Abstract

κ-Carrageenan has been suggested as a pelletisation aid for wet-extrusion/spheronization processes for several years. Until now there have been no systematic investigations regarding process development and stability for long-term production. The aim of this study was to develop a high drug-loaded pellet formulation with κ-carrageenan, so that a robust process cycle occurred over the course of several hours. Binary mixtures of κ-carrageenan and theophylline monohydrate were used and the drug content was varied from 90 to 95%. A twin-screw extruder was used; the power consumption and feed rates were recorded. The pellets were characterized by aspect ratio, diameter, 10% interval, tensile strength and dissolution behavior. The process ran on two occasions for 4.5 h each time. During the extrusion process neither the power consumption nor the feed rates differed significantly, so there was no need to stop the process or change the extrusion parameters. Regarding the spheronization, a cleaning of the spheroniser friction plate was necessary every five batches due to packing of the material on this plate. Overall the resulting pellets showed reproducible and adequate qualities regarding all investigated properties. In conclusion a robust pelletisation process over several hours could be verified. It was possible to produce 42 kg of pellets with adequate properties, without any problems during the process.

Links

Publisher Full Text

Authors

Krueger C, Thommes M

Institution

Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf, Germany.

Source

Pharmaceutical development and technology 18:1 2013 Feb pg 225-35

MeSH

Carrageenan
Dosage Forms
Drug Compounding
Drug Stability
Excipients
Solubility
Tensile Strength
Theophylline
Time Factors

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22780876