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METHOD OF PREPARING AN EXTRUDED COMPOSITION

[Category : - HEALTH]
[Viewed 204 times]

Hot-melt extrusion (HME) has been used in a wide range of manufacturing processes. Aside from its use in the plastics, rubber and food manufacturing sectors, HME has been used in the manufacture of pharmaceutical dosage forms e.g. tablets or films. In general terms, HME involves pumping a mixture of raw materials at controlled (often elevated) temperature and/or pressure through a barrel to produce a composition that is forced out of the barrel through a die. The raw materials are typically fed into the extruder (the extruder barrel) via a hopper. Flow through the barrel is usually associated with mixing, grinding, compressing, kneading and/or venting. Within the barrel are typically one or two rotating screws (corotating or counter rotating).

Initial extruded compositions (extrudates) usually require further processing before final use, for example into powders for tabletisation in the field of pharmaceuticals. However, many prior art extrusion methods (especially where Ibuprofen is extruded) result in sticky extrudates that require cryo-milling for powder formation. Cryo-milling is a time consuming and costly processing step that inhibits the scale-up of such processes to an industrial operation. Other resource-consuming, post-extrusion processing steps can include cooling, cutting, pelletising and micronisation.

It is amongst the objects of the present invention to attempt a solution to this problem (i.e. to improve the speed and efficiency with which a powdered extrudate can be formed), and to improve various characteristics of extrudates (and pharmaceutical forms derived therefrom) for pharmaceutical use, such as improved drug-loading, stability and taste-masking and, in the case of tablet forms in particular, increased disintegration rate, increased hardness and decreased friability.

Patent publications:

EP 3256106

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saumilbhatt (United Kingdom)

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