Bionpharma announced Wednesday the FDA approval of its etravirine tablets, an HIV therapy developed in partnership with STEERLife. The therapy was developed using STEERLife’s proprietary FragMelt continuous processing platform, which enables a sustainable, solvent-free manufacturing process.
Precise control: how FragMelt works with heat-sensitive drugs
Etravirine is extremely sensitive to heat and shear forces, meaning traditional manufacturing processes that apply heat or mechanical stress could degrade the drug, making it ineffective or unstable.
The FragMelt platform was specifically designed to work with heat-sensitive active pharmaceutical ingredients (APIs) through solvent-free melt fusion technology. Melt fusion applies simultaneous heat and shear to ingredients to create products with improved solubility. The process blends active ingredients with molten polymers under controlled conditions of pressure and temperature.
With FragMelt, excessive heat stress is avoided by shortening the time in the extruder, which combines the drug and polymer carrier, by increasing feed rates and screw speeds to enable the same energy input in a shorter time. The extruder melts the polymer carrier and breaks the drug into fine particles or dissolves it at the molecular level so it can be combined into the molten polymer. FragMelt allows for precise temperature controls during this process, raising the temperature enough to melt the polymer while keeping it below the degradation temperature of the active ingredient.
“FragMelt and our continuous processing approach were engineered specifically to solve complex formulation challenges such as these. This approval not only validates our platform but also reinforces the immense value of collaborative development and technology transfer in the generic pharmaceutical space,” said Indu Bhushan, CEO and director of STEERLife.
FragMelt prevents mechanical degradation of the API by controlling shear peaks, limiting the maximum amount of shear forces applied. The platform also ensures consistent energy distribution, avoiding spikes in temperature or stress.
Another advantage of the platform is that it enables solvent-free processing, which simplifies manufacturing and reduces environmental impact by decreasing waste.
Filed Under: Drug Discovery, Drug Discovery and Development
