Levodopa - administration &amp; dosage</subject><subject>Levodopa - pharmacokinetics</subject><subject>Magnetic resonance imaging</subject><subject>Magnetic Resonance Imaging - methods</subject><subject>Medical sciences</subject><subject>Methylcellulose - administration &amp; dosage</subject><subject>Methylcellulose - analogs &amp; derivatives</subject><subject>Methylcellulose - pharmacokinetics</subject><subject>Pharmacology. 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Psychology</topic><topic>General pharmacology</topic><topic>Hydrodynamically balanced systems</topic><topic>Hydrogel formation</topic><topic>Hydrogel, Polyethylene Glycol Dimethacrylate - chemistry</topic><topic>Hydrogen-Ion Concentration</topic><topic>Hypromellose Derivatives</topic><topic>Levodopa - administration &amp; dosage</topic><topic>Levodopa - pharmacokinetics</topic><topic>Magnetic resonance imaging</topic><topic>Magnetic Resonance Imaging - methods</topic><topic>Medical sciences</topic><topic>Methylcellulose - administration &amp; dosage</topic><topic>Methylcellulose - analogs &amp; derivatives</topic><topic>Methylcellulose - pharmacokinetics</topic><topic>Pharmacology. 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It is crucial to visualise and quantify processes of the hydrogel formation during the standard dissolution study. A method for imaging of CR, polymer-based dosage forms during dissolution study in vitro is presented. Imaging was performed in a non-invasive way by means of the magnetic resonance imaging (MRI). This study was designed to simulate in vivo conditions regarding temperature, volume, state and composition of dissolution media. Two formulations of hydrodynamically balanced systems (HBS) were chosen as model CR dosage forms. HBS release active substance in stomach while floating on the surface of the gastric content. Time evolutions of the diffusion region, hydrogel formation region and “dry core” region were obtained during a dissolution study of L-dopa as a model drug in two simulated gastric fluids (i.e. in fed and fasted state). 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subjects Analysis
Analytical, structural and metabolic biochemistry
Biological and medical sciences
Capsules
Chemistry, Pharmaceutical
Computer Simulation
Controlled release dosage forms
Delayed-Action Preparations - chemistry
Diffusion
Dosage Forms
Drug Combinations
Equipment Design
Fasting - metabolism
Fundamental and applied biological sciences. Psychology
General pharmacology
Hydrodynamically balanced systems
Hydrogel formation
Hydrogel, Polyethylene Glycol Dimethacrylate - chemistry
Hydrogen-Ion Concentration
Hypromellose Derivatives
Levodopa - administration & dosage
Levodopa - pharmacokinetics
Magnetic resonance imaging
Magnetic Resonance Imaging - methods
Medical sciences
Methylcellulose - administration & dosage
Methylcellulose - analogs & derivatives
Methylcellulose - pharmacokinetics
Pharmacology. Drug treatments
Physiological Phenomena
Polymers - chemistry
Solubility
Solvents - chemistry
Stomach - metabolism
Tablets
Technology, Pharmaceutical
Temperature
Time Factors
Water - chemistry
title An integrated system for dissolution studies and magnetic resonance imaging of controlled release, polymer-based dosage forms—A tool for quantitative assessment of hydrogel formation processes
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