Inventi Rapid: Pharmacokinetics & Pharmacodynamics Vol. 2013, Issue 2
[ISSN 2278-4101]
2013 pkd 97, CCC: $10 © Inventi Journals (P) Ltd
Published on Web 12/04/2013, www.inventi.in
RESEARCH ARTICLE
INTRODUCTION
Piroxicam (PIRO) is a nonsteroidal anti-inflammatory drug
(NSAID) of the oxicam family that has been recognized for
its value as a chemopreventative, anti-tumor agent, acute
and chronic musculoskeletal and joint disorders such as
ankylosing spondylitis, osteoarthritis, rheumatoid arthritis,
dysmenorrhoea and sometimes for pain associated with it.
[1]
Oxicams derive their anti inflammatory effect from
inhibition of cyclooxygenase (COX) activity and
subsequent repression of prostaglandin synthesis. Two
forms of COX are currently recognized. Cyclooxygenase-1
is found in the stomach, gastrointestinal tract, platelets
and kidney. It is this form that is responsible for most of
the side effects associated with NSAIDs.
[2]
Cyclooxygenase-2 (COX-2) predominates at areas of
inflammation, immune reaction, and increased cellular
activity. Although the precise anti-tumor mechanisms of
PIRO and other NSAIDs are unknown, some have
suggested that they may be secondary to the
aforementioned COX and PG inhibition.
[3]
For poorly soluble, highly permeable (class II) drugs
(like piroxicam), the rate of oral absorption is often
controlled by the dissolution rate in the gastrointestinal
(GI) tract.
[2]
Therefore, together with permeability, the
solubility and dissolution behaviour of a drug are key
determinants of its oral bioavailability. This undesired
property, may also increase the amount of GI damage, due
to long contact of drug with the mucous of G.
[4]
The pharmacokinetics of PIRO have been evaluated in
humans, monkeys, rats, rabbits, and dogs. PIRO is almost
completely absorbed following oral (p.o.) administration
with a long apparent terminal half-life (t
1/2
) in all species
evaluated. Once absorbed, it undergoes enterohepatic
recirculation and extensive metabolism in the dog, rabbit,
and humans, with only a small amount of the drug being
excreted unchanged, Neither hepatic disorders nor
1
Tatyasaheb Kore College of Pharmacy, Warananagar, Kolhapur, M. S.,
India.
E-mail: santosh14july@rediffmail.com
*Corresponding author
2
Bharti Vidyappeth’s College of Pharmacy, Kolhapur, M.S., India.
disruption of the cytochrome P-450 system alter the
elimination rate of PIRO. However, as part of the
metabolism of PIRO in humans, a glucuronide conjugate is
formed. Rabbits are limited in their ability to form
glucuronide conjugates. The potential usefulness of this
drug in rabbits, the long t
1/2
, the presence of a glucuronide
conjugate, and the likelihood of adverse effects make it
important to determine the pharmacokinetics and
bioavailability (F) of PIRO in rabbit. The purpose of this
study was to determine these factors after both a single
intravenous (i.v.) and p.o. administration.
[3]
The studies described in this work were designed to
evaluate a new sublingual tablet system using low doses of
piroxicam. In this system, water-soluble carrier particles
are covered with piroxicam and a bioadhesive material
during dry mixing. In principle, the tablet quickly
disintegrates into the ordered units consisting of carrier,
piroxicam and bioadhesive component. These units initially
adhere to the mucosa. The water-soluble carrier particles
gradually dissolve and piroxicam dissolves along with
them. With this approach, optimal exposure of active
substance to the dissolving fluid is combined with
bioadhesive retention of the drug in the oral cavity.
[5]
The
main objective of this report is to investigate single dose
pharmacokinetics after administration of mucoadhesive
fast disintegrating piroxicam tablet and marketed
formulation in rabbit and observed the improved systemic
exposure of the parent drug, especially regarding
absorption rate.
MATERIALS AND METHODS
Reagents and Samples
All the Analytical grade materials were used. Piroxicam
reference standard was collected from Asoj Soft Caps. Pvt.
Ltd., India. Mucoadhesive fast disintegrating tablets were
formulated using mannitol, sodium croscramellose (SCC),
microcrystalline cellulose (MCC), dicalcium phosphate
(DCP), magesium stearate and mango flavor as an
excipient. Acetonitrile (HPLC grade), Distilled water (HPLC
grade) were used as analytical grade solvent for analysis
purpose.
[6, 7]
All the excipients and solvents were
purchased from Loba Cheme, Mumbai.
Single Dose Pharmacokinetics of Mucoadehsive Fast
Disintegrating Sublingual Tablet of Piroxicam in Rabbits
Kate V K
1
, Payghan S A
1*
, Shinde A J
2
Abstract: Oromucosal delivery, especially that utilising the buccal and sublingual mucosa as the absorption site, is a promising
drug delivery route which promotes rapid absorption and high bioavailability, with subseqent almost immediate onset of
pharmacological effect. These advantages are the result of the highly vascularised oral mucosa through which drugs enter the
systemic circulation directly, thus bypassing the gastrointestinal tract and the first pass effect in the liver. MFD tablet of
piroxicam (PX) are subjected to in-vivo pharmacokinetic evaluation to evaluate whether these systems improve oral
bioavailability of the piroxicam. All the pharmacokinetic parameters of absorption, namely Ka, Cmax, Tmax, percent absorbed to
various times and AUC indicated rapid absorption and higher bioavailability of piroxicam when administered as MFD Tablet.
The absorption rate constant (Ka) was found to be increased compare with marketed formulation. Both Ka and AUC were
markedly increased by MFD tablet. Thus, the results of pharmacokinetic studies indicated rapid and higher oral absorption of
piroxicam when administered as MFD tablet.
1