Apparatus and method for cryogranulating a pharmaceutical composition
Inventors
Amoro, Edwin • Vanackere, Karel • White, Michael A.
Assignees
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Publication Number
US-12453702-B2
Publication Date
2025-10-28
Expiration Date
Abstract
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.
Core Innovation
The patent describes a cryogranulation system for making frozen drug pellets in a fluid medium, using a cryogranulation approach intended to improve pellet size homogeneity and minimize product loss associated with clogging and dispenser freezing. The document identifies an improved dispenser assembly for supplying a fluid into a cooling agent in the cryogranulation system, with the dispenser assembly mounted above the cooling agent.
The dispenser assembly includes a housing and a dispenser subassembly having an enclosure defining an interior chamber, at least one inlet port coupled to the interior chamber, and a plurality of dispenser ports. The dispenser ports include first and second rows of dispenser ports, where the first and second rows are angled with respect to vertical, and the dispenser ports of the first row are disposed at opposite angles with respect to the dispenser ports of the second row.
The document further characterizes dispenser port structure and port/conduit relationships in terms of upper versus lower internal conduit geometry and the arrangement of ports relative to cooling-agent flow. The patent also describes use of the system with pharmaceutical compositions in which the fluid includes biodegradable pharmaceutical substances and carrier particles, including diketopiperazine-based microparticles such as FDKP, including examples involving FDKP-based microparticles loaded with insulin to achieve improved pellet size distribution.
Claims Coverage
The independent claims cover 2 inventive features across a dispenser assembly and a method for supplying a fluid into a cooling agent in a cryogranulation system. The main inventive features include a mounted housing with an interior chamber and inlet port(s), and a dispenser port arrangement with first and second angled rows having opposite angles.
Mounted dispenser assembly with interior chamber and inlet coupling
A housing configured to mount the dispenser subassembly above the cooling agent, wherein the dispenser subassembly includes an enclosure defining an interior chamber and at least one inlet port coupled to the interior chamber.
First and second angled rows of dispenser ports with opposite angles
A plurality of dispenser ports including first and second rows of dispenser ports, wherein the first and second rows are angled with respect to vertical, and wherein the dispenser ports of the first row are disposed at opposite angles with respect to the dispenser ports of the second row.
Method of supplying fluid into cooling agent via interior chamber and dispenser ports
Providing a dispenser assembly including an enclosure defining an interior chamber and a plurality of dispenser ports, supplying the fluid to the interior chamber, and dispensing the fluid from the interior chamber through the dispenser ports into the cooling agent.
Angled dispenser port row geometry in the dispensing method
Dispensing wherein the dispenser ports include first and second rows of dispenser ports, the first and second rows are angled with respect to vertical, and the dispenser ports of the first row are disposed at opposite angles with respect to the dispenser ports of the second row.
The claim coverage centers on a cryogranulation dispenser assembly mounted above a cooling agent, with a chamber fed through inlet port(s) and a dispenser port layout using first and second angled rows arranged at opposite angles. The method claim applies the same dispenser structure to supply and dispense the fluid into the cooling agent, with the independent method requirements matching the independent dispenser port geometry.
Stated Advantages
Improved pellet size homogeneity.
Minimize product loss associated with clogging.
Minimize product loss associated with dispenser freezing.
Documented Applications
Cryogranulation of frozen drug pellets using a cryogranulation system that dispenses a fluid through the disclosed dispenser assembly into a cooling agent.
Making pellets from pharmaceutical compositions in a fluid medium including biodegradable pharmaceutical substances and carrier particles, including diketopiperazine-based microparticles such as FDKP-based microparticles.
Example use with FDKP microparticles loaded with insulin to improve pellet size distribution and reduce fines/dispenser freezing, as compared to other configurations shown in table data [procedural detail omitted for safety].
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