Antibiotic Bone Cement Powder Clumping Prevention

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Solution Overview

Problem

Current antibiotic polymethylmethacrylate bone cements, particularly those containing fosfomycin salts, are prone to clumping due to hygroscopicity, making them unsuitable for industrial production as flowable and free-flowing powders for medical applications.

Innovation Solution

A method involving mixing a bone cement base powder with trometamol-fosfomycin and drying to a water content of less than 1.0% by weight, combined with the addition of a polymerization initiator and radiopaquer, to produce a non-clumping, flowable bone cement powder suitable for storage and medical use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fosfomycin salts are used in bone cement powder, then antibiotic activity against multidrug-resistant bacteria is improved, but the powder becomes hygroscopic and prone to clumping

Engineering Contradiction:
Improveantibiotic activityVSAvoidflowability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent introduces an intermediary substance (such as magnesium stearate, silicon oxide, or colloidal silica) that acts as a mediator between the hygroscopic fosfomycin salts and the bone cement matrix. This intermediary forms a protective barrier that prevents direct contact with moisture while maintaining the antibiotic's efficacy, thus preventing clumping without compromising antibiotic activity.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent modifies the physical-chemical parameters of the bone cement powder by adjusting the water content to specific ranges (0.1-1.0% by weight) and incorporating hydrophobic additives. These parameter changes reduce the hygroscopicity of the powder mixture, allowing it to maintain flowability while containing fosfomycin salts with broad antibiotic activity against multidrug-resistant bacteria.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If water content is reduced to prevent clumping, then flowability is improved, but manufacturing precision and sterility requirements become more challenging

Engineering Contradiction:
ImproveflowabilityVSAvoidwater content control
Core Design Contradiction:
Stability of the object's compositionVSManufacturing precision

Solution Approach 1:

The patent applies preliminary action by pre-drying the bone cement powder to a controlled water content (0.1-1.0% by weight) before incorporating the fosfomycin salts and other additives. This preliminary drying step prevents subsequent clumping during storage and handling, while the controlled nature of the pre-drying process ensures manufacturing precision is maintained through standardized drying protocols.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent establishes specific parameter ranges for water content (0.1-1.0% by weight) and incorporates hydrophobic additives to maintain low moisture levels. These parameter specifications provide clear manufacturing targets that balance flowability requirements with sterility control, enabling precise control during the manufacturing process while preventing clumping during storage.

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 method results in a stable, flowable bone cement powder that meets mechanical stability requirements and prevents clumping, ensuring effective storage and use in medical applications, such as revision polymethylmethacrylate bone cements and local active substance release systems.

Implementation Method 1

The salts of fosfomycin are extraordinarily hygroscopic. They attract atmospheric humidity and deliquesce in the process.

Methodology Applied
Scientific EffectHygroscopicity: Absorption (physical)

Implementation Method 2

the bone cement powder is dried to a water content of less than or equal to 1.0% by weight

Methodology Applied
Scientific EffectDrying: Evaporation

Data Source

PatentUS9987390B2Method for producing an antibiotic polymethylmethacrylate bone cement powder, and an antibiotic polymethylmethacrylate bone cement powder
Publication Date: 2018.06.05 HERAEUS MEDICAL GMBH

AI summary

The invention relates to a method for producing an antibiotic bone cement, whereby, in a step A), a bone cement base powder with a water content of less than or equal to 1.0% by weight is mixed with trometamol-fosfomycin to form a bone cement powder, and, in a step X), the bone cement powder is dried to a water content of less than or equal to 1.0% by weight. The invention also relates to a bone cement powder that was produced according to said method and contains a bone cement base powder and trometamol-fosfomycin, whereby the bone cement powder has a water content of less than or equal to 1.0% by weight. The bone cement powder is free-flowing and does not clump and can be used for producing bone cements that meet ISO 5833.