Pharmaceutical Cryogranulation Dispenser for Uniform Pellet Formation
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Solution Overview
Problem
Existing cryogranulation systems are not suitable for manufacturing pharmaceutical formulations, leading to issues such as agglomeration, increased lyophilization times, lack of pellet formation, streaming, and clogging due to high viscosity substances, resulting in inefficient pelletization and product loss.
Innovation Solution
A cryogranulation system with an improved dispenser assembly that produces uniform pellets by dispensing pharmaceutical compositions into a cooling agent like liquid nitrogen, using a dispenser subassembly with inlet and outlet ports to control droplet size and a transport system to separate and collect pellets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If commercial cryogranulation systems are used for pharmaceutical formulations, then frozen pellets can be produced, but agglomeration and lack of uniform pellet size occur due to high viscosity substances
Solution Approach 1:
The pharmaceutical composition is divided into multiple droplets through a multi-port dispenser assembly, with each port producing individual pellets. This segmentation prevents agglomeration by ensuring proper spacing between droplets and allows consistent pellet formation even with high viscosity substances.
Solution Approach 2:
The dispenser assembly provides different local conditions at each dispenser port, with optimized geometry and spacing tailored for pharmaceutical formulations. The local droplet generation conditions are controlled to produce uniform pellets while accommodating the specific viscosity characteristics of pharmaceutical substances.
2Productivity
If conventional dispensing methods are used, then pharmaceutical composition can be introduced, but streaming and clogging occur due to high viscosity
Solution Approach 1:
The dispenser assembly incorporates dynamic flow control through its port geometry and positioning, allowing the system to adapt to varying viscosity conditions. The design enables continuous operation by preventing material stagnation and facilitating smooth flow despite high viscosity characteristics of pharmaceutical formulations.
3Productivity
If standard cryogranulation trays are used, then cooling agent flow can be maintained, but pellet separation and collection are inefficient
Solution Approach 1:
A transport assembly acts as an intermediary between the cooling agent flow and the collection system. This intermediary mechanism efficiently transfers pellets from the cooling agent stream to the collection container, minimizing product loss and improving overall collection efficiency while maintaining continuous cooling agent circulation.
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 process efficiency and drug product yield by minimizing fines and preventing dispenser freezing, suitable for pharmaceutical substances like proteins and peptides adsorbed onto carrier particles.
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.