Plasmid DNA Liquid Formulation Stabilization
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Solution Overview
Problem
Existing pharmaceutical formulations of nucleic acid constructs, such as plasmid DNA, are often provided in lyophilized form, which requires reconstitution and can lead to drug loss or contamination if not properly administered, necessitating a stable liquid formulation for enhanced safety and commercial viability.
Innovation Solution
A liquid formulation containing plasmid DNA with pharmaceutically acceptable carriers or excipients, including buffers like potassium phosphate and stabilizers like mannitol, sucrose, and salts like NaCl, maintains the plasmid DNA in a supercoiled form, ensuring stability and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If plasmid DNA is provided in lyophilized form for storage stability, then storage stability is improved, but reconstitution complexity and risk of drug loss or contamination increase
Solution Approach 1:
The patent changes the physical state parameter of plasmid DNA from solid (lyophilized) to liquid form, eliminating the need for reconstitution while maintaining storage stability through controlled liquid formulation with stabilizing excipients
Solution Approach 2:
The patent extracts and removes the reconstitution step from the administration process, directly providing plasmid DNA in a ready-to-use liquid formulation that eliminates potential sources of error and contamination
2Ease of operation
If plasmid DNA is provided in liquid formulation, then ease of administration is improved, but formulation stability and shelf life worsen
Solution Approach 1:
The patent creates a composite liquid formulation combining plasmid DNA with stabilizing excipients (sucrose, mannitol, salts, buffers) that work synergistically to maintain DNA structure and prevent degradation while enabling liquid form administration
Solution Approach 2:
The patent adjusts formulation parameters including pH, ionic strength, and excipient concentrations to optimize both the liquid state properties for administration and the stability properties for long-term storage
3Reliability
If plasmid DNA is maintained in supercoiled form, then biological activity is improved, but susceptibility to degradation increases
Solution Approach 1:
The patent introduces stabilizing excipients as intermediary substances that physically interact with plasmid DNA to protect the supercoiled structure from degradation while maintaining its biological activity
Solution Approach 2:
The patent optimizes formulation parameters such as pH, ionic composition, and temperature to maintain the supercoiled conformation of plasmid DNA and prevent structural degradation
Data Source
AI summary
The present invention relates to a liquid formulation pharmaceutical composition comprising plasmid DNA. The liquid formulation comprising plasmid DNA according to the present invention shows excellent efficacy in terms of storage stability of plasmid DNA, which is a pharmaceutically active ingredient, and accordingly, can be useful as a pharmaceutical composition with excellent product stability and safety.