Multiple Unit Dosage Form with Barrier Layer for Nutrient Depletion

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Solution Overview

Problem

Existing therapeutic agents often cause or exacerbate nutrient deficiencies, and there is a need for a formulation that combines a therapeutic drug with a nutritional supplement to address these deficiencies while providing effective treatment for various diseases and conditions.

Innovation Solution

A multiple unit dosage form comprising a therapeutic agent and a nutritional supplement, where the therapeutic agent and the nutritional supplement are formulated as a single dose with a barrier layer to prevent interaction between the two components, allowing for controlled release and enhanced efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a therapeutic agent is administered alone, then the therapeutic effect is provided, but nutrient deficiencies are caused or exacerbated

Engineering Contradiction:
Improvetherapeutic effectVSAvoidnutrient depletion
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The patent combines a therapeutic agent and a nutritional supplement into a single multiple unit dosage form. The therapeutic agent units and nutritional supplement units are mixed together in a unified dosage structure, allowing simultaneous administration of both components to treat the disease while preventing nutrient deficiencies.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The multiple unit dosage form serves dual functions: it provides therapeutic treatment for the disease condition and simultaneously supplies nutritional supplements to prevent or compensate for nutrient deficiencies. This multi-functional design eliminates the need for separate medications and supplements.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Stability of the object's composition

If a barrier layer is added to prevent interaction between therapeutic agent and nutritional supplement, then component stability is improved, but dosage form complexity increases

Engineering Contradiction:
Improvecomponent stabilityVSAvoiddosage form complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The dosage form is divided into distinct units: therapeutic agent units, nutritional supplement units, and barrier layers. This segmentation allows each component to maintain its stability while being part of a unified dosage form. The barrier layers are strategically placed between specific units to prevent unwanted interactions.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Barrier layers are introduced as intermediary elements between the therapeutic agent units and nutritional supplement units. These barrier layers prevent direct interaction between the two components that might cause instability or reduced efficacy, while still allowing both components to coexist in the same dosage form.

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 formulation effectively treats diseases and conditions by providing both therapeutic benefits and nutritional support, thereby preventing or attenuating nutrient depletion caused by therapeutic agents, and improving patient outcomes.

Implementation Method 1

a barrier layer, wherein the therapeutic agent and the nutritional supplement are formulated as a single dose... the barrier layer... prevents interaction between said therapeutic agent and said nutritional supplement

Methodology Applied
Scientific EffectPhysical containment: Physical Containment

Data Source

PatentUS12274791B2Multiple unit dosage form having a therapeutic agent in combination with a nutritional supplement
Publication Date: 2025.04.15 BONAFIDE HEALTH LLC
  • US12274791B2 patent drawing
  • US12274791B2 patent drawing
  • US12274791B2 patent drawing

AI summary

Compositions and methods for combination therapy are provided. The compositions comprise a multiple unit dosage form having both a therapeutic agent and a nutritional supplement. The combination therapy is useful for restoring a nutrient depletion associated with a particular disease state. Additionally, the combination therapy can prevent or attenuate the depletion of a nutrient caused, in whole or in part, by the co-administrated therapeutic drug. Methods of manufacturing the formulations are likewise described.