The patent, named ‘Method for Making Homogeneous Spray-Dried Solid Amorphous Drug Dispersions Using Pressure Nozzles,’ “refers to an improvement to the spray-drying process by choosing specific nozzles for processing,” according to Bend Research spokesman, Phoenix Ivers.
Ivers told in-PharmaTechnologist that the company’s spray-dried dispersion (SDD) technology using single-fluid – or swirl – nozzles, can be used to create an amorphous form of the drug, with larger droplets during spray-drying than those made using a two-fluid nozzle.
These large droplets form large particles, eliminating the need for granulation, and simplifying how the drug is handled and processed into tablet form.
As the new SDD technology eliminates the need for additional unit operations such as granulation, Bend claim solid dosage forms can be made more efficiently and less expensively.
“Extensive fundamental research and manufacturing experience has demonstrated that SDDs are readily scalable and suitable for manufacturing at a variety of scales with high yields,” explained Ivers.
“In addition, the SDD which offers enhanced bioavailability, often enables our clients to decrease the dose and thus reduces API manufacturing demands and costs,” he added.
Ready for commercial use
Bend’s new SDD technology is ready for use in a commercial manufacturing process, and has already been used for several compounds, 500 of which in vivo, and 38 in Phase III clinical trials.
The company claim the amorphous form of the drug achieves higher solubility in the gastrointestinal tract by forming nanoparticles which contain drug and polymer. As a consequence, Iver says this can “increase the amount of drug that is orally absorbed when administered to a patient.”
He added that Bend is now working with 50 clients from pharmaceutical companies, government agencies and university researchers to advance active compounds, paying particular attention to low-solubility actives used in medicine.
The SDD technology can be applied to various therapeutic areas, including cancer, heart disease, liver disease, and immune disorders.
“It is nearly a universal technology and is particularly valuable since an estimated 30-40 per cent of all new medicines being created by pharmaceutical companies require a technology to increase solubility and oral absorption,” said Ivers.