GLP-1 Peptide Tablet Spray-Drying With pH-Controlled Dissolution

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Solution Overview

Problem

Human GLP-1 peptides exhibit low bioavailability and require advance administration to ensure absorption, limiting their effectiveness in oral dosage forms.

Innovation Solution

A spray-drying process is employed to produce GLP-1 peptide tablets by adjusting the pH of the feed solution to be higher than the isoelectric point or within a specific range (about 5 to 10), resulting in enhanced dissolution rates and improved bioavailability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If GLP-1 peptides are administered orally in conventional dosage forms, then the drug can be taken conveniently, but the bioavailability remains low and absorption is delayed

Engineering Contradiction:
Improveconvenience of oral administrationVSAvoidbioavailability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent changes the pH parameter of the feed solution during spray-drying to be higher than the isoelectric point of the GLP-1 peptide (pH > 4.6). This parameter change modifies the peptide's charge state and interaction with the spray-drying environment, resulting in improved dissolution rate and bioavailability while maintaining oral administration convenience

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent utilizes the spray-drying process to transition the GLP-1 peptide from a liquid feed solution phase through rapid drying to form a solid powder tablet. This phase transition process, combined with pH control, creates a formulation that enhances dissolution and absorption characteristics

Inventive Principle:
Principle #36Phase transitions

2Reliability

If GLP-1 peptides are administered orally, then the drug can be absorbed, but the dissolution rate is slow and absorption is delayed

Engineering Contradiction:
ImproveabsorptionVSAvoidtime for dissolution and absorption
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

By adjusting the feed solution pH to be higher than the isoelectric point during spray-drying, the patent modifies the peptide's surface charge and interaction properties, which directly enhances the dissolution rate and reduces the time required for absorption

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent performs preliminary pH adjustment and spray-drying processing before tablet formation, pre-conditioning the peptide to have improved dissolution characteristics that will manifest during subsequent absorption in the gastrointestinal tract

Inventive Principle:
Principle #10Preliminary action

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 increases the dissolution rate of GLP-1 peptides, allowing for faster absorption and improved therapeutic efficacy by shortening the time between administration and meal intake.

Implementation Method 1

spray-drying a feed solution comprising the GLP-1 peptide and a feed solution solvent

Methodology Applied
Scientific EffectEvaporation: Evaporation

Implementation Method 2

spray-drying a feed solution comprising the GLP-1 peptide and a feed solution solvent

Methodology Applied
Scientific EffectSpray: Spray

Data Source

PatentEP4025192B1Process for producing a tablet comprising GLP-1 peptides
Publication Date: 2025.12.03 NOVO NORDISK AS
  • EP4025192B1 patent drawingFigure 1
  • EP4025192B1 patent drawingFigure 2
  • EP4025192B1 patent drawing

AI summary

The present invention relates to a process for producing a tablet comprising a GLP-1 peptide wherein the GLP-1 peptide is obtained by spray-drying of a feed solution comprising the GLP-1 peptide and a feed solution solvent, wherein the pH of the feed solution is higher that the pI of the GLP-1 peptide or wherein the pH of the feed solution is in the range of about 5 to about 10. The invention also relates to the tablet obtained by said process and the use of said tablet in medicine.