It was found that polyvinylpyrrolidone (PVP) is an effective additive durin
g crystallization of paracetamol and significantly influenced the crystalli
zation and crystal habit of paracetamol. These effects were attributed to a
dsorption of PVP onto the surfaces of growing crystals. It was found that t
he higher molecular weights of PVP (PVP 10 000 and PVP 50 000) were more ef
fective additives than lower molecular weight PVP (PVP 2000). Paracetamol p
articles obtained in the presence of 0.5% w/v of PVP 10 000 or PVP 50 000 h
ad near spherical structure and consisted of numerous rod-shaped microcryst
als which had agglomerated together. Particles obtained in the presence of
PVP 2000 consisted of fewer microcrystals. Differential scanning calorimetr
y (DSC) and X-ray powder diffraction (XPD) experiments showed that paraceta
mol particles, crystallized in the presence of PVP, did not undergo structu
ral modifications. By increasing the molecular weight and/or the concentrat
ion of PVP in the crystallization medium the amount of PVP incorporated int
o the paracetamol particles increased. The maximum amount of PVP in the par
ticles was 4.32% w/w. (C) 2000 Elsevier Science B.V. All rights reserved.