Methylphenidate Chewable Tablet with Barrier Coating for Swallowing Difficulty

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Solution Overview

Problem

There is a need for a quick-acting, stable, extended-release methylphenidate product that can be conveniently delivered to patients who have difficulty swallowing solid tablets and capsules, particularly for conditions like ADHD and Traumatic Brain Injury-related depression.

Innovation Solution

A methylphenidate extended-release chewable tablet is developed, comprising two immediate release components and a sustained release barrier-coated methylphenidate-ion exchange resin complex, providing a fast onset and 12-hour release profile, and can be divided into portions without affecting the release profile, making it suitable for patients with swallowing difficulties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If a solid extended-release tablet is used, then the drug provides prolonged release (8-12 hours), but patients have difficulty swallowing it

Engineering Contradiction:
Improverelease durationVSAvoidswallowability
Core Design Contradiction:
Duration of action of stationary objectVSEase of operation

Solution Approach 1:

The tablet is divided into multiple components with different release profiles (immediate release and sustained release portions), allowing patients to chew or swallow based on their ability while maintaining the extended release effect through the sustained release component

Inventive Principle:
Principle #1Segmentation

2Speed

If an immediate release formulation is used, then the drug acts quickly, but the release duration is short

Engineering Contradiction:
Improveonset speedVSAvoidrelease duration
Core Design Contradiction:
SpeedVSDuration of action of stationary object

Solution Approach 1:

The formulation combines immediate release methylphenidate components with sustained release methylphenidate-ion exchange resin complex in a single tablet, achieving both rapid onset (within 20-30 minutes) and prolonged release (12 hours) by merging different release mechanisms

Inventive Principle:
Principle #5Merging (Combining)

3Ease of operation

If the tablet is made chewable for easier administration, then swallowability improves, but the release profile may be compromised

Engineering Contradiction:
ImprovechewabilityVSAvoidrelease profile stability
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

Different regions of the tablet have different properties: the immediate release portion is designed for rapid dissolution when chewed, while the sustained release portion maintains its barrier coating and controlled release characteristics, allowing the tablet to be chewable without compromising the extended release profile

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

The chewable tablet achieves a fast onset of action within 20-30 minutes and maintains a 12-hour release profile, allowing for convenient dosing and flexibility in administration, particularly beneficial for patients who struggle with swallowing solid forms.

Implementation Method 1

The sustained release component has a barrier coating which is a pH-independent release, high tensile strength, water insoluble, water-permeable barrier coating

Methodology Applied
Scientific EffectpH-independent release:

Implementation Method 2

The sustained release component has a barrier coating which is a pH-independent release, high tensile strength, water insoluble, water-permeable barrier coating

Methodology Applied
Scientific EffectWater permeation: Permeation

Implementation Method 3

about 50% to about 90% w/w of a sustained release barrier coated methylphenidate-ion exchange resin complex-matrix

Methodology Applied
Scientific EffectIon exchange: Ion Exchange

Data Source

PatentUS11633389B2Methylphenidate extended release chewable tablet
Publication Date: 2023.04.25 TRIS PHARMA INC
  • US11633389B2 patent drawing

AI summary

An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.