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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...

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Method to Produce Durable Pellets at Lower Energy Consumption Using High Moisture Corn Stover and a Corn Starch Binder in a Flat Die Pellet Mill
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Properties of melt extruded enteric matrix pellets.

Sandra U Schilling1, Navnit H Shah, A Waseem Malick

  • 1Drug Dynamics Institute, University of Texas at Austin, Austin, USA. sschilling@mail.utexas.edu

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|September 29, 2009
PubMed
Summary

Hot-melt extrusion successfully created enteric matrix pellets using Eudragit S100. Efficient plasticization with triethyl citrate or methylparaben is key for gastric protection and controlled theophylline release.

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Drug Delivery Systems

Background:

  • Enteric matrix pellets are crucial for targeted drug delivery, requiring specific formulation properties for gastric protection and controlled release.
  • Hot-melt extrusion (HME) offers a continuous, efficient manufacturing process for pharmaceutical dosage forms.
  • Eudragit S100 is a potential enteric polymer for matrix pellet formulation, but its processability and drug release characteristics need optimization.

Purpose of the Study:

  • To investigate the properties of enteric matrix pellets manufactured via one-step hot-melt extrusion.
  • To evaluate Eudragit S100 as a matrix former and the impact of plasticizers on pellet properties and drug release.
  • To identify optimal plasticizers for achieving desired gastric protection and controlled theophylline release.

Main Methods:

  • Hot-melt extrusion was used to prepare enteric matrix pellets incorporating theophylline.
  • Five polymers, including Eudragit S100, were screened as matrix formers.
  • Various plasticizers (triethyl citrate, methylparaben, polyethylene glycol 8000, citric acid monohydrate, acetyltributyl citrate) were evaluated for their effect on processability and drug release.

Main Results:

  • Eudragit S100 demonstrated superior gastric protection and acceptable processability for enteric matrix pellets.
  • Efficient plasticization of Eudragit S100 with triethyl citrate (TEC) or methylparaben was necessary for optimal processing and drug release.
  • Water-soluble plasticizers compromised gastric protection, while insoluble plasticizers maintained low drug release in acidic conditions. Efficient plasticizers accelerated theophylline release at pH 7.4.

Conclusions:

  • Enteric matrix pellets (<1mm diameter) containing 30% theophylline can be successfully prepared by hot-melt extrusion using Eudragit S100 plasticized with TEC or methylparaben.
  • Plasticizer choice significantly impacts the microstructure, solid-state properties, and drug release profile of the enteric matrix pellets.
  • Optimized plasticization of Eudragit S100 is critical for developing stable and effective enteric matrix pellets via hot-melt extrusion.