Ready-to-use RECK formulation with stabilizers

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Solution Overview

Problem

The management of post-operative pain in arthroplasty procedures is hindered by the limited stability and potential microbial contamination of compounded RECK-containing solutions, which can lead to inadequate pain relief during rehabilitation.

Innovation Solution

A ready-to-use liquid formulation comprising ropivacaine, epinephrine, clonidine, and ketorolac, stabilized with sodium metabisulfite and EDTA, and stored in light-resistant containers, maintains potency of at least 90% for 90 days at 25°C, reducing the risk of contamination and degradation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If a RECK-containing solution is compounded and stored for extended periods, then the solution can be used for prolonged pain management, but the stability of the solution deteriorates and microbial contamination risk increases

Engineering Contradiction:
Improvestorage durationVSAvoidsolution stability
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent applies preliminary action by pre-stabilizing the RECK formulation with sodium metabisulfite and EDTA during manufacturing, and by pre-packaging it in light-resistant containers. This preliminary preparation prevents degradation and contamination before the solution is used, allowing extended storage without compromising stability or reliability.

Inventive Principle:
Principle #10Preliminary action

2Ease of manufacture

If a RECK-containing solution is prepared from commercially available products, then the preparation process is simplified, but the risk of microbial contamination and compounding errors increases

Engineering Contradiction:
Improvepreparation simplicityVSAvoidmicrobial contamination
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent applies the disposable approach by providing a pre-stabilized, single-use RECK formulation that is packaged in light-resistant containers. This eliminates the need for complex compounding procedures and reduces the risk of contamination by using a ready-to-use product that does not require further preparation at the point of use.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Reliability

If epinephrine is included in the RECK formulation, then the anesthetic effectiveness is improved, but the solution is more susceptible to degradation and color change

Engineering Contradiction:
Improveanesthetic effectivenessVSAvoidepinephrine stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies the intermediary principle by using sodium metabisulfite and EDTA as stabilizing agents that mediate between the epinephrine and other formulation components. These intermediaries prevent direct degradation pathways for epinephrine while maintaining its anesthetic effectiveness, thereby resolving the contradiction between effectiveness and stability.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 formulation ensures consistent and effective pain relief during post-operative rehabilitation by maintaining the stability and potency of the active ingredients, thereby improving patient outcomes and reducing the risk of microbial contamination.

Implementation Method 1

stabilized with sodium metabisulfite and EDTA

Methodology Applied
Scientific EffectOxidation prevention: Oxidation

Implementation Method 2

stabilized with sodium metabisulfite and EDTA

Methodology Applied
Scientific EffectChelation:

Implementation Method 3

stored in light-resistant containers

Methodology Applied
Scientific EffectPhotoprotection: Absorption (EM radiation)

Data Source

PatentUS10952963B2Ready to use liquid RECK formulation
Publication Date: 2021.03.23 QUVA PHARMA INC

AI summary

Disclosed herein is a ready-to-use liquid formulation comprising ropivacaine, epinephrine, clonidine, and ketorolac (collectively referred to as RECK). Also disclosed herein is a process for preparing the RECK-containing liquid formulation, as well as methods for using the same.