Semaglutide Microspheres High Drug Loading for Reduced Injection Pain

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Solution Overview

Problem

Current formulations of semaglutide, a GLP-1 agonist, face challenges such as low bioavailability, high doses required for oral administration, and significant pain and inflammatory responses during self-administration of sustained-release microspheres.

Innovation Solution

A pharmaceutical composition comprising sustained-release microspheres with a high content of semaglutide (at least 8 wt%) and a bioavailability enhancer, combined with a biodegradable polymer, to achieve enhanced bioavailability and stable long-term drug release with reduced initial release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If semaglutide is encapsulated in microparticles made of biodegradable polymers for long-term release, then long-term effective pharmacological effects are achieved, but a large number of microspheres must be administered which causes severe pain and inflammatory response at the administration site

Engineering Contradiction:
Improvelong-term drug releaseVSAvoidpain and inflammatory response
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent changes the key parameter of drug content concentration within the microspheres. By formulating microspheres with high semaglutide content (5-20 wt%, preferably 10-15 wt%), the patent reduces the total number of microspheres needed for administration from thousands to a manageable amount (0.1-10 mg), thereby maintaining long-term release effects while minimizing pain and inflammatory responses at the injection site.

Inventive Principle:
Principle #35Parameter changes

2Quantity of substance

If a large number of microspheres are administered to achieve long-term effective pharmacological effects, then sufficient drug delivery is achieved, but self-administration by patients becomes difficult

Engineering Contradiction:
Improvedrug delivery amountVSAvoidself-administration
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The patent optimizes the drug content parameter within microspheres to achieve high semaglutide concentration (5-20 wt%). This parameter change reduces the total microsphere quantity needed for effective drug delivery from large numbers to a small, patient-manageable amount (0.1-10 mg), enabling easy self-administration while maintaining sufficient pharmacological effects.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If oral administration is used for semaglutide, then patient compliance is improved, but bioavailability is much lower and significantly higher doses are required

Engineering Contradiction:
Improvepatient complianceVSAvoidbioavailability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent uses biodegradable polymer microspheres as an intermediary delivery system for semaglutide. This intermediary protects the peptide from enzymatic degradation in the gastrointestinal tract and facilitates absorption through the intestinal mucosa, thereby improving bioavailability while maintaining the convenience of oral administration for patient compliance.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 composition achieves high bioavailability of semaglutide, reducing the dosage needed and minimizing pain and inflammatory responses at the administration site, while providing sustained pharmacological effects for an extended period.

Implementation Method 1

sustained-release microspheres with a high content of semaglutide... combined with a biodegradable polymer, to achieve enhanced bioavailability and stable long-term drug release

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 2

biodegradable polymer... stable long-term drug release with reduced initial release

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentEP4552634A1Sustained release-microsphere formulation comprising semaglutide or pharmaceutically acceptable salt thereof and preparation method therefor
Publication Date: 2025.05.14 G2GBIO INC
  • EP4552634A1 patent drawingFigure 1
  • EP4552634A1 patent drawingFigure 2
  • EP4552634A1 patent drawingFigure 3A

AI summary

The present disclosure relates to a pharmaceutical composition useful for the prevention or treatment of diabetes, preservation of beta-cell function, hypertension, hyperlipidemia, obesity, non-alcoholic steatohepatitis, or neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease, which includes a sustained-release microsphere containing semaglutide or a pharmaceutically acceptable salt thereof, a bioavailability enhancer and a biodegradable polymer, so that the pharmaceutical composition do not have a high initial burst of drug, contain a high content of drug relative to the particle size and have a high bioavailability, and thus, can minimize pain and inflammatory response of patient that may occur when administered to the human body.