Prolonged release matrix pellets prepared by melt pelletization. I. Process variables

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A melt pelletization process was investigated in an 8 litre laboratory scale high shear mixer using a formulation with paracetamol, glyceryl monostearate 40-50, and microcrystalline wax. The effects of jacket temperature, product temperature during massing, product load, massing time and impeller speed were investigated by means of factorially designed experiments. The maximum yield of pellets in the range of 500-1400 μm was found to approx. 90%. For process conditions preventing deposition of moist mass, the process was found to be reproducible. Impeller speed and massing time were found to be important process variables. Remarkably low in vitro drug release rates were observed in USP-dissolution tests.
OriginalsprogEngelsk
TidsskriftDrug Development and Industrial Pharmacy
Vol/bind19
Udgave nummer15
Sider (fra-til)1867-1887
Antal sider21
ISSN0363-9045
StatusUdgivet - 1 jan. 1993

ID: 62958638