Fibrous Dosage Form for Predictable Drug Release

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Solution Overview

Problem

The manufacturing of granular pharmaceutical dosage forms is challenging due to issues like particle segregation and agglomeration, leading to unpredictable microstructural details and disintegration rates, which limits the ability to achieve rapid and controlled drug release.

Innovation Solution

The development of fibrous dosage forms with a three-dimensional structural network of fibers, where fiber segments are separated by free spacings to create interconnected free spaces, allowing for precise control of drug release rates and manufacturing processes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If granular dosage forms are used to achieve rapid drug release, then disintegration rate is improved, but manufacturing predictability deteriorates due to particle segregation and agglomeration

Engineering Contradiction:

Improvedisintegration rateVSAvoidmicrostructural predictability

Core Design Contradiction:

SpeedVSManufacturing precision

Solution Approach 1:

The patent transitions from granular solid processing to liquid-based processing parameters, enabling deterministic control of microstructure while maintaining rapid disintegration properties through controlled solidification or drying processes

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The invention creates controlled porous microstructures through liquid-based processing that provide rapid disintegration pathways while ensuring manufacturing predictability through deterministic process control, avoiding the segregation and agglomeration issues of granular processing

Inventive Principle:

Principle #31Porous materials

2Manufacturing precision

If liquid-based processing is used to achieve predictable manufacturing, then manufacturing precision is improved, but disintegration rate deteriorates due to non-porous solid microstructure

Engineering Contradiction:

Improveprocess predictabilityVSAvoiddisintegration rate

Core Design Contradiction:

Manufacturing precisionVSSpeed

Solution Approach 1:

The patent incorporates porous or cellular microstructures within the liquid-based processing framework, creating controlled void spaces that enable rapid disintegration while maintaining the deterministic control and manufacturing predictability of liquid-based processes

Inventive Principle:

Principle #31Porous materials

Solution Approach 2:

The invention creates composite microstructures combining solid matrix with porous or cellular elements, achieving both manufacturing predictability through liquid-based processing and rapid disintegration through controlled porosity

Inventive Principle:

Principle #40Composite materials

3Strength

If non-porous solid structure is used to maintain structural integrity, then strength is improved, but drug release speed deteriorates due to limited diffusion

Engineering Contradiction:

Improvestructural integrityVSAvoiddrug release rate

Core Design Contradiction:

StrengthVSSpeed

Solution Approach 1:

The patent designs porous or cellular structures with controlled porosity that maintain sufficient structural integrity while providing diffusion pathways for rapid drug release, optimizing the balance between strength and release speed

Inventive Principle:

Principle #31Porous materials

4Productivity

If granular processing is used to achieve rapid disintegration, then productivity is improved, but manufacturing complexity deteriorates due to uneven flow and dispensing issues

Engineering Contradiction:

Improvemanufacturing speedVSAvoidprocess complexity

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The patent replaces complex mechanical granular processing operations with simpler liquid-based processing operations, reducing manufacturing complexity while maintaining or improving productivity through deterministic flow characteristics of liquids

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS11129798B2Fibrous dosage form

Publication Date: 2021.09.28 BLAESI ARON H DR

AI summary

At present, the most prevalent pharmaceutical dosage forms, the oral immediate-release tablets and capsules, are granular solids. The problem of such solids is that their microstructure and properties are not predictable from physical models. As a consequence, product development and manufacture are resource-intensive and time-consuming, and quality control is statistical by testing instead of by design. Furthermore, the range of the drug release rate, and the variety of active ingredients that can be processed to a functional product, are limited in such dosage forms. Presented herein, accordingly, is a fibrous dosage form suitable for immediate-release applications prepared by a predictable liquid-based process. The fibrous dosage form includes a drug-containing solid comprising a three dimensional structural network of one or more drug-containing fibers.