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Feasability of a new process to produce fast disintegrating pellets as novel multiparticulate dosage form for

Thanh Huong Hoang Thi1, Siham Lhafidi1, Simone Pinto Carneiro2

  • 1Univ. Lille, Inserm, CHU Lille, U 1008-Controlled Drug Delivery Systems and Biomaterials, F-5900 Lille, France.

International Journal of Pharmaceutics
|September 26, 2015
PubMed

Insights

A novel orally disintegrating system using microcrystalline cellulose-based pellets was developed for pediatric patients. This system ensures rapid disintegration and fast drug release, overcoming challenges with pediatric dosage forms.

Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Pediatric Formulations

Background:

  • Pediatric patients often struggle with swallowing solid dosage forms like tablets and capsules.
  • Developing age-appropriate and flexible-dosed medications for children presents significant formulation challenges.

Purpose of the Study:

  • To develop a novel orally disintegrating multiparticulate system for pediatric use.
  • To create an alternative dosage form addressing swallowing difficulties and dose variability in children.

Main Methods:

  • Acetaminophen-loaded microcrystalline cellulose pellets were prepared using extrusion/spheronization and freeze-drying.
  • Pellet characteristics (size, sphericity, friability, drug release) were evaluated.
  • In vitro disintegration and internal porous structure (mercury intrusion, gas adsorption, SEM) were analyzed.

Main Results:

  • High drug loading (up to 75% w/w) pellets with good sphericity and low friability were produced.
  • Pellets demonstrated instantaneous disintegration (<5s) due to a porous internal structure.
  • Over 90% acetaminophen release was achieved within 15 minutes.

Conclusions:

  • The developed orally disintegrating multiparticulate system offers an age-appropriate and easily administrable dosage form for pediatric populations.
  • This novel system provides dosing flexibility and overcomes common administration issues in children.
  • The freeze-dried pellets exhibit favorable mechanical properties alongside rapid disintegration and dissolution.

Keywords:
Extrusion/spheronizationFast disintegrationFreeze-dryingPediatric dosage form

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