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Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets

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Authors
Nikolić, Nenad D.
Ibrić, Svetlana
Medarević, Đorđe
Đurić, Zorica
Article (Published version)
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Abstract
The aim of this study was establishing design space for robust formulation of hydrophilic extended release matrix tablets with tramadol hydrochloride as highly soluble, high dose drug. In the first part of the study, linear relationship between slope of Higuchi's model (K-h) and tablet surface/tablet volume (SA/V) ratio was confirmed varying drug loading in the range between 27.78 and 55.56% (w/w). Established relationship was tested in the second part of the study using different tablet shapes and sizes. Compression force was varied between 160 MPa and 300 MPa as critical process parameter, while drug loading and polymer concentration were recognized as critical input material attributes. High correlation was established between experimentally observed drug release profiles and drug release profiles predicted using K-h-SA/V relationship. Design space was established, where drug release could be accurately predicted for any drug loading/polymer content/compression force in the investig...ated range.

Keywords:
Design space / HPMC / Hydrophilic matrix tablets / Tramadol hydrochloride
Source:
Latin American Journal of Pharmacy, 2014, 33, 7, 1131-1138
Publisher:
  • Colegio Farmaceuticos Provincia De Buenos Aires, La Plata
Projects:
  • Advanced technologies for controlled release from solid drug delivery systems (RS-34007)

ISSN: 0326-2383

WoS: 000344932500011

[ Google Scholar ]
1
URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/2136
Collections
  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy
TY  - JOUR
AU  - Nikolić, Nenad D.
AU  - Ibrić, Svetlana
AU  - Medarević, Đorđe
AU  - Đurić, Zorica
PY  - 2014
UR  - http://farfar.pharmacy.bg.ac.rs/handle/123456789/2136
AB  - The aim of this study was establishing design space for robust formulation of hydrophilic extended release matrix tablets with tramadol hydrochloride as highly soluble, high dose drug. In the first part of the study, linear relationship between slope of Higuchi's model (K-h) and tablet surface/tablet volume (SA/V) ratio was confirmed varying drug loading in the range between 27.78 and 55.56% (w/w). Established relationship was tested in the second part of the study using different tablet shapes and sizes. Compression force was varied between 160 MPa and 300 MPa as critical process parameter, while drug loading and polymer concentration were recognized as critical input material attributes. High correlation was established between experimentally observed drug release profiles and drug release profiles predicted using K-h-SA/V relationship. Design space was established, where drug release could be accurately predicted for any drug loading/polymer content/compression force in the investigated range.
PB  - Colegio Farmaceuticos Provincia De Buenos Aires, La Plata
T2  - Latin American Journal of Pharmacy
T1  - Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets
VL  - 33
IS  - 7
SP  - 1131
EP  - 1138
ER  - 
@article{
author = "Nikolić, Nenad D. and Ibrić, Svetlana and Medarević, Đorđe and Đurić, Zorica",
year = "2014",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/2136",
abstract = "The aim of this study was establishing design space for robust formulation of hydrophilic extended release matrix tablets with tramadol hydrochloride as highly soluble, high dose drug. In the first part of the study, linear relationship between slope of Higuchi's model (K-h) and tablet surface/tablet volume (SA/V) ratio was confirmed varying drug loading in the range between 27.78 and 55.56% (w/w). Established relationship was tested in the second part of the study using different tablet shapes and sizes. Compression force was varied between 160 MPa and 300 MPa as critical process parameter, while drug loading and polymer concentration were recognized as critical input material attributes. High correlation was established between experimentally observed drug release profiles and drug release profiles predicted using K-h-SA/V relationship. Design space was established, where drug release could be accurately predicted for any drug loading/polymer content/compression force in the investigated range.",
publisher = "Colegio Farmaceuticos Provincia De Buenos Aires, La Plata",
journal = "Latin American Journal of Pharmacy",
title = "Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets",
volume = "33",
number = "7",
pages = "1131-1138"
}
Nikolić ND, Ibrić S, Medarević Đ, Đurić Z. Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets. Latin American Journal of Pharmacy. 2014;33(7):1131-1138
Nikolić, N. D., Ibrić, S., Medarević, Đ.,& Đurić, Z. (2014). Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets.
Latin American Journal of PharmacyColegio Farmaceuticos Provincia De Buenos Aires, La Plata., 33(7), 1131-1138.
Nikolić Nenad D., Ibrić Svetlana, Medarević Đorđe, Đurić Zorica, "Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets" 33, no. 7 (2014):1131-1138

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