Portal Rasmi Agensi Nuklear Malaysia

A BONE GRAFT SUBSTITUTES AS DRUG DELIVERY SYSTEM

Filing Number : PI 20085327

 

This product porous HA or HA/TCP with antibody drug delivery system is namely “Bonigent” .The objective is to develop a product as bone graft substitute (BGS) with special ability of delivering antibiotic drug (gentamycin) to bone tissue for better and more effective healing process. Malaysian Nuclear Agency already established technology of producing porous bone graft made from hydroxyapatite (HA) and successes in producing mixture powder of hydroxyapatite and tricalcium phosphate (HA/TCP). The purpose of this project is to investigate the feasibility of coated gentamycin as a drug delivery system (DDS) that serves dual functions, to combating biofilms and to enhance bone ingrowths. We also successfully in producing a scaffold bone graft substitutes coated with antibiotic gentamycin to combating bio-film and prevent the failure medical device implant for healthy and human nation. When a foreign material synthetic biomaterial (implants or scaffolds of bone graft substitutes) is introduced into the body, there would be normally formation of biofilm that can lead to systemic infection and cause device failure. Surgeon will use antibiotic such as gentamycin to avoid these effects. In this product, antibiotic (gentamycin) is incorporated into the scaffolds HA porous and would then be released slowly into the bone tissue upon implantation, this way would increase drug penetration, thus avoiding systemic infection, preventing the formation of biofilm and improved healing. Thus, from this project we successfully in getting the pattern file No: PI 20085327. Porous bone graft substitutes are coated with antibiotic by immerse technique. The gentamycin-coated porous bone graft substitutes are disinfected for medical implant. Porous HA and HA/TCP has the potential to be used as synthetic bone graft materials because it is bioactive and biocompatible with bone tissues. Surgeons would use antibiotics such as gentamycin to avoid these effects. With Bonigent, antibiotic (gentamycin) which may be in a crystalline or non-crystalline form is incorporated into the scaffolds hydroxyapatite (HA) porous which would then be released slowly into the bone tissue upon implantation. This will result in increased drug penetration, thus avoiding systemic infection and prevent the formation of biofilm and results in improved healing. This drug delivery system serves two important functions; first is in combating biofilms and secondly, enhancing bone ingrowths.

 

Product Application
Surgeons use bone grafts to repair and rebuild diseased bones in hips, knees, spine, and sometimes other bones and joints. Grafts can also repair bone loss caused by some types of fractures or cancers. Once the body accepts the bone graft, it provides a framework for growth of new, living bone.

  • Bonipor is designed to be used as new bone graft substitute (BGS) by orthopedic surgeons, craniofacial surgeons, dental surgeons and maxillofacial surgeons.
  • Bonigent is intended to be used as new bone graft substitute (BGS) already incorporated with antibiotic gentamycin with special feature of slow release into the local bone tissue. Bonigent is suitable for non-load bearing application in the field of orthopedic as well as dental and maxillofacial surgeries.

 

Product Advantages

  • Safer Alternative to Autograft
  • Provide an alternative to bone graft substitute using autograft (material from same patient) and allograft (materials from donor) procedures
  • Offer Safer and More Reliable Solution
  • HA/TCP porous BGS offers safer and more reliable solution to replace devoid bones and the repair of bone defects compared to autografts and allografts
  • No Reliance on Patient or Donor for BGS
  • Do not need to rely on patient or donor for BGS
  • Custom-Made
  • Product can be custom-made according to prescription by surgeons according to size, shape (blocks or chips) and strength
  • Local Material The use of local material in the fabrication process together with home grown technology brings the cost down
  • Slow Release of Antibiotic
    • Improved bone graft antibiotic locally slow release used in bone defect sites of osteomyelitis.
    • To prevent the biofilm formation especially in medical implants by using the gentamycin-coated HA slow release method.
    • Gentamycin-coated HA is biocompatible to human normal cell and is thus safe to use

 

Economic And Financial Feasibility
The market price of HA is around RM39,000 per kilogram. The purchase price of bone graft substitute by Ministry of Health Malaysia. The variable cost of producing HA is only RM3,500 per kilogram. This means that the selling price is 6.6 times of variable cost. With a huge margin to cover the fixed cost, the production of HA could financially be very attractive. By extension, the production of the porous bone graft Bonipor and the enhanced product of Bonigent are equally promising. Rough estimate of the cash flow analysis over five years indicates that production of bonegraf is a very profitable venture with an internal rate of return (IRR) of 370%. The estimated Net Present Value (NPV) at 8% interest rate for over 5 years is RM36,352,224.00. The payback period is within 1 year. Local production of bone graft for local usage may not have any significant economic impact. However there will be some saving of foreign exchange.