Thermally Treated Clay Mineral for Phosphate Binding

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Solution Overview

Problem

Current phosphate binders used in treating hyperphosphatemia, such as aluminum and calcium salts, and newer compounds like Sevelamer and lanthanum carbonate, suffer from significant side effects and gastrointestinal discomfort, and are costly, necessitating a more effective and safer alternative for reducing phosphate levels in body fluids.

Innovation Solution

A thermally treated silicate-containing clay mineral, enriched with divalent cations like magnesium, is used to enhance phosphate binding capacity, offering improved adsorption capabilities without the adverse effects of existing binders, and can be administered orally or externally during dialysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If aluminum and calcium salts are used as phosphate binders, then phosphate binding capacity is improved, but severe side effects occur including aluminum deposits in skeletal system and brain, and hypercalcemia with calcium salts

Engineering Contradiction:
Improvephosphate binding capacityVSAvoidside effects
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent uses magnesium hydroxide, a safe and inexpensive material, as a disposable phosphate binder that does not accumulate in the body like aluminum or lanthanum. The magnesium-based clay mineral can be administered repeatedly without long-term accumulation concerns, resolving the contradiction between binding capacity and harmful effects.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent modifies the phosphate binder by thermally treating the magnesium hydroxide-containing clay mineral at 400-800°C for 1-24 hours, which transforms the material properties and enhances phosphate binding capacity while maintaining safety. This parameter change (thermal treatment temperature and duration) allows the material to achieve high binding capacity without the harmful side effects of traditional binders.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If Sevelamer and lanthanum carbonate are used as newer phosphate binders, then calcium- and aluminum-free binding is achieved, but gastrointestinal disturbances and tissue accumulation occur

Engineering Contradiction:
Improvehypercalcemia and aluminum toxicityVSAvoidgastrointestinal disturbances and tissue accumulation
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

Magnesium hydroxide is a safe, inexpensive material that does not accumulate in tissues like lanthanum or cause gastrointestinal issues like Sevelamer. The patent utilizes this safe material as a disposable phosphate binder that can be administered long-term without accumulation concerns, eliminating both the harmful factors of newer binders.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

Thermal treatment of the magnesium hydroxide-containing clay mineral at 400-800°C transforms the material to enhance phosphate binding capacity while maintaining the safety profile of magnesium-based compounds, avoiding gastrointestinal disturbances associated with other calcium- and aluminum-free binders.

Inventive Principle:
Principle #35Parameter changes

3Quantity of substance

If Fosrenol is used as a phosphate binder, then phosphate binding capacity is improved, but gastrointestinal disturbances such as nausea, vomiting, diarrhea, constipation, abdominal pain, headaches, seizures, and encephalopathy occur

Engineering Contradiction:
Improvephosphate binding capacityVSAvoidgastrointestinal disturbances
Core Design Contradiction:
Quantity of substanceVSObject-generated harmful factors

Solution Approach 1:

The patent uses magnesium hydroxide, a naturally occurring safe material, as a phosphate binder that does not cause gastrointestinal disturbances. Magnesium compounds have a long history of safe use in medicine, and the clay mineral formulation delivers phosphate binding capacity without the severe gastrointestinal side effects of Sevelamer and lanthanum carbonate.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

Thermal treatment of the magnesium hydroxide-containing clay mineral enhances phosphate binding capacity through structural transformation, achieving effective phosphate binding without the gastrointestinal toxicity associated with conventional binders. The thermal treatment optimizes the material properties for high-capacity, safe phosphate binding.

Inventive Principle:
Principle #35Parameter changes

4Quantity of substance

If Lanthanum is used as a phosphate binder, then phosphate binding capacity is improved, but long half-life and accumulation in bones and tissues occur

Engineering Contradiction:
Improvephosphate binding capacityVSAvoidhalf-life and tissue accumulation
Core Design Contradiction:
Quantity of substanceVSDuration of action of stationary object

Solution Approach 1:

The patent uses magnesium hydroxide, a safe material with appropriate pharmacokinetics, as a phosphate binder that does not accumulate in bones and tissues like lanthanum. Magnesium is an essential element with regulated homeostasis, preventing dangerous accumulation, while providing effective phosphate binding capacity.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

Thermal treatment of the magnesium hydroxide-containing clay mineral enhances phosphate binding capacity while maintaining the favorable pharmacokinetic properties of magnesium-based compounds, including appropriate half-life and lack of tissue accumulation, contrasting with lanthanum's long half-life and accumulation issues.

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 treated silicate-containing clay mineral demonstrates a significantly higher phosphate binding capacity compared to traditional binders, reducing phosphate levels effectively and safely, with minimal gastrointestinal intolerance and reduced long-term healthcare costs.

Implementation Method 1

a silicate-containing clay mineral for use as an agent for reducing the concentration of inorganic phosphates in body fluids or dialysis fluids

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

The silica-containing clay mineral used has an average particle size of 0.1 to 1.5 μm and, according to the invention, is thermally treated before use at a temperature between 400°C and 800°C

Methodology Applied
Scientific EffectHeating: Heating

Data Source

PatentEP2854823B1Clay mineral for reducing inorganic phosphates, in particular in renal replacement therapy
Publication Date: 2019.03.06 FIM BIOTECH
  • EP2854823B1 patent drawingFigure 1
  • EP2854823B1 patent drawingFigure 2
  • EP2854823B1 patent drawingFigure 3

AI summary

The invention relates to a clay mineral for use as an agent for reducing the concentration of inorganic phosphate in liquids, in particular in bodily fluids or dialysis liquids, in order to treat hyperphosphatemia, in particular in a renal replacement therapy, wherein before use, the clay mineral is thermally treated at a temperature between 400°C and 800°C, preferably between 500°C and 700°C, in particular preferably at 550°C, over a time period of 60 min to 240 min, preferably 90 min to 180 min, in particular preferably 120 min.