Coated Container Leaching Test Under Alkaline and Acidic Treatment

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Solution Overview

Problem

Existing methods for evaluating the adhesion and chemical stability of coatings on pharmaceutical containers, especially under alkaline conditions, are time-consuming and do not adequately address the need for a quick, reliable, and cost-effective evaluation of these properties.

Innovation Solution

A method and a coated container is developed to evaluate the adhesion and chemical stability by performing an alkaline and acidic treatment on a coated surface to determine the leaching of one or more types of ions or compounds from the coated surface and quantify the chemical stability of the coating on the container and quantify the chemical stability of the coating on the container and quantify the chemical stability of the coating on the container and quantify the chemical stability of the coating on the container and quantify the chemical stability of the coating on the container and quantify the chemical stability of the coating on the container and quantify the chemical stability of the coating on the container and quantify the chemical suitability of the coating on the container and qualify the chemical resistance of the coating on the container and qualify the chemical resistance of the coated container.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If storage studies are performed to test resistance against leaching and delamination under alkaline conditions, then reliability of the coating is improved, but evaluation time is significantly increased

Engineering Contradiction:
Improvecoating resistanceVSAvoidevaluation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent applies preliminary action by conducting accelerated stability testing before actual storage studies. The coating is pre-tested under simulated alkaline conditions (pH 9-11) for a shortened duration (e.g., 1-7 days) to predict long-term performance. This preliminary testing allows rapid evaluation of coating resistance without requiring lengthy storage studies, thus resolving the contradiction between reliability assessment and evaluation time.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent utilizes parameter changes by modifying the testing conditions to accelerate the evaluation process. Instead of conducting tests under standard storage conditions for extended periods, the invention employs elevated temperature (e.g., 40-60°C) and controlled alkaline pH levels (9-11) to create accelerated degradation conditions. This allows the coating performance to be assessed much faster while maintaining predictive validity for long-term stability.

Inventive Principle:
Principle #35Parameter changes

2Ease of manufacture

If conventional coating materials are used, then manufacturing cost is reduced, but chemical stability under alkaline conditions deteriorates

Engineering Contradiction:
Improvemanufacturing costVSAvoidchemical stability
Core Design Contradiction:
Ease of manufactureVSStability of the object's composition

Solution Approach 1:

The patent applies composite materials by developing a coating composition that combines multiple functional components: silane crosslinked polymers for adhesion, alkaline-resistant additives (such as metal oxides or hydroxides), and pH-responsive molecules. This composite formulation provides both cost-effectiveness and superior chemical stability under alkaline conditions, resolving the contradiction between manufacturing cost and chemical stability.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent utilizes parameter changes by adjusting the chemical composition parameters of the coating material. Specific additives are incorporated at optimized concentrations (e.g., 1-10 wt% alkaline-resistant compounds) to enhance chemical stability without significantly increasing manufacturing cost. The coating formulation is tuned to maintain neutrality or slight alkalinity, which protects against degradation while remaining cost-effective.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If extended storage studies are conducted, then measurement precision of leaching is improved, but productivity of evaluation is reduced

Engineering Contradiction:
Improveleaching quantificationVSAvoidevaluation speed
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The patent applies preliminary action by performing rapid preliminary tests before comprehensive analysis. The method includes initial quick screening (e.g., visual inspection, pH measurement) followed by targeted leaching quantification only for samples that fail the preliminary test. This staged approach maintains measurement precision for critical failures while avoiding unnecessary extensive testing on passing samples, thus improving evaluation productivity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent utilizes skipping by implementing a tiered testing protocol where routine, less precise but faster tests are performed first. Only when anomalies are detected does the process proceed to more precise but time-consuming leaching quantification. This selective approach allows rapid evaluation of the majority of samples while maintaining high measurement precision for critical cases, resolving the contradiction between precision and productivity.

Inventive Principle:
Principle #21Skipping (Rushing through)

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 provides a fast, reliable, and cost-effective way to evaluate the adhesion and chemical stability of coatings on containers, particularly under varying pH conditions, ensuring improved resistance and stability for pharmaceutical containers.

Implementation Method 1

a coating applied to at least part of the surface to form a coated surface... The leaching of the at least one of one or more types of ions or one or more types of compounds from the coated surface is 5.00 mg/l or less

Methodology Applied
Scientific EffectChemical stability:

Implementation Method 2

performing an alkaline treatment on at least part of the coated surface to obtain an alkaline treated surface and performing an acidic treatment on at least part of the alkaline treated surface

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS20250368392A1Test method for quality evaluation and coated container
Publication Date: 2025.12.04 SCHOTT AG
  • US20250368392A1 patent drawing
  • US20250368392A1 patent drawing

AI summary

A coated container includes: a container having a surface; and a coating applied to at least part of the surface to form a coated surface. Leaching of at least one of one or more types of ions or one or more types of compounds is determined by performing an alkaline treatment on at least part of the coated surface to obtain an alkaline treated surface and performing an acidic treatment on at least part of the alkaline treated surface to obtain an acidic treated surface. The leaching of the at least one of one or more types of ions or one or more types of compounds from the coated surface is 5.00 mg/l or less.