TY - JOUR
T1 - Prolonged release matrix pellets prepared by melt pelletization. I. Process variables
AU - Thomsen, L.J.
AU - Schaefer, T.
AU - Sonnergaard, Jørn
AU - Kristensen, H.G.
PY - 1993/1/1
Y1 - 1993/1/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0027199593&partnerID=8YFLogxK
M3 - Journal article
AN - SCOPUS:0027199593
SN - 0363-9045
VL - 19
SP - 1867
EP - 1887
JO - Drug Development and Industrial Pharmacy
JF - Drug Development and Industrial Pharmacy
IS - 15
ER -