chemical engineering research and design 89 (2011) 328–334
Contents lists available at ScienceDirect
Chemical Engineering Research and Design
journal homepage: www.elsevier.com/locate/cherd
Effect of copolymer ratio on hydrolytic degradation of
poly(lactide-co-glycolide) from drug eluting coronary stents
Chhaya Engineer
a,1
, Jigisha Parikh
a,*
, Ankur Raval
b,2
a
Department of Chemical Engineering, Sardar Vallabhbhai National Institute of Technology, Ichchanath, Surat 395007, Gujarat, India
b
Sahajanand Medical Technologies Pvt. Ltd., Wakhariawadi, Nr. Dabholi Char Rasta, Ved Road, Surat, India
abstract
The in vitro hydrolytic degradation behavior of poly(d,l-lactide-co-glycolide) (PLGA) has been systematically inves-
tigated from the drug eluting coronary stents with respect to different copolymer compositions. The drug–polymer
coated stents were incubated in phosphate buffer saline (pH 7.4) at 37
◦
C and 120 rpm up to 12 months to facili-
tate hydrolytic degradation. Gel permeable chromatography, differential scanning calorimetry and scanning electron
microscopy were employed to characterize their degradation profiles. The study supports the bulk degradation behav-
ior for PLGA from coated stents. Molecular weight of polymer decreased immediately after immersion in PBS but
mass loss was not observed during first few days. The rate of hydrolytic degradation was influenced by copolymer
ratio, i.e., degradation of 50:50 PLGA was fastest followed by 65:35 PLGA and 75:25 PLGA. The drug release from PLGA
coated stent followed biphasic pattern which was governed by surface dissolution and diffusion of drug rather than
polymer degradation.
© 2010 The Institution of Chemical Engineers. Published by Elsevier B.V. All rights reserved.
Keywords: Poly(d,l-lactide-co-glycolide); Hydrolytic degradation; Restenosis; Drug eluting stent
1. Introduction
Coronary stents are a major advance in the treatment of
obstructive cardiovascular disease. However, in the substan-
tial number of patients, stent placement can trigger restenosis
after implantation (Costa et al., 2002). The concept of using
drug eluting stents for prolonged, sufficient, and localized
drug delivery to address restenosis is an important contem-
porary advance in interventional cardiology (Costa et al., 2002;
Babapulle and Eisenberg, 2002; Sousa et al., 2003).
Polymers play a critical role in local drug delivery from
the stent scaffold and to date, attempts to deliver drug with-
out polymer have not proven successful (Lansky et al., 2004;
Teirstein, 2004; John et al., 2008). The majority of first gen-
eration drug eluting coronary stent coatings are based on
hydrophobic polymers which retain and release drug in a con-
trolled fashion. Biodegradable polymers are often cited as an
alternative to biostable polymers for drug eluting stent coat-
∗
Corresponding author. Tel.: +91 261 2201689; fax: +91 261 2201641.
E-mail addresses: e.chhaya@ched.svnit.ac.in (C. Engineer), jk parikh@yahoo.co.in, jkp@ched.svnit.ac.in (J. Parikh),
ankur.med@sahmed.com (A. Raval).
Received 30 March 2010; Received in revised form 28 June 2010; Accepted 29 June 2010
1
Tel.: +91 261 2201689.
2
Tel.: +91 261 2521251; fax: +91 261 2520252.
ings (Doyle and Holmes, 2009; Hezi-Yamit et al., 2009). These
polymers degrade temporally, leaving behind only a bare metal
stent.
The family of aliphatic polyesters has been by far the
dominating choice for materials in degradable drug delivery
systems. The most extensively investigated and advanced
polymers in regard to available toxicological and chemical
data are the polylactide (PLA) and poly(lactide-co-glycolide)
(PLGA) (Lewis, 1990). The popularity of PLA and PLGA is fur-
ther explained by the fact that FDA has approved them for the
number of clinical applications (Edlund and Albertsson, 2002).
However the biocompatibility of these polymers, specifically
in a vascular setting, depends to a large extent on degradation
kinetics. Moreover, drug elution kinetics from the stent also
greatly depends upon polymer degradation.
In recent years, a number of parameters have been iden-
tified that influence the polymer degradation. Among them
are the copolymer composition (Vert et al., 1984), morphol-
0263-8762/$ – see front matter © 2010 The Institution of Chemical Engineers. Published by Elsevier B.V. All rights reserved.
doi:10.1016/j.cherd.2010.06.013