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Tablet disintegration and drug dissolution in viscous media: Paracetamol IR tablets

Authorized Users Only
2008
Authors
Parojčić, Jelena
Vasiljević, Dragana
Ibrić, Svetlana
Đurić, Zorica
Article (Published version)
Metadata
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Abstract
An investigation into the influence of viscous media on tablet disintegration and drug dissolution was performed with the aim to simulate the potential formulation-specific food effect for a selected highly soluble model drug. Literature data on the in vivo drug absorption in fasted and fed state have been evaluated for in vitro-in vivo correlation (IVIVC) purposes. In vitro studies were conducted in simple buffer media with or without addition of HPMC K4M as a viscosity enhancing agent. Good IVIVC correlation (r > 0.95) was obtained for paracetamol dissolution in viscous media at 50 rpm and fed state absorption profiles, while in vitro dissolution in simple media at lower stirring speed was predictable of drug products in vivo behaviour in the fasted state. The data obtained support the existing idea that relatively simple dissolution media and/or set of experimental conditions may be used to differentiate formulation-specific food-drug interactions. Such tests would be a useful tool ...in the development of formulations that would not be susceptible to the influence of co-administered meal and, furthermore, facilitate regulatory decision on the necessity to conduct food effect studies in vivo.

Keywords:
food effect / in vitro-in vivo correlation / paracetamol / viscous media
Source:
International Journal of Pharmaceutics, 2008, 355, 1-2, 93-99
Publisher:
  • Elsevier Science BV, Amsterdam

DOI: 10.1016/j.ijpharm.2007.11.058

ISSN: 0378-5173

PubMed: 18226480

WoS: 000255696200011

Scopus: 2-s2.0-41449099515
[ Google Scholar ]
48
37
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/1088
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Parojčić, Jelena
AU  - Vasiljević, Dragana
AU  - Ibrić, Svetlana
AU  - Đurić, Zorica
PY  - 2008
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1088
AB  - An investigation into the influence of viscous media on tablet disintegration and drug dissolution was performed with the aim to simulate the potential formulation-specific food effect for a selected highly soluble model drug. Literature data on the in vivo drug absorption in fasted and fed state have been evaluated for in vitro-in vivo correlation (IVIVC) purposes. In vitro studies were conducted in simple buffer media with or without addition of HPMC K4M as a viscosity enhancing agent. Good IVIVC correlation (r > 0.95) was obtained for paracetamol dissolution in viscous media at 50 rpm and fed state absorption profiles, while in vitro dissolution in simple media at lower stirring speed was predictable of drug products in vivo behaviour in the fasted state. The data obtained support the existing idea that relatively simple dissolution media and/or set of experimental conditions may be used to differentiate formulation-specific food-drug interactions. Such tests would be a useful tool in the development of formulations that would not be susceptible to the influence of co-administered meal and, furthermore, facilitate regulatory decision on the necessity to conduct food effect studies in vivo.
PB  - Elsevier Science BV, Amsterdam
T2  - International Journal of Pharmaceutics
T1  - Tablet disintegration and drug dissolution in viscous media: Paracetamol IR tablets
VL  - 355
IS  - 1-2
SP  - 93
EP  - 99
DO  - 10.1016/j.ijpharm.2007.11.058
ER  - 
@article{
author = "Parojčić, Jelena and Vasiljević, Dragana and Ibrić, Svetlana and Đurić, Zorica",
year = "2008",
abstract = "An investigation into the influence of viscous media on tablet disintegration and drug dissolution was performed with the aim to simulate the potential formulation-specific food effect for a selected highly soluble model drug. Literature data on the in vivo drug absorption in fasted and fed state have been evaluated for in vitro-in vivo correlation (IVIVC) purposes. In vitro studies were conducted in simple buffer media with or without addition of HPMC K4M as a viscosity enhancing agent. Good IVIVC correlation (r > 0.95) was obtained for paracetamol dissolution in viscous media at 50 rpm and fed state absorption profiles, while in vitro dissolution in simple media at lower stirring speed was predictable of drug products in vivo behaviour in the fasted state. The data obtained support the existing idea that relatively simple dissolution media and/or set of experimental conditions may be used to differentiate formulation-specific food-drug interactions. Such tests would be a useful tool in the development of formulations that would not be susceptible to the influence of co-administered meal and, furthermore, facilitate regulatory decision on the necessity to conduct food effect studies in vivo.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "International Journal of Pharmaceutics",
title = "Tablet disintegration and drug dissolution in viscous media: Paracetamol IR tablets",
volume = "355",
number = "1-2",
pages = "93-99",
doi = "10.1016/j.ijpharm.2007.11.058"
}
Parojčić, J., Vasiljević, D., Ibrić, S.,& Đurić, Z.. (2008). Tablet disintegration and drug dissolution in viscous media: Paracetamol IR tablets. in International Journal of Pharmaceutics
Elsevier Science BV, Amsterdam., 355(1-2), 93-99.
https://doi.org/10.1016/j.ijpharm.2007.11.058
Parojčić J, Vasiljević D, Ibrić S, Đurić Z. Tablet disintegration and drug dissolution in viscous media: Paracetamol IR tablets. in International Journal of Pharmaceutics. 2008;355(1-2):93-99.
doi:10.1016/j.ijpharm.2007.11.058 .
Parojčić, Jelena, Vasiljević, Dragana, Ibrić, Svetlana, Đurić, Zorica, "Tablet disintegration and drug dissolution in viscous media: Paracetamol IR tablets" in International Journal of Pharmaceutics, 355, no. 1-2 (2008):93-99,
https://doi.org/10.1016/j.ijpharm.2007.11.058 . .

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