MANP Peptide Formulations for Long-Term Storage Stability

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Solution Overview

Problem

There is a need for stable compositions of modified atrial natriuretic peptide (MANP) for long-term storage and transport, as existing formulations are not sufficiently stable for extended periods.

Innovation Solution

Pharmaceutically-acceptable formulations of MANP comprising sucrose, polysorbate-20, and acetate are developed, with specific concentrations and pH levels to maintain stability during storage and transport.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If MANP is stored in conventional formulations, then it can be used for therapeutic purposes, but it loses stability during long-term storage and transport

Engineering Contradiction:

ImproveMANP stabilityVSAvoidstorage duration

Core Design Contradiction:

Stability of the object's compositionVSDuration of action of stationary object

Solution Approach 1:

The patent optimizes multiple formulation parameters including pH (adjusted to specific ranges using acetate or other buffers), ionic strength, temperature conditions, and compositional ratios of excipients to achieve enhanced stability of MANP during long-term storage and transport

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent introduces specific excipients as intermediary substances that protect MANP from degradation. These include sucrose or mannitol (concentration 10-500 mM) as stabilizing agents, and polysorbate 20 or polysorbate 80 (concentration 0.01-0.5%) as surfactants that prevent aggregation and maintain peptide integrity during storage

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If MANP concentration is increased to improve therapeutic efficacy, then treatment effectiveness improves, but formulation stability and resistance to aggregation worsen

Engineering Contradiction:

Improvetherapeutic effectivenessVSAvoidresistance to aggregation

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent optimizes the concentration of MANP within specific ranges (0.1-10 mg/ml) and balances it with corresponding adjustments in excipient concentrations, particularly stabilizing agents and surfactants, to maintain both high therapeutic effectiveness and resistance to aggregation

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite formulation system where MANP is combined with multiple excipients including buffering agents (acetate, citrate, phosphate, etc.), stabilizing agents (sucrose, mannitol, glycerol, etc.), and surfactants (polysorbates, poloxamers, etc.) that work synergistically to maintain peptide stability and prevent aggregation at therapeutic concentrations

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS12427185B2Formulations of MANP and uses thereof

Publication Date: 2025.09.30 E-STAR BIOTECH LLC

AI summary

The present disclosure provides for, and includes, pharmaceutical formulations comprising an MANP peptide, methods of preparing such formulations, and uses of such formulations in the treatment of diseases and conditions for which use of the peptide contained in such formulations is indicated. The present disclosure further provides for, and includes, methods for increasing the stability by a peptide formulation and for reducing aggregation during production of a peptide formulation.