A Novel Beads-Based Dissolution Method for the In Vitro Evaluation of Extended Release HPMC Matrix Tablets and the Correlation with ... View Full Text


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Article Info

DATE

2013-01

AUTHORS

Uroš Klančar, Boštjan Markun, Saša Baumgartner, Igor Legen

ABSTRACT

The aim of this work was to establish alternative in vitro dissolution method with good discrimination and in vivo predictability for the evaluation of HPMC extended release matrix tablets. For this purpose, two different HPMC matrix tablet formulations were first evaluated by a range of conventional dissolution testing methods using apparatus 1, apparatus 2, and apparatus 3 according to US Pharmacopoeia. Obtained results showed low discrimination between the tested samples. Afterward, a novel dissolution testing method which combines plastic beads and apparatus 3 was developed with the aim to better mimic the mechanical forces that occur in vivo. Results showed that sufficiently large mechanical stress with high dips per minute program setting (apparatus 3) was needed to obtain in vitro discriminative results, which are in accordance with the in vivo data. The in vivo relevance of the method was confirmed with the establishment of the level A in vitro-in vivo correlation. More... »

PAGES

267-277

References to SciGraph publications

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  • 2009-09. Bio-Dis and the Paddle Dissolution Apparatuses Applied to the Release Characterization of Ketoprofen from Hypromellose Matrices in AAPS PHARMSCITECH
  • 2001-06. In Vivo–In Vitro Correlation (IVIVC) Modeling Incorporating a Convolution Step in JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
  • 2005-08. A Novel in Vitro and Numerical Analysis of Shear-Induced Drug Release from Extended-Release Tablets in the Fed Stomach in PHARMACEUTICAL RESEARCH
  • 2011-10. A time scaling approach to develop an in vitro–in vivo correlation (IVIVC) model using a convolution-based technique in JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
  • 2011-07. Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products in PHARMACEUTICAL RESEARCH
  • 2000-10. Hydrophilic Matrices for Controlled Drug Delivery: An Improved Mathematical Model to Predict the Resulting Drug Release Kinetics (the “sequential Layer” Model) in PHARMACEUTICAL RESEARCH
  • 2008-07. Dissolution Media Simulating Conditions in the Proximal Human Gastrointestinal Tract: An Update in PHARMACEUTICAL RESEARCH
  • 1985-05. In vitro — In vivo correlation of dissolution, a time scaling problem? Transformation of in vitro results to the in vivo situation, using theophylline as a practical example in EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
  • 1997. Convolution-Based Approaches for in Vivo-in Vitro Correlation Modeling in IN VITRO-IN VIVO CORRELATIONS
  • 2012-09. Correlating Cellulose Derivative Intrinsic Viscosity with Mechanical Susceptibility of Swollen Hydrophilic Matrix Tablets in AAPS PHARMSCITECH
  • 2011-09. Dissolution Testing for Generic Drugs: An FDA Perspective in THE AAPS JOURNAL
  • 2010-09. Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit in THE AAPS JOURNAL
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1208/s12248-012-9422-x

    DOI

    http://dx.doi.org/10.1208/s12248-012-9422-x

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1007903512

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/23188526


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    Download the RDF metadata as:  json-ld nt turtle xml License info

    HOW TO GET THIS DATA PROGRAMMATICALLY:

    JSON-LD is a popular format for linked data which is fully compatible with JSON.

    curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1208/s12248-012-9422-x'

    N-Triples is a line-based linked data format ideal for batch operations.

    curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1208/s12248-012-9422-x'

    Turtle is a human-readable linked data format.

    curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1208/s12248-012-9422-x'

    RDF/XML is a standard XML format for linked data.

    curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1208/s12248-012-9422-x'


     

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