Magnetic Resonance Imaging Analysis of Moving Fronts in Floating Dosage Forms

Kulinowski, Piotr; Dorożyński, Przemysław; Jachowicz, Renata; Jasiński, Andrzej

doi:10.12693/aphyspola.108.155

Cited by 6 publications

(6 citation statements)

References 5 publications

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“…Studies with a higher temporal resolution to observe the initial stage of matrix hydration were also performed by van der Weerd and Kazarian ( 6 ) and Kazarian and van der Weerd ( 7 ) using ATR-FTIR chemical imaging. Concerning structural details, results obtained by Chen et al are similar to the ones previously observed by our group ( 19 – 21 ), mainly due to the comparable echo times used. On the other hand, our approach has roots in two parameter analysis (T 2 and corresponding proton density) performed by Tritt-Goc et al ( 15 ).…”

Section: Introductionsupporting

confidence: 88%

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Magnetic Resonance Microscopy for Assessment of Morphological Changes in Hydrating Hydroxypropylmethyl Cellulose Matrix Tablets In Situ

et al. 2012

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PurposeTo resolve contradictions found in morphology of hydrating hydroxypropylmethyl cellulose (HPMC) matrix as studied using Magnetic Resonance Imaging (MRI) techniques. Until now, two approaches were used in the literature: either two or three regions that differ in physicochemical properties were identified.MethodsMultiparametric, spatially and temporally resolved T2 MR relaxometry in situ was applied to study the hydration progress in HPMC matrix tablets using a 11.7 T MRI system. Two spin-echo based pulse sequences—one of them designed to specifically study short T2 signals—were used.ResultsTwo components in the T2 decay envelope were estimated and spatial distributions of their parameters, i.e. amplitudes and T2 values, were obtained. Based on the data, five different regions and their temporal evolution were identified: dry glassy, hydrated solid like, two interface layers and gel layer. The regions were found to be separated by four evolving fronts identified as penetration, full hydration, total gelification and apparent erosion.ConclusionsThe MRI results showed morphological details of the hydrating HPMC matrices matching compound theoretical models. The proposed method will allow for adequate evaluation of controlled release polymeric matrix systems loaded with drug substances of different solubility.

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Section: Introductionsupporting

confidence: 88%

“…Kojima et al identified an interface layer between the gel and dry glassy core ( 18 ). In our previous work we have reported on the observation of three regions in the swelling HPMC matrices ( 19 ). Consequently, a dry core region, a hydrogel formation region and a hydrogel region were identified ( 20 ).…”

Section: Introductionmentioning

confidence: 99%

Magnetic Resonance Microscopy for Assessment of Morphological Changes in Hydrating Hydroxypropylmethyl Cellulose Matrix Tablets In Situ

et al. 2012

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“…In our previous research, a dissolution Apparatus 4 integrated with an MRI system was used for imaging of non-compressed HPMC matrix systems during the dissolution process. This arrangement allowed assessment of the parameters related to swelling, diffusion and erosion fronts ( 5 , 25 , 26 , 28 ). The concept of three moving fronts, introduced by Gao and Meury ( 10 ), for the first time was applied to the analysis of MRI data obtained inside the flow-through cell in 2005 ( 28 ).…”

Section: Introductionmentioning

confidence: 99%

“…This arrangement allowed assessment of the parameters related to swelling, diffusion and erosion fronts ( 5 , 25 , 26 , 28 ). The concept of three moving fronts, introduced by Gao and Meury ( 10 ), for the first time was applied to the analysis of MRI data obtained inside the flow-through cell in 2005 ( 28 ). The interface region between dry polymer and gel was identified and marked as “hydrogel formation region” ( 26 ), yet there was no justification for this assertion.…”

Section: Introductionmentioning

confidence: 99%

Magnetic Resonance Imaging and Image Analysis for Assessment of HPMC Matrix Tablets Structural Evolution in USP Apparatus 4

et al. 2010

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PurposeThe purpose of the study was to present a methodology for the processing of Magnetic Resonance Imaging (MRI) data for the quantification of the dosage form matrix evolution during drug dissolution. The results of the study were verified by comparison with other approaches presented in literature.MethodsA commercially available, HPMC-based quetiapine fumarate tablet was studied with a 4.7T MR system. Imaging was performed inside an MRI probe-head coupled with a flow-through cell for 12 h in circulating water. The images were segmented into three regions using threshold-based segmentation algorithms due to trimodal structure of the image intensity histograms.ResultsTemporal evolution of dry glassy, swollen glassy and gel regions was monitored. The characteristic features were observed: initial high expansion rate of the swollen glassy and gel layers due to initial water uptake, dry glassy core disappearance and maximum area of swollen glassy region at 4 h, and subsequent gel layer thickness increase at the expense of swollen glassy layer.ConclusionsThe temporal evolution of an HPMC-based tablet by means of noninvasive MRI integrated with USP Apparatus 4 was found to be consistent with both the theoretical model based on polymer disentanglement concentration and experimental VIS/FTIR studies.

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“…Therefore, there is a need to combine dissolution methods with other techniques to improve their specificity and to further elucidate the mechanisms of drug dissolution. In the recent decades, the application of combined methods that integrate drug dissolution and imaging techniques has increased noticeably (3)(4)(5)(6)(7)(8)(9)(10)(11)(12).…”

Section: Introductionmentioning

confidence: 99%

The Relationship Between the Evolution of an Internal Structure and Drug Dissolution from Controlled-Release Matrix Tablets

et al. 2015

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Abstract. In the last decade, imaging has been introduced as a supplementary method to the dissolution tests, but a direct relationship of dissolution and imaging data has been almost completely overlooked. The purpose of this study was to assess the feasibility of relating magnetic resonance imaging (MRI) and dissolution data to elucidate dissolution profile features (i.e., kinetics, kinetics changes, and variability). Commercial, hydroxypropylmethyl cellulose-based quetiapine fumarate controlled-release matrix tablets were studied using the following two methods: (i) MRI inside the USP4 apparatus with subsequent machine learning-based image segmentation and (ii) dissolution testing with piecewise dissolution modeling. Obtained data were analyzed together using statistical data processing methods, including multiple linear regression. As a result, in this case, zeroth order release was found to be a consequence of internal structure evolution (interplay between region's areas-e.g., linear relationship between interface and core), which eventually resulted in core disappearance. Dry core disappearance had an impact on (i) changes in dissolution kinetics (from zeroth order to nonlinear) and (ii) an increase in variability of drug dissolution results. It can be concluded that it is feasible to parameterize changes in micro/meso morphology of hydrated, controlled release, swellable matrices using MRI to establish a causal relationship between the changes in morphology and drug dissolution. Presented results open new perspectives in practical application of combined MRI/dissolution to controlled-release drug products.

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Magnetic Resonance Imaging Analysis of Moving Fronts in Floating Dosage Forms

Cited by 6 publications

References 5 publications

Magnetic Resonance Microscopy for Assessment of Morphological Changes in Hydrating Hydroxypropylmethyl Cellulose Matrix Tablets In Situ

Magnetic Resonance Microscopy for Assessment of Morphological Changes in Hydrating Hydroxypropylmethyl Cellulose Matrix Tablets In Situ

Magnetic Resonance Imaging and Image Analysis for Assessment of HPMC Matrix Tablets Structural Evolution in USP Apparatus 4

The Relationship Between the Evolution of an Internal Structure and Drug Dissolution from Controlled-Release Matrix Tablets

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