Research Papers

Development and Evaluation of Drug Eluting Stent Having Biphasic Release From a Single Layer of Biodegradable Polymer

[+] Author and Article Information
Ramila Mandal

Sahajanand Medical Technologies Pvt. Ltd.,
Surat, India

Sanjay Parmar

L. M. College of Pharmacy,
Ahmedabad, India

Jaynish Tailor

Sahajanand Medical Technologies Pvt. Ltd.,
Surat, 395004, India

Anita Mehta

L. M. College of Pharmacy,
Ahmedabad, 380009, India

Manuscript received August 13, 2012; final manuscript received December 18, 2012; published online February 4, 2013. Assoc. Editor: Paul A. Iaizzo.

J. Med. Devices 7(1), 011005 (Feb 04, 2013) (5 pages) Paper No: MED-12-1102; doi: 10.1115/1.4023414 History: Received August 13, 2012; Revised December 18, 2012

In stent restenosis is the major disadvantage of percutaneous transluminal angioplasty. To overcome this limitation, drug eluting stents were introduced. We have developed novel sirolimus eluting stent using biocompatible and biodegradable polymer matrix. Developed stent have biphasic release profile for sirolimus from a single layer of polymer matrix, having blend of slow and fast degrading polymers. Coating integrity of coated stents were evaluated after crimping and postexpansion with the help of scanning electron microscopy while thickness of coated stent was measured using destructive test method. This shows that drug-polymers bilayer was uniformly coated with the average thickness of 5.2 μms. There was no deformation after crimping and expansion of the stent. We have also measured in vitro and in vivo release profiles of sirolimus from stents which shows biphasic release characteristics, i.e., initial burst period followed by sustained release. In vitro release profile is well correlated with in vivo release in blood and arterial tissues. Developed stents showed good efficacy and safety in porcine coronary artery model.

Copyright © 2013 by ASME
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Fig. 1

SEM images of stent in various situations. (a) SEM image of sterile crimped stent, (b) SEM image of sterile post-expansion stent, (c) SEM image of sterile normal stent.

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Fig. 2

In vitro release of Sirolimus from the stents. In vitro release analysis of 11 mm, 16 mm, and 39 mm length stent shows similar type of release pattern.

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Fig. 3

In vivo concentration of Sirolimus in tissue (ng/mg) and blood (ng/ml) at various time intervals after stent implantation. Sirolimus concentration in tissue shows biphasic release profile, i.e., initial burst release and then sustain release.

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Fig. 4

% Cumulative concentration in blood versus % cumulative release in vitro of Sirolimus from 16 mm stent

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Fig. 5

Histological sections of stented coronary arteries (a) developed stent and (b) BMS after eight weeks of implantation




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