Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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A Novel Drug Delivery Approach to Olanzapine Orally Dispersible Tablet (ODT) in the Phase of Schizophrenia and Its Pharmacokinetics

  • Kim, Hyun-Jo (R&D Center, Product Planning & Development Div., Korean Drug Co. LTD.) ;
  • Park, Jeong-Hwan (R&D Center, Product Planning & Development Div., Korean Drug Co. LTD.)
  • Received : 2010.07.30
  • Accepted : 2010.10.07
  • Published : 2010.10.20
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Abstract

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 $f_2$ 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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References

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