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Related Experiment Videos

Developing a study method for producing 400 microm spheroids.

G Dupont1, M P Flament, P Leterme

  • 1Faculté des Sciences Pharmaceutiques et Biologiques, Laboratoire de Pharmacotechnie Industrielle, BP 83 Rue du Professeur Laguesse, Lille 59006, France.

International Journal of Pharmaceutics
|November 14, 2002
PubMed
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Developing 400 micrometer spheroids for food application enhances patient compliance. This study outlines a method for selecting suitable excipients for producing these small, sprinkleable dosage forms, particularly for pediatric and geriatric populations.

Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems

Background:

  • Improving patient compliance, especially in pediatric and geriatric populations, is crucial for effective medication delivery.
  • Developing orally disintegrating dosage forms or sprinkleable formulations can enhance adherence.
  • Extrusion-spheronization is a common technique for producing spherical pellets, but requires careful optimization of excipients and process parameters.

Purpose of the Study:

  • To develop a methodology for selecting appropriate wet masses for producing 400 micrometer spheroids via extrusion-spheronization.
  • To assess the feasibility of producing small-sized spheroids suitable for sprinkling on food.
  • To evaluate the impact of different excipients on the processability and quality of 400 micrometer extrudates.

Main Methods:

  • Development of parameters to assess wet mass and extrudate qualities: plasticity, cohesiveness, brittleness, and appearance.

Related Experiment Videos

  • Feasibility studies using a cylinder extruder with a 400 micrometer orifice.
  • Testing of various excipient combinations, including lactose, Avicel PH 101, Precirol ato 5, and Gelucire 50/02, with sodium lauryl sulfate solution.

    • Main Results:

    • Extrusion of lactose/Avicel PH 101/water (50/50/60) was not feasible through the 400 micrometer orifice.
    • Precirol ato 5 and Gelucire 50/02, when wetted with 0.5% sodium lauryl sulfate solution, exhibited plastic flow through the 400 micrometer orifice.
    • Avicel PH 101 did not enhance plasticity for the 400 micrometer orifice.
    • Feasibility of 400 micrometer micropellets was confirmed with appropriately selected excipients.

    Conclusions:

    • A viable methodology for selecting excipients for 400 micrometer spheroid production was established.
    • Gelucire 50/02 and Precirol ato 5 are suitable excipients for creating 400 micrometer spheroids using extrusion-spheronization.
    • The feasibility of incorporating drugs into these 400 micrometer spheroids was considered for future development.