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Rate-programmed drug delivery systems release drugs in a controlled manner to maintain therapeutic levels. Three main designs include reservoir, matrix, and hybrid systems.Reservoir systems consist of a drug core enclosed within a membrane that controls drug release. In non-swelling reservoir systems, polymers like ethyl cellulose or polymethacrylates are used. These do not hydrate in aqueous media and control release through membrane thickness, porosity, or insolubility. This type includes...
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Development of carvedilol-cyclodextrin inclusion complexes using fluid-bed granulation: a novel solid-state

Ellen C P Alonso1, Karina Riccomini2, Luis Antônio D Silva1

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|July 29, 2016
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Summary

Fluid-bed granulation (FB) effectively creates carvedilol (CARV) inclusion complexes with modified cyclodextrins, significantly enhancing CARV dissolution and offering a viable large-scale production method.

Keywords:
carvedilolhydroxypropyl-β-cyclodextrinhydroxypropyl-γ-cyclodextrinsolid-state inclusion complex

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Carvedilol (CARV) is a beta-blocker with poor aqueous solubility, limiting its oral bioavailability.
  • Modified cyclodextrins, such as hydroxypropyl-β-cyclodextrin (HPβCD) and hydroxypropyl-γ-cyclodextrin (HPγCD), are known to improve the solubility and dissolution of poorly soluble drugs.
  • Inclusion complexation is a promising strategy to enhance the physicochemical properties of CARV.

Purpose of the Study:

  • To evaluate the formation and characteristics of carvedilol (CARV) inclusion complexes with HPβCD and HPγCD.
  • To compare the efficacy of fluid-bed granulation (FB) and spray drying (SD) in preparing these inclusion complexes.
  • To assess the impact of complexation on CARV dissolution, flowability, and particle size.

Main Methods:

  • Solid inclusion complexes of CARV with HPβCD and HPγCD were prepared using FB and SD.
  • Characterization involved differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), powder X-ray diffraction, scanning electron microscopy (SEM), flowability, particle size analysis, and in vitro dissolution studies.

Main Results:

  • DSC, FTIR, and X-ray diffraction confirmed successful CARV inclusion within both HPβCD and HPγCD, particularly in acidic conditions.
  • Spray-dried (SD) complexes exhibited a ~7-fold increase in CARV dissolution rate compared to raw CARV.
  • Fluid-bed granulated (FB) complexes with HPβCD showed a ~5-fold dissolution improvement, superior flowability, and larger particle size.

Conclusions:

  • Fluid-bed granulation (FB) is a suitable and potentially superior method for the large-scale production of solid dosage forms containing CARV inclusion complexes.
  • HPγCD demonstrates excellent potential for CARV complexation, offering a viable alternative to HPβCD.
  • The study highlights the benefits of cyclodextrin complexation for improving CARV's dissolution profile and manufacturability.