Research Article
Role of P-Glycoprotein Inhibitors in the Bioavailability
Enhancement of Solid Dispersion of Darunavir
Saleha Rehman,
1
Bushra Nabi,
1
Mohammad Fazil,
1
Saba Khan,
1
Naimat Kalim Bari,
2
Romi Singh,
3
Shavej Ahmad,
3
Varinder Kumar,
3
Sanjula Baboota,
1
and Javed Ali
1
1
Department of Pharmaceutics, School of Pharmaceutical Education & Research, Jamia Hamdard, New Delhi 110062, India
2
Institute of Nanoscience and Technology, Phase X, Mohali, Chandigarh, Punjab, India
3
Research and Development Centre, Sun Pharmaceuticals Industries Ltd., Gurgaon, Haryana, India
Correspondence should be addressed to Javed Ali; javedaali@yahoo.com
Received 7 July 2017; Revised 15 September 2017; Accepted 2 October 2017; Published 31 October 2017
Academic Editor: Kamla Pathak
Copyright © 2017 Saleha Rehman et al. Tis is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Objective. Te aim of the present study was to improve bioavailability of an important antiretroviral drug, Darunavir (DRV), which
has low water solubility and poor intestinal absorption through solid dispersion (SD) approach incorporating polymer with P-
glycoprotein inhibitory potential. Methods. A statistical approach where design of experiment (DoE) was used to prepare SD of
DRV with incorporation of P-glycoprotein inhibitors. Using DoE, diferent methods of preparation, like melt, solvent evaporation,
and spray drying method, utilizing carriers like Kolliphor TPGS and Soluplus were evaluated. Te optimized SD was characterized
by DSC, FTIR, XRD, and SEM and further evaluated for enhancement in absorption using everted gut sac model, efect of food on
absorption of DRV, and in vivo prospect. Results and Discussion. DSC, FTIR, XRD, and SEM confrmed the amorphicity of drug
in SD. Oral bioavailability studies revealed better absorption of DRV when given with food. Absorption studies and in vivo study
fndings demonstrated great potential of Kolliphor TPGS as P-glycoprotein inhibitor for increasing intestinal absorption and thus
bioavailability of DRV. Conclusion. It is concluded that SD of DRV with the incorporation of Kolliphor TPGS was potential and
promising approach in increasing bioavailability of DRV as well as minimizing its extrusion via P-glycoprotein efux transporters.
1. Introduction
Acquired Immunodefciency Syndrome (AIDS) has been one
of the most devastating pandemic diseases over the last few
decades caused by its etiologic agent Human Immunodef-
ciency Virus (HIV). Latest reports reveal that globally 40
million people are infected with HIV including 2.1 million
from India in 2013 [1]. HIV is responsible for killing helper
T-lymphocytes (CD4
+
T-cells) which play a key role in the
process of gaining immunity to specifc pathogens, including
HIV itself. No complete cure is possible for people with AIDS
and life-long treatment with a combination of antiretroviral
drugs; that is, Highly Active Antiretroviral Terapy (HAART)
is the only therapeutic intervention with proven efcacy
against HIV infection [2, 3].
HIV protease inhibitors (PIs) currently are the key com-
ponents of frst-line therapy in both treatment-resistant and
treatment-experienced patients. Te introduction of novel
second-generation PIs such as Darunavir Ethanolate (DRV)
with activity against wild type HIV-1 virus and multidrug
resistant strains requires at least four concomitant mutations
in the viral genome for resistance development, thus provid-
ing clinicians with superior drugs to counter the development
of resistance [4]. DRV is coadministered with food and low
dose Ritonavir (RTV), a potent CYP3A4 inhibitor as a phar-
macokinetic booster to result in clinically relevant increase in
the systemic exposure (bioavailability increase by up to 40%)
of DRV [5, 6]. However, DRV sufer from disadvantages such
as low solubility in water (0.15 mg/ml) and poor intestinal
uptake due to drug efux through active efux transporter P-
glycoprotein (P-gp) and by drug metabolism via Cytochrome
P450 (CYP) 3A [7, 8].
Te current clinical antiretroviral therapies have subop-
timal therapeutic efect attributed to poor bioavailability of
anti-HIV drugs which is due to either their poor solubility,
extreme frst pass metabolism, extrusion into intestine lumen
Hindawi
BioMed Research International
Volume 2017, Article ID 8274927, 17 pages
https://doi.org/10.1155/2017/8274927