A Novel Injectable Solidifying Formulation for Improved Bone Fracture Healing

Application

The healing of fractures could be a slow process that implies patient suffering and temporary disability, and incurs costs to healthcare, insurance and social security systems. The current interventions for stabilization of complicated fractures improve the ultimate outcomes but do not accelerate the natural healing processes of the bone. There is a need for non-surgical intervention that could potentially accelerate fracture healing processes.

Our Innovation

• Using injectable polymeric implants – liquids that solidify in the vicinity of the fracture:
• The solidified implants are expected to perform several functions:
• Isolate the fracture site
• Allow adherence, proliferation and differentiation of mesenchymal stem cells present in the fracture and periosteum
• Contain and release in controlled manner locally available drugs that augment bone regeneration, e.g. simvastatin

Advantages

• Non-surgical
• Minimally invasive
• Acceptable viscosity allowing injection via various cannulas
• Immediate solidification upon contact with aqueous surface, e.g. fracture hematoma, tissues etc.

Figure 1 The solidification kinetics is rapid even without freely available water

Figure 2 The solidification kinetics is rapid to allow shaping of the residue into any desired form

Technology

• Pharmaceutically acceptable ingredients:
• Eudragit ® polymers (pharmaceutical polymethacrylates)
• Main solvent: N-methyl pyrrolidone (NMP)
• Co-solvents: PEG 400, propylene glycol, DMSO
• Regulatory bodies approved drugs – simvastatin etc
• Approved formulation additives – calcium salts, other approved additives

Opportunity

• First-of-a-kind product in fracture care: a minimally invasive non-surgical solution.
• The formulation is a suitable carrier for various active agents.

Patent Status

Published WO 2018/055615