Polyunsaturated Fatty Acid Salt Binders for Tablet Strength

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Solution Overview

Problem

Existing tablet formulations face challenges in achieving high strength and low friability at wider compression forces, leading to issues like capping and early wear and tear of high-speed compression machines. Additionally, specialized tablets like MUPS are sensitive to compression force variations, affecting their integrity and functionality.

Innovation Solution

The use of polyunsaturated fatty acid salts as binders in tablet formulations provides exceptional tablet characteristics at low compression forces, suitable for high-speed processing. These formulations, containing 5-50% w/w fatty acid salts, offer good cushioning for sensitive components and can be processed using direct compression and wet granulation technologies without magnesium stearate.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If conventional binders are used to achieve high tablet strength, then tablet strength is improved, but compression force range becomes narrow and capping occurs

Engineering Contradiction:

Improvetablet strengthVSAvoidcompression force range

Core Design Contradiction:

StrengthVSAdaptability or versatility

Solution Approach 1:

The patent changes the chemical and physical parameters of the binder by using polyunsaturated fatty acid salts with specific molecular structures (multiple double bonds) instead of conventional binders. This parameter change enables the binder to provide adequate adhesion across a wide compression force range (0.5-5 kN), resolving the contradiction between achieving high tablet strength and maintaining adaptability to varying compression forces without capping

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs composite material strategy by formulating tablets with polyunsaturated fatty acid salts combined with specific diluents and lubricants in optimized ratios. This composite formulation enhances both tablet strength and the width of compression force range, allowing consistent tablet quality across varying compression forces while preventing capping

Inventive Principle:

Principle #40Composite materials

2Strength

If high compression forces are used to achieve high tablet strength, then tablet strength is improved, but machine wear and energy consumption increase

Engineering Contradiction:

Improvetablet strengthVSAvoidenergy consumption and machine wear

Core Design Contradiction:

StrengthVSLoss of energy

Solution Approach 1:

The patent changes the binder parameters to polyunsaturated fatty acid salts that provide high binding efficiency at lower compression forces. This enables achieving the required tablet strength (breaking force > 20 N) at reduced compression forces (0.5-5 kN), thereby reducing energy consumption and minimizing wear on high-speed compression machines while maintaining adequate tablet strength

Inventive Principle:

Principle #35Parameter changes

3Loss of energy

If low compression forces are used to reduce machine wear, then energy consumption is reduced, but tablet strength becomes insufficient

Engineering Contradiction:

Improveenergy consumptionVSAvoidtablet strength

Core Design Contradiction:

Loss of energyVSStrength

Solution Approach 1:

The patent changes the chemical composition parameters of the binder to polyunsaturated fatty acid salts with specific molecular characteristics (multiple double bonds, specific chain lengths). These parameter changes enable the binder to provide sufficient adhesion and binding force even at low compression forces (0.5-5 kN), achieving both reduced energy consumption and adequate tablet strength simultaneously

Inventive Principle:

Principle #35Parameter changes

4Stability of the object's composition

If conventional binders are used for MUPS tablets, then tablet integrity is maintained, but sensitivity to compression force variations increases

Engineering Contradiction:

Improvetablet integrityVSAvoidsensitivity to compression force

Core Design Contradiction:

Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The patent changes the binder parameters to polyunsaturated fatty acid salts that exhibit stable binding characteristics across varying compression forces. This parameter change reduces MUPS tablet sensitivity to compression force variations, maintaining tablet integrity and protected coated pellet structure even when compression force fluctuates, unlike conventional binders that show high sensitivity

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentEP4009960B1Method of preparing a solid dosage form and a binder

Publication Date: 2025.06.04 EVONIK OPERATIONS GMBH

AI summary

The present invention is related to a method of preparing a solid dosage form, comprising the steps of: a) preparing a binder consisting of at least one polyunsaturated fatty acid salt; b) adding the binder and ingredients for the solid dosage form to a mixer; c) optionally carrying out one or more of the following steps: granulation, drying and sizing, d) blending the contents of the mixer; and e) compressing or slugging the blended contents to produce a solid dosage form wherein the binding parameter (BP) for the solid dosage form is at least 2 and is determined by: BP = H/C, wherein H is the tablet breaking force in Newton (N) and C is the compression force in kilo Newton (kN). Solid dosage forms prepared according to this method and the use of PUFA salts as binder in tableting applications for compression of solid components are further comprised by the present invention.