The evaluation of physical properties of injection molded systems based on poly(ethylene oxide) (PEO)
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The evaluation of physical properties of injection molded systems based on poly(ethylene oxide) (PEO). / Pajander, Jari; Rensonnet, Alexia; Hietala, Sami; Rantanen, Jukka; Baldursdottir, Stefania.
In: International Journal of Pharmaceutics, Vol. 518, No. 1-2, 25.02.2017, p. 203-212.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - The evaluation of physical properties of injection molded systems based on poly(ethylene oxide) (PEO)
AU - Pajander, Jari
AU - Rensonnet, Alexia
AU - Hietala, Sami
AU - Rantanen, Jukka
AU - Baldursdottir, Stefania
N1 - Copyright © 2016 Elsevier B.V. All rights reserved.
PY - 2017/2/25
Y1 - 2017/2/25
N2 - The effect of product design parameters on the formation and properties of an injection molded solid dosage form consisting of poly(ethylene oxide)s (PEO) and two different active pharmaceutical ingredients (APIs) was studied. The product design parameters explored were melting temperature and the duration of melting, API loading degree and the molecular weight (Mw) of PEO. The solid form composition of the model APIs, theophylline and carbamazepine, was of specific interest, and its possible impact on the in vitro drug release behavior. Mw of PEO had the greatest impact on the release rate of both APIs. High Mw resulted in slower API release rate. Process temperature had two-fold effect with PEO 300,000g/mol. Firstly, higher process temperature transformed the crystalline part of the polymer into metastable folded form (more folded crystalline regions) and less into the more stable extended form (more extended crystalline regions), which lead to enhanced theophylline release rate. Secondly, the higher process temperature seemed to induce carbamazepine polymorphic transformation from p-monoclinic form III (carbamazepine (M)) into trigonal form II (carbamazepine (T)). The results indicated that the actual content of carbamazepine (T) affected drug release behavior more than the magnitude of transformation.
AB - The effect of product design parameters on the formation and properties of an injection molded solid dosage form consisting of poly(ethylene oxide)s (PEO) and two different active pharmaceutical ingredients (APIs) was studied. The product design parameters explored were melting temperature and the duration of melting, API loading degree and the molecular weight (Mw) of PEO. The solid form composition of the model APIs, theophylline and carbamazepine, was of specific interest, and its possible impact on the in vitro drug release behavior. Mw of PEO had the greatest impact on the release rate of both APIs. High Mw resulted in slower API release rate. Process temperature had two-fold effect with PEO 300,000g/mol. Firstly, higher process temperature transformed the crystalline part of the polymer into metastable folded form (more folded crystalline regions) and less into the more stable extended form (more extended crystalline regions), which lead to enhanced theophylline release rate. Secondly, the higher process temperature seemed to induce carbamazepine polymorphic transformation from p-monoclinic form III (carbamazepine (M)) into trigonal form II (carbamazepine (T)). The results indicated that the actual content of carbamazepine (T) affected drug release behavior more than the magnitude of transformation.
KW - Calorimetry, Differential Scanning
KW - Carbamazepine
KW - Chromatography, Gel
KW - Drug Compounding
KW - Drug Liberation
KW - Polyethylene Glycols
KW - Powder Diffraction
KW - Spectroscopy, Fourier Transform Infrared
KW - Theophylline
KW - X-Ray Diffraction
KW - Journal Article
U2 - 10.1016/j.ijpharm.2016.12.050
DO - 10.1016/j.ijpharm.2016.12.050
M3 - Journal article
C2 - 28025074
VL - 518
SP - 203
EP - 212
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
SN - 0378-5173
IS - 1-2
ER -
ID: 185745559