A comparison of three extrusion systems: part II: the influence of formulation and spheronization conditions on pellet properties

In the first part of the current study, the influence of water quantity and extrusion speed was investigated for a highly soluble drug product at a fixed concentration in the formula. A design of experiments underlined significant differences between the three extrusion systems. The influence of for...

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Bibliographic Details
Published in:Pharmaceutical Technology 2011-06, Vol.35 (6), p.56
Main Authors: Desire, Amelie, Paillard, Bruno, Bougaret, Joel, Baron, Michel, Couarraze, Guy
Format: Magazinearticle
Language:English
Subjects:
Cellulose
Comparative analysis
Design of experiments
Drugs
Extrusion
Ingredients
Mathematical models
Methods
Particle size
Pelletizing
Pharmaceutical industry
Prescription drugs
Product development
Production processes
Raw materials
Software
Studies
Variance analysis
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Summary:In the first part of the current study, the influence of water quantity and extrusion speed was investigated for a highly soluble drug product at a fixed concentration in the formula. A design of experiments underlined significant differences between the three extrusion systems. The influence of formulation and spheronization conditions on product properties has been widely described in the literature. The research fully compares the dome extruder with other systems using a design-of-experiments approach to enable full analysis and good process understanding. Pellets were prepared from a binary mixture of a drug substance and microcrystalline cellulose. Analysis of variance was performed to determine the significance of the model. The ideal extrusion system gives the best results in terms of productivity and pellet quality, but also has the least influence on those same properties when the formula used changes, and allows pellet properties to be adjusted or improved with spheronization variables.
ISSN:1543-2521
2150-7376