Direct compression properties of melt-extruded isomalt.

Isomalt, a sugar alcohol, was melt-extruded prior to compression in order to improve its tabletting properties. After fusion, crystalline isomalt was transformed into an amorphous form as shown by X-ray diffraction and differential scanning calorimetry (DSC). The tabletting properties of amorphous isomalt were dramatically improved.

In vitro and in vivo evaluation of starch-based hot stage extruded double matrix systems.

The objective of developing a double matrix system consisting of a hot stage extruded starch pipe surrounding a hot stage extruded and drug-containing starch core, was to obtain a monolithic matrix system applicable in the domain of sustained drug release. The behaviour of the systems was evaluated through dissolution testing and through a randomised crossover bioavailability study on nine male volunteers. All double matrix systems showed in vitro a nearly constant drug release profile after an initial slower release phase of 4 h.

Influence of the formulation composition on the in vitro characteristics of hot stage extrudates.

The aim of this study was to evaluate the influence of the formulation composition on the characteristics of starch based hot stage extrudates in order to obtain high quality and high efficacy matrices for controlled drug delivery. Their characteristics were compared to those of a reference formulation, for which in vivo data were available. The influence of the starch type, the plasticizer and the lubricant were investigated.

Characterization and evaluation of isomalt performance in direct compression.

Isomalt is a sugar substitute with a wide range of potential pharmaceutical applications as a result of its physicochemical properties. Four grades of this material were evaluated for their physical characteristics. Only Palatinit(R) C and F exhibited potential characteristics for direct compression.

Influence of the process parameters on the characteristics of starch based hot stage extrudates.

The influence of the process parameters on the characteristics of matrix formulations produced by means of hot stage extrusion was investigated using three experimental designs. The first one was designed to evaluate the importance of the screw speed (150-450 rpm) and the feed rate (2-12 kg/h), while the second and the third were designed to study the importance of the temperature profile (60-120 degrees C). The extrudates were produced with a laboratory twin screw extruder equipped with a 3-mm cylindrical die.