A team of scientists at Indian Institute of Technology Roorkee has developed an advanced orthopaedic implant technology for sustained drug release which would prove to be a boon to millions suffering from joint diseases such as osteoarthritis, osteoporosis, fragility fractures and sports injuries. The innovation is validated at laboratory scale and the technology is available for transfer to the industry for commercial application.

Total joint or bone replacement, sometimes imperative to minimise pain and increase mobility of patients suffering from musculoskeletal (MSK) disorders, can be complicated by infection of orthopaedic implants which can lead to rejection or costly revision surgery. All metallic implants available in the market now are biologically compatible but inert. This leads to weak interface with the bone causing aseptic loosening. In fact, aseptic loosening and peri-prosthetic bacterial infection are the two foremost causes of implant failure. The innovative implant, developed by three IIT scientists Dr Debrupa Lahiri, Manoj Kumar Rangaswamy and Prof Partha Roy can prevent infection and promote osseo-integration concurrently.

“Researchers usually focus on designing of ceramic coatings on metal implants to improve the osseo-integration and stability of the implant, while ignoring microbial susceptibility or vice versa, to prevent implant related infection while ignoring bone mineralisation. However, both osseo-integration and antibacterial functionalities are required for implant coating to attain long-term success. This is lacking in the existing implants and leads to a failure rate of about 10 per cent,” Dr Lahiri, an assistant professor at the Department of Metallurgical and Materials Engineering at the IIT, told Pharmabiz.

MSK patients who undergo bone or joint replacement operations are administered antibiotics orally or intravenously after surgery to curb infections. However, the method is not effective in target specific drug delivery and increases risk of toxicity. The new technology comprises a metal implant with hydroxyapatite coating loaded with antibiotics using a novel method to maintain osseo-integration while providing sustained release of antibiotic to the target area to prevent infection. It ensures continuous release of the drug for up to 180 hours thereby checking microbial infections.

“Our invention improves the orthopaedic implant quality by simultaneously promoting osseo-integration and inhibiting microbial cells and biofilm formation. This would increase the success rate of implants substantially. When used to replace a damaged bone permanently, it provides immediate relief from pain and helps the patient rejoin active life quickly,” she added.

Dr Lahiri and her team have been working on the project for more than five years to create a fool-proof know-how which has the potential to radically change the treatment and management of MSK. The invention assumes significance as MSK disorders are the second most cause of disability worldwide affecting more than1.7 billion people. In India, 12-15 per cent of the population are affected by MSK disorders.

The trio of inventors has handed over the technology to Biotech Consortium India Limited, a public sector company promoted by the Department of Biotechnology, to facilitate its speedy commercialisation. “Our method has been validated in the lab through in vitro drug release kinetics, mechanical behaviour and antimicrobial activity tests. It offers the domestic industry an opportunity to tap the fast-growing orthopaedic devices market,” Partha Roy, another member of the research team, opined.

“A few companies have evinced interest in it and held talks with BCIL for technology transfer,” Dr Lahiri added.

The orthopaedic devices market in the country is witnessing a rapid growth as sedentary lifestyle and overworking or under utilising joints contribute to a rise in osteoporosis or arthritis cases. It is estimated that there will be around 60 million osteoarthritis cases in India by 2025. The market is experiencing a double digit growth rate and expected to expand by 20 per cent annually, touching nearly $2.5 billion by 2030.