Multilayer Orodispersible Tablet for Content Uniformity

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Solution Overview

Problem

Current orodispersible tablets face challenges in achieving uniformity of active substance content and compatibility between components, leading to non-uniform disintegration and palatability, especially when multiple active substances are combined, and the application of high compression forces can be detrimental to sensitive substances like polymer-coated ones.

Innovation Solution

A multilayer orodispersible tablet design with superimposed and integral layers, each containing a mixture of soluble agents, disintegrants, and swelling agents, allowing for the combination of active substances with varying release profiles and taste masking, while minimizing the need for high compression forces.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a single mixture comprising both tableting excipients and active substances is used, then the tablet can be manufactured with a simple process, but the content uniformity of each active substance becomes non-uniform and segregation risk increases

Engineering Contradiction:

Improvemanufacturing process simplicityVSAvoidcontent uniformity

Core Design Contradiction:

Ease of manufactureVSManufacturing precision

Solution Approach 1:

The tablet is divided into multiple layers, with each layer containing a specific active substance and its associated excipients. This segmentation prevents mixing of different powder populations during tableting, ensuring content uniformity for each active substance while maintaining a relatively simple manufacturing process using standard tableting equipment.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Each layer of the tablet has a localized composition tailored to its specific active substance requirements. The excipients in each layer are selected and proportioned locally to optimize dissolution, stability, and content uniformity for that particular active substance, rather than using a single uniform excipient mixture throughout the entire tablet.

Inventive Principle:

Principle #3Local quality

2Ease of operation

If multiple active substances are combined in a single tablet mixture, then patient compliance improves, but the risk of incompatibility between components increases

Engineering Contradiction:

Improvepatient complianceVSAvoidcomponent compatibility

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

Multiple active substances are segregated into different layers of the tablet, physically separating potentially incompatible components. This allows multiple drugs to be combined in a single tablet for improved patient compliance while eliminating compatibility issues by preventing direct contact between incompatible substances.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The tablet layers act as intermediaries that separate incompatible active substances. Each layer serves as an independent compartment that prevents direct interaction between potentially incompatible components, while still allowing both substances to be administered simultaneously to the patient.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Strength

If high compression forces are applied to ensure layer adhesion, then the tablet structural integrity improves, but the integrity of sensitive polymer-coated active substances is compromised

Engineering Contradiction:

Improvetablet structural integrityVSAvoiddamage to polymer-coated active substances

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The layers are pre-compressed individually before final assembly into the multilayer tablet. This preliminary compression creates a stable, self-supporting structure in each layer that maintains its integrity during subsequent handling and final tablet formation, eliminating the need for high compression forces that would damage sensitive polymer coatings.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The tableting process uses a dynamic, multi-step compression approach rather than a single high-force compression. The process adapts the compression force applied at each stage to the specific requirements of each layer, applying gentle pre-compression to protect sensitive coatings and then assembling layers with minimal additional force.

Inventive Principle:

Principle #15Dynamics

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 multilayer design ensures uniform content distribution, reduces incompatibility risks, and allows for rapid disintegration in the mouth, improving patient compliance and treatment efficacy by providing controlled release profiles and taste masking without compromising the integrity of sensitive active substances.

Implementation Method 1

Each layer comprises a mixture of tableting excipients, in particular soluble agents, disintegrants and/or swelling agents

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Implementation Method 2

Each layer comprises a mixture of tableting excipients, in particular soluble agents, disintegrants and/or swelling agents

Methodology Applied

Scientific EffectSwelling:

Implementation Method 3

The term 'orodispersible tablet' means a tablet intended to be disintegrated or dissolved in the mouth, without chewing, on contact with saliva

Methodology Applied

Scientific EffectDissolution: Solvation

Data Source

PatentUS8263126B2Orally-dispersible multilayer tablet

Publication Date: 2012.09.11 ETHYPHARM SA

AI summary

The present invention relates to a multilayer orodispersible tablet and to the process for preparing it.