Partial Dip Coating of Tablet Cores for Modified Release

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Solution Overview

Problem

Existing modified release dosage forms face challenges such as complexity, high cost, and limited ability to customize release rates, often requiring multiple coating steps and compartments, which can affect swallowability and release profiles.

Innovation Solution

A method using dipping technology to apply a semi-permeable or low-permeable coating to a tablet core, varying the coating length along the axis to customize the release rate, allowing for both immediate and modified release portions without the need for multiple pieces or layers, thereby simplifying manufacturing and reducing costs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If multiple coating steps and compartments are used to achieve modified release, then release rate control is improved, but device complexity and manufacturing cost increase

Engineering Contradiction:

Improverelease rate controlVSAvoidcoating steps and compartments

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The tablet is divided into distinct functional zones: a first portion with immediate release properties and a second portion with modified release properties. This segmentation allows different release rates to be achieved within a single tablet structure without requiring multiple coating steps or compartments, thereby reducing device complexity while maintaining release rate control.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the tablet are given different local properties: the first portion has properties favoring rapid dissolution (immediate release), while the second portion has properties favoring controlled dissolution (modified release). This local differentiation is achieved through varying composition or coating characteristics in different tablet regions, enabling release rate control without increasing overall device complexity.

Inventive Principle:

Principle #3Local quality

2Adaptability or versatility

If multiple coating steps are used to apply modified release coating, then release profile customization is improved, but manufacturing time and cost increase

Engineering Contradiction:

Improverelease profile customizationVSAvoidmanufacturing time

Core Design Contradiction:

Adaptability or versatilityVSLoss of time

Solution Approach 1:

The invention combines multiple release profile requirements into a single tablet formulation by integrating both immediate release and modified release portions in one structure. This merging eliminates the need for multiple separate coating steps, reducing manufacturing time while maintaining the ability to customize release profiles through the combined action of different tablet portions.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The tablet structure is designed to perform multiple functions simultaneously: the first portion provides immediate release function, while the second portion provides modified release function. This multi-functionality is achieved within a single tablet unit, eliminating the need for multiple coating operations and reducing manufacturing time while maintaining release profile customization capability.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Duration of action of moving object

If complete coating is applied to tablet core, then modified release is achieved, but immediate release portion is reduced or eliminated

Engineering Contradiction:

Improvemodified release durationVSAvoidimmediate release drug amount

Core Design Contradiction:

Duration of action of moving objectVSQuantity of substance

Solution Approach 1:

The tablet is segmented into a first portion containing immediate release drug and a second portion containing modified release drug. This segmentation allows both immediate and modified release functions to coexist, ensuring that immediate release is not reduced or eliminated while still achieving modified release duration through the second portion.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The tablet exhibits local quality differences where the first portion is formulated for rapid dissolution to provide immediate release, while the second portion is formulated for controlled dissolution to provide modified release duration. This local differentiation ensures that both immediate and modified release requirements are met without compromising either function.

Inventive Principle:

Principle #3Local quality

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

This approach enables customized release profiles with reduced processing time and costs, providing quick relief followed by sustained release, suitable for various active ingredients and indications, while maintaining convenience and effectiveness.

Implementation Method 1

a semi-permeable or low-permeable coating to a tablet core

Methodology Applied

Scientific EffectPermeation: Permeation

Data Source

PatentUS9259394B2Partial dip coating of dosage forms for modified release

Publication Date: 2016.02.16 KENVUE BRANDS LLC

AI summary

A dosage form comprising a tablet core containing at least one active ingredient and having at least one modified release coating that partially surrounds the tablet core is disclosed. The tablet core is preferably in the form of a compressed core wherein the at least one modified release coating is provided on a position of the exterior surface of the compressed core using dipping technology. The invention also relates to a method of manufacturing the dosage form and a method of treatment using the dosage form.