Cryogranulation Dispenser Assembly for Uniform Pharmaceutical Pellets
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Solution Overview
Problem
Existing cryogranulation systems are not suitable for manufacturing pharmaceutical formulations, leading to issues such as agglomeration during freezing, lack of pellet formation, streaming, and clogging due to high viscosity, resulting in inefficient processing and product loss.
Innovation Solution
A cryogranulation system with an improved dispenser assembly that supplies pharmaceutical compositions into a cooling agent, producing uniform pellets of a predetermined size range, using a housing and dispenser subassembly with inlet and outlet ports, and a transport assembly to separate and collect the pellets, suitable for pharmaceutical substances like diketopiperazine-based microparticles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional cryogranulation systems are used for pharmaceutical formulations, then the system can process materials, but agglomeration occurs during freezing and pellet formation is inconsistent
Solution Approach 1:
The dispenser assembly is divided into multiple independent nozzle units, each capable of dispensing pharmaceutical composition separately. This segmentation allows for precise control of droplet formation and distribution into the cryogenic liquid, ensuring uniform pellet sizes and preventing agglomeration by maintaining consistent spacing and dispersion of droplets.
Solution Approach 2:
The nozzle assembly incorporates nozzles with specific geometric configurations and orientations tailored for pharmaceutical formulations. The local quality of each nozzle (including its angle, diameter, and positioning) is optimized to produce uniform droplet patterns that freeze into consistent pellets, addressing the specific requirements of pharmaceutical manufacturing rather than general-purpose cryogranulation.
2Ease of manufacture
If high viscosity pharmaceutical compositions are processed, then the material can be handled, but streaming and clogging occur in the dispenser
Solution Approach 1:
The dispenser assembly incorporates movable or adjustable nozzle components that can adapt their positioning or orientation dynamically. This dynamic capability allows the system to maintain optimal flow characteristics for high viscosity pharmaceutical compositions, preventing clogging by adjusting the dispensing geometry in response to material properties and preventing streaming through controlled adjustment of droplet release parameters.
3Productivity
If existing cryogranulation equipment is used, then frozen pellets can be produced, but the system lacks precise control for pharmaceutical manufacturing requirements
Solution Approach 1:
The system incorporates feedback mechanisms that monitor the cryogranulation process parameters such as droplet dispersion, freezing rate, and pellet formation. This feedback enables real-time adjustments to maintain precise control over pellet size and quality, ensuring pharmaceutical-grade consistency while maintaining high productivity through automated process optimization.
Solution Approach 2:
The dispenser assembly is designed with adjustable parameters including nozzle geometry, dispensing rate, and positioning that can be precisely controlled and modified. These parameter changes allow the system to be optimized for specific pharmaceutical formulations and manufacturing requirements, achieving both high productivity and precise manufacturing control that conventional systems cannot provide.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system achieves more homogeneous pellet sizes, improving the efficiency of the process and drug product yield by preventing agglomeration and clogging, and ensuring consistent pellet formation and transport.
Implementation Method 1
The material is frozen by the liquid nitrogen into pellets or granules
Implementation Method 2
The material is frozen by the liquid nitrogen into pellets or granules
Data Source
AI summary
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.