Method of preparing sustained release pellets and products thereof

Claim 1

IN THE METHOD OF PREPARING SOLID LIPID SUSTAINED RELEASE PHARMACEUTICAL PELLETS HAVING A SOLID MEDICAMENT RANDOMLY DISPERSED THROUGHOUT A LIPID MATERIAL RESISTANT TO DISINTEGRATION AND SLOWLY DISPERSIBLE IN THE GASTROINTESTINAL TRACT, THE IMPROVEMENT WHICH CONSISTS ESSENTIALLY OF THE STEPS OF: (A) FORMING A MOLTEN SLURRY OF SOLID MEDICAMENT RANDOMLY DISPERSED THROUGHOUT A LIPID MATERIAL, SAID LIPID MATERIAL BEING CAPABLE OF SOLIDIFICATION AT ROOM TEMPERATURE, RESISTANT TO DISINTEGRATION AND SLOWLY DISPERSIBLE IN THE GASTROINTESTINAL TRACT; (B) ATOMIZING THE MOLTEN SLURRY THROUGH A PRESSURE NOZZLE HAVING A DISCHARGE OPENING FORMING ATOMIZED DROPLET PARTICLES OF MEDICAMENT CONTAINING LIPID MATERIAL HAVING A MASS THAT WHEN CONVERTED TO SPERICAL PELLETS, EACH OF SAID PELLETS HAS A PREDETERMINED DIAMETER IN THE RANGE OF FROM ABOUT 250 MICRONS TO ABOUT 2,000 MICRONS, AND; (C) PASSING THE MOLTEN SLURRY OF ATOMIZED DROPLET PARTICLES OF MEDICAMENT CONTAINING LIPID MATERIAL THROUGH AIR HAVING A TEMPERATURE LOWER THAN THE SOLIDIFICATION TEMPERATURE OF THE LIPID MATERIAL UNTIL THE ATOMIZED MOLTEN DROPLET PARTICLES CONGEAL AS SOLID SPHERICAL PELLETS HAVING SOLID MEDICAMENT RANDOMLY DISPERSED THROUGHOUT THE LIPID MATERIAL.