MYDGF Protein Formulation Stabilization for Myocardial Infarction
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Solution Overview
Problem
Current treatments for acute myocardial infarction (AMI) do not effectively address ischaemic damage and reperfusion-induced myocardial injury, leading to significant morbidity and mortality.
Innovation Solution
A pharmaceutical formulation comprising myeloid-derived growth factor (MYDGF) protein, optimized with stabilizing excipients such as histidine buffer, methionine, sucrose, and polysorbate, to enhance stability and allow intravenous administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If protein-based therapy is used to treat myocardial infarction, then therapeutic effectiveness is improved, but protein stability and storage capability deteriorate
Solution Approach 1:
The patent modifies the physical and chemical parameters of the protein formulation by adjusting pH to a specific range (5.0-7.0), optimizing excipient concentrations, and controlling protein concentration levels. These parameter changes stabilize the protein structure and prevent degradation while maintaining therapeutic activity.
Solution Approach 2:
The patent creates a composite formulation system combining the protein therapeutic with specific excipients (buffers, stabilizers, tonicity agents, surfactants). This composite approach protects the protein from degradation through synergistic effects of multiple components working together in the formulation.
2Reliability
If protein concentration is increased to improve therapeutic activity, then treatment efficacy is improved, but protein degradation accelerates
Solution Approach 1:
The patent optimizes the protein concentration parameter within a specific range (0.5-200 mg/mL) and adjusts formulation parameters (pH, excipient concentrations) to match this protein concentration level. This coordinated parameter optimization maintains therapeutic activity while preventing concentration-induced degradation.
3Ease of operation
If formulation is designed for intravenous administration, then ease of operation is improved, but formulation complexity increases
Solution Approach 1:
The patent designs a multi-functional formulation that simultaneously achieves intravenous compatibility, protein stabilization, proper tonicity, and pH control through a single integrated composition. This universal formulation approach simplifies administration while managing complexity through systematic design.
Data Source
AI summary
The present invention generally relates to pharmaceutical formulations which are useful for treating acute coronary syndrome. More specifically, the invention pertains to a novel pharmaceutical formulation which comprises a myeloid-derived growth factor (MYDGF) protein which is useful for treating a myocardial infarction in a subject in need thereof. The pharmaceutical formulation of the invention provides a significantly improved long-term stability compared to commonly used formulations. In addition, the pharmaceutical formulation of the invention allows an easy lyophilisation and reconstitution without any significant loss of the therapeutically active protein. The invention also pertains to a formulation for use in a method for treating a myocardial infarction in a subject in need thereof. The method comprises an intravenous administration of a MYDGF protein to the subject on top of standard of care.