Orthopedic Implant for Sustained Drug Release

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Introduction

 

Present invention improves the present orthopedic implant system quality by simultaneously promoting Osseo-integration and inhibiting microbial cells and biofilm formation. This invention is planned to increase the success rate of orthopedic implants by reducing the early implant failure due to infection. These are generally used to replace a damaged bone permanently and providing immediate relief of pain to patient and helping to rejoin active life. The new implant comprises a metal implant with Hydroxyapatite (HA ) coating loaded with antibiotics using a novel method to maintain Osseo-integration while providing sustained release of antibiotic to prevent infection.

 

Market

 

Increase in the aging population and sedentary lifestyle, musculoskeletal ( MSK ) disorders are the second most cause of disability worldwide, Musculoskeletal conditions, which affect over 1.7 billion people globally, include joint diseases, such as, osteoarthritis, osteoporosis, fragility fractures, back and neck pain, soft tissue rheumatism, injuries due to sports, workplace and road traffic accidents. In India, 12-15% of the population seems to suffer from MSK. The global biomaterials market, including medical device and implants, is estimated to be greater than $130.17 billion US Dollars by the end of 2021 and is expected to increase by 13.2 % every year. The largest market size amongst all biomaterial products belongs to orthopedic devices which is expected to reach $41.2 billion US Dollars by 2019. The current size of the Indian orthopedic devices market is ~$375 million US Dollars (Rs. 2,400 crores) and it will grow ~ 20% every year for the next decade to reach $2.5 billion US Dollars (Rs. 16,000 crores) by 2030. The invention offers itself as an opportunity to tap the untapped markets by meeting the unmet need for a better orthopedic implant.

 

Validation

 

This novel implant has been validated in lab through a no. of tests including the following:

 

TESTS

RESULTS

In vitro drug release kinetics

•  Fastest release of drug about 51% within fits 24 hrs by diffusion mechanism

•  Around 80% drug is released within first 120 hrs

•  Sustained release up to 180 hrs through degradation of polymer

Mechanical behaviour

Tested using Nanovea M1 mechanical tester & Vickers diamond indenter

•  Insignificant decrease in hardness and elastic modulus

•  Increase in fracture toughness

Antimicrobial activity

Tested using Agar disc diffusion method by exposing implants to culture of S. aureus

•  Distinctly clear and bacteria free zone observed around the novel implant

 

Key Features

 

•  Concurrently, prevents infection and promotes Osseo-integration

•  Sustained release of drug up to 180 hours

•  Enhanced fracture toughness by 29%

•  Improved mechanical and tribological properties

 

Stage of Development

 

This is a lab scale validated technology

•  Biocompatibility found to be favourable

•  Validated the antimicrobial activity of the implant

•  Validated increase in fracture toughness

 

Applications

 

Bone Replacement for

•  Severe Arthritis

•  Sports Injury

•  Accidental bone damage

 

For further information please contact

 

Biotech Consortium India Limited

V Floor, Anuvrat Bhawan

210, Deen Dayal Upadhay Marg

New Delhi-110002

Phones: +91 (011) 23219064-67