Scientific Research and Essays

  • Abbreviation: Sci. Res. Essays
  • Language: English
  • ISSN: 1992-2248
  • DOI: 10.5897/SRE
  • Start Year: 2006
  • Published Articles: 2729

Full Length Research Paper

Development and execution of a novel strategic statistical tool to determine in-vitro in-vivo correlation for sustained release capsules of metoprolol tartrate in humans

Sabahuddin Siddique
  • Sabahuddin Siddique
  • Patel College of Pharmacy, Madhyanchal Professional University, Bhopal, M. P., India.
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Mohi Iqbal Mohammed Abdul
  • Mohi Iqbal Mohammed Abdul
  • College of Pharmacy, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia.
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Syed Ata Ur Rahman
  • Syed Ata Ur Rahman
  • College of Pharmacy, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia.
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Durdana Lateef
  • Durdana Lateef
  • College of Science, Taibah University, Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia.
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Anirbandeep Bose
  • Anirbandeep Bose
  • TAAB Biostudy Services, Jadavpur, Kolkata, India
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Shubhasis Dan
  • Shubhasis Dan
  • TAAB Biostudy Services, Jadavpur, Kolkata, India
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Faraz Siddiqui
  • Faraz Siddiqui
  • Sun Pharmaceutical Industries Limited, Halol, Gujrat, India.
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  •  Received: 06 November 2018
  •  Accepted: 30 November 2018
  •  Published: 15 January 2019

Abstract

The aim of this present study was to develop and formulate sustained release coated metoprolol tartrate matrix granules and to design an in-vitro in-vivo correlation (IVIVC) tool based on bioavailability data available from human volunteers. USP apparatus II, paddle type was used for generation of in-vitro drug release data for each formulation. The similarity factor (f2) was determined using dissolution data parameters of the formulations. Twenty-four healthy male volunteers participated in the two-way crossover bioequivalent study where the volunteers were treated in a completely randomized fashion. The percent drug dissolved in the dissolution test and percent absorbed data shows a ‘level A’ IVIVC was achieved with a good linear regression relation. Different release rate formulation including Fast, Moderate and Slow release formulations exhibited an excellent covenant between the three dosage forms.

Key words: Sustained-release capsules, metoprolol tartrate, bioavailability, in-vitro in-vivo correlation (IVIVC), humans.