Mucoadhesive Pullulan Capsules for Vaginal Antiprogestin Delivery

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Solution Overview

Problem

Existing antiprogestin treatments, particularly when administered orally, face limitations such as poor chronic administration efficacy and systemic side effects, making them less ideal for hormone-dependent disorders.

Innovation Solution

Mucoadhesive capsules comprising pullulan and a capsule fill formulation with a selective progesterone receptor modulator or antiprogestin, designed for vaginal delivery, which adheres to the vaginal mucosa for sustained release, minimizing systemic exposure and maximizing local drug concentration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If antiprogestins are administered orally, then systemic delivery is achieved, but systemic side effects increase and chronic administration efficacy decreases

Engineering Contradiction:
Improvechronic administration efficacyVSAvoidsystemic side effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces the vaginal mucosa as an intermediary delivery route between oral administration and direct local action. The mucoadhesive capsule adheres to the vaginal mucosa, allowing the antiprogestin to be absorbed locally and enter the bloodstream at lower systemic concentrations, thereby reducing side effects while maintaining therapeutic efficacy for hormone-dependent disorders

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention employs mucoadhesive materials that provide localized action at the vaginal mucosa. The capsule is designed to adhere specifically to the vaginal wall, creating a localized reservoir that releases the drug slowly at the absorption site, improving chronic administration efficacy while minimizing systemic exposure

Inventive Principle:
Principle #3Local quality

2Reliability

If higher doses are used to achieve therapeutic levels, then treatment efficacy improves, but systemic concentrations increase and side effects worsen

Engineering Contradiction:
Improvetreatment efficacyVSAvoidside effects
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent changes the administration route parameter from oral to vaginal, which fundamentally alters the pharmacokinetic profile. This route change allows achieving therapeutic efficacy at lower doses because the drug is absorbed directly from the vaginal mucosa into the systemic circulation, bypassing first-pass metabolism and reducing the required dose while minimizing side effects

Inventive Principle:
Principle #35Parameter changes

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 mucoadhesive capsules provide effective, sustained delivery of antiprogestins to the vaginal mucosa, reducing systemic concentrations and minimizing side effects, while achieving therapeutic levels for conditions like endometriosis and uterine fibroids with lower doses compared to oral administration.

Implementation Method 1

mucoadhesive capsules comprising pullulan

Methodology Applied
Scientific EffectMucoadhesion: Adhesive

Implementation Method 2

for delivering the active agent to the vaginal mucosa

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentEP2854763B1Formulations for vaginal delivery of antiprogestins
Publication Date: 2018.09.26 REPROS THERAPEUTICS INC
  • EP2854763B1 patent drawingFigure 1
  • EP2854763B1 patent drawingFigure 2
  • EP2854763B1 patent drawingFigure 3

AI summary

The subject matter of the present invention is pertinent to the field of vaginal delivery of pharmaceutically active agents. Embodiments of the instant invention disclose methods for treating a variety of progesterone related disorders by vaginal administration of a pullulan capsule comprising one or more antiprogestins.