Pharmaceutical Particle Drying via Glass Transition Modulation

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Solution Overview

Problem

Conventional secondary drying processes for pharmaceutical compositions are slow and energy-inefficient, requiring long times to reduce residual solvent content to acceptable levels, especially as the glass transition temperature of particles increases during solvent removal, hindering mass transfer and evaporation rates.

Innovation Solution

Exposing pharmaceutical particles to a volatile mobility-enhancing agent, such as water or ethanol, reduces the glass transition temperature, enhancing solvent diffusion and mass transfer rates, allowing for quicker and more efficient removal of residual solvent through controlled drying conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional secondary drying processes are used to remove residual solvent from pharmaceutical particles, then the residual solvent content is reduced to acceptable levels, but the drying time becomes excessively long and energy consumption increases

Engineering Contradiction:
Improveresidual solvent contentVSAvoiddrying time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The invention changes the physical-chemical parameters of the drying system by introducing a volatile mobility-enhancing agent that temporarily reduces the glass transition temperature of the particles. This parameter change maintains the particles in a more mobile state during drying, significantly accelerating solvent removal rates while keeping the process energy-efficient and time-effective

Inventive Principle:
Principle #35Parameter changes

2Reliability

If conventional secondary drying processes are used to remove residual solvent from pharmaceutical particles, then the residual solvent content is reduced to acceptable levels, but energy consumption increases

Engineering Contradiction:
Improveresidual solvent contentVSAvoidenergy consumption
Core Design Contradiction:
ReliabilityVSLoss of energy

Solution Approach 1:

By temporarily modifying the glass transition temperature through the volatile mobility-enhancing agent, the invention enables solvent removal at lower energy inputs. The particles remain in a more mobile state that facilitates solvent diffusion and evaporation without requiring excessive thermal energy, thus reducing overall energy consumption while achieving the same residual solvent content

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If the glass transition temperature of particles increases during solvent removal, then the particles become more stable, but mass transfer and evaporation rates decrease

Engineering Contradiction:
Improveparticle stabilityVSAvoidmass transfer rate
Core Design Contradiction:
Stability of the object's compositionVSProductivity

Solution Approach 1:

The invention dynamically adjusts the glass transition temperature during the drying process by introducing a volatile mobility-enhancing agent. This creates a time-dependent system where the Tg is temporarily reduced to enhance mass transfer and evaporation rates, allowing the process to proceed rapidly while maintaining final particle stability once the agent evaporates

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The volatile mobility-enhancing agent induces a temporary parameter change in the glass transition temperature, creating a window of enhanced molecular mobility that accelerates solvent removal. This dynamic parameter adjustment resolves the contradiction between stability and productivity by allowing rapid drying when needed while preserving final product stability

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

The process significantly reduces the time required to achieve low residual solvent levels, improving the efficiency of solvent removal and maintaining high mass-transfer rates throughout the drying process.

Implementation Method 1

exposing the particles in a chamber to a volatile mobility-enhancing agent that is different from the solvent, so that the glass-transition temperature of the particles is reduced

Methodology Applied
Scientific EffectGlass transition:

Implementation Method 2

removing the stripping gas from the chamber along with at least a portion of the solvent

Methodology Applied
Scientific EffectEvaporation: Evaporation

Implementation Method 3

enhancing solvent diffusion and mass transfer rates

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentEP2043610B1Drying of drug-containing particles
Publication Date: 2015.07.01 BEND RESEARCH INC
  • EP2043610B1 patent drawingFigure 1~2
  • EP2043610B1 patent drawingFigure 3~4
  • EP2043610B1 patent drawingFigure 5~6

AI summary

A secondary drying process is disclosed for removing residual solvent from drug-containing particles that have been formed by solvent-based processes.