Multi-Layered Tablet Triple Release Profile

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Solution Overview

Problem

Current oral multi-layered tablets do not provide a triple combination release of active agents, limiting patient compliance and treatment options.

Innovation Solution

A multi-layered tablet design featuring two external drug-containing layers in stacked arrangement with a preformed passageway or gastro-resistant coating, allowing for a triple combination release profile through a combination of immediate, rapid, extended, and delayed release mechanisms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a multi-layered tablet design is used to provide different release profiles for different drugs, then patient compliance and treatment options are improved, but the device complexity and manufacturing difficulty increase

Engineering Contradiction:

Improverelease profile controlVSAvoidtablet structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The tablet is divided into multiple layers (first drug-containing layer, second drug-containing layer, and intermediate layer) that can be stacked in different configurations. Each layer can contain different drugs with different release profiles (immediate release, sustained release, delayed release), allowing versatile treatment regimens while maintaining a relatively simple overall structure.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent describes tablet configurations where layers are stacked and nested together, with an intermediate layer positioned between outer drug-containing layers. This nesting approach allows multiple functional layers to be integrated into a single compact unit, providing complex release profiles without proportionally increasing device complexity.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If multiple drug-containing layers are stacked to achieve triple combination release, then therapeutic effectiveness is improved, but the manufacturing precision requirements increase

Engineering Contradiction:

Improvedrug release profileVSAvoidlayer stacking alignment

Core Design Contradiction:

ReliabilityVSManufacturing precision

Solution Approach 1:

The manufacturing process is segmented into sequential steps: forming the first drug-containing layer, adding the intermediate layer, and then adding the second drug-containing layer. This stepwise approach allows each layer to be manufactured and positioned separately, reducing the overall manufacturing precision requirements compared to forming all layers simultaneously.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The intermediate layer serves as a mediator between the two drug-containing layers. It provides a stable platform for stacking, ensures proper spacing and alignment, and can contain excipients that facilitate bonding between layers. This intermediary layer simplifies the stacking process and reduces precision requirements by providing a reference surface for subsequent layer placement.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Stability of the object's composition

If barrier layers are added to prevent drug interaction, then drug stability is improved, but the device complexity and number of layers increase

Engineering Contradiction:

Improvedrug compatibilityVSAvoidnumber of layers

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The intermediate layer positioned between the two drug-containing layers serves as a barrier that prevents direct contact and potential interaction between drugs from different layers. This intermediary layer contains excipients that provide physical separation while maintaining tablet integrity, thereby ensuring drug stability without requiring additional barrier layers that would increase device complexity.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 achieves a triple combination release profile, enhancing patient compliance and offering new treatment opportunities by precisely controlling the release of multiple active agents over time.

Implementation Method 1

an osmotic device comprising a core coated with a semipermeable membrane

Methodology Applied

Scientific EffectOsmosis: Osmosis

Implementation Method 2

having at least one preformed passageway through it

Methodology Applied

Scientific EffectPermeation: Permeation

Implementation Method 3

gastro-resistant coated core

Methodology Applied

Scientific EffectpH-dependent dissolution:

Data Source

PatentUS9833412B2Triple combination release multi-layered tablet

Publication Date: 2017.12.05 OSMOTICA KERESKEDELMI ES SZOLGALTATO KFT

AI summary

This invention pertains to a multi-layered tablet for a triple combination release of active agents to an environment of use. More particularly, the invention pertains to a multi-layered tablet (1) comprising two external drug-containing layers (2 and 3) in stacked arrangement with respect to and on opposite sides of an oral dosage form (4) that provides a triple combination release of at least one active agent. In one embodiment of the invention the dosage form is an osmotic device. In another embodiment of the invention the dosage form is a gastro-resistant coated core. In yet another embodiment of the invention the dosage form is a matrix tablet. In a different embodiment the dosage form is a hard capsule.