Sulfoalkyl Ether Cyclodextrin Fluidized Bed Processing
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Solution Overview
Problem
Existing sulfoalkyl ether cyclodextrin (SAE-CD) compositions have poor physical properties, such as poor dissolution rates and compression characteristics, making them unsuitable for various pharmaceutical applications like dry powder inhalers and tabletting, due to their particle size distribution and surface characteristics.
Innovation Solution
A method involving fluidized bed spray agglomeration or granulation to produce SAE-CD compositions with controlled particle sizes, moisture content, and surface characteristics, resulting in improved flowability, compressibility, and dissolution rates, tailored for specific pharmaceutical formulations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional drying methods are used for SAE-CD, then production is simpler, but dissolution rate is poor
Solution Approach 1:
The patent changes the physical parameters of the drying process by using fluidized bed technology with controlled temperature, airflow, and particle suspension to create a porous particle structure that enhances dissolution rate while maintaining manufacturing feasibility
Solution Approach 2:
The fluidized bed drying process creates particles with increased porosity and surface area, transforming the dense structure from conventional drying into a porous structure that allows faster water penetration and dissolution
2Ease of manufacture
If conventional processing is used for SAE-CD, then manufacturing is easier, but compression characteristics are poor
Solution Approach 1:
The patent modifies the physical parameters of the particles through fluidized bed processing, creating a particle morphology and density that improves compressibility and tablet formation while maintaining ease of manufacturing through a single-step process
3Ease of manufacture
If standard particle size distribution is used, then production is simpler, but flowability is poor
Solution Approach 1:
The fluidized bed drying process inherently produces a controlled particle size distribution through the interaction of airflow, particle suspension, and drying kinetics, improving flowability while maintaining production simplicity
Solution Approach 2:
The dynamic fluidized bed environment during drying creates particles with optimized surface characteristics and size distribution that enhance flow properties, transforming static conventional drying into a dynamic process that self-optimizes particle morphology
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 resulting SAE-CD compositions exhibit enhanced physical properties, including rapid dissolution and improved tabletting characteristics, making them more suitable for use in dry powder inhalers and other pharmaceutical applications.
Implementation Method 1
subjecting the liquid feed to a combination fluidized bed spray drying process whereby the SAE-CD is agglomerated and dried to below the point of deliquescence to form a particulate SAE-CD composition
Implementation Method 2
subjecting the liquid feed to a combination fluidized bed spray drying process whereby the SAE-CD is agglomerated and dried
Data Source
AI summary
A particulate SAE-CD composition is provided. The SAE-CD composition has an advantageous combination of physical properties not found in known solid forms of SAECD. In particular, the SAE-CD composition possesses an advantageous physicochemical and morphological property profile such that it can be tailored to particular uses. The SAE-CD composition of the invention has improved flow and dissolution performance as compared to known compositions of SAE-CD.


