Glass Container Coating for Low-Temperature Seal Integrity
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Solution Overview
Problem
Pharmaceutical compositions, especially those containing proteins and nucleic acids, are prone to degradation due to enzymatic and chemical processes, and existing storage methods like freeze-drying are expensive and risky, with conventional silicon oil coatings compromising seal tightness at low temperatures.
Innovation Solution
A glass container with a coating having a glass transition temperature at −60° C. or below, a specific hardness, and a crystallization/melting temperature range overlap from −75° C. to −100° C., providing a tight seal and maintaining sterility even at −80° C., using a coating composition with cross-linked and non-cross-linked polysiloxane structural units.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional silicon oil coatings are used on glass containers, then the container can be manufactured with standard materials, but the seal tightness is compromised at low temperatures (−80° C.)
Solution Approach 1:
The patent changes the key parameter of the coating material from conventional silicon oil to a polymer composition with glass transition temperature of −60° C. or below. This parameter change ensures the coating remains flexible and maintains seal tightness at low temperatures of −80° C. and below, resolving the contradiction between standard manufacturing and low-temperature performance.
Solution Approach 2:
The patent uses a composite polymer composition containing cross-linked and non-cross-linked polysiloxane structural units, along with other polymer components. This composite material combines the benefits of different polymer types to achieve both adhesion to glass and flexibility at low temperatures, maintaining seal integrity where conventional silicon oil fails.
2Reliability
If freeze-drying is used to prevent degradation of pharmaceutical compositions, then enzymatic activity is prevented, but the method is expensive and requires complex re-dispersion procedures
Solution Approach 1:
The patent employs a pre-filled syringe system with a disposable sealed container that maintains pharmaceutical composition stability through the specialized coating rather than freeze-drying. This eliminates expensive lyophilization equipment and complex re-dispersion procedures, providing a cheaper, simpler ready-to-use solution that prevents degradation through the low-temperature-seal coating.
3Reliability
If freeze-drying is used to store pharmaceutical compositions, then hydrolysis is prevented, but the composition is not ready-to-use and requires re-dispersion
Solution Approach 1:
The patent performs preliminary sealing of the pharmaceutical composition in a pre-filled syringe at the manufacturing stage using the specialized low-temperature coating. This preliminary action ensures the composition remains stable and prevents hydrolysis during storage, while also being ready-to-use immediately without requiring any re-dispersion or additional processing by the patient.
4Reliability
If a coating with low glass transition temperature is applied to maintain seal tightness at low temperatures, then sterility is maintained, but the coating requires specific manufacturing conditions
Solution Approach 1:
The patent specifies precise parameter ranges for the coating material, including glass transition temperature of −60° C. or below and specific hardness values. These parameter changes enable the coating to be applied using standard dip-coating or spray-coating techniques followed by controlled drying, maintaining sterility through proper formulation rather than complex manufacturing conditions.
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 solution ensures a tight seal and prevents degradation of pharmaceutical compositions at very low temperatures, ensuring the integrity and sterility of the contents for extended periods, suitable for ready-to-use compositions like pre-filled syringes.
Implementation Method 1
The coating has a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10° C./min. The crystallization temperature range and the melting temperature range overlap at a temperature of from −75° C. to −100° C.
Implementation Method 2
The coating has a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10° C./min. The crystallization temperature range and the melting temperature range overlap at a temperature of from −75° C. to −100° C.
Data Source
AI summary
A glass container for pharmaceutical compositions includes a hollow cylindrical body having at least one open end. At least a part of a surface of the glass container includes a coating. The coating has a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10° C./min. The crystallization temperature range and the melting temperature range overlap at a temperature of from −75° C. to −100° C.