Calcium-Free Phosphate Binder for Dialysis Patients

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Solution Overview

Problem

Current treatments for hyperphosphatemia in patients with reduced kidney function are inadequate, as existing phosphate binders often cause side effects, mineral deficiencies, or excessive calcium intake, and there is a need for a safe and effective method to inhibit blood phosphorus level elevation without requiring water intake.

Innovation Solution

A lactic acid bacterium-based inhibitor, specifically from genera such as Bifidobacterium, Lactobacillus, and Enterococcus, administered in oral capsule forms that are acid-resistant and enteric, to reduce blood phosphorus levels by improving intestinal environment and phosphorus metabolism.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If calcium-containing phosphate binders are used to lower blood phosphorus levels, then phosphorus binding effectiveness is improved, but excessive calcium intake occurs leading to cardiovascular disorders

Engineering Contradiction:
Improvephosphorus binding effectivenessVSAvoidexcessive calcium intake and cardiovascular disorders
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts and removes calcium from the phosphate binder composition, using only calcium-free components such as aluminum hydroxide, magnesium hydroxide, and iron compounds to bind phosphorus in the intestine, thereby eliminating the harmful effect of excessive calcium intake while maintaining phosphorus binding effectiveness

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention uses composite phosphate binder formulations combining multiple calcium-free binding agents (aluminum hydroxide, magnesium hydroxide, iron compounds) to achieve effective phosphorus binding without relying on calcium-containing materials, thus resolving the contradiction between binding effectiveness and calcium-related harm

Inventive Principle:
Principle #40Composite materials

2Reliability

If ion-exchange resin phosphate binders are used to lower blood phosphorus levels, then phosphorus binding effectiveness is improved, but side effects such as constipation, abdominal fullness, nausea, and vomiting occur

Engineering Contradiction:
Improvephosphorus binding effectivenessVSAvoidconstipation, abdominal fullness, nausea, and vomiting
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The invention removes ion-exchange resin components from the phosphate binder formulation and replaces them with hydroxide-based binding agents (aluminum hydroxide, magnesium hydroxide) and iron compounds that bind phosphorus through precipitation reactions rather than ion exchange, thereby eliminating the resin-related gastrointestinal side effects while maintaining binding effectiveness

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention changes the binding mechanism parameter from ion exchange (resin-based) to precipitation reactions (hydroxide and iron-based), which fundamentally alters how phosphorus is bound and eliminates the harmful gastrointestinal effects associated with resin binders

Inventive Principle:
Principle #35Parameter changes

3Reliability

If phosphate binders are administered in sufficient amounts to effectively lower blood phosphorus levels, then phosphorus control is improved, but mineral deficiencies occur due to excessive binding of essential minerals

Engineering Contradiction:
Improveblood phosphorus controlVSAvoidessential mineral intake
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The invention enhances the local binding affinity and specificity of the phosphate binder in the intestinal environment, allowing effective phosphorus binding at lower dosages through optimized hydroxide-to-phosphorus ratios and iron compound formulations, thereby reducing excessive binding of essential minerals while maintaining phosphorus control

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The invention uses aluminum hydroxide and magnesium hydroxide in controlled amounts that provide sufficient phosphorus binding capacity without excessively binding essential minerals like calcium and potassium, achieving the right balance between phosphorus control and mineral preservation

Inventive Principle:
Principle #16Partial or excessive action

4Reliability

If activated vitamin D is administered to manage phosphorus metabolism, then phosphorus regulation is improved, but calcium-containing phosphate binders cannot be administered in sufficient amounts

Engineering Contradiction:
Improvephosphorus regulationVSAvoidmedication administration complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention removes calcium from the phosphate binder formulation, making it compatible with activated vitamin D administration by eliminating the calcium-loading effect that would interfere with vitamin D therapy, thus allowing both medications to be used together without dosage limitations

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The calcium-free phosphate binder acts as an intermediary that enables the concurrent use of activated vitamin D by removing the conflicting calcium component, thereby simplifying the overall medication regimen and allowing sufficient dosing of both agents

Inventive Principle:
Principle #24Intermediary (Mediator)

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 lactic acid bacterium inhibitor is highly safe, readily administrable, and effectively inhibits blood phosphorus level elevation, reducing the risk of constipation and mineral deficiencies while maintaining nutrient intake, particularly beneficial for dialysis patients.

Implementation Method 1

a lactic acid bacterium-based inhibitor... to reduce blood phosphorus levels by improving intestinal environment and phosphorus metabolism

Methodology Applied
Scientific EffectPhosphorus binding: Adsorption

Data Source

PatentUS9056122B2Method for inhibition of blood phosphorus level elevation
Publication Date: 2015.06.16 MORISHITA JINTAN CO LTD
  • US9056122B2 patent drawing

AI summary

The present invention provides a method for inhibiting blood phosphorus level elevation, including administering to a patient in need thereof a composition comprising a lactic acid bacterium as an active ingredient. The method may further include encapsulating the composition comprising a lactic acid bacterium in a capsule. The inhibitor for blood phosphorus level elevation of the present invention is highly safe, is readily administrable, and can sufficiently inhibit a blood phosphorus level elevation.