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Alternative extrusion-spheronization aids.

Satishkumar P Jain1, Pirthi Pal Singh, Purnima D Amin

  • 1Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, University of Mumbai, Mumbai, Maharashtra, India.

Drug Development and Industrial Pharmacy
|June 5, 2010
PubMed
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Several agents show promise as alternatives to microcrystalline cellulose (MCC) for extrusion-spheronization, offering effective pellet formation. However, none fully replicate MCC

Area of Science:

  • Pharmaceutical technology
  • Drug delivery systems
  • Excipient science

Background:

  • Microcrystalline cellulose (MCC) is a common extrusion-spheronization aid.
  • MCC has limitations including active adsorption, prolonged dissolution, and drug degradation.
  • Sensitive drugs like ranitidine are particularly affected by MCC's drawbacks.

Purpose of the Study:

  • To review alternative agents for extrusion-spheronization.
  • To evaluate natural, semisynthetic, and synthetic excipients.
  • To identify potential replacements for MCC in pellet production.

Main Methods:

  • Characterization of alternative spheronizing aids.
  • Evaluation of intrinsic properties (solubility, water absorption, rheology).

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  • Assessment of drug release and pellet properties (sphericity, porosity, friability).
  • Main Results:

    • Crospovidone, carrageenan, chitosan, pectinic acid, glycerides, beta-cyclodextrin (β-CD), and cellulose derivatives are effective alternatives.
    • These agents can produce pellets without plasticizers or lubricants.
    • Polyethylene oxide requires plasticizers/lubricants for pellet formation.

    Conclusions:

    • Several excipients demonstrate efficacy as extrusion-spheronization aids.
    • These alternatives offer advantages over MCC for specific applications.
    • No alternative fully matches MCC's formulation and processing flexibility.