Apparatus and method for cryogranulating a pharmaceutical composition

摘要

Cryogranulation systems with improved dispenser assemblies are provided for use in manufacturing frozen pellets of pharmaceutical substances in a fluid medium. Methods of cryogranulating the pharmaceutical substance in the fluid medium are also provided. In particular embodiments, the dispenser assembly is used with suspensions or slurries of pharmaceutical compositions including biodegradable substances, such as proteins, peptides, and nucleic acids. In certain embodiments, the pharmaceutical substance can be adsorbed to any pharmaceutically acceptable carrier particles suitable for making pharmaceutical powders. In one embodiment, the pharmaceutical carrier can be, for example, diketopiperazine-based microparticles. The dispenser assembly improves the physical characteristics of the cryopellets formed and minimizes product loss during processing.

主权项

1. A composition comprising a plurality of substantially homogeneous frozen pellets of a pharmaceutical composition comprising diketopiperazine microparticles, wherein said composition is formed by dispensing a solution or a suspension of the pharmaceutical composition through a dispenser assembly into a flow of a cooling agent to form the frozen pellets, the dispenser assembly including first and second rows of dispenser ports, the rows of dispenser ports being disposed perpendicularly with respect to the flow of the cooling agent, separating the frozen pellets from the cooling agent by a transport assembly, and transporting the frozen pellets to a pellet receptacle.