Abiraterone Acetate Self-Microemulsion System for Oral Bioavailability

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Solution Overview

Problem

Abiraterone acetate has low solubility and permeability, leading to low bioavailability and stability issues, particularly when administered orally, and is heavily influenced by food intake, requiring specific timing for optimal absorption.

Innovation Solution

A self-microemulsion system comprising glycerol monolinoleate, medium chain triglyceride, PEG-40 hydrogenated castor oil, and 2-(2-ethoxyethoxy)ethanol is developed to enhance solubility and stability, allowing for improved absorption and bioavailability, and can be taken with or without food.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If abiraterone acetate is administered orally as a conventional tablet, then the dosage can be easily controlled, but the oral bioavailability is very low due to low solubility and poor permeability

Engineering Contradiction:
Improveoral bioavailabilityVSAvoidpreparation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent uses a self-microemulsion system comprising multiple components (glycerol monolinoleate, medium chain triglyceride, PEG-40 hydrogenated castor oil, and 2-(2-ethoxyethoxy)ethanol) to form a composite preparation that enhances both solubility and permeability of abiraterone acetate, thereby improving oral bioavailability while maintaining reasonable preparation complexity

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent changes the physical and chemical parameters of the drug delivery system by converting abiraterone acetate from a conventional crystalline tablet into a self-microemulsion system with specific oil phase and emulsion phase ratios, which fundamentally alters the dissolution and absorption characteristics to improve bioavailability

Inventive Principle:
Principle #35Parameter changes

2Reliability

If abiraterone acetate is taken on an empty stomach to control plasma concentration, then the absorption is more predictable, but the patient compliance is reduced due to strict timing requirements

Engineering Contradiction:
Improveplasma concentration controlVSAvoiddosing convenience
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The self-microemulsion system changes the physicochemical parameters of the drug formulation to reduce food-effect sensitivity, allowing the drug to be taken with or without food while maintaining relatively stable plasma concentration, thereby improving dosing convenience without sacrificing reliability

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the dosage of abiraterone acetate is increased to compensate for low bioavailability, then the effective drug amount can be sufficient, but the side effects are increased

Engineering Contradiction:
Improveeffective drug amountVSAvoidside effects
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent changes the delivery system parameters from conventional tablet to self-microemulsion, which improves the efficiency of drug absorption and utilization. This allows achieving the same effective drug amount at lower doses, thereby reducing side effects while maintaining therapeutic efficacy

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 self-microemulsion system significantly increases oral bioavailability and stability of abiraterone acetate, reducing the impact of food on absorption and allowing for flexible dosing times, while maintaining long-term storage stability.

Implementation Method 1

a self-microemulsion system for loading abiraterone acetate... comprises an oil phase and an emulsion phase... the oil phase comprises glycerol monolinoleate and medium chain triglyceride; the emulsion phase comprises PEG-40 hydrogenated castor oil and 2-(2-ethoxyethoxy)ethanol

Methodology Applied
Scientific EffectMicellar solubilization: Microemulsion

Data Source

PatentEP4197541B1Abiraterone acetate-containing composition and application thereof
Publication Date: 2024.07.24 HUNAN HUIZE BIO PHARMA CO LTD
  • EP4197541B1 patent drawingFigure 1~2
  • EP4197541B1 patent drawingFigure 3~4
  • EP4197541B1 patent drawingFigure 5~6

AI summary

Disclosed is a self-microemulsion system for loading abiraterone acetate, and a composition and an application thereof. The self-microemulsion system for loading abiraterone acetate has excellent solubility and stability for abiraterone acetate, and the composition formed by dissolving abiraterone acetate in this system can significantly reduce the effect of food on the absorption of abiraterone acetate, and reduce the differences between preprandial administration and postprandial administration, thus making it possible to take the medicament on both an empty and a full stomach and reducing the limitation for the time of taking medicament.