Bend Research Inc., an independent drug-formulation development and manufacturing company, announced today that it has received a new U.S. patent covering a process for making spray-dried solid amorphous dispersions of drugs using pressure nozzles.
The patent, which adds further protection to the company’s spray-dried dispersion (SDD) technology, can be used to make solid amorphous dispersions with larger particle sizes and minimal fines (e.g., small particles). By spray-drying with a pressure nozzle, relatively large droplets are formed that dry to form dense particles with good properties for making solid dosage forms, such as tablets.
“This patent is an important addition to our spray-drying patent portfolio,” said Bend Research President and CEO Rod Ray. “Customers come to Bend Research for the quality of our science, engineering, and clinical-supply manufacture, and our ability to move fast. Having patents that protect intellectual property offers them another key benefit by adding value to the formulations our scientists and engineers produce.”
The patent, which is titled “Method for Making Homogeneous Spray-Dried Solid Amorphous Drug Dispersions Using Pressure Nozzles,” was assigned Patent No. 7,780,988 by the U.S. Patent and Trademark Office. The inventors are Bend Research employees Ron Beyerinck, Rod Ray, Dan Dobry, and Dana Settell.
The patent covers a spray-drying process for producing solid amorphous dispersions from drugs with low aqueous solubility and polymers. In many cases, the resulting formulations increase the amount of drug that is orally absorbed when administered to a patient.
The patent addresses a common problem encountered using conventional spray-drying processes: they often produce small particles, including numerous very small particles known as “fines.” As a result, solid amorphous dispersions produced using conventional processes often have poor flow characteristics and are difficult to collect efficiently and formulate into solid dosage forms. The technology covered by this patent makes it possible to produce larger particles with fewer fines, improving particle flow characteristics and collection efficiencies and simplifying downstream handling and processing.
The patent is one in a growing of number of formulation- and process-related patents associated with Bend Research’s SDD technology. The SDD technology has successfully enabled the advancement of hundreds of compounds from preclinical studies to several large Phase 3 clinical trials.