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In vitro quantitative ((1))H and ((19))F nuclear magnetic resonance spectroscopy and imaging studies of fluvastatin™ in Lescol® XL tablets in a USP-IV dissolution cell.
J Control Release. 2011 Dec 20; 156(3):345-54.JC

Abstract

Swellable polymeric matrices are key systems in the controlled drug release area. Currently, the vast majority of research is still focused on polymer swelling dynamics. This study represents the first quantitative multi-nuclear (((1))H and ((19))F) fast magnetic resonance imaging study of the complete dissolution process of a commercial (Lescol® XL) tablet, whose formulation is based on the hydroxypropyl methylcellulose (HPMC) polymer under in vitro conditions in a standard USP-IV (United States Pharmacopeia apparatus IV) flow-through cell that is incorporated into high field superconducting magnetic resonance spectrometer. Quantitative RARE ((1))H magnetic resonance imaging (MRI) and ((19))F nuclear magnetic resonance (NMR) spectroscopy and imaging methods have been used to give information on: (i) dissolution media uptake and hydrodynamics; (ii) active pharmaceutical ingredient (API) mobilisation and dissolution; (iii) matrix swelling and dissolution and (iv) media activity within the swelling matrix. In order to better reflect the in vivo conditions, the bio-relevant media Simulated Gastric Fluid (SGF) and Fasted State Simulated Intestinal Fluid (FaSSIF) were used. A newly developed quantitative ultra-fast MRI technique was applied and the results clearly show the transport dynamics of media penetration and hydrodynamics along with the polymer swelling processes. The drug dissolution and mobility inside the gel matrix was characterised, in parallel to the ((1))H measurements, by ((19))F NMR spectroscopy and MRI, and the drug release profile in the bulk solution was recorded offline by UV spectrometer. We found that NMR spectroscopy and 1D-MRI can be uniquely used to monitor the drug dissolution/mobilisation process within the gel layer, and the results from ((19))F NMR spectra indicate that in the gel layer, the physical mobility of the drug changes from "dissolved immobilised drug" to "dissolved mobilised drug".

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Authors+Show Affiliations

Zhang Q
Department of Chemical Engineering & Biotechnology, University of Cambridge, Cambridge CB2 3RA, UK.
Gladden L
No affiliation info available
Avalle P
No affiliation info available
Mantle M
No affiliation info available

MeSH

Anticholesteremic AgentsChemistry, PharmaceuticalDelayed-Action PreparationsEquipment DesignFatty Acids, MonounsaturatedFluvastatinHydrodynamicsIndolesMagnetic Resonance ImagingMagnetic Resonance SpectroscopySolubilityTablets

Pub Type(s)

Journal Article

Language

eng

PubMed ID

21911016

Citation

Zhang, Qilei, et al. "In Vitro Quantitative ((1))H and ((19))F Nuclear Magnetic Resonance Spectroscopy and Imaging Studies of Fluvastatin™ in Lescol® XL Tablets in a USP-IV Dissolution Cell." Journal of Controlled Release : Official Journal of the Controlled Release Society, vol. 156, no. 3, 2011, pp. 345-54.
Zhang Q, Gladden L, Avalle P, et al. In vitro quantitative ((1))H and ((19))F nuclear magnetic resonance spectroscopy and imaging studies of fluvastatin™ in Lescol® XL tablets in a USP-IV dissolution cell. J Control Release. 2011;156(3):345-54.
Zhang, Q., Gladden, L., Avalle, P., & Mantle, M. (2011). In vitro quantitative ((1))H and ((19))F nuclear magnetic resonance spectroscopy and imaging studies of fluvastatin™ in Lescol® XL tablets in a USP-IV dissolution cell. Journal of Controlled Release : Official Journal of the Controlled Release Society, 156(3), 345-54. https://doi.org/10.1016/j.jconrel.2011.08.039
Zhang Q, et al. In Vitro Quantitative ((1))H and ((19))F Nuclear Magnetic Resonance Spectroscopy and Imaging Studies of Fluvastatin™ in Lescol® XL Tablets in a USP-IV Dissolution Cell. J Control Release. 2011 Dec 20;156(3):345-54. PubMed PMID: 21911016.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In vitro quantitative ((1))H and ((19))F nuclear magnetic resonance spectroscopy and imaging studies of fluvastatin™ in Lescol® XL tablets in a USP-IV dissolution cell. AU - Zhang,Qilei, AU - Gladden,Lynn, AU - Avalle,Paolo, AU - Mantle,Michael, Y1 - 2011/09/03/ PY - 2011/07/01/received PY - 2011/08/25/revised PY - 2011/08/26/accepted PY - 2011/9/14/entrez PY - 2011/9/14/pubmed PY - 2012/3/28/medline SP - 345 EP - 54 JF - Journal of controlled release : official journal of the Controlled Release Society JO - J Control Release VL - 156 IS - 3 N2 - Swellable polymeric matrices are key systems in the controlled drug release area. Currently, the vast majority of research is still focused on polymer swelling dynamics. This study represents the first quantitative multi-nuclear (((1))H and ((19))F) fast magnetic resonance imaging study of the complete dissolution process of a commercial (Lescol® XL) tablet, whose formulation is based on the hydroxypropyl methylcellulose (HPMC) polymer under in vitro conditions in a standard USP-IV (United States Pharmacopeia apparatus IV) flow-through cell that is incorporated into high field superconducting magnetic resonance spectrometer. Quantitative RARE ((1))H magnetic resonance imaging (MRI) and ((19))F nuclear magnetic resonance (NMR) spectroscopy and imaging methods have been used to give information on: (i) dissolution media uptake and hydrodynamics; (ii) active pharmaceutical ingredient (API) mobilisation and dissolution; (iii) matrix swelling and dissolution and (iv) media activity within the swelling matrix. In order to better reflect the in vivo conditions, the bio-relevant media Simulated Gastric Fluid (SGF) and Fasted State Simulated Intestinal Fluid (FaSSIF) were used. A newly developed quantitative ultra-fast MRI technique was applied and the results clearly show the transport dynamics of media penetration and hydrodynamics along with the polymer swelling processes. The drug dissolution and mobility inside the gel matrix was characterised, in parallel to the ((1))H measurements, by ((19))F NMR spectroscopy and MRI, and the drug release profile in the bulk solution was recorded offline by UV spectrometer. We found that NMR spectroscopy and 1D-MRI can be uniquely used to monitor the drug dissolution/mobilisation process within the gel layer, and the results from ((19))F NMR spectra indicate that in the gel layer, the physical mobility of the drug changes from "dissolved immobilised drug" to "dissolved mobilised drug". SN - 1873-4995 UR - https://www.unboundmedicine.com/medline/citation/21911016/In_vitro_quantitative___1__H_and___19__F_nuclear_magnetic_resonance_spectroscopy_and_imaging_studies_of_fluvastatin™_in_Lescol®_XL_tablets_in_a_USP_IV_dissolution_cell_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-3659(11)00653-5 DB - PRIME DP - Unbound Medicine ER -