Polymer-Stabilized Vasopressin Formulation for Long-Term Storage
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Solution Overview
Problem
Current formulations of vasopressin suffer from poor long-term stability, leading to significant degradation and reduced efficacy in maintaining blood pressure.
Innovation Solution
A pharmaceutical composition comprising vasopressin or its pharmaceutically-acceptable salt, combined with a polymeric pharmaceutically-acceptable excipient, such as dextrose and acetic acid, stabilizes vasopressin by reducing degradation to less than 10% over one week at 60°C and maintaining stability for up to 30 months at refrigerated temperatures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current formulations of vasopressin are used, then the drug can be administered for blood pressure elevation, but the formulation suffers from poor long-term stability and significant degradation
Solution Approach 1:
The patent changes the chemical parameters of the formulation by incorporating specific excipients (polyethylene glycol, hydrophilic polymers, buffers at controlled pH levels) and adjusting concentration ratios to reduce vasopressin degradation. This resolves the contradiction by modifying formulation parameters to achieve both stability and extended shelf life
Solution Approach 2:
The patent creates a composite pharmaceutical formulation by combining vasopressin with multiple stabilizing excipients including polyethylene glycol, hydrophilic polymers, and buffer systems. This composite approach addresses the stability issue while maintaining the therapeutic function, resolving the contradiction between reliability and duration
2Reliability
If storage conditions are optimized to reduce degradation, then stability is improved, but storage time and temperature constraints limit practical use
Solution Approach 1:
The patent applies preliminary stabilization actions during formulation preparation by incorporating stabilizing excipients and adjusting pH levels before storage. This preliminary protection allows the formulation to maintain stability over extended periods without requiring stringent ongoing storage conditions, thus resolving the contradiction between stability and storage time
Solution Approach 2:
The patent modifies storage parameters by demonstrating that the optimized formulation can be stored at higher temperatures (e.g., 25°C or 40°C) for extended periods with minimal degradation compared to conventional formulations. This parameter change resolves the contradiction by reducing the time loss associated with strict refrigeration requirements
Data Source
AI summary
Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.