Spray-Dried Interferon Beta Powder for Spherical Inhalation Particles

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Solution Overview

Problem

Existing dry powder formulations of interferon-beta for pulmonary delivery lack spherical particle shape and exhibit reduced activity, making them unsuitable for effective inhalation administration.

Innovation Solution

A dry powder formulation of interferon-beta is prepared by spray drying a liquid composition comprising interferon-beta, acetate buffer, arginine, poloxamer 188, methionine, and hydrophobic amino acids, ensuring high morphological completeness and activity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Shape

If freeze-drying and jet-milling are used to prepare dry powder IFN-β, then the formulation can be obtained, but the particles do not exhibit spherical shape and IFN activity is significantly reduced

Engineering Contradiction:

Improveparticle shapeVSAvoidIFN activity

Core Design Contradiction:

ShapeVSReliability

Solution Approach 1:

The patent changes the drying parameters by using spray drying with optimized inlet temperature (80-150°C) and outlet temperature (40-80°C) instead of freeze-drying, and adjusts the liquid composition parameters including pH (3.0-5.0), protein concentration (0.1-10 mg/mL), and additive concentrations to achieve spherical particles with high IFN activity

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses a composite liquid composition containing IFN-β combined with multiple protective agents including arginine (10-150 mM), poloxamer 188 (0.1-10 mg/mL), methionine (0.5-5 mM), and hydrophobic amino acids (5-30% w/v) to maintain protein structure and activity during spray drying, resulting in spherical particles with preserved biological function

Inventive Principle:

Principle #40Composite materials

2Shape

If spray drying is used with optimized composition, then spherical particles with high activity are achieved, but the formulation complexity increases

Engineering Contradiction:

Improvemorphological completenessVSAvoidformulation complexity

Core Design Contradiction:

ShapeVSDevice complexity

Solution Approach 1:

The patent employs poloxamer 188 as a multi-functional additive that serves as both a surfactant to enable spray drying and a protective agent to maintain IFN-β stability, reducing the need for separate protective components while achieving spherical particles with high activity

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 formulation achieves spherical particles with high recovery rates and stable activity, enabling effective inhalation delivery and treatment of diseases such as multiple sclerosis, cancer, autoimmune diseases, and viral infections.

Implementation Method 1

spray drying a liquid composition at an inlet temperature of 90 to 130°C and an outlet temperature of 40 to 80°C

Methodology Applied

Scientific EffectEvaporation: Evaporation

Data Source

PatentEP4656184A1Dry powder formulation of interferon beta and method for preparing same

Publication Date: 2025.12.03 ABION INC

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AI summary

The present invention relates to a dry powder formulation of interferon beta and a method for preparing same and, more specifically, to a dry powder formulation of interferon beta in the form of spherical particles having a high degree of morphological perfection, prepared by spray-drying a liquid composition containing interferon beta, and a method for preparing the dry powder formulation of interferon beta.