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academies
Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
May 14-15, 2018 | Montreal, Canada
Global Summit on
Biopharma & Biotherapeutics
D
uring the last few years, especially after the introduction
of Biopharmaceutics Classification System (BCS) and its
acknowledgment by various health regulatory agencies,
the concept of Biowaivers and IVIVC are the main focus of
attention in academia, regulatory agencies, pharmaceutical
industrial sectors and R&Ds. The aim of this study was to
develop and optimize Nimesulide oral controlled release
tablet formulations using various excipients for IVIVC studies.
In present work, HPMC K4M was used in the development
of three types of dosage form immediate, intermediate and
controlled release tablets. Design expert® version 7. Using
central composite rotatable design (CCRD) was used for the
optimization of all formulations. Weight variation, friability,
hardness, disintegration, dissolution and assay were found
to be in acceptable limits. The assay was performed using
an isocratic HPLC method. RP-18 column (Supelcosil LC-
18-DB 250x4.6 mm, 5 μm (Supelco, Bellefonte, PA, USA)
having mobile phase consisting of Acetonitrile, Phosphate
buffer (pH 5.5) and methanol in the ratio of 35:45:20 was
used respectively. All validation parameters were found
within the acceptance limits. Single centered cross over,
four cycle healthy human volunteer study was performed on
12 healthy male volunteers after taking informed consent.
The time versus plasma drug concentration was then used
for evaluating pharmacokinetic parameters including in-
vivo bioequivalence using Kinetica 4.4.1. a PK/PD software
while Phoenix WinNonlin IVIVC toolkit 1.0 was used for
IVIVC studies. All values of average and individual internal
percentage prediction error of Cmax and AUClast were
less than 10 and 15 respectively, in all medium. Internal
percentage prediction error (%PE) of Cmax was 1.840 and
3.05% while AUClast were found to be 9.98 and 7.17% at
pH6.8 and 7.4 with USP dissolution apparatus II at 100rpm.
e:
muhammad.hanif@bzu.edu.pkIn-vivo in-vitro
correlation (IVIVC) studies of the BCS class II drug
Muhammad Hanif
Bahauddin Zakariya University, Pakistan