Extended Release hCG Microsphere Formulations for Sustained Dosing

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Solution Overview

Problem

Current commercially available human chorionic gonadotropin (hCG) dosage forms have immediate release profiles, requiring frequent injections due to their short duration of action, which is inconvenient and can lead to poor patient compliance and less effective treatments.

Innovation Solution

Development of extended release hCG formulations encapsulated in microspheres formed by block copolymers, such as those containing polyethylene glycol (PEG), which provide sustained release profiles lasting from one week to several months, allowing for fewer and less frequent administrations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If immediate release hCG dosage forms are used, then therapeutic levels are achieved quickly, but frequent injections are required

Engineering Contradiction:

Improvespeed of achieving therapeutic levelsVSAvoidduration of action

Core Design Contradiction:

SpeedVSDuration of action of moving object

Solution Approach 1:

The hCG dosage form is segmented into multiple microsphere particles, each containing encapsulated hCG. This segmentation allows the hCG to be released gradually from numerous individual microspheres over an extended period, resolving the contradiction between achieving rapid therapeutic levels and maintaining duration of action.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The release rate parameter of hCG is changed from immediate to extended release by encapsulating it in microspheres. This parameter change allows the hCG to be released over a prolonged period (1-4 weeks), resolving the contradiction between rapid achievement of therapeutic levels and extended duration of action.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If frequent injections are administered, then sustained dosing is maintained, but patient compliance decreases

Engineering Contradiction:

Improvesustained dosingVSAvoidpatient compliance

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The microsphere formulation provides continuous release of hCG over 1-4 weeks, eliminating the need for frequent discrete injections. This continuous action maintains sustained dosing while significantly improving patient compliance by reducing the number of administrations required.

Inventive Principle:

Principle #20Continuity of useful action

3Duration of action of moving object

If extended release formulations are developed, then injection frequency is reduced, but formulation complexity increases

Engineering Contradiction:

Improveduration of actionVSAvoidformulation complexity

Core Design Contradiction:

Duration of action of moving objectVSDevice complexity

Solution Approach 1:

The formulation uses composite materials consisting of hCG encapsulated within biocompatible polymer microspheres. This composite structure enables extended release over 1-4 weeks while maintaining a relatively simple overall formulation approach that can be manufactured using established microsphere technology.

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS20220062177A1Extended release formulations of human chorionic gonadotropin (HCG)

Publication Date: 2022.03.03 INNOCORE TECH HLDG BV

AI summary

The present disclosure relates to extended release dosage forms of human chorionic gonadotropin (hCG) or derivatives or isoforms thereof. The extended release hCG dosage forms comprise biodegradable polymer microspheres and provide for extended release of hCG over a desired time period.