Tablet disintegration and drug dissolution in viscous media: Paracetamol IR tablets
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2008
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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.
Ključne reči:
food effect / in vitro-in vivo correlation / paracetamol / viscous mediaIzvor:
International Journal of Pharmaceutics, 2008, 355, 1-2, 93-99Izdavač:
- Elsevier Science BV, Amsterdam
DOI: 10.1016/j.ijpharm.2007.11.058
ISSN: 0378-5173
PubMed: 18226480
WoS: 000255696200011
Scopus: 2-s2.0-41449099515
Institucija/grupa
PharmacyTY - 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 . .