Single-Dose Thyroid Hormone Packaging for Stability
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing pharmaceutical preparations of thyroid hormones T3 and T4 in water-alcohol solutions face issues with chemical and physical instability, leading to dose inaccuracies and contamination, particularly in single-dose squeezable containers.
Innovation Solution
A single-dose pharmaceutical preparation of T3 and T4 in a water-alcohol solution is packaged in a one-component LDPE plastic container or a multi-component laminated plastic container, with a sachet made of laminated film materials, ensuring high stability and accurate dose delivery by maintaining ethanol concentration and minimizing impurities and microbiological contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If a water-alcohol solution of T3 and T4 is used for immediate gastrointestinal absorption, then the hormone availability is improved, but the chemical and physical stability deteriorates due to ethanol evaporation and impurity formation
Solution Approach 1:
The patent employs an inert atmosphere by filling the headspace of the container with nitrogen gas. This prevents oxidation reactions between the alcohol solution and oxygen, thereby maintaining chemical stability while preserving the rapid absorption benefits of the liquid formulation.
Solution Approach 2:
The patent utilizes a single-dose disposable container system. The container is designed for one-time use only, eliminating the need for long-term storage and repeated access operations that could compromise stability. This disposable approach ensures the solution remains chemically and physically stable throughout its intended use lifecycle.
2Speed
If a multi-dose glass container with dropper is used, then the liquid formulation provides immediate absorption, but the measurement precision of the administered dose deteriorates
Solution Approach 1:
The patent divides the liquid formulation into multiple discrete, pre-measured single-dose containers. Each container holds a precisely defined volume (e.g., 1 mL) that corresponds to a specific therapeutic dose. This segmentation eliminates the need for manual measurement with droppers, ensuring accurate dosing while maintaining the advantages of liquid administration.
3Ease of operation
If a squeezable container with low Young's modulus is used for easy administration, then the ease of operation is improved, but the reliability of preserving solution stability deteriorates due to alcohol loss and impurity increase
Solution Approach 1:
The patent employs a composite packaging structure consisting of a flexible squeezable container made from specific plastic materials (e.g., polyethylene or polypropylene with ethylene vinyl acetate) that balance mechanical flexibility for easy squeezing with chemical resistance to prevent alcohol evaporation and impurity formation. The composite design integrates materials with complementary properties to simultaneously achieve ease of operation and solution stability.
Data Source
AI summary
The present invention relates to a single-dose formulation for oral use of the thyroid hormones triiodothyronine or liothyronine (T3) and tetraiodothyronine or thyroxine (T4) in water-alcohol solution, which is physically and chemically stable, protected against accidental or microbiological contamination, in a container for pharmaceutical use which is squeezable and impermeable to the evaporation of the volatile substances it contains, and the corresponding means for implementing it.