Physiology-Based Pharmacokinetic Model for Individualized Medicament Dosage

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Solution Overview

Problem

Existing methods for medicament dosage, such as Target Controlled Infusion, do not account for individual patient physiological, anatomical, biochemical, and genetic factors, leading to suboptimal pharmacokinetic and pharmacodynamic profiles.

Innovation Solution

A method utilizing physiology-based pharmacokinetic and pharmacodynamic models to determine an optimal time profile for medicament administration, incorporating real-time physiological measurements and iterative adaptation to achieve precise dosage, is combined with an automated dosage device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a black-box pharmacokinetic model is used for medicament dosage control, then the system is simpler to implement, but individual patient physiological factors cannot be taken into account

Engineering Contradiction:
Improvemodel complexityVSAvoidindividualization capability
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The patent segments the pharmacokinetic model into multiple physiological compartments (central compartment, peripheral compartments, organs) that can individually represent different body systems. This allows the model to capture individual patient physiological factors while maintaining a structured, manageable framework for implementation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent performs preliminary determination of patient-specific physiological parameters (organ volumes, blood flow rates, enzyme activities) before medicament administration. This pre-characterization of individual physiology enables the model to be tailored to each patient beforehand, resolving the contradiction between model complexity and individualization capability.

Inventive Principle:
Principle #10Preliminary action

2Adaptability or versatility

If a physiology-based pharmacokinetic model is used to account for individual patient factors, then individualized dosage can be achieved, but the system complexity increases

Engineering Contradiction:
Improveindividualization capabilityVSAvoidmodel complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent changes the parameters of the pharmacokinetic model to reflect individual patient physiology by incorporating measured physiological data (organ sizes, blood flow rates, enzyme expression levels) into the model parameters. This allows the same model structure to be adapted to different patients through parameter adjustment rather than requiring entirely different models.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent implements feedback loops where physiological measurements are continuously taken, the pharmacokinetic model is updated with these measurements, and dosage recommendations are adjusted accordingly. This feedback mechanism manages model complexity by using real-time data to maintain accuracy without requiring overly complex predetermined models.

Inventive Principle:
Principle #23Feedback

3Manufacturing precision

If real-time physiological measurements are integrated into the dosage control system, then dosage precision is improved, but measurement and system complexity increase

Engineering Contradiction:
Improvedosage precisionVSAvoidmeasurement system complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent employs a multi-functional integrated system that combines physiological sensing, pharmacokinetic modeling, and dosage control in a single platform. The system can measure multiple physiological parameters (blood flow, enzyme activity, organ function) and uses them collectively to determine dosage, reducing overall system complexity through functional integration.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent introduces a pharmacokinetic model as an intermediary between physiological measurements and dosage control decisions. Rather than directly translating raw measurements into dosage commands, the model processes the measurement data through physiological relationships to generate optimized dosage recommendations, simplifying the control architecture.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If iterative adaptation of the pharmacokinetic model is performed to optimize dosage profile, then treatment efficacy is improved, but computational time and complexity increase

Engineering Contradiction:
Improvetreatment efficacyVSAvoidcomputational time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent performs preliminary iterative optimization of the pharmacokinetic model during patient setup or baseline characterization before actual medicament administration begins. This pre-optimization establishes an accurate individualized model that can then be used for rapid dosage determination during treatment, reducing real-time computational requirements.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent applies partial iterative adaptation by focusing computational efforts on the most critical model parameters and physiological compartments that have the greatest impact on dosage accuracy. Rather than fully optimizing all model aspects continuously, the system performs targeted iterations on key parameters, reducing computational time while maintaining treatment efficacy.

Inventive Principle:
Principle #16Partial or excessive action

Data Source

PatentUS9095653B2Method for the timed dosage of medicaments
Publication Date: 2015.08.04 BAYER AG
  • US9095653B2 patent drawing
  • US9095653B2 patent drawing
  • US9095653B2 patent drawing

AI summary

The invention relates to a method for the controlled dosage of a medicament as a function of time by means of a method for the determination of a corresponding dosage profile and corresponding control of a dosage instrument.