Pharmaceutical Particle Formation via Melt Granulation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing methods for producing pharmaceutical particles from melts are cumbersome, often requiring multiple stages and solvents, leading to irregular shapes and handling difficulties, as well as environmental and safety concerns due to solvent residues.
Innovation Solution
A method involving the formation of globular particles by guiding melt droplets with a process gas in a processing chamber, allowing repeated contact and solidification to achieve uniform particle size and shape, using a spouted bed mechanism to circulate and grow particles to desired size.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If solvents are employed in particle production methods, then particles can be formed, but solvent residues impair product quality and require removal steps
Solution Approach 1:
The invention extracts and eliminates the harmful solvent component from the particle production process. Instead of using solvent-based methods, the patent employs a solvent-free melt granulation process where particles are formed by melting and solidifying the pharmaceutical substance directly, thereby taking out the solvent entirely from the system and avoiding all associated harmful residues
Solution Approach 2:
The invention changes the physical state parameter of the pharmaceutical substance from solid to melt and back to solid, replacing the solvent-based liquid state approach. By controlling temperature parameters to melt the substance and then allowing controlled solidification, the process achieves particle formation without requiring solvent removal steps
2Ease of manufacture
If solidified melt is comminuted to produce particles, then particles are obtained, but the process requires multiple stages with different apparatuses and produces irregular shapes
Solution Approach 1:
The invention merges the melting, solidification, and particle formation stages into a single integrated process step. By spraying the melt directly into a fluidized bed of solid particles where it solidifies and forms uniform granules in one operation, the patent eliminates the need for separate comminution apparatus and multiple processing stages
Solution Approach 2:
The invention performs preliminary action by pre-forming uniform spherical particles through controlled spray solidification before any size adjustment is needed. The melt is sprayed in a controlled manner to form uniform droplets that solidify into regularly shaped particles, eliminating the need for subsequent comminution to achieve uniformity
3Productivity
If melt is sprayed in a spray tower, then particles are formed, but a large proportion of unwanted particle size is formed requiring separation and remelting
Solution Approach 1:
The invention implements feedback control by continuously monitoring particle formation in the fluidized bed and adjusting spray parameters accordingly. The fluidized bed environment provides continuous contact between droplets and solid particles, allowing real-time control of particle growth and size distribution, thereby minimizing the formation of unwanted particle sizes that would require separation and remelting
Solution Approach 2:
The invention changes the environmental parameters from a simple spray tower atmosphere to a controlled fluidized bed environment with specific temperature, gas flow, and particle circulation conditions. These parameter changes optimize droplet solidification and particle growth to produce the desired size distribution directly, reducing waste material
4Ease of manufacture
If particles are produced by comminution, then particles are obtained, but irregular shapes make further handling difficult
Solution Approach 1:
The invention applies spheroidality by forming particles as uniform spheres or spheroids through controlled spray solidification in the fluidized bed. The spherical shape is achieved by allowing droplets to solidify symmetrically around a core particle, creating regularly shaped granules that are much easier to handle, flow, and process compared to irregular comminuted particles
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
This method produces particles with a consistent length-width ratio and size distribution, enhancing handling properties and avoiding solvent-related issues, while maintaining pharmaceutical substance quality and safety.
Implementation Method 1
repeated guiding of solid particles past sprayed droplets in the processing chamber with the aid of a process gas jet which is guided in a defined way and whose temperature is fixed, depending on the solidification point of the melt, so that at least some of the droplets come into contact with particles and solidify thereon
Implementation Method 2
using a spouted bed mechanism to circulate and grow particles to desired size
Data Source
AI summary
The invention relates to a method for producing particles with a length-width ratio of less than about 1.4 from a pharmaceutical substance, which method includes the following stages, that is: (a) provision of a melt of the pharmaceutical substance; (b) production of droplets of the melt by spraying into a processing chamber; (c) repeated guiding of solid particles past sprayed droplets in the processing chamber with the aid of a process gas jet which is guided in a defined way and whose temperature is fixed, depending on the solidification point of the melt, so that at least some of the droplets come into contact with particles and solidify thereon; (d) removal of particles from the processing chamber as a function of the particle size. The invention further relates to particles of pharmaceutical substances and the use thereof.