Biodegradable Hydrocortisone Implant for Circadian Cortisol Release

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Solution Overview

Problem

Conventional treatments for chronic adrenal insufficiency, such as oral hydrocortisone and continuous subcutaneous infusion, fail to mimic the natural circadian cortisol rhythm, leading to suboptimal therapeutic adherence and clinical symptoms due to non-compliance and hepatic metabolism, and require frequent dosing which complicates patient management.

Innovation Solution

A biodegradable hydrocortisone implant with sustained release, inserted subcutaneously, that mimics the circadian cortisol rhythm by direct delivery into the bloodstream, avoiding hepatic metabolism and simplifying dosing, thereby improving therapeutic adherence and maintaining consistent drug levels.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If oral hydrocortisone is administered, then glucocorticoid replacement is achieved, but the natural circadian cortisol rhythm is not restored and hepatic metabolism limits effectiveness

Engineering Contradiction:

Improvetherapeutic effectivenessVSAvoidcircadian rhythm restoration

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The invention extracts hydrocortisone from the oral administration pathway and delivers it directly into the bloodstream through subcutaneous implantation, bypassing the hepatic first-pass metabolism that limits oral hydrocortisone effectiveness and prevents circadian rhythm restoration

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

A biodegradable polymer implant serves as an intermediary delivery system that releases hydrocortisone directly into the bloodstream in a controlled manner, mimicking the natural circadian cortisol rhythm without requiring oral ingestion and hepatic metabolism

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If continuous subcutaneous infusion is used, then direct bloodstream delivery is achieved, but frequent dosing and patient intervention are required

Engineering Contradiction:

Improvedirect bloodstream deliveryVSAvoiddosing frequency

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The hydrocortisone is pre-loaded into a biodegradable polymer implant that is implanted subcutaneously, eliminating the need for frequent dosing interventions. The implant releases the drug automatically over an extended period, providing preliminary action that eliminates the complexity of frequent dosing

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The biodegradable implant provides continuous release of hydrocortisone directly into the bloodstream over an extended period, maintaining continuous useful action without requiring frequent patient intervention or dosing adjustments

Inventive Principle:

Principle #20Continuity of useful action

3Reliability

If multiple daily doses are administered, then adequate cortisol coverage is attempted, but therapeutic adherence decreases due to complexity

Engineering Contradiction:

Improvecortisol coverageVSAvoidpatient adherence

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The invention uses a disposable biodegradable implant that is implanted once and gradually degrades over time, releasing hydrocortisone continuously. This eliminates the need for repeated dosing and improves adherence by replacing complex multiple-dose regimens with a single implantation that provides adequate cortisol coverage throughout the implant's functional life

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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 implant achieves physiological cortisol levels and circadian rhythm restoration, enhancing clinical symptom remission and adherence by providing continuous, stable drug delivery without the need for patient intervention, thus improving quality of life and treatment efficacy.

Implementation Method 1

The implant comprises a biodegradable polymer matrix and hydrocortisone dispersed in the polymer matrix. The implant has continuous release of the active ingredient for an extended period of time.

Methodology Applied

Scientific EffectDiffusion: Diffusion

Implementation Method 2

The implant is inserted subcutaneously and has continuous release of the active ingredient for an extended period of time. The biodegradable polymer matrix allows the implant to be absorbed by the body without requiring removal.

Methodology Applied

Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentUS12544330B2Long-lasting reabsorbable subcutaneous implant with sustained release of pre-concentrated pharmacologically active substance in polymer for the treatment of chronic adrenal insufficiency or hypocortisolism

Publication Date: 2026.02.10 PERACCHI EDSON LUIZ

AI summary

Long-acting resorbable subcutaneous implant with extended release of pre-concentrated pharmacologically active substance in polymer for treatment of chronic adrenal insufficiency. The implant is inserted subcutaneously and has continuous release of the active ingredient for an extended period of time. The implant may have in its constitution only hydrocortisone but is preferably formed by hydrocortisone particles homogeneously dispersed in a bio erodible and bioabsorbable polymer matrix. Such a polymer matrix may be formed of a polymer or a polymer blend. The release of the drug in this system occurs through diffusion, at a relatively constant rate, and it is possible to change the rate of release of the drug through the thickness or material of this membrane.