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Effect of composition in the development of carbamazepine hot-melt extruded solid dispersions by application of mixture experimental design

Authorized Users Only
2014
Authors
Đuriš, Jelena
Ioannis, Nikolakakis
Ibrić, Svetlana
Đurić, Zorica
Kachrimanis, Kyriakos
Article (Published version)
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Abstract
ObjectivesThis study investigates the application of hot-melt extrusion for the formulation of carbamazepine (CBZ) solid dispersions, using polyethyleneglycol-polyvinyl caprolactam-polyvinyl acetate grafted copolymer (Soluplus, BASF, Germany) and polyoxyethylene-polyoxypropylene block copolymer (Poloxamer 407). In agreement with the current Quality by Design principle, formulations of solid dispersions were prepared according to a D-optimal mixture experimental design, and the influence of formulation composition on the properties of the dispersions (CBZ heat of fusion and release rate) was estimated. MethodsPrepared solid dispersions were characterized using differential scanning calorimetry, attenuated total reflectance infrared spectroscopy and hot stage microscopy, as well as by determination of the dissolution rate of CBZ from the hot-melt extrudates. Key findingsSolid dispersions of CBZ can be successfully prepared using the novel copolymer Soluplus. Inclusion of Poloxamer 407 as... a plasticizer facilitated the processing and decreased the hardness of hot-melt extrudates. Regardless of their composition, all hot-melt extrudates displayed an improvement in the release rate compared to the pure CBZ, with formulations having the ratio of CBZ:Poloxamer 407=1:1 showing the highest increase in CBZ release rate. ConclusionsInteractions between the mixture components (CBZ and polymers), or quadratic effects of the components, play a significant role in overall influence on the CBZ release rate.

Keywords:
carbamazepine / mixture design / Poloxamer 407 / solid dispersion / Soluplus
Source:
Journal of Pharmacy and Pharmacology, 2014, 66, 2, 232-243
Publisher:
  • Wiley-Blackwell, Hoboken
Funding / projects:
  • Advanced technologies for controlled release from solid drug delivery systems (RS-34007)

DOI: 10.1111/jphp.12199

ISSN: 0022-3573

PubMed: 24350884

WoS: 000329753300007

Scopus: 2-s2.0-84892766139
[ Google Scholar ]
25
20
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2185
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Đuriš, Jelena
AU  - Ioannis, Nikolakakis
AU  - Ibrić, Svetlana
AU  - Đurić, Zorica
AU  - Kachrimanis, Kyriakos
PY  - 2014
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2185
AB  - ObjectivesThis study investigates the application of hot-melt extrusion for the formulation of carbamazepine (CBZ) solid dispersions, using polyethyleneglycol-polyvinyl caprolactam-polyvinyl acetate grafted copolymer (Soluplus, BASF, Germany) and polyoxyethylene-polyoxypropylene block copolymer (Poloxamer 407). In agreement with the current Quality by Design principle, formulations of solid dispersions were prepared according to a D-optimal mixture experimental design, and the influence of formulation composition on the properties of the dispersions (CBZ heat of fusion and release rate) was estimated. MethodsPrepared solid dispersions were characterized using differential scanning calorimetry, attenuated total reflectance infrared spectroscopy and hot stage microscopy, as well as by determination of the dissolution rate of CBZ from the hot-melt extrudates. Key findingsSolid dispersions of CBZ can be successfully prepared using the novel copolymer Soluplus. Inclusion of Poloxamer 407 as a plasticizer facilitated the processing and decreased the hardness of hot-melt extrudates. Regardless of their composition, all hot-melt extrudates displayed an improvement in the release rate compared to the pure CBZ, with formulations having the ratio of CBZ:Poloxamer 407=1:1 showing the highest increase in CBZ release rate. ConclusionsInteractions between the mixture components (CBZ and polymers), or quadratic effects of the components, play a significant role in overall influence on the CBZ release rate.
PB  - Wiley-Blackwell, Hoboken
T2  - Journal of Pharmacy and Pharmacology
T1  - Effect of composition in the development of carbamazepine hot-melt extruded solid dispersions by application of mixture experimental design
VL  - 66
IS  - 2
SP  - 232
EP  - 243
DO  - 10.1111/jphp.12199
ER  - 
@article{
author = "Đuriš, Jelena and Ioannis, Nikolakakis and Ibrić, Svetlana and Đurić, Zorica and Kachrimanis, Kyriakos",
year = "2014",
abstract = "ObjectivesThis study investigates the application of hot-melt extrusion for the formulation of carbamazepine (CBZ) solid dispersions, using polyethyleneglycol-polyvinyl caprolactam-polyvinyl acetate grafted copolymer (Soluplus, BASF, Germany) and polyoxyethylene-polyoxypropylene block copolymer (Poloxamer 407). In agreement with the current Quality by Design principle, formulations of solid dispersions were prepared according to a D-optimal mixture experimental design, and the influence of formulation composition on the properties of the dispersions (CBZ heat of fusion and release rate) was estimated. MethodsPrepared solid dispersions were characterized using differential scanning calorimetry, attenuated total reflectance infrared spectroscopy and hot stage microscopy, as well as by determination of the dissolution rate of CBZ from the hot-melt extrudates. Key findingsSolid dispersions of CBZ can be successfully prepared using the novel copolymer Soluplus. Inclusion of Poloxamer 407 as a plasticizer facilitated the processing and decreased the hardness of hot-melt extrudates. Regardless of their composition, all hot-melt extrudates displayed an improvement in the release rate compared to the pure CBZ, with formulations having the ratio of CBZ:Poloxamer 407=1:1 showing the highest increase in CBZ release rate. ConclusionsInteractions between the mixture components (CBZ and polymers), or quadratic effects of the components, play a significant role in overall influence on the CBZ release rate.",
publisher = "Wiley-Blackwell, Hoboken",
journal = "Journal of Pharmacy and Pharmacology",
title = "Effect of composition in the development of carbamazepine hot-melt extruded solid dispersions by application of mixture experimental design",
volume = "66",
number = "2",
pages = "232-243",
doi = "10.1111/jphp.12199"
}
Đuriš, J., Ioannis, N., Ibrić, S., Đurić, Z.,& Kachrimanis, K.. (2014). Effect of composition in the development of carbamazepine hot-melt extruded solid dispersions by application of mixture experimental design. in Journal of Pharmacy and Pharmacology
Wiley-Blackwell, Hoboken., 66(2), 232-243.
https://doi.org/10.1111/jphp.12199
Đuriš J, Ioannis N, Ibrić S, Đurić Z, Kachrimanis K. Effect of composition in the development of carbamazepine hot-melt extruded solid dispersions by application of mixture experimental design. in Journal of Pharmacy and Pharmacology. 2014;66(2):232-243.
doi:10.1111/jphp.12199 .
Đuriš, Jelena, Ioannis, Nikolakakis, Ibrić, Svetlana, Đurić, Zorica, Kachrimanis, Kyriakos, "Effect of composition in the development of carbamazepine hot-melt extruded solid dispersions by application of mixture experimental design" in Journal of Pharmacy and Pharmacology, 66, no. 2 (2014):232-243,
https://doi.org/10.1111/jphp.12199 . .

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