Co-processed Lubricant MCG for Tablet Hardness and Flow

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Solution Overview

Problem

Traditional lubricants used in pharmaceutical solid dosage forms often lack sufficient bulk density and flowability, limiting their suitability for continuous manufacturing and resulting in tablets with lower hardness and potentially inconsistent disintegration times.

Innovation Solution

A co-processed excipient comprising microcrystalline cellulose, sodium carboxymethylcellulose, and a pharmaceutically acceptable lubricant, such as magnesium stearate, is developed to enhance bulk density, flowability, and tablet hardness, while maintaining comparable disintegration times to traditional formulations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If traditional lubricants are used in tablet formulation, then the material can be compressed into tablets, but the bulk density and flowability are insufficient for continuous manufacturing

Engineering Contradiction:
Improvecontinuous manufacturing capabilityVSAvoidbulk density
Core Design Contradiction:
ProductivityVSQuantity of substance

Solution Approach 1:

The patent combines microcrystalline cellulose and magnesium stearate into a single co-processed excipient material. This merging of lubricant and filler creates a unified material with improved bulk density and flow characteristics, enabling continuous manufacturing while maintaining lubrication functionality.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention creates a composite excipient material consisting of microcrystalline cellulose and magnesium stearate in specific ratios. This composite material exhibits superior bulk density and flowability compared to traditional pure lubricants, making it suitable for high-speed continuous tablet manufacturing.

Inventive Principle:
Principle #40Composite materials

2Strength

If traditional lubricants are used, then the tablet can be ejected from the die, but the tablet hardness is reduced

Engineering Contradiction:
Improvetablet hardnessVSAvoidejection from die
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The patent modifies the physical and chemical parameters of the lubricant by co-processing it with microcrystalline cellulose. This changes the particle morphology, surface area, and distribution characteristics, resulting in a material that provides adequate lubrication for ejection while simultaneously enhancing tablet hardness through improved compression characteristics.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If more lubricant is added to improve flowability, then the material flows better, but the tablet hardness decreases

Engineering Contradiction:
ImproveflowabilityVSAvoidtablet hardness
Core Design Contradiction:
ProductivityVSStrength

Solution Approach 1:

The co-processed excipient creates local quality variations at the particle level, where microcrystalline cellulose provides structural integrity and magnesium stearate provides lubrication. This localized functional distribution allows the material to exhibit both excellent flowability and high tablet hardness simultaneously, avoiding the trade-off present in traditional formulations.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS11925707B2Co-processed lubricant:MCG for tablets
Publication Date: 2024.03.12 JRS PHARMA GMBH & CO KG
  • US11925707B2 patent drawing
  • US11925707B2 patent drawing
  • US11925707B2 patent drawing

AI summary

The present invention is directed to a co-processed lubricant excipient which can be used to manufacture tablets, and pharmaceutical compositions containing the same.