Stabilizing Single-Stranded Nucleic Acid in Liquid Form
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Solution Overview
Problem
Nucleic acid molecules, particularly single-stranded nucleic acids, are unstable in solutions and challenging to handle at ambient temperatures, leading to decomposition issues, which hampers their use in pharmaceutical compositions for conditions like pulmonary fibrosis.
Innovation Solution
A composition comprising a single-stranded nucleic acid molecule (PK-0051) is stabilized by dissolving it in a buffer with a pH range of 4.6 to 7.0, allowing the molecule to remain effective at ambient temperature for extended periods, including exposure to light and high temperatures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If single-stranded nucleic acid molecules are stored in solution at ambient temperature, then ease of operation is improved, but stability of the object's composition deteriorates due to decomposition
Solution Approach 1:
The patent applies parameter changes by adjusting the pH of the buffer solution to a specific range (pH 4.6-7.0, preferably pH 5.5-6.5) to stabilize the single-stranded nucleic acid molecule. This chemical parameter modification prevents decomposition while maintaining the molecule in a soluble, handleable state at ambient temperature, thus resolving the contradiction between ease of operation and stability.
2Stability of the object's composition
If nucleic acid molecules are stabilized through freeze-drying storage, then stability of the object's composition is improved, but ease of operation deteriorates due to complex handling requirements
Solution Approach 1:
The patent changes the chemical environment parameter (pH) to enable stable storage in liquid form at ambient temperature, eliminating the need for freeze-drying or freezing. This allows the nucleic acid to be handled as a simple liquid solution while maintaining stability, thus improving ease of operation compared to freeze-dried forms.
3Stability of the object's composition
If pH buffer is added to stabilize nucleic acid molecule, then stability of the object's composition is improved, but device complexity increases due to additional components
Solution Approach 1:
The patent introduces a pH buffer as an intermediary substance that mediates between the nucleic acid molecule and the environment. The buffer acts as a protective intermediary that maintains optimal pH conditions, preventing decomposition without requiring complex stabilization systems or multiple additives.
Solution Approach 2:
By focusing on a single critical parameter (pH) and controlling it within a specific range, the patent achieves stabilization with minimal additional components. This simple parameter-controlled approach avoids the complexity that would arise from using multiple stabilizing agents or complex formulation systems.
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 composition maintains at least 80% of its nucleic acid content after storage at various conditions, ensuring stability and efficacy as a pharmaceutical agent for pulmonary fibrosis treatment.
Implementation Method 1
a buffer, and having the following features: (a) being in the form of a solution at ambient temperature; and (b) a content of the nucleic acid molecule after storage at 25°C, relative humidity 60% for 4 weeks
Data Source
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AI summary
The present invention provides a composition containing a single-stranded nucleic acid molecule consisting of a nucleotide sequence shown by 5'-AGCAGAGUACACACAGCAUAUACC-P-GGUAUAUGCUGUGUGUACUCUGCUUC-P-G-3' (SEQ ID NO: 1) (in the sequence, P is a proline derivative linker represented by (I) in the DESCRIPTION) and a buffer, and having the following features: (a) being in the form of a solution at ambient temperature; and (b) a content of the nucleic acid molecule after storage at 25°C, relative humidity 60% for 4 weeks, of not less than 80% relative to the content at the time of start of the storage.