Mucolytic Tablet Formulation for Sample Viscosity and Assay Compatibility

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Solution Overview

Problem

Existing mucolytic tablets for biological sample collection devices, such as those containing N-acetyl-L-cysteine (NALC), face issues with incomplete solubilization and interference with molecular reactions and microbial survivability, affecting the accuracy of diagnostic analyses.

Innovation Solution

A mucolytic tablet composition comprising 15% to 65% NALC, 6% to 30% buffering agent, 10% to 14% water-soluble anti-adherent, and 2% to 10% chelating and lubricant agents, designed to solubilize in a specific resuspension buffer, ensuring complete dissolution and optimal action on biological samples without interfering with molecular assays or microbial survivability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a mucolytic tablet containing NALC is used to reduce sample viscosity, then the biological sample becomes suitable for further analysis, but the constituents of the tablet do not solubilize completely and interfere with molecular reactions

Engineering Contradiction:

Improvesample viscosity reductionVSAvoidmolecular reaction accuracy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent changes the chemical composition parameters of the tablet by selecting specific buffering agents (phosphates, citrates) and chelating agents (EDTA, EGTA) that are compatible with molecular assays. The tablet formulation was optimized to contain NALC (15-65% by weight) combined with specific buffers and chelators at controlled concentrations to achieve complete solubilization without interfering with PCR or antibody-based analyses.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent introduces buffering agents and chelating agents as intermediary substances that mediate between the NALC mucolytic agent and the biological sample. These intermediaries ensure complete solubilization of the tablet constituents while preventing interference with molecular reactions by controlling pH and sequestering metal ions that might otherwise inhibit enzymatic reactions.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If a mucolytic tablet is used to process biological samples, then viscosity is reduced, but certain constituents alter microbial survivability by being a food source or toxic to microbes

Engineering Contradiction:

Improvesample processingVSAvoidmicrobial analysis accuracy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent modifies the chemical environment parameters by selecting buffering agents (phosphates, citrates) and chelating agents (EDTA, EGTA) that maintain pH and metal ion concentrations within ranges that do not promote or inhibit microbial growth. The formulation ensures that NALC remains effective for mucolysis while the buffer and chelator system maintains conditions neutral to microbial survivability.

Inventive Principle:

Principle #35Parameter changes

3Productivity

If the tablet is designed to solubilize rapidly in resuspension buffer, then dissolution time is reduced, but complete solubilization of all constituents is not achieved

Engineering Contradiction:

Improvedissolution speedVSAvoidcomplete solubilization

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent changes the physical and chemical parameters of the tablet formulation by selecting highly soluble buffering agents (phosphates, citrates) and chelating agents (EDTA, EGTA) that enhance the overall solubility of the tablet in resuspension buffer. The NALC is formulated at optimized concentrations (15-65% by weight) combined with these soluble excipients to achieve complete and rapid dissolution within 1-2 minutes.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite tablet material combining NALC with buffering agents and chelating agents that have complementary solubility properties. This composite formulation ensures that all constituents, including the hydrophobic NALC, solubilize completely and rapidly in the aqueous resuspension buffer, achieving both speed and completeness of dissolution.

Inventive Principle:

Principle #40Composite materials

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 tablet effectively reduces biological sample viscosity, enabling homogeneous mixing and accurate diagnostic analysis without altering microbial survivability or interfering with molecular assays, with a stable shelf life and rapid dissolution in the resuspension buffer.

Implementation Method 1

NAC may reduce viscosity of the biological sample, making the biological sample suitable for further analysis

Methodology Applied

Scientific EffectMucolysis:

Implementation Method 2

6% to 30% by weight of a buffering agent

Methodology Applied

Scientific EffectBuffering:

Implementation Method 3

2% to 10% by weight of at least one chelating and lubricant agent

Methodology Applied

Scientific EffectChelation:

Data Source

PatentUS10139321B2Mucolytic tablet for a sample collection device

Publication Date: 2018.11.27 CALIBRESCIENTIFIC AMER IP LLC

AI summary

The present disclosure relates to a mucolytic tablet for a sample collection device that causes mucolysis of biological samples collected in the sample collection device. The mucolytic tablet includes N-acetyl L-cysteine (NALC), a pharmaceutically active mucolytic agent that reduces the viscosity of mucus containing biological samples. The mucolytic tablet also includes one or more chelating agents, water-soluble anti-adherent/s, and at least one buffering agent.