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KMID : 0369820100400050297
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Jorunal of Korean Pharmaceutical Sciences
2010 Volume.40 No. 5 p.297 ~ p.304
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A Novel Drug Delivery Approach to Olanzapine Orally Dispersible Tablet (ODT) in the Phase of Schizophrenia and Its Pharmacokinetics
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Kim Hyun-Jo
Park Jeong-Hwan
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Abstract
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The present work focuses on preparation of olanzapine, orally dispersing tablets by direct compression method. Effect of super disintegrant crospovidone, disintegration time, drug content on in vitro release has been studied. A factorial design was employed in formulating a prompt dispersible tablet. The selected independent variables crospovidone and fmelt showed significant effect on dependent variables i.e. disintegration time and percent drug dissolved. Disintegration time and percent drug dissolved decreased with increase in the level of crospovidone. The similarity factor f2 was found to be 97.48 for the developed formulation indicating the release was similar to that of the marketed formulation. Pharmacokinetics of olanzapine after single-dose oral administration of orally disintegrating tablet in normal volunteers were evaluated and the results showed that PK parameters (Cmax, Tmax, AUC) of the designed ODT matrix were similar to those of commercial product, Zyprexa Zydis(R) as a reference.
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KEYWORD
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Olanzapine, Schizophrenia, Crospovidon, Fmelt, Direct compression and orally dispersible tablet(ODT)
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