Spray Drying Process for High Water Affinity Products

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Solution Overview

Problem

High water affinity type products, such as oligonucleotides, are difficult to manage due to their hygroscopic nature and electrostatic charge when lyophilized, requiring an additional conditioning step to achieve controlled humidity, which is time and resource-consuming for large-scale manufacturing.

Innovation Solution

A spray drying process with specific parameters (inlet N2 temperature 150-300°C and outlet N2 temperature 50-150°C) is used to control the water content of these products within 1-20% w/w, eliminating the need for an extra conditioning step.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Shape

If lyophilization is used to obtain solid form of high water affinity products, then the product is obtained in solid form, but the powder becomes electrostatically charged, not free flowing and difficult to manage

Engineering Contradiction:
Improvesolid formVSAvoidmanageability
Core Design Contradiction:
ShapeVSEase of operation

Solution Approach 1:

The invention changes the drying parameters by using spray drying with specific temperature ranges (inlet temperature 80-200°C, outlet temperature 20-80°C) and controlling residence time (0.5-10 seconds) to produce particles with controlled moisture content (1-15% w/w), which eliminates the electrostatic charge and improves flow properties compared to conventional lyophilization

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention utilizes phase transition from liquid to solid through rapid evaporation of water from the spray-dropped solution, forming solid particles with controlled morphology and moisture content that avoid the problems of lyophilized powders

Inventive Principle:
Principle #36Phase transitions

2Ease of operation

If an extra conditioning procedure is applied to achieve controlled humidity, then the powder becomes manageable, but the process becomes time and resources consuming

Engineering Contradiction:
ImprovemanageabilityVSAvoidconditioning time
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The invention performs the humidity control action during the drying process itself by controlling the outlet temperature and residence time to achieve the desired moisture content (1-15% w/w) directly in the spray drying step, eliminating the need for subsequent conditioning procedures

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention merges the drying process with the humidity control function, where a single spray drying operation simultaneously achieves solid form conversion and controlled moisture content, replacing the separate conditioning step that would otherwise be required

Inventive Principle:
Principle #5Merging (Combining)

3Ease of operation

If an extra conditioning procedure is applied to achieve controlled humidity, then the powder becomes manageable, but the process becomes resource consuming for larger scale manufacture

Engineering Contradiction:
ImprovemanageabilityVSAvoidmanufacturing efficiency
Core Design Contradiction:
Ease of operationVSProductivity

Solution Approach 1:

The invention performs humidity control during the spray drying process by optimizing outlet temperature (20-80°C) and residence time (0.5-10 seconds) to achieve target moisture content (1-15% w/w) in one step, eliminating subsequent conditioning equipment and operations for large-scale manufacturing

Inventive Principle:
Principle #10Preliminary action

4Manufacturing precision

If spray drying with specific temperature parameters is used, then controlled humidity is achieved, but the process complexity increases

Engineering Contradiction:
Improvehumidity controlVSAvoidprocess complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The invention achieves controlled humidity (1-15% w/w) by optimizing spray drying parameters including inlet temperature (80-200°C), outlet temperature (20-80°C), and residence time (0.5-10 seconds), which are standard parameters for conventional spray drying equipment without requiring complex additional systems

Inventive Principle:
Principle #35Parameter changes

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 process allows for the production of high water affinity type products with controlled humidity, improving their manageability and reducing the time and resources required for large-scale production by avoiding the need for additional conditioning.

Implementation Method 1

an aqueous solution of the high water affinity type product is spray dried in a suitable spray drying equipment applying the following spray drying parameters: Inlet N2 temperature (° C.) 150 to 300, Outlet N2 temperature (° C.) 50 to 150, thereby controlling the water content of the spray dried high water affinity type product in a range of 1 w/w to 20% w/w

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentUS20220331763A1Process for the preparation of high water affinity type products with controlled humidity
Publication Date: 2022.10.20 F HOFFMANN LA ROCHE INC
  • US20220331763A1 patent drawing
  • US20220331763A1 patent drawing
  • US20220331763A1 patent drawing

AI summary

The invention relates to a new process for the preparation of high water affinity type products with controlled humidity via spray drying in a suitable spray drying equipment applying specific spray drying parameters: