Method and production system for producing a pharmaceutical extrudate comprising a low-dose active pharmaceutical ingredient

摘要

A method for producing an pharmaceutical extrudate (101) comprising a low dose active pharmaceutical ingredient in which an extrusion material is conveyed by an extruder screw (102) of a screw extruder device (100) from a feeding section (103) of the screw extruder device (100) to an output section (108) of the screw extruder device (100). An extrusion liquid (109) is pumped with a predetermined volumetric flow rate, wherein the extrusion liquid (109) comprises a carrier solution in which a dosed quantity of the active pharmaceutical ingredient is suspended, dissolved or melted. The extrusion liquid (109) is added to the extrusion material within an injection section (106) of the screw extruder device (100). The extrusion liquid (109) is mixed with the extrusion material within a mixing section (107) of the screw extruder device (100) to produce the pharmaceutical extrudate (101). The pharmaceutical extrudate (101) is outputted at the output section (108) of the screw extruder device (100). The carrier solution may be polyethylene glycol and distilled water. The preferred active ingredient is ibuprofen. A production system for producing a pharmaceutical extrudate is also claimed.