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Engineer C.,Sardar Vallabhbhai National Institute of Technology, Surat | Parikh J.,Sardar Vallabhbhai National Institute of Technology, Surat | Raval A.,Sahajanand Medical Technologies Pvt. Ltd.
Chemical Engineering Research and Design | Year: 2011

The in vitro hydrolytic degradation behavior of poly(d,. l-lactide-co-glycolide) (PLGA) has been systematically investigated 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 facilitate 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 behavior 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.


Raval A.,Sardar Vallabhbhai National Institute of Technology, Surat | Parikh J.,Sardar Vallabhbhai National Institute of Technology, Surat | Engineer C.,Sahajanand Medical Technologies Pvt. Ltd.
Industrial and Engineering Chemistry Research | Year: 2011

Implantation of Drug Eluting Stents (DES) is the most accepted technique currently available to treat cardiovascular blockages. First generation DES uses polymers for drug delivery which are nondegradable in nature and remains attached to stent surface lifetime. Biodegradable polymers have gained immense attention for controlled drug delivery of therapeutic drugs from cardiovascular stents in recent times as nondegradable polymers are associated with long-term adverse events. Studies showed that permanent contact with this polymer creates local inflammatory reactions and long-term stent thrombosis which raises concerns over the widespread use of DES. Biodegradable polymers are widely accepted biomaterials in human health care area and have proved its biocompatibility as drug delivery vehicle in various medicinal applications. This research work is carried out to study mechanisms affecting drug release kinetics from coated cardiovascular stents composed of biodegradable poly lactide-co-caprolactone and polyvinyl pyrrolidone. A conventional air brush technique was effectively modified so that Co-Cr L605 metallic stents were coated within multiple layers having drug Sirolimus blended together with biodegradable polymeric matrix. Kinetic studies for drug dissolution from a stent are carried out in simulated biological fluid using high performance liquid chromatography (HPLC) with simultaneous monitoring of surface morphology by scanning electron microscopy (SEM). Drug elution data analyzed by mathematical models suggested a combination of surface drug dissolution and diffusion as major drug release mechanisms. Investigation of different top coats revealed that drug release is influenced by the hydrophobicity of the drug free protective layer. © 2011 American Chemical Society.


Engineer C.,Sardar Vallabhbhai National Institute of Technology, Surat | Parikh J.,Sardar Vallabhbhai National Institute of Technology, Surat | Raval A.,Sahajanand Medical Technologies Pvt. Ltd.
Trends in Biomaterials and Artificial Organs | Year: 2011

Biodegradable polymers are extensively used in medical device industry for the controlled delivery of pharmaceutical agent to the targeted region. Successful performance of any controlled drug delivery system (DDS) relies on the drug elution kinetics which further depends on the degradation behavior of the biodegradable polymers. Thus, fundamental understanding of the polymer degradation phenomena is the important aspect in the design and development of controlled drug delivery system. Polymer degradation is the complex phenomena known to be affected by the various inter-related factors such as polymer physico-chemical properties, drug-polymer interaction, preparation technique, degradation environment, etc. This article intends to provide the overview of the degradation mechanisms of biodegradable polymers, factors influencing the degradation, advanced characterization techniques of polymer degradation, various modeling approach to study polymer degradation and influence of polymer degradation on biocompatibility.


Raval A.,Sardar Vallabhbhai National Institute of Technology, Surat | Parikh J.,Sardar Vallabhbhai National Institute of Technology, Surat | Engineer C.,Sahajanand Medical Technologies Pvt. Ltd.
Chemical Engineering Research and Design | Year: 2010

Targeted drug delivery systems are used to minimize the adverse effects of the pharmaceutical agents while maintaining the high local drug concentrations. To minimize post-angioplasty complications like tissue hyperplasia and related restenotic events, cardiovascular stents coated with anti-inflammatory, anti-proliferative agents have been proposed. The efficacy and toxicity of local therapeutics depends upon drug release kinetics which will further decide drug deposition, distribution, and retention at the target site. Drug eluting stents (DES) presently possesses clinical importance as an alternative to coronary artery bypass grafting due to ease of procedure and comparable safety and efficacy. This paper focuses on preparation and evaluation of controlled drug release biodegradable systems for stent base drug delivery providing insight of the drug elution mechanism which ultimately governs release kinetics. Multiple layers of dexamethasone-biodegradable polymers were successfully spray coated on Co-Cr alloy L605 metallic stents by modified air brush technique. In vitro drug elution data acquired by high performance liquid chromatography (HPLC) revealed that release of dexamethasone can be modulated up to 3 weeks by optimized use of blends of biodegradable poly- l-lactide-co-caprolactone and polyvinyl pyrrolidone. Surface investigation by scanning electron microscopy (SEM) represented smooth surface finish without any irregularities suggesting the efficacy of utilization of optimal coating parameters for multiple layer coating. © 2010 The Institution of Chemical Engineers.


Raval A.,Sardar Vallabhbhai National Institute of Technology, Surat | Parikh J.,Sardar Vallabhbhai National Institute of Technology, Surat | Engineer C.,Sahajanand Medical Technologies Pvt. Ltd.
Brazilian Journal of Chemical Engineering | Year: 2010

Utilization of biodegradable polymers for controlled drug delivery has gained immense attention in the pharmaceutical and medical device industry to administer various drugs, proteins and other biomolecules both systematically and locally to cure several diseases. The efficacy and toxicity of this local therapeutics depends upon drug release kinetics, which will further decide drug deposition, distribution, and retention at the target site. Drug Eluting Stent (DES) presently possesses clinical importance as an alternative to Coronary Artery Bypass Grafting due to the ease of the procedure and comparable safety and efficacy. Many models have been developed to describe the drug delivery from polymeric carriers based on the different mechanisms which control the release phenomenon from DES. Advanced characterization techniques facilitate an understanding of the complexities behind design and related drug release behavior of drug eluting stents, which aids in the development of improved future drug eluting systems. This review discusses different drug release mechanisms, engineering principles, mathematical models and current trends that are proposed for drug-polymer coated medical devices such as cardiovascular stents and different analytical methods currently utilized to probe diverse characteristics of drug eluting devices.


Engineer C.,Sardar Vallabhbhai National Institute of Technology, Surat | Parikh J.,Sardar Vallabhbhai National Institute of Technology, Surat | Raval A.,Sahajanand Medical Technologies Pvt. Ltd.
Trends in Biomaterials and Artificial Organs | Year: 2010

In-vitro degradation of 50/50 PLGA for programmed drug release has been systematically investigated from the drug eluting stents. Mass loss, molecular weight reduction, thermal changes and surface morphology of the drug eluting stents were analyzed as a function of degradation time. It was observed that degradation of 50/50 PLGA occurs in two phases. Quick decrease in molecular weight but little mass loss took place during first phase whereas in second phase, molecular weight reduction is slow with significant mass loss. This phenomenon supports heterogeneous degradation mechanism of PLGA. Drug release was attributed to diffusion rather then polymer degradation.


Sinha R.P.,Mahatma Gandhi Cardiac and Critical Care Center | Kothari S.R.,Sahajanand Medical Technologies Pvt. Ltd | Thakkar A.S.,Sahajanand Medical Technologies Pvt. Ltd
Journal of Clinical and Diagnostic Research | Year: 2016

A well executed transseptal puncture is crucial for successful percutaneous transvenous mitral balloon valvotomy. We report a case of accidentally damaged Mullins sheath dilator. Due to immediate unavailability of another dilator at cardiac catheterization laboratory, angioplasty guidewire and balloon was used as an additional assisting armamentarium for successful percutaneous transvenous mitral balloon valvotomy. © 2016, Journal of Clinical and Diagnostic Research. All rights reserved.


Sinha R.P.,Mahatma Gandhi Cardiac and Critical Care Center | Agarwal D.,Mahatma Gandhi Cardiac and Critical Care Center | Sarang A.M.,Sahajanand Medical Technologies Pvt. Ltd | Thakkar A.S.,Sahajanand Medical Technologies Pvt. Ltd
Journal of Clinical and Diagnostic Research | Year: 2015

Dextrocardia with situs inversus is a rare clinical entity with an estimated incidence ranges from 1 in 8000 to 1 in10,000. Percutaneous intervention in patient with dextrocardia and situs inversus is clinically challenging due to abnormal orientation of coronary geometry and the intervention requires appropriate use of guiding catheters, engagement technique, appropriate radiological angles as well as views. In this case-report, we describe percutaneous intervention with stenting in 48-year-old male patient with dextrocardia and situs inversus. We successfully deployed drug-eluting stents in right coronary artery and left circumflex artery. © 2015, Journal of Clinical and Diagnostic Research. All rights reserved.


PubMed | Gandhi Medical College & Hospital, Secunderabad Diagnostic & Research Center, Sahajanand Medical Technologies Pvt. Ltd. and Yashoda Hospital
Type: Journal Article | Journal: The Indian journal of medical research | Year: 2016

The genesis of atherosclerotic lesions, a major cardiovascular risk factor starts in the early stage of life. If the premature development of cardiovascular risk factors can be anticipated during childhood, cardiovascular events can be prevented effectively by taking appropriate measures. This study was carried out to assess the role of in utero malnutrition in cardiovascular disease development by comparing cord blood lipid profiles and serum insulin levels between small-for-gestational-age (SGA) and appropriate-for-gestational-age (AGA) term newborns.Consecutive full-term infants who were born between June 20 and August 19, 2013, at the Obstetric Unit of a Hospital at Secunderabad, India, were enrolled in this study. Participating newborns were divided into SGA group (n = 51; test group) and AGA group (n = 52; control group) based on their gestational age and body weight. Cord blood lipid profile and insulin levels were compared between these two groups.As compared to the newborns in AGA group, SGA group of newborns had significantly (P<0.01) higher levels of cholesterol, triglyceride and low-density lipoprotein. No difference was observed between the groups for high-density lipoprotein and insulin levels. Mild and moderate anaemia was observed among mothers of both groups, while severe anaemia was seen in mothers of SGA group only.SGA newborns exhibited elevated lipid profiles as compared to AGA newborns. Hence, SGA newborns should be closely monitored for cardiovascular morbidities during childhood, adolescence and early adult life.


Patent
Sahajanand Medical Technologies Pvt. Ltd. | Date: 2014-07-30

The present disclosure relates to a coated implantable medical device, comprising: a base layer comprising mTOR inhibitor, and at least one biodegradable polymer; a middle layer comprising mTOR inhibitor, and at least one biodegradable polymer; and a top layer selected from the group consisting of hydrophilic polymer, and combination of hydrophilic polymer and antioxidant, wherein the total mTOR inhibitor concentration over the medical device is in the range of 0.7 to 3.00 g/mm2. The present disclosure further relates to a method of preparing a coated implantable medical device.

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