Investigation of influence of process variables on mechanical strength, size and homogeneity of pharmaceutical granules produced by fluidised hot melt granulation

Chirangano Mangwandi*, N. A. Zainal, Liu JiangTao, Y. Glocheux, Ahmad B. Albadarin

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

8 Citations (Scopus)
301 Downloads (Pure)

Abstract

The overall aim of the project was to study the influence of process variables on the distribution of a model active pharmaceutical ingredient (API) during fluidised melt granulation of pharmaceutical granules with a view of optimising product characteristics. Granules were produced using common pharmaceutical excipients; lactose monohydrate using poly ethylene glycol (PEG1500) as a meltable binder. Methylene blue was used as a model API. Empirical models relating the process variables to the granules properties such as granule mean size, product homogeneity and granule strength were developed using the design of experiment approach. Fluidising air velocity and fluidising air temperature were shown to strongly influence the product properties. Optimisation studies showed that strong granules with homogeneous distribution of the active ingredient can be produced at high fluidising air velocity and at high fluidising air temperatures.

Original languageEnglish
Pages (from-to)173-180
Number of pages8
JournalPowder Technology
Volume272
Early online date08 Dec 2014
DOIs
Publication statusPublished - Mar 2015

Keywords

  • granulation
  • Polyethylene Glycols
  • homogeneity
  • fluidised bed hot melt granulation
  • granule strength

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