Glass Container Coating for -80°C Pharmaceutical Storage
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Solution Overview
Problem
Glass containers used for storing pharmaceutical compositions at low temperatures, such as −80° C. or below, face challenges in maintaining a tight seal due to the risk of compromised closure integrity during cooling, thawing, or storage and transport.
Innovation Solution
A method involving a glass container with a specific coating that has overlapping crystallization and melting temperature ranges, and a controlled cooling procedure with rates of ≤6.0° C./min from −50° C. to −80° C. and <5.0° C./min from −80° C. to −96° C., to ensure container closure integrity at extreme temperatures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If a glass container with a stopper is used for storing pharmaceutical compositions, then the container can be sealed and stored for extended periods, but the tight seal may be compromised during cooling or thawing at low temperatures
Solution Approach 1:
The patent applies parameter changes by modifying the coating's thermal properties - specifically selecting a coating material whose crystallization temperature range overlaps with its melting temperature range at the storage temperature (−80°C). This parameter optimization allows the coating to maintain sealing functionality despite temperature fluctuations during storage and transport
Solution Approach 2:
The patent uses a composite coating material applied to the glass container surface. This coating layer acts as an intermediary between the glass container and the pharmaceutical composition, providing enhanced sealing performance at low temperatures while maintaining the structural integrity of the glass container
2Loss of time
If the container is cooled rapidly to reach −80°C or below, then storage time is reduced, but the seal integrity may be compromised during cooling
Solution Approach 1:
The patent optimizes the cooling rate parameter to ≤6.0°C./min in the range from −50°C. to −80°C. This controlled parameter change prevents thermal shock to the coating and stopper materials, avoiding seal compromise while still achieving the required storage temperature efficiently
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 effectively maintains container closure integrity at temperatures of −80° C. or below, preventing leaks and ensuring the stability of pharmaceutical compositions during storage and transport.
Implementation Method 1
the coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10° C./min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature from −75° C. to −100° C.
Implementation Method 2
the coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10° C./min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature from −75° C. to −100° C.
Implementation Method 3
cooling the glass container with a cooling rate of ≤6.0° C./min in a range of from −50° C. to −80° C.
Data Source
AI summary
A method for storing a pharmaceutical composition at a temperature of −80° C. or below, which includes defined cooling rates, and a glass container suitable for this purpose, which includes a coating whose crystallization temperature range and melting temperature range is overlapping.