Selenium Disulfide Petrolatum Mixing for Stable MGD Formulations
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Solution Overview
Problem
Manufacturing chemically and physically stable selenium disulfide formulations is challenging due to aggregation and reactivity issues, particularly at large scale, which affects their efficacy in treating meibomian gland dysfunction (MGD).
Innovation Solution
A low-temperature mixing process is employed, using high-shear mixing with a viscous carrier like petrolatum below its melting point to create a steady flow, ensuring uniform dispersion of micronized selenium disulfide particles without aggregation or degradation, followed by cooling and filling into a dispenser under controlled conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If selenium disulfide particles are mixed with viscous carrier material at conventional temperatures, then mixing efficiency improves, but particle aggregation and chemical degradation occur
Solution Approach 1:
The patent applies parameter changes by controlling the temperature to remain below the melting point of the viscous carrier material during mixing. This temperature parameter control prevents selenium disulfide particle aggregation and chemical degradation while maintaining manufacturability through controlled mixing conditions.
Solution Approach 2:
The patent employs preliminary action by pre-cooling the viscous carrier material below its melting point before introducing selenium disulfide particles. This preliminary temperature control creates optimal conditions for particle dispersion that prevent aggregation and degradation during the subsequent mixing process.
2Ease of operation
If mixing temperature is increased to improve flow, then viscosity decreases, but selenium disulfide degradation accelerates
Solution Approach 1:
The patent applies parameter changes by optimizing the temperature parameter to remain below the melting point of the carrier material. This parameter control achieves adequate flow characteristics for mixing while preventing thermal degradation of selenium disulfide, resolving the contradiction between flow and stability.
3Productivity
If conventional mixing processes are used, then production speed increases, but particle aggregation occurs reducing formulation stability
Solution Approach 1:
The patent employs preliminary action by pre-cooling the carrier material and controlling environmental conditions before mixing begins. This preliminary preparation enables faster mixing speeds without causing particle aggregation, as the low temperature conditions are already established to prevent aggregation during high-speed mixing.
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 process results in a stable selenium disulfide composition with uniform particle distribution, minimal degradation, and extended shelf life, suitable for treating MGD without surfactants or dispersing agents, maintaining therapeutic efficacy over time.
Implementation Method 1
the temperature of the mixture is below melting point of the viscous carrier material (e.g., during the mixing)
Implementation Method 2
the viscous carrier material has a steady flow pattern during the mixing
Implementation Method 3
the temperature of the mixture is below congealing point of the viscous carrier material during the mixing
Implementation Method 4
high-shear mixing with a viscous carrier like petrolatum below its melting point to create a steady flow, ensuring uniform dispersion
Data Source
AI summary
Described herein are methods for the manufacture of compositions useful for the treatment of meibomian gland dysfunction. Said methods utilize rheological properties of petrolatum induced by a high shear mixing feature of the method. The products of the methods of manufacture described herein are stable anhydrous composition of selenium disulfide which are substantially free of selenium disulfide agglomerates and degradation products.