Manufacturing of a fast-dissolving dosage form - investigating powder handling and control of surface characteristics

[摘要] An early stage in the manufacture of a proprietary fast dissolving dosage form (FDDF), involves dissolution/suspension of the active agent in an aqueous solution. To allow use of aqueous labile drugs and/or coated drug particles in the FDDF, the development of an alternative approach is sought i.e. that which allows independent dosing of drug powders and liquid components. The focus of this work is on the powder dosing aspect. A vacuum based filling system was investigated and was generally shown to be capable of delivering accurate 50 mg and 400 mg doses of model drug particles with high precision (RSD <2 %). The investigated model materials included coated sugar spheres, paracetamol, ibuprofen and excipient powders with typical diameters between 100 μm-500 μm. The strength of vacuum used to collect the powder was seen to affect the dose weight for certain materials more than others; the magnitude of this effect was linked to the Carr’s Index. The dosing equipment was shown to be capable of collecting doses rapidly (< ½ second), hence being suitable for a potential, future automated process.

[发布机构] University:University of Birmingham;Department:School of Chemical Engineering

[关键词] T Technology;TP Chemical technology