IJPR  articles are Indexed in SCOPUSClick Here     Impact Factor for Five Years is 0.13 (2013 - 2018).    

logo

INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence

IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
ISSN
0975-2366
Current Issue
Article In Press
No Data found.
ADOBE READER

(Require Adobe Acrobat Reader to open, If you don't have Adobe Acrobat Reader)

Index Page 1
Click here to Download
IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

Click to download
 

Article Detail

Label
Label
A Bioequivalence Evaluation of Two Different Olanzapine Orodispersible Tablet ormulations.

Author: UPLOADED BY-ADMIN, ARVIND R. DESAI, RAJESH KUMAR GOEL
Abstract: The objective was to demonstrate bioequivalence between olanzapine orodispersible 10mg tablet formulation (Torrent Pharmaceutical Ltd., India) as test and Zyprexa® Zydis® (Olanzapine) 10mg tablet (Eli Lilly & Company, Brazil) as reference. A total of 24 healthy human volunteers were participate. Each volunteer has received a single dose of olanzapine in each period of the study. The study design used was single-dose, randomized, open-label, two-period, two-treatment, two-sequence and crossover. Blood samples were taken before, and up to 144 hrs after drug administration. Plasma concentrations of olanzapine were determined by a validated LC-MS/MS method. The pharmacokinetic parameters, Cmax and Tmax, were obtained directly from plasma concentration data, Ke was estimated by log-linear regression, and the area under curve (AUC) was calculated by the linear trapezoidal rule. The parameter Cmax, AUC0-t and AUC0-inf, were tested for bioequivalence after logtransformation of data, while the differences of Tmax were evaluated non-parametrically. When Cmax, AUC0-t and AUC0-inf were analysed using analysis of variance, no statistically significant difference was observed between the two different olanzapine orodispersible 10mg tablet formulations. The 90% confidence intervals of the mean values for Cmax, AUC0-t and AUC0-inf were 95.44-111.47%, 95.27-111.03% and 89.43-109.16% respectively. All of these values were within the bioequivalence acceptance range of 80-125%. We found that both formulations were bioequivalent and therefore interchangeable in clinical practice.
Keyword: US-FDA, ANOVA, AUC, Vd, t1/2
Download: Request For Article
 












ONLINE SUBMISSION
USER LOGIN


Username
Password
Login | Register
News & Events

Terms and Conditions
Disclaimer
Refund Policy
Instrucations for Subscribers

0.12
2018CiteScore
 
8th percentile
Powered by  Scopus
Google Scholar

hit counters free