TY - JOUR
T1 - The influence of thermal history on the physical behavior of poly(ethylene glycol) (PEG)
AU - Baldursdóttir, Stefanía Guðlaug
AU - Tian, Fang
AU - Santacruz, Bruno Gallo
AU - Jørgensen, Anna Cecilia
AU - Rantanen, Jukka Tapio
PY - 2012/3
Y1 - 2012/3
N2 - Objectives: To investigate the influence of thermal history on the physical behavior of poly(ethylene glycol) (PEG), commonly used as a pharmaceutical excipient. Materials and methods: Rheological investigations together with SEM imaging and solid state analysis by XRPD and DSC were used to characterize PEG as starting material, as well as PEG:lactose monohydrate granules. For granulation experiments PEG 6000 was used and for further investigations of physicochemical properties, three Mw of PEG (300010000) with different thermal histories obtained by melting the PEG followed by solidification with specific cooling rates. Results and discussion: More uniform granules were obtained when fast cooled PEG was used as binder. XRPD suggested similar crystallinity for the different Mw and thermal history did not influence the results drastically. However, rheological analysis and DSC measurements indicated different melting behavior dependent on the Mw of PEG. PEG 6000 and 10000 were affected by the thermal treatment where stepwise melting was observed with slower cooling rate probably due to increased formation of extended structures. Conclusions: Increased cooling rate gives rise to increased randomness, more folded structure of PEG, which reflects in the outcome of the granulation process.
AB - Objectives: To investigate the influence of thermal history on the physical behavior of poly(ethylene glycol) (PEG), commonly used as a pharmaceutical excipient. Materials and methods: Rheological investigations together with SEM imaging and solid state analysis by XRPD and DSC were used to characterize PEG as starting material, as well as PEG:lactose monohydrate granules. For granulation experiments PEG 6000 was used and for further investigations of physicochemical properties, three Mw of PEG (300010000) with different thermal histories obtained by melting the PEG followed by solidification with specific cooling rates. Results and discussion: More uniform granules were obtained when fast cooled PEG was used as binder. XRPD suggested similar crystallinity for the different Mw and thermal history did not influence the results drastically. However, rheological analysis and DSC measurements indicated different melting behavior dependent on the Mw of PEG. PEG 6000 and 10000 were affected by the thermal treatment where stepwise melting was observed with slower cooling rate probably due to increased formation of extended structures. Conclusions: Increased cooling rate gives rise to increased randomness, more folded structure of PEG, which reflects in the outcome of the granulation process.
U2 - 10.3109/10837450.2010.531733
DO - 10.3109/10837450.2010.531733
M3 - Journal article
SN - 1083-7450
VL - 17
SP - 195
EP - 203
JO - Pharmaceutical Development and Technology
JF - Pharmaceutical Development and Technology
IS - 2
ER -