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

VSEngineering Contradiction Analysis

1Ease of manufacture

If conventional drying methods are used for SAE-CD, then production is simpler, but dissolution rate is poor

Engineering Contradiction:
Improvedrying process simplicityVSAvoiddissolution rate
Core Design Contradiction:
Ease of manufactureVSSpeed

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

Inventive Principle:
Principle #35Parameter changes

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

Inventive Principle:
Principle #31Porous materials

2Ease of manufacture

If conventional processing is used for SAE-CD, then manufacturing is easier, but compression characteristics are poor

Engineering Contradiction:
Improveprocessing simplicityVSAvoidcompression characteristics
Core Design Contradiction:
Ease of manufactureVSStrength

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

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If standard particle size distribution is used, then production is simpler, but flowability is poor

Engineering Contradiction:
Improveproduction simplicityVSAvoidflowability
Core Design Contradiction:
Ease of manufactureVSEase of operation

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

Inventive Principle:
Principle #35Parameter changes

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

Inventive Principle:
Principle #15Dynamics

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

Methodology Applied
Scientific EffectEvaporation: Evaporation

Implementation Method 2

subjecting the liquid feed to a combination fluidized bed spray drying process whereby the SAE-CD is agglomerated and dried

Methodology Applied
Scientific EffectFluidization: Fluidisation

Data Source

PatentUS9617352B2Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof
Publication Date: 2017.04.11 CYDEX PHARMACEUTICALS INC
  • US9617352B2 patent drawing
  • US9617352B2 patent drawing
  • US9617352B2 patent drawing

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.