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Continuous-release drug delivery systems offer a strategic approach to maintaining therapeutic drug levels over extended periods following oral administration. By modulating the release rate of active pharmaceutical ingredients, these systems minimize fluctuations in plasma concentrations, which enhances clinical efficacy and reduces the need for frequent dosing. Such characteristics make them particularly advantageous in managing chronic diseases where patient adherence and stable drug...
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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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Rate-programmed drug delivery systems (DDS) are designed to release drugs at specific, controlled rates to maintain consistent therapeutic levels. These systems are categorized based on their release mechanisms, including dissolution-controlled DDS, diffusion-controlled DDS, and combined dissolution-diffusion-controlled DDS.In dissolution-controlled DDS, the release rate depends on the slow dissolution of the drug itself or the surrounding matrix. Drugs with inherently slow dissolution rates,...
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Amorphous-based controlled-release gliclazide matrix system.

Zheng Lu1, Yonglai Yang2, Rae-Ann Covington2

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This study developed stable amorphous gliclazide dispersions using spray-drying, enhancing solubility and enabling controlled release oral systems for essential diabetes medication.

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HPMCAScontrolled-release matrix tabletcopovidonegliclazidespray-dried dispersion

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Gliclazide, a BCS class II compound, requires enhanced oral bioavailability.
  • Developing stable amorphous solid dispersions is key for improving drug solubility and dissolution.
  • Controlled release systems aim to optimize drug delivery and therapeutic efficacy.

Purpose of the Study:

  • To develop a hydrophilic oral controlled release system (CRS) for gliclazide using its amorphous form.
  • To produce spray-dried dispersions (SDDs) of gliclazide with various carriers (HPMCAS, copovidone).
  • To characterize solid-state properties and evaluate dissolution performance of the developed SDDs and matrix tablets.

Main Methods:

  • Spray-drying of gliclazide with HPMCAS or copovidone.
  • Solid-state characterization using XRPD, SEM, MDSC, and FTIR.
  • In vitro dissolution testing of SDDs and matrix tablets under USP standards.
  • Stability testing of the developed formulations over six months.

Main Results:

  • Spray-dried dispersions (SDDs) exhibited enhanced solubility (1.5- to 4.0-fold) and prolonged supersaturation.
  • Optimized SDDs were successfully incorporated into HPMC-based hydrophilic matrix tablets.
  • The developed matrix systems showed stable dissolution profiles over six months (f2=85).

Conclusions:

  • Hydroxypropyl methylcellulose acetate succinate (HPMCAS) is a suitable carrier for producing stable, homogeneous amorphous gliclazide SDDs.
  • The developed hydrophilic matrix systems incorporating gliclazide SDDs are promising for oral controlled release applications.
  • Spray-drying technology effectively enhances the oral delivery of poorly soluble drugs like gliclazide.